the immuassay handbook parte95

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INDEX

Note: Page numbers followed by “f ” indicate figure, and “t” indicate tables.

Index Terms Links

A

A-ACHR. See Anti-acetylcholine

receptor

ABBOTT PRISM Retest Server (APRS) 615 615f

Abortion, threatened 757–758 767–768

Absorbance, on-chip detection methods

for 181 181t

Abuscreen online

for amphetamines 968 968t

for benzodiazepines 970 971t

for cannabis 973 974t

for cocaine 974 975t

for LSD 976 976t

for methadone 977 978t

for opiates 979 980t

for phencyclidine 982 983t

Access 2 Immunoassay System 589–596 589f–590f

antibodies used in 593

assay principle of 592–593 592f–595f

assay protocol of 590–591 590f–591f

calibration of 593–594

data processing of 596

LIS interfacing of 596

product features of 591–592

separation for 596

signal generation and detection of 596

Accuracy 11 20–26

analytical goals for 670–671

of digital ELISA 237 238f

of free analyte immunoassay 135–136

for method evaluation 397

in method evaluation 399–400

Index Terms Links


Acecainide 948 948f

Acetaminophen 961 961f

Acoustic wave-guide devices 205–206

Acquired immune deficiency syndrome

(AIDS) 913–918

Acridinium ester (AE)

chemiluminescence 568 569f

Acromegaly 778

ACT. See Artemisinin-based

combination therapy

ACTH. See Adrenocorticotropic

hormone

Acute coronary syndromes 818

ADA methods. See Antidrug antibody

methods

ADCs. See Antibody–drug conjugates

Addison’s disease 696 698–699 883

Adenovirus 927

Adipic acid dihydrazide (ADH) 163

Adipokines 793

Adjusters 333–335

Adjuvant 248

Administration, for POCT 463

Adrenal cortex 695–704

analytes for 696–701

clinical disorders of 695–696

normal function of 695 695f

Adrenal tumor 696

Adrenocortical insufficiency 701

Adrenocorticotropic hormone (ACTH) 695 699–701

ADV. See Aujeszky’s disease virus

Adverse pregnancy outcome 772

ADVIA Centaur XP 567–570 567f

AE enhancement features of 568


assay principle of 568 569f

assay protocol of 567 568f


Index Terms Links


ADVIA Centaur XP (Cont.)




separation for 569–570 570f

signal generation and detection by 570

user interface of 570

AE chemiluminescence. See Acridinium

ester chemiluminescence

AEB. See Average number of enzyme-

labeled protein molecules per bead

AEV. See Avian encephalomyelitis virus

Affinity chromatography 311–312

Affinity constant 30

Affinity maturation 247

Affinity preparative assays 178–179

Aflatoxin, detection of 65 65f

AFP. See Alphafetoprotein

Age issues 429

Agglutination assays 509–510

Agglutination inhibition 67

Agitation 294

Agranulocytes 795

AIDS. See Acquired immune deficiency

syndrome

Air-lift fermentors 253–254

AITD. See Autoimmune thyroid disease

Albuminuria 791–792 791t

Alcohol 428 984

Alere Triage System. See Triage

System

Alkaline phosphatase (ALP) 269 367 367t 715

IMMULITE and IMMULITE 1000

use of 572–573 573f

placental 835

Allergens 857–858

classification of 857–858 859t

common properties of 858

Index Terms Links


Allergens (Cont.)

identification of 864–865

microarrays for 865–866 865f

Allergen-specific IgE antibodies 861–863 862f

Allergy 857–868 858f


clinical applications for 864–866

diagnosis and therapy of 859–860 860f

standardization and evaluation of 863–864 864f

All-laboratory mean 475–476

All-laboratory precision 13

All-laboratory trimmed mean (ALTM) 451

ALP. See Alkaline phosphatase

Alphafetoprotein (AFP)

in cancer 835 836f 840–841

in pregnancy 762–765 763f-765f 764t-765t

AlphaLISA, in early phase discovery and

lead identification 648

ALTM. See All-laboratory trimmed

mean

Alzheimer’s disease, epitope mapping in 214–215

Ambient analyte assay 109–122

applications of 111–120

free hormone immunoassays 118–120 119f

in microarrays 295–296

microspot assays 111–118

recent developments with 121

theoretical principles of 109–111 110f–112f

Amenorrhea 723

AMH. See Anti-Müllerian hormone

Amikacin 951–952 951f

Amines 302 302f

Ammonium sulfate, precipitation by 295

Amniocentesis 439

Amniotic fluid 438–439

Amperometric detection 83 83f 181t 183

Amperometric sensors 204–206 204f

Amphetamine 965 965f 967t–968t

Index Terms Links


Amplification strategies

for immunostaining 368 370t

for signal generation 279–282 281f

ANA. See Antinuclear antibodies

Analytes

for adrenal cortex 696–701

for allergy 860–863

antibodies to 406

antibody binding with 29

for autoimmune disease 870–888

binding proteins and 18

of calcium metabolism 709–715

calibration 320

for cancer markers 838–853

for cardiac markers 819–829

concentration impacts of 18

for diabetes mellitus 784–793

for ELISA 383

for fertility 724–733

for growth 778–781

for hematology 797–805

for IBD 891–893

for IVF-ET 739–743

for leukemia 808–814 808t

for lymphoma 808–814 808t

new 523 528–529 529t

for pregnancy 762–773

in qualitative immunoassays 139–140

in saliva of interest 437–438 438t

thyroid 679–689

for virilization 748–755

Analyte-specific reagents (ASRs) 654–655

Analytical goals 669–671

Analytical information, immunoassay

product technologies providing 526

Analytical processing, for POC

diagnostics 103–105

Index Terms Links


Analytical sensitivity 11 11f

of digital ELISA 225f 226–228 228f 228t


Anaplasma phagocytophilum 628–629

ANCA. See Anti-neutrophil cytoplasmic

antibodies

Androgen resistance 724

Androgen-secreting tumors of ovary 747

Androstanediols 754–755

Androstenedione 751–752 752f

Anemia 796

Anencephaly 759

Aneuploidy screening 773–776 773f–774f 774t–775t

Animal testing, infectious disease

immunoassay for 155

Anorchia 724

Anorexia nervosa 723–724

Anosmia 724

Anti-acetylcholine receptor (A-ACHR) 886–887

Anti-adrenal cortical antibodies 883

Anti-analyte antibodies 406

Anti-animal antibodies 403–406 404f 404t–405t

Antiarrhythmic agents 948–950

Antibiotics 951–953

Antibodies 7 245–266

See also specific antibodies

analyte binding with 29

to assay reagents 406

biasing effects of 130–131 131f

binding interference 18–19

bispecific 255–256

circulating 403–407

comparison of 261–263 262t

in competitive immunoassays 7–8 10f

conjugates of 260

detection and quantification of 50–53 51f–55f

developing 111 113f

dilution curves of 42–43 42f–43f

Index Terms Links


Antibodies (Cont.)

diversity of 247

in dose-response curve 33 34f

in ELISA 8 8f 384–387

fragments of 254–255 255f

free analyte immunoassay and 130 130f

fusion proteins of 260 260t

to GH 778

heterophilic 19 20f

immunization and 248

immunometric assay of 7–8 9f

in infectious disease 149–156

kinetics of antigen interactions with 29–33

for lateral flow immunoassays 98

for micro- and nanoscale immunoassays 180

for microarray 192

miniantibodies 260

in nanotechnology 260–261

pair-wise epitope mapping of 214

physical masking of 18

plastic surface binding of 287–290 289f

polyclonal antisera 248–249 249f

precision and 12

properties of 7 29

qualitative immunoassays of 140 142–146

screening tests 252–253

sensitivity and 48 48f

in standardization 319–320

structure of 245–247 245f–246f 246t

in vivo response of 247

Antibody gene amplification 256–257 257f

Antibody microarray 111–113 114f

Antibody occupancy 39–40 40f

Antibody screening methods, for LFIAs 99 99f

Antibody-coupled microspheres,

competitive immunoassay for 169–170

Antibody–drug conjugates (ADCs) 301

Anti-cardiolipin antibodies 887–888

Index Terms Links


Anti-centromere 878 878t

Anticoagulants 432

Anti-complex immunoassay 61–62 62f

Anticonvulsants 953–958

Anti-cyclic citrullinated peptide 879–880

Anti-DNase B 929–930

Antidrug antibody (ADA) methods 654

Anti-dsDNA 875–876

Anti-GBM. See Anti-glomerular

basement membrane

Antigens 8 248

conformation alteration of 18

controls for 364–365

dilution curves of 42–43 42f–43f

in ELISA 384–387

excess 340–341

kinetics of antibody interactions with 29–33

MAbs binding with 29–30 30f

in qualitative immunoassays 140–141

Antigen retrieval 362–364

enzymatic 364

heat-induced 362–363

Antigen-coupled microspheres,

competitive immunoassay for 170–171

Antigenic determinants 248

Anti-glomerular basement membrane

(Anti-GBM) 881

Anti-HBc 905

Anti-HBe assay 906

Anti-HBs assay 906 906f

Anti-histone 877–878

Anti-IgE 862

Anti-intrinsic factor antibodies 883–884

Anti-Jo-1 881

Anti-LKM 884–885

Anti-microorganism antibodies 406

Anti-microsomal 881–882

Anti-mitochondrial antibodies 884

Index Terms Links


Anti-Müllerian hormone (AMH)

in androgen disorders 745–746 748

in fertility 721–722 728–729 728t

in IVF-ET 740–743 741f–742f

Anti-myelin-associated glycoprotein 888

Anti-neutrophil cytoplasmic antibodies

(ANCA) 880–881

Antinuclear antibodies (ANA) 870–875 871t–872t 872f

Anti-parietal cell antibodies 883–884

Anti-RNP 876–877

Anti-Scl-70 878–879

Antisera. See Polyclonal antisera

Anti-Sm 876

Anti-SMA 884

Anti-SSA/Ro 877

Anti-SSB/La 877

Anti-streptolysin O (ASO) 929–930

Anti-therapeutic antibody (ATA)

methods 654

Antithrombin 806

Apoenzyme reactivation immunoassay

system 79–80

Apolipoproteins 823

APRS. See ABBOTT PRISM Retest

Server

Aptamer technology 99

for LFIAs 99–100

ARCHITECT analyzers 561–566 561f–562f


assay principle of 565

assay protocols of 562–564 563f–564f 564t

calibration of 565

informatics, data processing, and LIS

interfacing of 566


separation for 565

signal generation and detection by 565–566 566f

Arginine 303

Index Terms Links


Arginine test 780

ART. See Assisted reproductive

technologies

Artemisinin-based combination therapy (ACT) 940

Ascitic fluid 254

ASO. See Anti-streptolysin O

Aspergillus 941–942

Aspiration

for separation 295

in washing 294

ASRs. See Analyte-specific reagents

Assay drift 25–26

troubleshooting guide for 481–482

Assay validation, biomarker 650

Assembly, of LFIAs 94

Assisted reproductive technologies

(ART) 738

Association rate constant (ka) 29–30

ATA methods. See Anti-therapeutic

antibody methods

Atherosclerosis 817

Atopic disease 864–865

Aujeszky’s disease virus (ADV) 629

Autoantibodies 19 406

Autoimmune cholangitis 884

Autoimmune disease 869–890


Autoimmune thyroid disease (AITD) 686

Autoimmune thyroiditis 881–882

Automated analyzers 465–468

assay drift with 26

automation goals for 465

considerations and criteria for 466–468

information sources for 465–466

Automated dual technology batch

analyzer 511–512

Automated heterogeneous batch

analyzer 511

Index Terms Links


Automated homogeneous batch analyzer 511

Automated multianalyte batch analyzers 512

Automation, of immunoassay tests 521

Automation goals 465

Average number of enzyme-labeled

protein molecules per bead (AEB) 225

analytical sensitivity with 225f 226–228 228f 228t

dynamic range with 228–229 228f

Avian encephalomyelitis virus (AEV) 636

Avian immunoassay product technologies

AEV diagnosis with 636

avian leukosis virus diagnosis with 636

avian reovirus diagnosis with 636–637

CAV diagnosis with 638

IBDV diagnosis with 637

infectious bronchitis virus diagnosis

with 637

influenza A diagnosis with 639

Mycoplasma diagnosis with 637–638

NDV diagnosis with 638

Pasteurella multocida diagnosis with 638

reticuloendotheliosis virus diagnosis with 638

Salmonella enteritidis diagnosis with 639

Avian influenza 639

Avian leukosis virus 636

Avian Mycoplasma 637–638

Avian reovirus 636–637

Avidin–biotin 279 280f

Avidity 340–341

testing 145

AxSYM 555–560 555f




calibration of 558

data processing of 558–559



Index Terms Links


AxSYM (Cont.)

separation for 558


B

B lymphocytes 247

Back-gating 810

Back-titration method, for free analyte

immunoassay 133 134f

Bacterial diseases 929–938

Barbiturates 969 969f

Bardet–Biedl syndrome 724

Barker hypothesis 762 763f

Bartonella henselae 934–935

Batch manufacturing, of LFIAs 93–94 95f

Bayes’ theorem 666

Beads, separation with 292

Bead-based microarray 194–195

BeadChip system 195

BeadXpress 195

Benzodiazepines 969–971 969f 970t–972t

Beta-2 glycoprotein I antibodies 887–888

Between-assay imprecision 399


Between-lot precision 13 399

Between-run precision 13 444

BHV-1. See Bovine herpesvirus 1

Bias 20–26 662–663

precision and 13 13f

Bile acids 641

Binding. See also Nonspecific binding

alteration of site of 18

interference with 18–19

to solid phase 297

strength of 29


Binding affinity constant (KD)

in interactions 215–217 215f

Index Terms Links


SPR analysis of 215–217 215f

Binding blocking agents, in free analyte

immunoassay 136

Binding early 211

Binding late 211

Binding proteins

analyte displacement from 18

in free analyte immunoassay 135–136

Binding site

alteration of 18

FOB 296

SPR biosensor analysis of 213–215

Bioelectronics chips 175

Biohazard detection 203

Biological receptor 203–204

Biological rhythms 429–430

Biological variation 670 670f

Biological warfare agents 203

Bioluminescence detection 278

Bioluminescence resonance energy

transfer (BRET) 75

Bioluminescent immunoassays 75

Biomarkers

in drug development 647–658 647f 650t–651t 653f

655t–657t

method validation 650

new 528

safety 649

Biosensors. See Immunological

biosensors. See also SPR biosensors

Biotin-conjugated molecules binding to

LumAvidin microspheres 163

Biotinylation 310 311f

Biowarfare, infectious disease

immunoassay for 155

Bismaleimide method. See

Homobifunctional coupling

Bispecific antibodies 255–256

Index Terms Links


Bispecific recombinant antibodies 259–260

Bivalent recombinant antibodies 259–260

Black box analyzer 511

Bladder tumor antigen 851

Blastomycosis 941

Blocking buffers 319

for ELISA 388 391

for infectious disease immunoassay 151

Blocking solution 151

Blood bank testing 153 154f

Blood collection

containers for 431 431t

oral fluid and 436

by skin puncture 433–434

systems for 431

tube 408

by venepuncture 430–432

withdrawal for 431

Blotting, for LFIA manufacture 91

BLV. See Bovine leukemia virus

BMD. See Bone mineral density

BNP. See B-type natriuretic peptide

Bone markers

of formation 715–717

limitations of 718–719

of resorption 717–718

Bone metabolism 705–720

analytes of 709–715

biochemical markers of 715–719


ion, hormone and bone marker

changes in 718t

normal 705 705f

Bone mineral density (BMD) 706

Borrelia burgdorferi 627 931–932 932t

Boundary layer kinetics 56 56f

Bovine herpesvirus 1 (BHV-1) 632–633

Bovine leukemia virus (BLV) 633

Index Terms Links


Bovine serum albumin (BSA) 131 131f

Bovine viral diarrhea virus (BVDV) 633–634

Breadth of menu, for random-access

analyzers 512

BRET. See Bioluminescence resonance

energy transfer

Bridge recognition 35–36

Brighteners 345

Brucella abortus 632

Brucella species 937

BSA. See Bovine serum albumin

B-type natriuretic peptide (BNP) 827–828 827f 827t

Buffers

for ELISA 391

in standardization 319

for xMAP Technology 160–161 160t

Buprenorphine 971–972 972t 981f

Burkitt’s lymphoma 920

BVDV. See Bovine viral diarrhea virus

C

CA 15–3. See Cancer antigen 15–3

CA 19–9. See Carbohydrate antigen 19–9

CA 27–29. See Cancer antigen 27–29

CA 125. See Cancer antigen 125

CAD. See Coronary artery disease

CAH. See Congenital adrenal hyperplasia

Calcitonin 714–715

Calcium channel antibodies 887

Calcium metabolism 705–720

analytes of 709–715


ion, hormone and bone marker

changes in 718t

normal 705 705f

Calibration 315 320–322

of digital ELISA 238

dose-response curve of 35 35f

Index Terms Links


Calibration (Cont.)

for ELISA 392

of immunoassays 9–10

of micro- and nanoscale

immunoassays 180

for qualitative immunoassays 144

Calibration curve 9 35 323


reduced and stored 321–322

stored 333–336

Calibration curve fitting 323–336

electronic data transmission 335–336

for ELISA 392

error profiles 329–331 332f


methods for 325–329

metrics for 326–327

outliers 332–333

over shelf life 335

response transformation 323–324 324f

response-error relationship 324–325 324f

software for 336

Calibration-free concentration analysis

(CFCA) 219 219f

Calibrators 9 35 321

matrices 321

sensitivity and 11

Calprotectin 891–893 892f

Cancer antigen 15–3 (CA 15–3) 843–845

Cancer antigen 27–29 (CA 27–29) 843–845

Cancer antigen 125 (CA 125) 842–843

Cancer markers 833–856 833t


in diagnosis 833–837 836f

history and classification 837–838 837f

immunochromatography for 852

novel experimental and minor 853–856 853t

Candida albicans 942

Index Terms Links


Canine immunoassay product

technologies

Anaplasma phagocytophilum diagnosis with 628–629

bile acid assessment with 641

Borrelia burgdorferi diagnosis with 627

cortisol assessment with 641

Diroflaria immitis diagnosis with 625–626 626f 626t

Ehrlichia canis diagnosis with 626t 628

Ehrlichia ewingii diagnosis with 628

giardia diagnosis with 626–627

heart disease assessment with 641–642

Leishmania infantum/Leishmania

donovani diagnosis with 627–628

pancreatic disease assessment with 639–640 640f

parvovirus diagnosis with 626

T4 assessment with 640–641

Cannabis 972–974 972f 973t–974t

Cantilever approach 181t 184

Capacitive detection 181t 183

Capillary action 294

Capillary electrophoresis 312

potential market impact of 528

Capillary flow 177

Capture antibody 37

in digital ELISA 229

for micro- and nanoscale

immunoassays 180

in microspot assays 111 113f

Capture bridge assay 52 52f

Capture protein 287–288

Capture reagent, for infectious disease

immunoassay 149–150

Carbamazepine 954 954f

Carbodiimide coupling 309 309f

with N-hydroxysuccinimide 309 310f

of protein to MagPlex microspheres 161–163

Carbohydrates 303

Carbohydrate antigen 19–9 (CA 19–9) 841–842 841f

Index Terms Links


Carbohydrate-deficient transferrin

(CDT) 984

Carbon radioactive labels, detection

errors with 12

Carboxamide 303

Carboxylic acid 303

Carcinoembryonic antigen (CEA) 835 836f 838–840

Carcinoma 833

Cardiac markers 817–832


clinical disorders 817–819

normal function 817

Cardiac troponin 819–821 819f–820f

CART. See Cocaine- and amphetamine-

regulated transcript

Cartridge–reader configuration,

integrated disposable versus 179–180 179f 179t

Cassette assembly, for manufacture of

LFIAs 93

Cat Scratch Disease (CSD) 934–935

Catalyzed reporter deposition technique 193 281–282

Cats. See Feline immunoassay product

technologies

Cattle. See Ruminant immunoassay

product technologies

Causation, correlation and 419

CAV. See Chicken anemia virus

CBA. See Cytometric Bead Array

CCD. See Charge-coupled device

CDL. See Cornelia de Lange

CDR grafting 256

CDRs. See Complementarity-

determining regions

CDT. See Carbohydrate-deficient

transferrin

CEA. See Carcinoembryonic antigen

CEDIA. See Cloned enzyme donor

immunoassay

Index Terms Links


Celiac disease 885

Cell fusion 252

Cell-based assays, in early phase

discovery and lead identification 648

Centrifugation 441

Cerebrospinal fluid (CSF) 438

CFCA. See Calibration-free

concentration analysis

CGM. See Continuous Glucose

Monitoring

Chagas disease 940

Chain shuffing 259

Characterization, in immunoassay

development 417–418

Charcoal 294–295

Charge-coupled device (CCD), for

microspot assays 111–113 114f

Charge-induced enzyme activation 77 77f

Checkerboard immunoassay 345

Chemical warfare agents 203

Chemifuorescent immunoassays, for

infectious disease 150–151 150t

Chemiluminescence 511

Chemiluminescence detection 272–273 273f

direct 276–278 277f

enhanced 273–274 274f

on-chip detection methods for 181t 182

Chemiluminescence resonance energy

transfer (CRET) 75

Chemiluminescent immunoassay

technology (ChLIA), PRISM use of 612 613f–614f

Chemiluminescent immunoassays 75

enzyme labels in 272–273 273f

for infectious disease 150–151 150t

Chemiluminescent magnetic

microparticle immunoassay (CMIA),

ARCHITECT analyzers 565

Chicken anemia virus (CAV) 638

Index Terms Links


Childhood hypothyroidism 674

Chimeric antibodies 256

Chip format 297

ChLIA. See Chemiluminescent

immunoassay technology

Chlorpyrifos, detection of 64f 65

Chromatography, for conjugate

purification 311–312

Chromogens 367 367t

Chromogenic immunoassays, for

infectious disease 150–151 150t

Chromogranin A 895–896

Chromogranin B 896–897

Chromophobe adenomas 723

Chromosome defects, of fetus 758–759

Chronic anemia 925

Chronic mucocutaneous candidiasis 942

Chronic Q fever 936

Churg–Strauss syndrome 880

Ciclosporin 958–959

Circadian rhythms 429 695

Circulating antibodies 403–407

CK-MB. See Creatinine kinase

Class switching 247

Class-capture assay 52 54f–55f

Classical swine fever virus (CSFV) 630

Clearblue fertility monitor 534–535 536f 537–538

assay procedure and performance of 538 539f

Clearblue ovulation tests 534–535 536f 537–538

assay procedure and performance of 538

latest developments in 538 538f

Clearblue pregnancy test 533–534 534f–535f 537–538


latest developments in 537–538 537f–538f

Click chemistry 301

Clinical chemistry analyzers 513

with attached immunoassay modules 513

Index Terms Links


Clinical classification, troubleshooting

guide for 494–497

Clinical concepts 667

Clinical considerations, for automated

analyzers 467

Clinical diagnostic testing

immunoassay product technologies

used in 509–515

LFIAs in 533–536 534f–536f

market trends in 517–531 517f–518f 518t 521f–524f

529t

Clinical focus, of immunoassay product

technologies 531

Clinical information, immunoassay


Clinical laboratory

changing role of 529

LBAs in 654–656 655t–656t

Clinical outcome, POCT and 457–459

Clinical phase, LBAs in 653–656 655t–657t

Clinical sensitivity 664–665 665t

Clinical specificity 664–665 665t

Clinical utility 665–666 666t

Clinicians, immunoassay product

technologies purchased by 527

Clonality 810

Cloned enzyme donor immunoassay

(CEDIA) 80 81f 946

Clonidine test 779–780

Cloning antibodies 253

recombinant antibodies 257–258

Clotting activators 432

CMIA. See Chemiluminescent magnetic

microparticle immunoassay

CMV. See Cytomegalovirus

Coagulation 806–807

Coagulation factors 806

Cocaine 974 974f 975t

Index Terms Links


Cocaine- and amphetamine-regulated

transcript (CART) 897

Coccidioidomycosis 941

Collagen cross-link molecules 717

Colloidal gold 278

Colloidal selenium 279

Colorimetry 270–271 270f 301

Commercial controls 472–473

Competitive immunoassay 8 10f 35

See also Non-competitive

immunoassays

Access 2 Immunoassay System use of 592 593f

for antibody quantification 51–52 52f

for antibody-coupled microspheres 169–170

anti-complex immunoassay compared with 61–62

for antigen-coupled microspheres 170–171

design of 35–36 35f

ELISA 384 384f

immunometric combined with 171–172

microscale and nanoscale 178–179

sensitivity of 39–47 42f–44f 46f

separation in 287


washing in 293

with xMAP Technology 169–171 170f

Complement 19

Complementarity-determining regions

(CDRs) 245–246 245f

Complementary metal oxide

semiconductor-based sensors 181t 183

Complexity of effects 419

Component-resolved diagnostics (CRD) 865

Concentration

percentage binding and 42–45 45t

SPR biosensor analysis of 218–220

Conductometric detection 181t 183

Confidence interval 667 668t

Confirmation, qualitative immunoassays for 141–142

Index Terms Links


Confocal microscopy 282–283

for microspot assays 111–113 114f

Congenital adrenal hyperplasia (CAH) 696 747–748 747f

Congenital hypothyroidism 673–674

Congenital rubella syndrome (CRS) 923

Conjugates 301

categories of 301–302

characterization of 312–313 313f

purification of 310–312

Conjugate pad 90

Conjugate–specimen interactions 422

Conjugation methods 301–314

protein–protein coupling 302–308

protein–small molecule coupling 308–310 309f

Conn’s syndrome 696

Constants. See Affinity constant;

Equilibrium constant

Constant bias 20 21f

Consumer diagnostics

digital interfaces used in 536

fertility monitors 534–535 536f 537–538 539f

LFIAs in 533–536 534f–536f

ovulation tests 534–535 536f 537–538 538f

Persona contraception monitor 537–539 539f

pregnancy tests 533–534 534f–535f 537–538 537f–538f

Contact angle 176–177

Contact tip dispensers 91–92

Contamination 408

Continuous Glucose Monitoring (CGM) 203

Continuous measurement 666–667 667f

Contraception monitors 537–539 539f

Contrast agents 407

Controls

commercial 472–473

for immunochemistry 364–365


Control bias 470–471

Control sera, for assay drift 26

Index Terms Links


Control sheets 444 445t

Controlled ovarian stimulation (COS) 736

GnRH agonist-controlled 737 739

GnRH antagonist-controlled 737 739

protocols for 736–737 736f

response to 738–739

Core laboratories 519–520

Cornelia de Lange (CDL) syndrome 762

Coronary artery disease (CAD) 817–818

Correlation 22–25 23f 23t 398

causation and 419


Corticotrophin-releasing hormone

(CRH) 695

Cortisol 641 696–699 697f

COS. See Controlled ovarian stimulation

Cost containment, immunoassay product

technology use and 518–519

Cost reduction, in immunoassay product

technologies 524–525

Cotinine. See Nicotine

Counterstains 373–374

Counting efficiency 267

Counts per minute (c.p.m.) 267

Coxiella burnetii 936–937

C-peptide 786–787

insulin and 787

c.p.m. See Counts per minute

Craniopharyngioma 723

CRD. See Component-resolved

diagnostics

C-reactive protein (CRP) 824–826 825f

Creatinine kinase (CK-MB) 821–822

CREST syndrome 878 878t

CRET. See Chemiluminescence

resonance energy transfer

CRH. See Corticotrophin-releasing

hormone

Index Terms Links


Cross-reactivity 15–20 17f 318

CRP. See C-reactive protein

CRS. See Congenital rubella syndrome

Cryptosporidium 941

CSD. See Cat Scratch Disease

CSF. See Cerebrospinal fluid

CSFV. See Classical swine fever virus

Cumulative sum charts. See Cusum

charts

Curve model 323

Cushing’s disease 696 748

Cushing’s syndrome 696–698 698f 700–701 700f

748

management of 701–702

Customer base, for immunoassay

product technologies 526–527

Cusum charts 446 446t 447f

Cutoff value

for qualitative immunoassays 143–144 143f

in qualitative immunoassays 141

Cutting, for manufacture of LFIAs 93

CYFRA 21–1 849–850

Cysteine 303

Cytological specimens 357–358

storage of 361

Cytomegalovirus (CMV) 919

Cytometric Bead Array (CBA) 195

D

Dane particle 903

Data management, for POCT 461

D-dimer test 807–808

Decalcification 361–362

Decantation 295

Definitive methods 317

Degrees of freedom 326

Dehydroepiandrosterone sulfate

(DHEAS) 746 752–753 753f 753t

Index Terms Links


Deming regression 24 25f 25t

Dengue 921–922

Dengue hemorrhagic fever (DHF) 922

Dengue shock syndrome (DSS) 922

Deoxypyridinoline 717

Dependent responses 419

Design of Experiments (DOE) 418

particulars of 419

problems assuaged by 418–419

process for 418

Detecting antibody 37

Detection 267–286

amplification strategies for 279–282 281f

of antibodies 50–53 51f–55f

bioluminescence for 278

direct chemiluminescence 276–278 277f

direct fluorescence 274–275 275f

in ELISA 389–390

enzyme labels for 268t 269–274

errors of 12

for immunostaining 367–368 367t

interference in 20

liquid-phase assays for 51

long wavelength fluorescence 275

micro and nanoparticle labels 278–279

microarrays 283

miniaturization 282–283

multiple analytes and 282–283

phosphorescence for 278

protein A 279

qualitative immunoassays for 140

radioactive labels for 267–269

solid-phase immunoassays for 51–53 51f–55f

streptavidin/avidin–biotin 279 280f

time-resolved fluorescence 275–276 276f

Detection rate 665

Detection reagent, for infectious disease

immunoassay 150–151 150t

Index Terms Links


Detection system 203–204

Developing antibody, in microspot

assays 111 113f

Dextran-coated charcoal 294–295

DHEAS. See Dehydroepiandrosterone

sulfate

DHF. See Dengue hemorrhagic fever

DHT. See Dihydrotestosterone

Diabetes

gestational 761

maternal 761

Diabetes mellitus 783–794 784t


Diabodies 260

Diagnosis 661

cancer markers in 833–837 836f

qualitative immunoassays for 141–142

Diagnostic efficiency 666

Dialysis 312

DIC. See Disseminated intravascular

coagulation

Difference plots 23 23f

Diffusion

in gel 342–344 342f–344f

in solid-phase immunoassays 54–56

Diffusion-based immunoassays 179

Digital ELISA 223–242

accuracy of 237 238f

analytical sensitivity of 225f 226–228 228f 228t


approach to 223–226 224f–225f 227f

assay development for 234–239

assay speed of 238–239

background interference in 235–236 236f

biotinylated detection antibody

labeling 231 231f–232f

calibration of 238

dose response and linearity in 236

Index Terms Links


Digital ELISA (Cont.)

dynamic range of 228–229 228f

efficiency of capture and labeling steps in 232–233 233t

enzyme conjugate labeling of

biotinylated detection antibodies 231 232f

future of 241–242

genesis of 223–224

goal of 225–226

instrumentation for 239–240 240f

optimization of 235

Poisson statistics in 225

protein capture on beads 230 230f

protocols for 235

reagents for 234

reproducibility of 237 238f

schematics 224 225f

sensitivity of 236–237 237f

specificity of 233–234

theoretical considerations with 229–234

Digital interface, of consumer diagnostic

LFIAs 536

Digitoxin 949–950

Digoxin 948–949 949f

Dihydrotestosterone (DHT )

in androgen disorders 754

in fertility 722 733 733f

1,25–Dihydroxyvitamin D 709–712 709t

Dilution 21

accuracy and 21–22

calibration of 322

limit of 152

in washing 294

Dilution concentrations 329 331f

Dilution curves, of antibodies 42–43 42f–43f

Dilution test, in free analyte

immunoassay 136

Dilutional linearity. See Linearity of

dilution

Index Terms Links


Diphenylhydantoin. See Phenytoin

Dipping, for LFIA manufacture 91

Direct analyte detection 296

Direct binding assays 218–219 218f–219f

Direct coupling 303–306 304f–305f

Direct equilibrium dialysis (ED) 128–129 128f

Direct fluorescence 274–275 275f

Direct linear master curves 334

Diroflaria immitis 625–626 626f 626t

Discovery, in immunoassay development 417

Disintegrations per minute (d.p.m.) 267

Dispensing, for manufacture of LFIAs 91–94

Disseminated intravascular coagulation

(DIC) 796 807–808

Dissociation rate constant (kd) 29–30

from fractal clusters 56

DNA immunization 248

DOE. See Design of Experiments

Dogs. See Canine immunoassay product

technologies

Dose 32

Dose response, in digital ELISA 236

Dose-response curve 32–33 33f–34f

of antibody affinity and concentration 131–133 132f–133f

calibration 35 35f

immunometric 37–38 38f

for percentage binding 45 46f

sensitivity and 39

Down syndrome 758 765 768–769 771–772

Down-conversion 278

d.p.m. See Disintegrations per minute

Drift. See Assay drift

Drink 427–428

Drugs

interference with 407 413–414

monitoring 430 671

oral fluid collection and 437

in participant preparation 428–429

Index Terms Links


Drugs (Cont.)

thyroid and 677–678

Drug development

clinical phase 653–656 655t–657t

early phase discovery and lead

identification 648

LBAs in 647–658 647f 650t–651t 653f

655t–657t

lead optimization 647f 648–650

nonclinical 650–653 650t–651t 653f

Drugs of abuse 963–988

immunoassays for 964–983 964t

legal substances 984–985

rapid immunoassay tests for 986–987 987t

steroids 985–986

treatment for 963–964

in workplace 964

Drying

for LFIA manufacture 91

for manufacture of LFIAs 92–93

DSS. See Dengue shock syndrome

DxI 600 and 800 597–602 597f–598f


assay principle of 600–601 600f

assay protocol of 598–599 599f

calibration of 601




separation for 601

signal generation and detection of 601

Dyed latex particles 278

Dynamic range, of digital ELISA 228–229 228f

Dynamic tests 430

Dyshormonogenesis 674

E

E3G. See Estrone-3-glucuronide

Index Terms Links


Early growth phase, of market

development 523 523f

Early phase discovery, LBAs in 648

Early pregnancy detection 757 767

EBV. See Epstein–Barr virus

ECL. See Electrochemiluminescence

Economics, of POCT 456–457 457t

Ectopic ACTH syndrome 696

Ectopic pregnancy 758 768

ED. See Direct equilibrium dialysis;

Estimated dose

Edge effects 12

Effective analyte concentration 18

Efficiency

diagnostic 666

quantum 271

separation 287

Ehrlichia canis 626t 628

Ehrlichia ewingii 628

EI. See Erythema infectiosum

EIAs. See Enzyme immunoassays

EIAV. See Equine infectious anemia virus

Ekin’s calculations 41 47

Elecsys immunoassay systems 603–608 603f



assay protocol of 603

calibration of 604–606 606f



product features of 604 604f

separation for 606

signal generation and detection of 606 607f

Electroactive labels 83–84

amperometric detection 83 83f

electrochemiluminescence 83–84 83f

Electrochemiluminescence (ECL) 83–84 83f 277–278

Elecsys immunoassay systems use of 604 606 607f

Index Terms Links


Electrokinetic separation 293

assays for 178–179

Electroosmotic flow (EOF) 177

Electrophoresis 294 312

rocket 346 346f

Electrospray 312–313

EliA autoimmunity assays 617 618f

ELISA. See Enzyme-linked

immunosorbent assay

EM. See Erythema migrans

Embryo culture 737–738

Embryo transfer in IVF cycle 738–739

Embryonic phase, of market


EMIT. See Enzyme multiplied

immunoassay technique. See also

Enzyme-multiplied immunoassay

technique

Empirical methods 325 325f

Encapsulated enzymes 70

Endemic mycoses 941

Endogenous signal-generating

substances 20

Enhanced luminescence 511

Enzymatic antigen retrieval 364

Enzymatic immunostaining 367–368 367t

counterstains for 373–374

Enzymes 8

in amperometric sensors 204–206 204f

catalysts of 20

cofactors of 20

for ELISA 389–390

encapsulated 70

inhibitors of 20

SiMoA detection of 232

Enzyme amplification detection system 279 281f

Enzyme channeling immunoassay 78–79 78f–79f

Enzyme cofactor immunoassay 79–80 80f

Index Terms Links


Enzyme complementation immunoassay 80–81 81f

Enzyme effector immunoassays 70 79–81

enzyme cofactor immunoassay 79–80 80f

enzyme complementation

immunoassay 80–81 81f

enzyme inhibitor immunoassay 78f 80

substrate-linked fluorescence

immunoassay 79

Enzyme immunoassays (EIAs) 76–79

charge-induced enzyme activation 77 77f

disadvantages of 269

enzyme channeling 78–79 78f–79f

enzymes for 268t 269

enzyme-multiplied immunoassay 76–77 76f

heterogeneous 510–511

homogeneous 511

Enzyme inhibitor immunoassay 78f 80

Enzyme labels 268t 269–274

chemiluminescence 272–273 273f

colorimetry 270–271 270f

enhanced chemiluminescence 273–274 274f

fluorometry 271–272 271f–272f

Enzyme multiplied immunoassay

technique (EMIT), ARCHITECT

analyzers 563–564

Enzyme-linked immunosorbent assay

(ELISA) 8 9f 38 946

See also Digital ELISA

analyte for 383

antibody or antigen reagents for 384–387

assay format for 383–385

capture 388

development of 381–394 382f

for epitope mapping 213

hardware and software for 391–392

for infectious disease immunoassay 149 150t 152–153

key steps of 383–388

optimization for 390–391

Index Terms Links


Enzyme-linked immunosorbent assay

(ELISA) (Cont.)

quality control and validation for 392

requirements for 383

separation in 388–389

signal generation and detection in 389–390

standardization and calibration for 392

tips and troubleshooting for 392–393

washing in 388–389

Enzyme-multiplied immunoassay

technique (EMIT) 76–77 76f 946

CEDIA compared with 80–81

EOF. See Electroosmotic flow

Epidemiology, infectious disease

immunoassay for 155

Epitopes 248

Epitope mapping 213–215

in Alzheimer’s disease 214–215

pair-wise 213–214 213f

of therapeutic antibodies 214

of virus-like particles 214

EPR spectroscopy 70 70f

Epstein–Barr virus (EBV) 920

immunoassay for 153

EQA. See External quality assessment

Equilibrium constant (Keq) 30

commonly encountered 32

in dilution curves 43 43f

in dose-response curve 33 34f

percentage binding and 42–43

in Scatchard plot 30 31f 32

sensitivity and 48–49 49f–50f

Equine immunoassay product

technologies

EIAV diagnosis with 631

foal immunoglobulin G diagnosis with 631–632

progesterone assessment with 642

Equine infectious anemia virus (EIAV) 631

Index Terms Links


Equivocal 141–142

Errors

of detection 12

experimental 419

lack-of-fit 323

manipulation 12

relative 151–152

Error profiles 329–331 332f

Erythema infectiosum (EI) 925

Erythema migrans (EM) 931 932t

Erythrocytes, agglutination and 67–68 68f

Erythropoiesis 795

Erythropoietin 804–805

Escherichia coli 933

Estimated dose (ED), troubleshooting

guide for 488–491

Estimation

of precision 13

sensitivity and 38–39 39f

Estradiol 729–730 729f 730t 738–740

739f

Estriol 768–769 768f 769t

Estrogen receptor 845

Estrone-3-glucuronide (E3G), LFIAs of 534–535 536f

Ethanol. See also Alcohol

precipitation by 295

Ethnic issues 429

Euthyroid 673

Exercise 427

Experimental design, in immunoassay


Experimental error 419

Experimental performance, theoretical

models and 57–58

Expression immunoassay 282

External quality assessment (EQA) 441 448–454 449t

design of 448–450

informative presentation of 452 453f

Index Terms Links


External quality assessment (EQA) (Cont.)

limitations of 454

performance assessment 451–454

for POCT 454

for quality assessment 442

samples for 450

target value for 450–451 451t


F

FABP. See Fatty acid-binding proteins

Factory master curves 333–336

Factory-determined calibration curve,

for random-access analyzers 512

FAICEA. See Fragment-absorbed

immunocapture enzyme assay

False-positive rate 665

Familial dysalbuminemic

hyperthyroxinemia (FDH) 678

Fatty acid-binding proteins (FABP) 822–823

FCCS. See Fluorescence cross-

correlation spectroscopy

FCS. See Fluorescence correlation

spectroscopy

FDH. See Familial dysalbuminemic

hyperthyroxinemia

Feature phase, of market development 523 523f

Fecal occult blood 845–846

Feeder cells 253

Feline immunoassay product

technologies

bile acid assessment with 641

cortisol assessment with 641

FeLV diagnosis with 623–625 624f 624t

FIV diagnosis with 624–625 624t

heart disease assessment with 641–642

pancreatic disease assessment with 639–640 640f

T4 assessment with 640–641

Index Terms Links


Feline immunodeficiency virus (FIV) 624–625 624t

Feline leukemia viruses (FeLV) 623–625 624f 624t

FeLV. See Feline leukemia viruses

Femtoliter wells 239

Ferritin 802–803

Ferrocene-labeled antigens 83 83f

Fertility 721–734 721f–722f



Fertility monitors 534–535 536f 537–538 539f

Fertilization 737–738

Fetal death 760

Fetal distress 760

Fetal growth retardation 760

Fetal hydrops 925

FETs. See Field effect transistors

Fetus

chromosome defects of 758–759

NTD of 759

Fibrin 807

Fibrinogen 807

Fibrinolysis 795–796

Field effect transistors (FETs) 181t 183

Fifth’s Disease 925

Filters 297

Filtration membranes, for LFIAs 97 97f

Financial considerations, for automated

analyzers 467

FITC. See Fluorescein isothiocyanate

Fitting master curves 334–335

FIV. See Feline immunodeficiency virus

Fixation

for IHC 358–360

quality control for 359–360

types of 358–359 358t

FLC. See Free light chain

FLEXMAP 3D 158–160 159f 194–195

Index Terms Links


Flow control

in microfluidic microchips 186–188 186f–187f

in POC diagnostics 105–106 105f–106f

Flow cytometry, potential market impact of 527–528

FlowCytomix 195

Fluidic microchips 175

Fluorescein isothiocyanate (FITC) 292

Fluorescence correlation spectroscopy (FCS) 75

Fluorescence cross-correlation

spectroscopy (FCCS) 75

Fluorescence detection 301

direct 274–275 275f

long wavelength 275


time-resolved 275–276 276f

Fluorescence energy transfer dye system,

of Alere Triage System 541 542f

Fluorescence fuctuation analysis 74–75 75f

Fluorescence immunoassays 71–75

enzyme labels in 271–272 271f–272f

fluorescence fuctuation analysis 74–75 75f

fluorescence protection immunoassay 73–74 73f–74f

FPIA 71 71f

FRET 71–73 72f

substrate-linked 79

Fluorescence microscopy 509

Fluorescence polarization 511

Fluorescence polarization immunoassay (FPIA) 71 71f

AxSYM 555–560 555f–558f

IMx 549–554 549f–554f

Fluorescence protection immunoassay 73–74 73f–74f

Fluorescence resonance energy transfer (FRET) 71–73 72f

CRET compared with 75

in early phase discovery and lead

identification 648

with FCCS 75

fluorescence protection immunoassay

compared with 74

Index Terms Links


Fluorescence resonance energy transfer (FRET) (Cont.)

proximity hybridization immunoassay

with 81–82

time-resolved 72–73

Fluorescence-labeled antibodies 509

Fluorescent immunostaining 367–368 369t

counterstains for 374

Fluorescent labeling

for immunostaining 367–368 369t

for LFIAs 100–101

in microspot assays 111–113 113f

specimen storage 361

Fluorescent-activated cell sorters 509

Fluoroimmunoassay 946–947

Fluorometry 271–272 271f–272f

Fluorophores 271

FMD. See Foot-and-mouth disease

Foal immunoglobulin G 631–632

FOB. See Fractional occupancy of

binding sites

Folate 797–801 798f 799t 800f

Follicle-stimulating hormone (FSH)

in androgen disorders 746 748

fertility and 721–722 721f–722f 726–727 726t

Follitropin. See Follicle-stimulating

hormone

Food 427–428

Foot-and-mouth disease (FMD) 634

Formaldehyde 358–359 358f–359f

Förster resonance energy transfer. See

Fluorescence resonance energy

transfer

Forward-phase protein microarrays

(FPPMs) 191 191f

Flowl cholera 638

FPIA. See Fluorescence polarization

immunoassay

Index Terms Links


FPPMs. See Forward-phase protein

microarrays

Fractal cluster kinetics 56 57f

Fractional occupancy 109–111 110f–112f

Fractional occupancy of binding sites (FOB) 296

Fragment-absorbed immunocapture

enzyme assay (FAICEA) 718

Francisella tularensis 937–938

Free analyte immunoassay 123–138

antibody addition 130 130f

antibody affinity and concentration 131–133 132f–133f

back-titration method for 133 134f

binding blocking agent in 136

binding protein in 135–136

BSA effect 131 131f

concentration 123–124

different patient populations 130–131 131f

dilution test for 136

direct equilibrium dialysis 128–129 128f

features of 129–134

labeled analog tracer method for 133 135f

labeled antibody methods for 133–134 135f

protein bound T4 and FT4 129 129f

reference method comparison for 136

serum dilution 129 130f

serum proteins in 127–128 127f

spreadsheets for 124 125t–126t

tests of validity for 135–136

in vitro measurement of 128–136

Free drug concentration 947

Free floating specimens 357

Free hormone concentration 123

principles of 123

of thyroxine 123

Free hormone immunoassays 118–120 119f

Free light chain (FLC) assay 852–853

Free testosterone 750–751 751f

Free thyroid hormone (FTH) 682

Index Terms Links


Free thyroxine (FT4) 123 681–683 682f

antibodies and 130 130f

antibody affinity and concentration 131–133 132f–133f

back-titration method and 133 134f

biochemical profiles of 692 692t

BSA effect 131 131f

concentration of 123–124

different patient populations 130–131 131f

labeled analog tracer method and 133 135f

labeled antibody methods and 133–134 135f

protein bound T4 and 129 129f

serum dilution 129 130f

serum proteins and 127–128 127f

spreadsheets for 124 125t–126t

Free triiodothyronine (FT3) 683–684 684f

biochemical profiles of 692 692t

FRET. See Fluorescence resonance

energy transfer

Frozen specimens 357

storage of 361

FSH. See Follicle-stimulating hormone

FT3. See Free triiodothyronine

FT4. See Free thyroxine

FTH. See Free thyroid hormone

Functional phase, of market


Functional sensitivity 11 11f


Fungi 941–942

Fusion proteins 260 260t

G

Gabapentin 954–955 954f

Galectin-3 828

GAS. See Group A Streptococcus

Gastrin 898

Gastritis 932

Index Terms Links


Gastrointestinal tract 891–900

disorders of 891

normal function of 891

Gauss–Newton algorithm 327

Gel diffusion 342–344 342f–344f

Gel fltration chromatography 294

Gene amplification, antibodies 256–257 257f

Gentamicin 952 952f

Gestational diabetes 761

GH. See Growth hormone

GHB. See Glycated hemoglobin

GHBP. See Growth hormone-binding

protein

GHD. See Growth hormone deficiency

GHRH. See Growth hormone-releasing

hormone

Giardia 626–627 941

Glass particles, separation with 290–291

Glucagon 899

Glucagon tolerance test 779

Glucose tolerance test 780

GlucoWatch 203

Glucuronides 754–755

Glycated hemoglobin (GHB) 788–790 788f

Glycated proteins 790–791

GnRH. See Gonadotropin-releasing

hormone

Goiter 673

Gold

clusters of 278

colloidal 278

Gold nanoparticles 278–279

agglutination of 68

Gonadal dysgenesis 723

Gonadotropin-releasing hormone

(GnRH) 721–722 721f

agonist-controlled COS 737 739

antagonist-controlled COS 737 739

Index Terms Links


Gonadotropin-releasing hormone

(GnRH) (Cont.)

fertility and 735

stimulation test 725 726f

Good laboratory practice 459

Goodpasture’s syndrome 869 881

Granulocytes 795

Grave’s disease 675 881–882

Gray zone 141–142 144

of qualitative immunoassays 143–145 143f 146f

Group A Streptococcus (GAS) 929–930

Growth



normal childhood 777

Growth hormone (GH)

as analyte 778–780

antibodies to 778

excessive secretion of 778 780

in normal growth 777

resistance to 778 780

Growth hormone deficiency (GHD) 777–778

Growth hormone insufficiency 778–780

Growth hormone receptor deficiency 778

Growth hormone-binding protein (GHBP) 777 780

Growth hormone-releasing hormone (GHRH) 777 780

H

HAGA. See Human anti-goat antibody

Hair 439

Half-life 267

HAMA response. See Human anti-mouse

antibody response

Haptens 8 248 302

HARA. See Human anti-rabbit antibody

Hashimoto’s thyroiditis 674–675 881–882

HAT selection 252

HAV. See Hepatitis A virus

Index Terms Links


HBeAg 905

HBsAg assay 140–142 142f 905–906 906f

HBV. See Hepatitis B virus

hCG. See Human chorionic

gonadotropin

HCM. See Hypercalcemia of malignancy

HCV. See Hepatitis C virus

HDFN. See Hemolytic disease of fetus

and newborn

HDV. See Hepatitis D virus

Healy’s test 15

Heart disease 641–642

Heart failure (HF) 818–819

Heartworm 625–626 626f 626t

Heat-induced epitope retrieval (HIER) 362–363 811

Helicobacter pylori 932–933

Hemagglutination 67 68f

Hematology 795–816



coagulation 806–807

DIC 807–808

immunodetection methods 808–814

malarial parasites 814

normal blood function 795–796

thrombophilia 805–806

thrombosis and hemostasis 805 805t

Hematoxylin 373

Hemochromatosis 796

Hemoglobin 795

Hemolysis 408 433

Hemolysis immunoassay 69 69f

Hemolytic disease of fetus and newborn (HDFN) 761

Hemolytic uremic syndrome (HUS) 933

Hemopoiesis 795

Hemorrhage 796

Hemostasis 795–796 805 805t

Hemostatic disorders 796–797

Index Terms Links


Hepatitis 901–912 901t

Hepatitis A virus (HAV) 901–902 902f–903f

Hepatitis B virus (HBV) 903–907 903t–904t 905f–907f 907t

Hepatitis C virus (HCV) 907–908 908f 908t

Hepatitis D virus (HDV) 909–910 910f

Hepatitis E virus (HEV) 910–911

Hepatocarcinoma 903–904

HER-2. See Human epidermal growth

factor receptor

Herbal remedies 407

Hereditary vitamin D-resistant rickets

(HVDRR) 710

Heroin metabolite 980–981 981f 981t

Herpes simplex virus (HSV) 921

Heterobifunctional coupling 303–304 304f 306–308 306t–307t

308f

Heterogeneous EIAs 510–511

Heterogenous immunoassay 8

homogenous immunoassays compared with 67

microscale and nanoscale 178

separation in 287

Heterophile antibodies 19 20f 406

Heterophile interference 412–413

Heteroscedastic responses 324

HEV. See Hepatitis E virus

HF. See Heart failure

HGPRT. See Hypoxanthine guanine

phosphoribosyl transferase

HHM . See Humoral hypercalcemia of

malignancy

HIC. See Hydrophobic interaction

chromatography

HIER. See Heat-induced epitope

retrieval

High-dose hook effects 18–19 19f 152 409

Highthroughput screening (HTS) 648

Index Terms Links


Hirsutism 745–747



Histidine 303

Histoplasmosis 941

HIV. See Human immunodeficiency virus

HIV Combo assays 140

HIV testing 153 154f

Hodgkin’s disease 797

Hog cholera virus 630

Hollow fiber reactors 253

Homeostatic set point 661–662

Home-use immunoassay tests 513–514 522–523

Homobifunctional coupling 303–304 304f 306 306f

Homocysteine 824

Homogeneous EIAs 511

Homogenous immunoassays 8 10f 67–88

bioluminescent immunoassays 75

chemiluminescent immunoassays 75

electroactive labels 83–84

enzyme effector immunoassays 70 79–81

enzyme immunoassays 76–79

fluorescence immunoassays 71–75

heterogenous immunoassay compared with 67

isotopic labels 82–83

lysis immunoassays 69–70 69f

microscale and nanoscale 178

oxygen-channeling immunoassays 84–85 84f

particle agglutination 67–69

proximity-induced hybridization 81–82

separation in 287

spin immunoassays 70 70f

surface-enhanced Raman scattering 76

Homoscedastic responses 324

Hook effects 18–19 18f–19f

Hormone Replacement Therapy (HRT) 738

Horseradish peroxidase (HRP) 269 367 367t

Index Terms Links


Horses. See Equine immunoassay

product technologies

1HPT 706

HRP. See Horseradish peroxidase

HRT. See Hormone Replacement

Therapy

HSA. See Human serum albumin

HSV. See Herpes simplex virus

HTLV. See Human T-cell leukemia virus

HTS. See Highthroughput screening

Human anti-goat antibody (HAGA) 413

Human anti-mouse antibody (HAMA)

response 256

Human anti-rabbit antibody (HARA) 413

Human chorionic gonadotropin (hCG)

in cancer 850

LFIAs of 533–534 534f–535f

in pregnancy 765–768 766f 766t–767t

test 732 732f 732t

Human epidermal growth factor

receptor (HER-2) 850–851

Human immunodeficiency virus (HIV) 913–917

diagnosis of 914–915 914f

pathogenesis of 914

therapeutic monitoring of 915–916

Human MAbs 254

Human serum albumin (HSA) 123

Human T-cell leukemia virus (HTLV) 924–925

Humanization 256

Humanized antibodies 256

Humoral hypercalcemia of malignancy (HHM) 706 707f

HUS. See Hemolytic uremic syndrome

HVDRR. See Hereditary vitamin

D-resistant rickets

Hybrid selection 252

Hybridoma cells 250

Hydrophobic interaction

chromatography (HIC) 311

Index Terms Links


17α-Hydroxysuccinimide 753–754 753f

N-Hydroxysuccinimide (NHS) 309 310f

25–Hydroxyvitamin D 709–712 709t

Hypercalcemia 705–706 706t 707f

Hypercalcemia of malignancy (HCM) 705–706

Hypercortisolemia 696

Hyperglycemia 783

Hyperprolactinemia 724

Hypertension 819

Hyperthyroidism 675–676 690–691 691t

Hypertrichosis 745

Hypocalcemia 707 707t

Hypocortisolemia 696

Hypoglycemia 783 785t

Hypogonadism

female 723

male 723–724

Hypogonadotropic hypogonadism 723–724

Hypoparathyroid 707

Hypopituitarism 778

Hypothyroidism 673–675 690 690 t

Hypoxanthine guanine phosphoribosyl

transferase (HGPRT) 251 251t

I

IBD. See Infammatory bowel disease

IBDV. See Infectious bursal disease virus

ICIA. See Ion capture immunoassay

ICSI. See Intracytoplasmic sperm

injection

Icterus 408

Idiometric assay 63

IEC. See Ion exchange chromatography

IF. See Intrinsic factor

IgA antibodies 246 246t

IgA anti-deamidated gliadin 886

IgA anti-endomysium 885

IgA anti-tissue transglutaminase 885–886

Index Terms Links


IgD antibodies 246 246t

IgE antibodies 246 246t

allergen-specific 861–863 862f

anti- 862

quantitative measurement of 863 864f

total serum 860–861

IGFs. See Insulin-like growth factors

IgG antibodies 245–247 245f 246t

polyclonal anti-IgG 292

purification of 249

IgG anti-deamidated gliadin 886

IgM antibodies 246 246f 246t

IgY antibodies 246

purification of 249

IHC. See Immunohistochemistry

IM. See Infectious mononucleosis

Imine 305 305f

Immobilization 212 212f

surface activity and 212–213 212f

IMMULITE 2000 and IMMULITE

2000 XPi 575–578 575f







product features of 575–577 576f–577f

separation for 578


IMMULITE® and IMMULITE 1000 571–574 571f



assay protocol of 571–574

calibration of 572



product features of 572 572f–573f

Index Terms Links


IMMULITE® and IMMULITE 1000 (Cont.)

separation for 573 573f

signal generation and detection by 573 573f

Immune complex-enhanced enzyme-

channeling immunoassay 78–79 79f

Immune complexes 407

Immune lymphocytes 251

Immune status assessment 623–639 624f 624t 626f

626t

Immunization 7 248

DNA 248

immunogens 248 248t

Immunoadsorption 249

Immunoaffinity purification 249

Immunoassays. See also specific

immunoassay

alternative formats for 520–521

IgG antibodies in 246

characteristics of 29

charge-induced enzyme activation 77 77f

design of 34–58

for drugs of abuse 964–983 964t 986–987 987t

electrochemiluminescence 83–84 83f

EMIT 76–77 76f

enzyme channeling 78–79 78f–79f

enzyme cofactor 79–80 80f

enzyme complementation 80–81 81f

enzyme inhibitor 78f 80

experimental and theoretical

performance of 57–58

fluorescence protection 73–74 73f–74f

history of 61

interferences with 948

performance measures of 11–26

scintillation proximity 82–83 82f

substrate-linked fluorescence 79

thermodynamic principles of 30

types of 7–10

Index Terms Links


Immunoassay development 417–424

design overview 417–418

experimental design in 418–421

key principles in 421–423

Immunoassay interferences 403–416

clinical consequences of 411–414

identification of potential 409–410

prevention of 411

scope of 403–409 404t

strategies to prove 410–411

Immunoassay product technologies.

See also Market trends in


advances in 520–523 521f–522f

in clinical diagnostic testing 509–516

future developments in 514–515

other applications of 514

in veterinary diagnostic testing 623–646 624f 624t 626f

626t 640f

ImmunoCAP allergy assays 617 618f–619f

Immunocapture format

ELISA 384 386f


Immunocapture immunoassays, Access 2

Immunoassay System use of 593 595f

Immunochemistry 339–357

antigen retrieval 362–364

comparative studies 352–353

controls for 364–365

decalcification for 361–362

immunological reaction 339–342 340f–341f

labeled immunoassay 352

qualification by diffusion in gel 342–344 342f–344f

qualitative analysis by

immunoelectrophoresis 344–345 344f

quantification by in-gel 345–347 346f

quantification by in-liquid 347–351 348f–349f

quantification by particle enhanced 351–352

Index Terms Links


Immunochemistry (Cont.)

specimen formats for 357–358

specimen storage for 361

Immunochromatography 292–293

for tumor markers 852

Immunocytochemistry 357

examples of 375–376 376f–377f

Immunodiagnostics. See also Consumer

diagnostics

future of business of 523–529 523f–524f 529t

marketing theory applied to 523–524 523f–524f

microfluidic technologies for 184–189

summary of trends in 530–531

Immunodiagnostic markers, in

microfluidic microchips 184 184t–185t

Immunoelectrophoresis 344–345 344f 509

Immunoenzymatic labeling 810–814

Immunofixation 345

Immunofluorescence 275 808–810 812–813


Immunogen 8 302

Immunogenicity 248

studies of 219

testing 650 650t 653f 654

Immunoglobulin 245–247

Immunohistochemistry (IHC) 357

examples of 375 375f–376f

fixation for 358–360

Immunological biosensors 203–208

amperometric sensors 204–206 204f

live-cell nanomechanical assays 206

microcantilever sensors 206

overview of 203–204

piezoelectric mass sensors 205–206 205f

Immunological reaction 339–342 340f–341f

Immunometric immunoassays 7–8 7f–9f 35

See also Capture bridge

assay; Class-capture assay; Enzyme-

Index Terms Links


Immunometric immunoassays (Cont.)

linked immunosorbent assay;

Selective antibody immunometric assay

for antibody quantification 52–53 53f–55f

of antinuclear antibodies 873 874f

competitive combined with 171–172

cross-reactivity in 16–17 17f

design of 36–37 36f

ELISA 383

with MagPlex microspheres 166–168 167f

microscale and nanoscale 178–179

no-wash 168

sensitivity of 40 47–49 48f–50f

separation in 287

single-site 36–37 36f


two-site 37–38 37f–38f 296

washing in 293


Immuno-PCR 282

Immunophenotyping 810

Immunoprecipitate 341–342

Immunoradiometric assays (IRMA) 510

Immuno-Rate technology, of VITROS

systems 585–588 585f–587f

Immunostaining 365–373

counterstains 373–374

detection system selection for 367–368 367t


mounting 374–375

optimization research for 365–367 366t

techniques for 370–373 371f–372f

Immunosuppression 958–961

monitoring 153–155

Imprecision 12–15

in method evaluation 399

Impregnation, for manufacture of LFIAs 92

Index Terms Links


IMx 511–512 549–554 549f


assay principle of 550 551f–554f


calibration of 550



product features of 550

separation for 550

signal generation and detection by 552–553 554f

In vitro diagnostics (IVDs)

digital ELISA in 223

immunoassay market status in 517–518 517f–518f 518t 529–530

530f

In vitro fertilization (IVF) 735–744

COS 736–737 736f

fertilization and embryo culture 737–738

historical perspective on 735–736

oocyte retrieval 737

programme for 736–738 736f

into twenty-first century 736

In vitro fertilization and embryo transfer

(IVF-ET) 738–739


pregnancy detection in 738

In vivo imaging 528

In vivo monitoring 521 521f–522f

Incidence 665

Incubation

assay drift with 26

precision and 12

Indefinite 141–142

Independent controls 419

Index of individuality 662

Indirect format, for qualitative

immunoassays 142

Index Terms Links


Indirect immunoassays


of antinuclear antibodies 873 873f

ELISA 384 385f


Individual control failure 478–481

Individual laboratory performance 452

Infectious bronchitis virus 637

Infectious bursal disease virus (IBDV) 637

Infectious disease

antibodies relevant to 149–156

diagnosis 623–639 624f 624t 626f

626t

Infectious disease immunoassay 149–156

acute disease confirmation with 153 154f

for animal testing 155


for biowarfare 155

blocking buffers for 151

blood bank testing with 153 154f

capture reagent selection for 149–150

detection reagent selection for 150–151 150t

development of 149–151

dilutional linearity 152

for epidemiology 155

formats for 149

heterogeneity of antibody in 151

for immunosuppression monitoring 153–155

instrumentation for 152–153

isotype specificity in 151

for pathogens in pregnancy 153

quantitation range of 151–152

selectivity of 152

specificity of 152

stability of 152

for transplantation monitoring 153–155

for vaccination efficacy 153

vaccine immunity studies 151

Index Terms Links


Infectious disease immunoassay (Cont.)

validation of 151–152

Infectious mononucleosis (IM) 920

Infertility 723

test strategy for 733 734f

Inflammatory bowel disease (IBD) 891


Influenza A 639

Inhibin 729

Inhibin A 769–771 770f 770t

Inhibition assays 219–220 220f

Initially reactive (IR) 141–142

In-line manufacturing, of LFIAs 94 96f

Instantaneous results, immunoassay


Instrumentation

for digital ELISA 239–240 240f

for ELISA 391–392

precision and variations in 12

Insulin

as analyte 784–788 784f 785t

assay performance of 787

C-peptide and 787

PCOS and 746

Insulin stress test (IST) 779

Insulin tolerance test (ITT) 779

Insulin-dependent diabetes mellitus. See

Type 1 diabetes

Insulin-like growth factors (IGFs) 777 780–781

Integrated disposable configuration,

cartridge–reader versus 179–180 179f 179t

Integrated reagent packs, for random-

access analyzers 512

Interaction kinetics 209–210

Interference 17–20

analytical goals for 671

with immunoassays 948

in immunoassays 403–416

Index Terms Links


Interference (Cont.)


from NSB 235–236 236f

in oral fluid collection 436

from serum separators 433

from tube and stopper 432–433

Internal quality control (IQC) 441–448 442t

out-of-control assay run 448 448t–449t

for POC devices 448

programs for 443–446 444t

for quality assessment 442

samples for 442–443

software programs for 446–448

International Standards 315–316 320

International Unit (IU) 316

Intracytoplasmic sperm injection (ICSI) 736

Intrinsic factor (IF) 795 801–802

Iodine-induced hyperthyroidism 676

Ion capture immunoassay (ICIA)

AxSYM 555–560 555f–558f

IMx 549–554 549f–554f

Ion exchange chromatography (IEC) 311

IQC. See Internal quality control

IR. See Initially reactive

IRMA. See Immunoradiometric assays

Iron overload 796

Islet cell autoantibodies 882–883 883t

Isoelectric focusing 312

Isotopic labels 82–83

Isotype specificity, in infectious disease

immunoassay 151

IST. See Insulin stress test

ITT. See Insulin tolerance test

IU. See International Unit

IVDMIA. See Multivariate index assay

IVDs. See In vitro diagnostics

IVF. See In vitro fertilization

Index Terms Links


IVF-ET. See In vitro fertilization and

embryo transfer

J

Jaundice 901

Jod-Basedow phenomenon 676

Johne’s disease 633

K

ka. See Association rate constant

Kallman’s syndrome 724

KD. See Binding affinity constant

kd. See Dissociation rate constant

Keq. See Equilibrium constant

Ketosis 783

Kinetics

of antibody-antigen interactions 29–33

of ELISA 390

of interactions 209–210 215–217 215f

of reactions 296

of reduced volume 178

of solid-phase immunoassays 54–56 56f–57f

SPR biosensor analysis of 215–217 216f–218f

Klinefelter’s syndrome 723–724

L

Labeled analog tracer method, for free

analyte immunoassay 133 135f

Labeled analytes 320

Labeled antibody methods 320

for free analyte immunoassay 133–134 135f

Labeled immunoassay 352

Label-free detection methods 193 194t

Label-free technology 521

Lab-on-a-chip (LOC) 175 176t

Laboratory environment considerations,

for automated analyzers 466

Index Terms Links


Laboratory managers, immunoassay

product technologies purchased by 526–527

Laboratory-developed tests (LDTs) 519 654–655

Lack-of-fit error 323

Lamb wave 205f

Lambert–Eaton syndrome 887

Lamination, for manufacture of LFIAs 93

Lamotrigine 955 955f

Langmuir plot. See Reciprocal plot

Laser nephelometry 68

Late growth phase, of market


Late pregnancy 768

Late-onset congenital adrenal

hyperplasia (LOCAH) 746–747

Lateral flow immunoassays (LFIAs) 89–108 292

antibodies on conjugates for 98 98t

antibody screening methods for 99 99f

antibody selection for 98

aptamer technology for 99–100

architecture of 90–91 90f

assembly of 94

blood collection for 97 97f

common dyes in 100 101t

common particles in 100 102t

consumer diagnostics using 533–536 534f–536f

current market for 89–90 90t

delivery of plasma for 97 97f

device design considerations for 105–106

digital interface of 536

imaging systems for 103–104 104f

manufacturing of 91–95 91f

monoclonal versus polyclonal

antibodies for 98 98t

multiplexing for 106 106f

ovulation tests 534–535 536f

plasma separation for 97 97f

for POC diagnostics 95–106

Index Terms Links


Lateral flow immunoassays (LFIAs) (Cont.)

pregnancy tests 533–534 534f–535f

quantification and reader integration

for 105–106

reader integration with 106

sample addition control for 105

sample collection and handling for 96–97

sample flow control for 105–106 105f–106f

scanning systems for 104 104f

signal generation in 100–103

signal transduction and analytical

processing for 103–105

Latex, dyed particles of 278

Latex agglutination 67–68 68f 509

Law of Mass Action 29–33

LBA laboratory 655–656 656t

LBAs. See Ligand binding assays

LDTs. See Laboratory-developed tests

Lead identification, LBAs in 648

Lead optimization, LBAs in 647f 648–650

Least squares regression 22–24 25f 325 326f

Legionella 934

Legionnaire’s Disease 934

Leishmania infantum/Leishmania donovani 627–628

Leptospira interrogans 935–936

Leucine zippers 260

Leukemia 708 797

analytes 808–814 808t

Levetiracetam 955–956 955f

Levey–Jennings control charts 444–446 445f

LFIAs. See Lateral flow immunoassays

LH. See Luteinizing hormone

LHRH. See Gonadotropin-releasing

hormone

Ligand binding assays (LBAs)

in clinical phase 653–656 655t–657t

in drug development 647–658 647f 650t–651t 653f

655t–657t

Index Terms Links


Ligand binding assays (LBAs) (Cont.)


identification 648

in lead optimization 647f 648–650

in nonclinical drug development 650–653 650t–651t 653f

Light addressable potentiometric

sensors 181t 183

Likelihood ratio 666

Limit of blank (LOB) 400

Limit of detection (LOD) 400–401 422

Limit of dilution 152

Limit of quantitation (LOQ) 401

Limiting dilution 253

Limits of detection (LODs), of ELISA 223

Line probe assay, of antinuclear

antibodies 874–875

Linear master curves 334

Linear regression model 327

Linearity

in digital ELISA 236


Linearity of dilution

of infectious disease immunoassay 152

interference with 410 410t


Lipemia 408

Lipids 428

Lipoprotein A 823–824

Lipoprotein-associated phospholipase A2

(LP-PLA2) 826

Liposomes 69–70

Liquid handling robot 239

Liquid phase, RIA with 510

Liquid-phase assays, for quantification of

antibodies 51

Liquid-phase separation 294–295

Live-cell nanomechanical assays 206

Load-seal-image (LSI) module 239

Index Terms Links


LOB. See Limit of blank

LOC. See Lab-on-a-chip

LOCAH. See Late-onset congenital

adrenal hyperplasia

LOCI. See Luminescent oxygen-

channeling immunoassays

LOD. See Limit of detection

LODs. See Limits of detection

Long wavelength fluorescence 275

LOQ. See Limit of quantitation

Love-wave device 206

Low-dose hook effects 18 18f

LP-PLA2. See Lipoprotein-associated

phospholipase A2

LSD. See Lysergic acid diethylamide

LSI module. See Load-seal-image

module

LumAvidin microspheres 157–158

biotin-conjugated molecules binding to 163

Luminescence detection 301

Luminescent oxygen-channeling

immunoassays (LOCI) 84–85 84f

Luminex 100/200 158–160 159f

Luminex analyzers 158–160 159f

Luteinizing hormone (LH)

in androgen disorders 746 748

fertility and 721–722 721f–722f 724–726 725t

726f

IVF-ET and 738

LFIAs of 534–535 536f

Luteinizing hormone-releasing hormone

(LHRH). See Gonadotropin-

releasing hormone

Lutropin. See Luteinizing hormone

Lyme disease 627 931 932t

Lymphocytes, immune 251

Lymphoma 708 797

analytes 808–814 808t

Index Terms Links


Lyophilization, for LFIAs 101

Lysergic acid diethylamide (LSD) 975–976 975f 976t–977t

Lysine 302 302f

Lysis immunoassays 69–70 69f

M

ß2M. See ß2-Microglobulin

MAbs. See Monoclonal antibodies

Magnetic nanoparticle agglutination 68–69

Magnetic particles 279

Magnetizable particles, separation with 291

MAGPIX 160 194–195

MagPlex microspheres 157–158

carbodiimide coupling of protein to 161–163

immunometric immunoassays with 166–168 167f

magnetic separators for 161 161t

Malaria 940–941

Malarial parasites 814

MALDI-TOF. See Matrix-assisted laser

desorption/ionization time-of-fight

mass spectrometric analysis

Male Turner’s syndrome 724

4–(4–N-Maleimidophenyl) butyric acid

hydrazide-hydrochloride (MPBH) ,

modification of carboxylated

microspheres 163–164

Manipulation errors 12

Mannich reaction 309–310 310f

Manufacture, in immunoassay


Manufacturing of LFIAs 91–95 91f

assembly 94

dispensing for 91–94

process options for 93–94

Market trends in immunoassay product

technologies 517–532

changing role of clinical laboratory 529

customer base changes 526–527

Index Terms Links


Market trends in immunoassay product

technologies (Cont.)

future market requirements 524–526

future of immunodiagnostics business 523–529 523f–524f 529t

immunoassay market status 517–518 517f–518f 518t 529–530

530f

impact of new technologies 527–528

market drivers 518–520 521f–522f

marketing theory applied to 523–524 523f–524f

new analytes 523 528–529 529t

new market segments 519–520 530

summary of trends 530–531

technology advances 520–523 521f–522f

in vivo imaging 528

Marketing theory 523–524 523f–524 f

Marquardt–Levenberg algorithm 327

Mass detection sensors 205–206 205f

Mass spectrometry (MS) 312–313

for microarray immunoassays 193–194

Mass transport limitations 296

Master calibration curve 333–335

Maternal diabetes 761

Matrix components 408

Matrix effects 38 317–318

interference from 235–236 236f

Matrix-assisted laser desorption/

ionization time-of-fight mass

spectrometric analysis (MALDITOF) 193–194 283 312–313

Mature phase, of market development 523 523f

Maximum acceptable concentrations

(MaxAC) 331

MDA. See Methylenedioxyamphetamine

MDDC. See Minimal distinguishable

difference in concentration

MDMA. See

Methylenedioxymethamphetamine

MDx. See Molecular diagnostics

Measles 924

Index Terms Links


Medications. See Drugs

Medtronic MiniMed Guardian

Continuous Glucose Monitoring

(CGM) System 203

Medullary carcinoma of thyroid 708–709

Megaloblastic anemia 797

MEIA. See Microparticle capture

enzyme-immunoassay

Membrane filtration 292

Memory B cells 247

MEN. See Multiple endocrine neoplasia

MEN2A. See Multiple endocrine

neoplasia type 2A

Menopause 723

Menstrual cycle 429 723

Meso Scale Discovery (MSD) platform 150–151

Metabolic status assessment 639–643 640f

Methadone 976–978 977f 977t–978 t

Methamphetamine 965 965f 967t–968t

Methionine 303

Method comparison 22–25 23f 23t

Method evaluation 395–402

assay groups 395

cost-effective initial test evaluation 396–397

evaluation against current method 397–398

final evaluation tests 399–401

initial screen 395–396

report for 401

Method-related performance 452

Methotrexate 959 959f

Methylenedioxyamphetamine (MDA) 966 966f 967t–968 t

Methylenedioxymethamphetamine (MDMA) 966–969 966f 967t–968t

Micro total analysis systems (µTAS) 175

Microarrays 175–176 190–197

for allergens 865–866 865f

antibodies for 192

applications of 195–196 196t

bead-based 194–195

Index Terms Links


Microarrays (Cont.)

in clinical diagnostics 196–197

detection strategies for 193–194 193f 194t

formats of 191 191f

manufacture of 191–192

protein attachment on 297–299

receptor-ligand interaction on 296–297

recombinant antibody binding on 299

self-assembling protein 192

separation with 295–299

signal generation and 283

solid-phase medium of 297

washing for 299

Microcantilever sensors 206

Microchips 175

Microchip immunoassays 175–202 176t

Microfabrication 176

Microfluidic immunodiagnostics 184–189

commercial devices 189–190 190f

flow control in 186–188 186f–187f

immunodiagnostic markers in 184 184t–185t

for low-resource settings 188–189 189f

Microfluidic microchips 175

Microfluidic paper-based electrochemical

devices (mPEDs) 181t 183

ß2–Microglobulin (ß2M) 847–848

Microparticle capture enzymeimmunoassay (MEIA)

AxSYM 555–559 555f–558 f

IMx 549–554 549f–554 f

Microparticle enzyme immunoassay 947

Microparticle labels 278–279

MicroPlex microspheres 157–158 158f

Microscale immunoassays 175–202 176t

antibodies for 180

capture antibody support in 180

design of 178–184

format of 178–179

integrated disposable versus cartridge-reader 179–180 179f 179t

Index Terms Links


Microscale immunoassays (Cont.)

on-chip detection methods 181–184 181t


standardization and calibration of 180

Microscopic polyangiitis 880

Microspheres

ADH modification of carboxylated 163

buffers for 160–161 160t

MPBH modification of carboxylated 163–164

of xMAP Technology 157–158 158f

Microsphere coupling 161–164

ADH modification of carboxylated

microspheres 163

assay performance and 165 166f

biotin-conjugated molecules binding

to LumAvidin microspheres 163

carbodiimide coupling of protein to

MagPlex microspheres 161–163

competitive immunoassay for

antibodies in 169–170

competitive immunoassay for antigens in 170–171

confirmation of 164

magnetic separators for 161 161t

MPBH modification of carboxylated

microspheres 163–164

Microsphere-based multiplex

immunoassays 513

Microspots 175–176

Microspot assays 111–118

antibodies of 111 113f

application of 117–118

construction of 117 117f

detection of 111–113 114f

equilibrium in 116 116f–117f

occupancy rate of 116

sensitivity of 113–116 114f–116 f

MicroTip technology, of VITROS

systems 585–588 585f–587f

Index Terms Links


Microtiter plates 297

for ELISA 388

Microtitration plates, separation with 291–292

Microtomy 360

Microwave method 363

Microwell technology, of VITROS

systems 579–588 580f–581f

Mild hypothyroidism 675

Milk 439

MinAC. See Minimum acceptable

concentrations

Miniantibodies 260

Miniaturization 175–202 176t

advantages and disadvantages of 175 176t

capillary flow 177

electroosmotic flow 177

fundamentals of 176–178

nanoscale analysis systems 178

reduced volume and low-concentration

samples in 177 177t

reduced volume kinetics 178

signal generation and 282–283

surface tension in 176–177

viscosity in 176–177

Minimal distinguishable difference in

concentration (MDDC) 13

Minimum acceptable concentrations

(MinAC) 331

MIS. See Müllerian-inhibiting substance

Miscarriage 760

Mixed anhydride method 309 310f

Mixed-meal tolerance test (MMTT) 786

MMTT. See Mixed-meal tolerance test

Molecular bridge 268

Molecular diagnostics (MDx) 518 520 522


MoM. See Multiples of the normal

Median

Index Terms Links


Monoclonal antibodies (MAbs) 38 250–254 250f

antigen binding with 29–30 30f

cell fusion 252

cloning 253


human 254

hybrid selection 252

immune lymphocytes 251

for LFIAs 98 98t

myeloma cell lines 251–252 251t

in pair-wise epitope mapping 213–214 213f

production of 250 250f

purification of 254

rabbit 254

screening tests 252–253

storage and propagation of 253–254

Mosaic-format immunoassay 283

Mounting 374–375

Moving average precision profile 15 16t 17f

MPBH. See 4-(4-N-Maleimidophenyl)

butyric acid hydrazide-hydrochloride

mPEDs. See Microfluidic paper-based

electrochemical devices

MS. See Mass spectrometry

MSD platform. See Meso Scale

Discovery platform

Mucin 16 (MUC16) 842

Müllerian-inhibiting substance (MIS) 740–743 741f–742f

MultiBead 195

Multiphoton detection 267

Multiple binding assay system, specificity with 62

Multiple endocrine neoplasia (MEN) 706 894

Multiple endocrine neoplasia type 2A

(MEN2A) 708–709

Multiple pituitary hormone deficiencies 778

Multiple reaction monitoring-MS

(MRM-MS) 193–194

Multiple washing 294

Index Terms Links


Multiples of the normal Median (MoM) 757

Multiplex bead assays

of antinuclear antibodies 875

for infectious disease immunoassay 153

Multiplex immunoassays 157–174

of antinuclear antibodies 873–875 875f

commercial applications and platforms 172 172t

competitive 169–171 170f

coupling confirmation 164

development of 160–165 160t

formats of 165–172

immunometric 165–168 167f

immunometric with competitive 171–172

indirect 168–169 168f

Luminex analyzers for 158–160 159f

microsphere coupling in 161–164 161t

microsphere-based 513

optimization of 164–165 166f

signal generation and 282–283

xMAP microspheres for 157–158 158f

xMAP Technology for 157

Multiplex testing 523

Multivariate index assay (IVDMIA) 197

Mumps 924

Mutagenesis 259

Mycobacterium bovis 635–636

Mycobacterium paratuberculosis 633

Mycophenolic acid 959–960 960f

Mycoplasma 637–638

Mycoplasma hyopneumoniae 631

Myeloma 250

cells 251–252 251t

Myoglobin 822

N

NAb assays. See Neutralizing antibody

assays

Nanofluidic approaches 176

Index Terms Links


Nanoparticles 176

for labels 278–279

Nanoscale immunoassays 175–202 176t

antibodies for 180

capture antibody support in 180

design of 178–184

format of 178–179

integrated disposable versus cartridge–

reader 179–180 179f 179t

miniaturization towards 178

on-chip detection methods 181–184 181t


standardization and calibration of 180

Nanotechnology 176

antibodies in 260–261

NDV. See Newcastle disease virus

Near-patient immunoassay tests 513

NECs. See Neuroendocrine cancers

Negative feedback 695

Negative interference 17

Negative likelihood ratio 666

Negative patient sample concentrations 499–501

Negative predictive values (NPV) 665

Nelson’s syndrome 701

NENs. See Neuroendocrine neoplasms

Neospora caninum 634

Nephelometry 67

Nephelometry inhibition 510

Neural tube defects (NTD) 759 763f 764 765f

765t

Neuroendocrine cancers (NECs) 894

Neuroendocrine neoplasms (NENs) 894 895f

markers for 894–899 895t

Neuroendocrine system 893–894

Neuron-specific enolase (NSE) 848–849 848f

Neuropathy-associated antibodies 888

Neutralizing antibody (NAb) assays 654

Newcastle disease virus (NDV) 638

Index Terms Links


NFAs. See Nonesterifed fatty acids

NHS. See N-Hydroxysuccinimide

Nicotine 984–985 985f

NNE. See Neuron-specific enolase

Nonclinical drug development, LBAs in 650–653 650t–651t 653f

Non-competitive immunoassays 61–66

anti-complex immunoassay 61–62 62f

selective antibody immunometric

assay 63 63f

universal selective antibody system 63–65 64f–65f

Noncontact, pump-driven solenoid

dispensers 92

Nonesterifed fatty acids (NFAs), BSA

effect on 131 131f

Noninvasive immunoassay tests,


Nonisotopic immunoassay 945–947

Nonlinear curve models 327–329

Non-neuronal enolase (NNE). See

Neuron-specific enolase

Nonspecific binding (NSB) 31

antibody-antigen kinetics 31

in infectious disease immunoassay 151

interferences from 235–236 236f

in microarray immunoassay 297

sensitivity and 43–45 44f 45t 49

49f–50f

of thyroxine 129


Non-thyroidal illness 430

Non-thyroidal illness syndrome (NTIS) 677

Nontoxic goiter 676

Normal range 497–499 661

Not Confirmed Reactive 141–142

No-wash immunometric immunoassays 168

NPV. See Negative predictive values

NSB. See Nonspecific binding

NSE. See Neuron-specific enolase

Index Terms Links


NTD. See Neural tube defects

NTIS. See Non-thyroidal illness syndrome

Nucleic acid programmable protein array 192

O

OAPR. See Odds on being affected given

a positive result

Occupancy principle 109 110f

Occupancy rate (OR), in microspot

assays 116

Odds 666

Odds on being affected given a positive

result (OAPR) 665

OHSS. See Ovarian hyperstimulation

syndrome

On-chip detection methods 181–184 181t

absorbance detection 181 181t

amperometric detection 181t 183

cantilever approach 181t 184

capacitive detection 181t 183

chemiluminescence detection 181t 182

complementary metal oxide

semiconductor-based sensors 181t 183

conductometric detection 181t 183

FETs 181t 183

fluorescence detection 181t 182

light addressable potentiometric

sensors 181t 183

mPEDs 181t 183

phosphorescence detection 181t 182

QCM 181t 184

SERS 181t 182–183

SPR 181t 183

thermal lens microscope 181t 182

On-chip equilibrated affinity assays 178–179

Oocyte retrieval 737

Operational considerations, for

automated analyzers 467–468

Index Terms Links


Opiates 978–980 978f–979f 979t–981t

Optimization

of digital ELISA 235

for ELISA 390–391

of multiplex immunoassays 164–165 166f

of qualitative immunoassays 143

theoretical models of 40–41

Optimization models 40–41

OR. See Occupancy rate

Oral fluid collection 435–438

Osteocalcin 715–716

Osteomalacia 707

Osteoporosis 708

OTC diagnostics. See Over-the-counter

diagnostics

Ouabain 252

Outliers 332–333

Out-of-control assay run 448 448t–449t

Ovarian hyperstimulation syndrome

(OHSS) 737

Ovary, androgen-secreting tumors of 747

Overall performance 452 452f

Over-the-counter (OTC) diagnostics 533–536 534f–536f

Ovulation tests 534–535 536f 537–538 538f

Oxime 308

Oxycodone 981 981f 982t

Oxygen-channeling immunoassays 84–85 84f

P

P1NP. See Procollagen type 1 amino

terminal peptide

PA. See Pernicious anemia

PACIAs. See Particle counting

immunoassays

Packaging, of LFIAs 93

Paget’s disease of bone 708

PAGs. See Pregnancy-associated

glycoproteins

Index Terms Links


Pair-wise epitope mapping 213–214 213f

of therapeutic antibodies 214

Pancreatic disease 639–640 640f

Pancreatic polypeptide 898

Panning 256

phage antibody library 258–259 258f

PAP. See Prostatic acid phosphatase

PAPP-A. See Pregnancy-associated

plasma protein-A

Paraffn embedded specimens 357

processing to 360

storage of 361

Parallelism 21

Paraneoplastic syndrome 888

Paraproteins 407

Parasites 939

Parathyroid adenoma 706

Parathyroid disorders 706 707f

Parathyroid hormone (PTH) 712–714

Parathyroid hormone-related protein

(PTHrP) 706

Paratuberculosis 633

Participant preparation 427–429

Particles

glass 290–291

magnetizable 291

plastic 290–291

Particle agglutination 67–69

erythrocytes and latex 67–68 68f

gold nanoparticles 68

magnetic nanoparticles 68–69

Particle counting immunoassays

(PACIAs) 67–68

Particle enhanced turbidimetric

immunoassay (PETIA) 563

Particle enhanced turbidimetric

inhibition immunoassay (PETINIA) 563

Particle–conjugate interactions 422

Index Terms Links


Particle–specimen–conjugate

interactions 422

Parvovirus 626

Parvovirus B19 925

Pasteurella multocida 638

Pathological changes 430

Patient, immunoassay product

technologies purchased by 527

Patient sample concentrations 499–501

PBD. See Photothermal beam defection

PCOS. See Polycystic ovarian syndrome

PDDR. See Pseudo-vitamin D-deficiency

rickets

PEG. See Polyethylene glycol

PEG-assisted second antibody

precipitation 295

Percentage binding

concentration and 42–45 45t

dose-response curve for 45 46f

equilibrium constant and 42–43

Performance assessment 451–454

Periodate method. See Direct coupling

Pernicious anemia (PA) 883

Persona contraception monitor 537–539


latest developments in 539 539f

Personalized medicine

biomarkers in 528

MDx in 520

PETIA. See Particle enhanced

turbidimetric immunoassay

PETINIA. See Particle enhanced

turbidimetric inhibition

immunoassay

Phadia Laboratory Systems 617–620 618f




Index Terms Links


Phadia Laboratory Systems (Cont.)


Phadiatop 863

Phage display library 256

altering characteristics with 259

construction of 256–258 257f

panning of 258–259 258f

of synthetic recombinant antibodies 259

Pharmacokinetic (PK) assessment 650–653 650t–651t

Phase 1 trials 653

Phase 1–2 trials 653

Phase 2 trials 653

Phase 3 trials 653

Phencyclidine 981–982 982f 982t–983t

Phenobarbital 956 956f

Phenytoin 956–957 956f

Phospholipid antibody syndrome 887–888

Phosphorescence detection 278


Phosphors, up-converting 73

Photothermal beam defection (PBD) 68

PICP. See Procollagen type I carboxy-

terminal peptide

PIER. See Proteolytic-induced epitope

retrieval

Piezoelectric mass sensors 205–206 205f

PISA. See Protein in situ array

Pituitary gigantism 778

Pituitary tumors 696

PK assessment. See Pharmacokinetic

assessment

4PL model 327–329 328f 329t 330f

5PL model 327–329 328f 329t 330f

3PLA 81 82f

Placental abruption 761

Placental growth factor (PlGF) 772–773 772t

Placental insufficiency 760 765 769

Index Terms Links


PLAs. See Proximity ligation

immunoassay

Plasma preparation 432

Plasma renin 829

Plasmacytoma cells 251–252 251t

Plasmin 795–796

Plasminogen 795–796

Plastic particles, separation with 290–291

Plastic surface, protein binding to 287–290 289f

Platelets 795

PlGF. See Placental growth factor

Plots. See Calibration curve; Difference

plots; Dilution curves; Dose-

response curve; Reciprocal plot;

Saturation plot; Scatchard plot;

Scatter plots; Sips plot

POC. See Point-of-care

POCT. See Point-of-care testing

Point-of-care (POC) 89

antibodies on conjugates for 98 98t

antibody screening methods for 99 99f

antibody selection for 98

aptamer technology for 99–100

biosensors for 203

blood collection for 97 97f

common dyes in 100 101t

common particles in 100 102t

delivery of plasma for 97 97f

device design considerations for 105–106

evolving future performance in 95–106

existing technology improvements for 95–106

imaging systems for 103–104 104f

integrated disposable versus cartridge–

reader for 179–180 179f 179t

monoclonal versus polyclonal

antibodies for 98 98t

multiplexing for 106 106f

plasma separation for 97 97f

Index Terms Links


Point-of-care (POC) (Cont.)

quantification and reader integration for 105–106

reader integration with 106

sample addition control for 105

sample collection and handling for 96–97

sample flow control for 105–106 105f–106f

scanning systems for 104 104f


signal transduction and analytical

processing for 103–105

Point-of-care (POC) diagnostics

Alere Triage System 541–544 542f–544f

LFIAs in 533–536 534f–536f

market trends in 519–520

user convenience and 525–526

Point-of-care testing (POCT) 455–464

data management for 461

delivery options for 455–459 457t

EQA for 454

IQC for 448

practical management for 461–463

quality assurance and 459–461

Polarization fluoroimmunoassay 946

Polyclonal antibodies, for LFIAs 98 98t

Polyclonal anti-IgG 292

Polyclonal antisera 248–249 249f

purification of 249

Polycystic ovarian syndrome (PCOS) 745–746

Polycythemia 796

Polyethylene glycol (PEG)

precipitation by 295

surface coatings 298

Pontiac Fever 934

Poor assay sensitivity 503–505

Poor recovery 501–503

Porcine immunoassay product

technologies

CSFV diagnosis with 630

Index Terms Links


Porcine immunoassay product

technologies (Cont.)

Mycoplasma hyopneumoniae diagnosis with 631

PRRS diagnosis with 629–630

PRV/ADV diagnosis with 629

swine influenza virus diagnosis with 630–631

Porcine reproductive and respiratory

syndrome (PRRS) 629–630

Positive interference 17

Positive likelihood ratio 666

Positive predictive values (PPV) 665

Postpartum thyroiditis syndrome (PTT) 676

Posttest odds 666

Post-transplant lymphoproliferative

disorder (PTLD) 920

Posture 428

PPV. See Positive predictive values

Prader–Willi syndrome 724

Pre-analytical phase 441

Precipitation 295

Precipitin assays 509

Precision 11–15

analytical goals for 670

bias and 13 13f

estimation of 13

hierarchy of 12–13

MDDC 13

profile 11 13–15 14t 15f

16t 17f

within-assay 476–478

Precision outliers 332

Precision profiles 330

Preclinical bridging 649

Preeclampsia 760–761 771

Pre-equilibrated affinity assays 178–179

Pregnancy 757–776


aneuploidy screening 761–776 773f–774f 774t–775t

Index Terms Links


Pregnancy (Cont.)

clinical conditions and disorders 757–762

detection of 738

early detection 757 767

ectopic 758 768

infectious disease immunoassay during 153

late 768

in participant preparation 429

thyroid disease in 676–677

Pregnancy of Unknown Location (PUL) 758

Pregnancy tests 522–523 533–534 537–538

consumer use of 533–534 534f–535f 537–538 537f–538f

Pregnancy-associated glycoproteins (PAGs) 643

Pregnancy-associated plasma protein-A

(PAPP-A) 771–772 771t

Premature labor 759–760

Premature luteinization 735

Pressure cooker method 363

Preterm delivery 759–760

Pretest odds 666

Prevalence 665–666 666t

Primary amenorrhea 723

Primary biliary cirrhosis 884

Primary hypogonadism

female 723

male 723–724

Primary hypothyroidism 674–675

Primary tube, for random-access

analyzers 512

Primidone 957 957f

Prion disease 634–635

PRISM 609–615 609f–610f

assay principle of 612 612t 613f–614f


biologic reagents used in 612

calibration of 612


LIS interfacing of 615 615f

Index Terms Links


PRISM (Cont.)


separation for 612


Pristane 254

Probabilistic testing 668–669 668f

Procainamide 950 950f

Process phase, of market development 523 523f

Procollagen I extension peptides 716–717

Procollagen type 1 amino terminal

peptide (P1NP) 716

Procollagen type I carboxy-terminal

peptide (PICP) 716

Proficiency testing 315 441


Progesterone 738

equine immunoassay product

technologies assessing 642

in fertility 730–731 730f 730t

in pregnancy 761–773

ruminant immunoassay product

technologies assessing 642–643

Progesterone receptor 845

Prognosis 835

Proinsulin 787

Prolactin 727–728 727t

Prolactinomas 723

Proportional bias 20 21f

Propoxyphene 982–983 983f

Prostate-specific antigen (PSA) 846–847

Prostatic acid phosphatase (PAP) 834

Protein

bead capture of 230 230f

biotinylated detection antibody

labeling of 231 231f–232f

capture 287–288

covalent attachment to solid phases 290

functional chemistry of 302–303

Index Terms Links


Protein (Cont.)

glycated 790–791

microarray attachment of 297–299

plastic surface binding of 287–290 289f

Protein A 279

Protein C 805–806

Protein in situ array (PISA) 192

Protein interactions 209–210

Protein S 805–806

Protein–protein conjugates 301–308 302f

categories of 303–305 304f–305f

common coupling methods for 305–308

genetic engineering for 308

Protein–small molecule conjugates 302 302f 308–310 309f

common methods for 308–310

Proteolytic-induced epitope retrieval (PIER) 811

Proteomics 190–197

Proximity hybridization immunoassay 81–82

Proximity ligation immunoassay (PLAs) 81 82f

Proximity-induced hybridization 81–82

proximity hybridization immunoassay 81–82

proximity ligation immunoassay 81 82f

Prozone effect 152

PRRS. See Porcine reproductive and

respiratory syndrome

PRV. See Pseudorabies virus

PSA. See Prostate-specific antigen

Pseudo-Cushing 696

Pseudo-linear master curves 334

Pseudorabies virus (PRV) 629

Pseudo-vitamin D-deficiency rickets (PDDR) 710

Psychogenic infertility 724

PTH. See Parathyroid hormone

PTH-related protein 714

PTHrP. See Parathyroid hormone-

related protein

PTLD. See Post-transplant

lymphoproliferative disorder

Index Terms Links


PTT. See Postpartum thyroiditis

syndrome

PUL. See Pregnancy of Unknown

Location

Pulsatile secretion 429–430

Puncture site 430–431 434

Purchasing budget holder, immunoassay

product technologies purchased by 526

Purification, of MAbs 254

Pyoderma 930

Pyridinium cross-linked carboxy-

terminal telopeptides 717–718

Pyridinoline 717

Q

QC. See Quality control

QCM. See Quartz crystal microbalance

Q-dot labeling 193

QDs. See Quantum dots

Quadroma 255

Qualitative immunoassays 10 139–147

analyte in 139–140

antigen and antibody detection with 140

avidity testing 145

calibration for 144

clinical applications of 141–142 142f

cutoff value 143–144 143f

definition of 139–140

design of 142–146

development of 141–146

features of 139–142

format selection for 142–143

fourth generation of 140

gray zone of 141–145 143f 146f

by immunoelectrophoresis 344–345 344f

optimization of 143

quality control for 144

reagent choice for 143

Index Terms Links


Qualitative immunoassays (Cont.)

regulatory requirements for 141

ROC Curve 143–144 143f

types of 139

verification and validation of 145–146 146f

viral antibody 145

Quality assurance 441–454

IQC and EQA for 442 442t

POCT and 459–461

pre-analytical requirements for 441

Quality control (QC)

for ELISA 392

for fixation 359–360

for IgE assay 864

for POCT 462–463

in qualitative immunoassays 141 144

Quantification

of antibodies 50–53 51f–55f

of immunoassay product technologies

market 530

by in-gel immunochemistry 345–347 346f

by in-liquid immunochemistry 347–351 348f–349f

liquid-phase assays for 51

by particle enhanced

immunochemistry 351–352

solid-phase immunoassays for 51–53 51f–55f

Quantitation range 151

of infectious disease immunoassay 151–152

Quantitative airbrush-type dispensers 92

Quantitative immunoassays 10 139.

See also Semiquantitative assays

Quantitative predictions, of optimization

models 40–41

Quantum dots (QDs) 72 275

Quantum yield 271

Quartz crystal microbalance (QCM) 181t 184 205

Quervain’s subacute thyroiditis 676

Quinidine 950 950f

Index Terms Links


R

Rabbit MAbs 254

Race issues 429

Radial immunodiffusion 509

Radial partition immunoassay 511

Radiative energy attenuation (REA),

AxSYM 555–559 555f–558f

Radio immunoassay (RIA) 945

for epitope mapping 213

Radioactive labels 267–269

detection errors with 12

preparation of 267–269

Radioactivity, measurement of 267

Radioimmunoassay (RIA) 510

Radiolysis 267

Raman spectroscopy 76

Random-access analyzers

with bulk reagent packs 512–513

unitized systems 513

Rate constants

association 29–30

dissociation 29–30

Rate nephelometry 510

REA. See Radiative energy attenuation

Reaction kinetics limitations 296

Reagents

antibodies to 406

controls for 365

cross-reactivity of 408–409

for digital ELISA 234

in ELISA 384–387 391

interference from 235–236 236f


Reagent excess assays 35

See also Immunometric

immunoassays

Reagent limited assays 35

See also Competitive immunoassay

Index Terms Links


Receiver Operating Characteristic

(ROC) Curve 143–144 143f 666–667 667f

Receptor-ligand interaction, on

microarrays 296–297

Reciprocal plot 31 31f

Recombinant antibodies 256–260

altering characteristics of 259

bivalent and bispecific 259–260

cloning 257–258


gene amplification 256–257 257f

library construction for 256–258 257f

microarray binding of 299

propagation of 259

selection of 258–259 258f

synthetic 259

Recombinant Fab fragments 256–257

Recovery 21

accuracy and 21

calibration of 322

poor 501–503

Red blood cells 795

Reduced calibration curve 321–322

Reduced volume

kinetics of 178

low-concentration samples and 177 177t

Reference interval 661–663 662f

analytical goals 670


Reference laboratories 520

Reference materials 317

Reference method. See also Definitive

methods

free analyte immunoassay and 136

Reference range 661

Regression 323 325–326 326f

Deming 24 25f 25t

least squares 22–24 25f

Index Terms Links


Regression (Cont.)

linear 327

Regulations

immunoassay product technology use

and 519 531

for POCT 459–461

Reimbursement, immunoassay product

technology use and 518–519

Relative binding capacity 123

Relative error 151–152

Relative potency (RP) 16

Repeatedly reactive (RR) 141–142

Report points 210–211 212f

Reproducibility, of digital ELISA 237 238f

Reproductive status assessment 639–643 640f

Research, digital ELISA in 223

Research use only (RUO) 655–656

Residual outliers 332

Residual sum of squares error (RSSE) 326

Resistance to thyroid hormones (RTH) 678–679

Resistant ovary syndrome 723

Resonance energy transfer

bioluminescence 75

chemiluminescence 75

fluorescence 71–73 72f

time-resolved fluorescence 72–73

Response transformations 323–324 324f

Response units (RU) 210

Response-error relationship 324–325 324f

Response-surface model 418

Reticuloendotheliosis virus 638

Reverse phase chromatography (RPC) 311

Reverse transcriptase polymerase chain

reaction (RT-PCR) analysis 155

Reverse-phase protein microarrays

(RPPMs) 191 191f

RFs. See Rheumatoid factors

Rhesus (Rh) disease 761

Index Terms Links


Rheumatoid factors (RFs) 19 143 879

RIA. See Radio immunoassay;

Radioimmunoassay

Rickets 707

Ring test 340–341

RMS. See Root mean square

ROC Curve. See Receiver Operating

Characteristic Curve

Rocket electrophoresis 346 346f

Root mean square (RMS) 13

Rotavirus 926

RP. See Relative potency

RPC. See Reverse phase chromatography

RPPMs. See Reverse-phase protein

microarrays

RR. See Repeatedly reactive

RSSE. See Residual sum of squares error

RTH. See Resistance to thyroid

hormones

RT-PCR analysis. See Reverse

transcriptase polymerase chain

reaction analysis

RU. See Response units

Rubella 923–924

Rufer case 411–412

Ruminant immunoassay product

technologies

BHV-1 diagnosis with 632–633

BLV diagnosis with 633

Brucella abortus diagnosis with 632

BVDV diagnosis with 633–634

FMD diagnosis with 634

Mycobacterium bovis diagnosis with 635–636

Mycobacterium paratuberculosis diagnosis with 633

Neospora caninum diagnosis with 634

PAG assessment with 643

progesterone assessment with 642–643

TSE diagnosis with 634–635

Index Terms Links


RUO. See Research use only

Rutgeerts score 892

S

SAF. See Supercritical angle fluorescence

Safety biomarkers 649

Salmonella enteritidis 639

Salts, precipitation by 295

Sample application pad 90

Sample collection 427–440

amniotic fluid 438–439

blood by skin puncture 433–434

blood by venepuncture 430–432

cerebrospinal fluid 438

hair 439

milk 439

oral fluid 435–438

participant preparation for 427–429

semen 439

serum separators for 433

storage an d transportation 440

sweat 439

timing of 429–430

tube and stopper interference 432–433

urine 434–435

Sample interference 318

Sample tubes and cups, for random-

access analyzers 512

Sample type, of immunoassay product

technologies 525

SAMs. See Self-assembled monolayers

Sandwich assays 7 38

See also Enzyme-

linked immunosorbent assay;

Immunometric immunoassays


Sandwich format, for qualitative

immunoassays 142

Index Terms Links


Sarcoma 833

Saturation plot 32 32f

SAW. See Surface acoustic wave

Scatchard plot 30–31 30f–31f

equilibrium constant in 30 31f 32

Scatter plots 23 23f

SCC antigen. See Squamous cell

carcinoma antigen

scFv 257

Scintillant 267

Scintillation proximity assay (SPAs) 82–83 82f

Screening

aneuploidy 761–776 773f–774f 774t–775t

initial 395–396

MAbs 252–253

qualitative immunoassays for 141–142

for thyroid disease 691 691t

Screen-positive rate (SPR) 666

SEC. See Size exclusion

chromatography

Second antibody 7–8 301

in ELISA 389

precipitation 295

Secondary amenorrhea 723

Secondary amine 305 305f

Secondary hypogonadism

female 723

male 724

Secondary hypothyroidism 675

Secondary standards 320–321

SELDI-TOF MS. See Surface-enhanced

laser-desorption/ionization time-of-

fight MS

Selective antibody immunometric assay 63 63f

See also Universal selective

antibody system

Selective Antibody System 63 63f

Index Terms Links


Selectively infective phage (SIP)

technology 258–259

Selectivity 152


Selenium, colloidal 279

SELEX. See Systematic evolution of

ligands by exponential enrichment

Self-assembled monolayers (SAMs) 298

Self-assembling protein microarrays 192

Self-powered integrated microfluidic

blood analysis system (SIMBAS) 189 189f

Semen 439

Semiquantitative assays 140

regulatory requirements for 141

Sensitivity 11 11f

of ambient analyte assay 109

analytical 11

antibodies and 48 48f

antibody occupancy 39–40 40f

competitive assay design and 41–47 42f–44f 46f

determinants of 38–50

of digital ELISA 236–237 237f

estimation and 38–39 39f

functional 11

in immunoassay development 422

of immunoassay product technologies 526

immunometric assay design and 47–49 48f–50f

labeled antibody equilibrium constant and 48–49 49f–50f

for method evaluation 397 400–401

of microspot assays 113–116 114f–116f

nonspecific binding and 43–45 44f 45t 49

49f–50f

poor 503–505

of qualitative immunoassays 140–141

specific activity of labeled antibody and 49 49f–50f

specificity and 664–665 665t

theoretical models and quantitative

predictions of 40–41

Index Terms Links


Sensorgrams 210–211 212f

Separation 7 287–300

with beads 292

electrokinetic 293

in ELISA 388–389

with glass and plastic particles 290–291

immunochromatography 292–293

interference in 20

liquid-phase 294–295

with magnetizable particles 291

with membrane fltration 292

microarray immunoassay 295–299

precision and 12

standardization of 320

in surface-coated solid phases 287–293

with tubes, wells, and microtitration

plates 291–292

washing 293–294

Western blot method 293

Separation efficiency 287

Serine 303

SeroMAP microspheres 157–158

SERS. See Surface-enhanced Raman

scattering

Sertoli cell-only syndrome 724

Serum dilution

of FT4 129 130f

profiles of 130 130f

Serum preparation 431–432

Serum proteins 127–128 127f

Serum tartrate-resistant acid

phosphatase 718

Sex chromosomal aneuploidy 759

Sex hormone-binding globulin (SHBG)

in androgen disorders 746 749–750

in fertility 722

SGA. See Small for gestational age

SH mode. See Shear horizontal mode

Index Terms Links


SHBG. See Sex hormone-binding

globulin

Shear horizontal (SH) mode 205–206 205f

Shewhart control charts. See Levey–

Jennings control charts

Shiga-toxin producing E. coli (STEC) 933

Sialyl Lewis. See Carbohydrate antigen 19–9

Sickle-cell disease 761

SID-MRM-MS. See Stable isotope

dilution-MRM-MS

Signal generation 7 267–285

advances in 521

amplification strategies for 279–282 281f

assay drift with 26

bioluminescence 278

direct chemiluminescence 276–278 277f

direct fluorescence 274–275 275f

in ELISA 389–390

enzyme labels for 268t 269–274

long wavelength fluorescence 275

micro and nanoparticle labels 278–279

in micro- and nanoscale

immunoassays 180–181

microarrays 283

miniaturization 282–283

multiple analytes and 282–283

phosphorescence for 278

protein A 279

radioactive labels for 267–269

streptavidin/avidin–biotin 279 280f

time-resolved fluorescence 275–276 276f

Signal level, troubleshooting guide for 482–484

Signal transduction, for POC

diagnostics 103–105

Signal-to-noise ratio 38–39

compound detection and 204

in micro- and nanoscale

immunoassays 180–181

Index Terms Links


Silent ischemia 817–818 818f

Silver enhancement 278

SIMBAS. See Self-powered integrated

microfluidic blood analysis system

SiMoA. See Single molecule array

Single molecule array (SiMoA) 223–224

analytical sensitivity with 225f 226–228 228f 228t

dynamic range with 228–229 228f

enzyme detection by 232

Single radial immunodiffusion 346 346f

Single-site immunometric assays 36–37 36f

SIP technology. See Selectively infective

phage technology

Sips plot 32 32f

Sirolimus 960

SISCAPA. See Stable isotope standards

with capture by anti-peptide

antibodies

Sitagliptin 649

Size exclusion chromatography

(SEC) 311

See also Gel fltration

chromatography

Slide agglutination 509

Slitting, for manufacture of LFIAs 93

SLO. See Smith–Lemli–Opitz syndrome

Small for gestational age (SGA) 760

Small molecules

anti-complex immunoassay for 61–62 62f

non-competitive immunoassays for 61–65

selective antibody immunometric assay for 63 63f

universal selective antibody system for 63–65 64f–65f

xMAP microspheres for 157–158 158f

Small molecule–small molecule

conjugates 302 302f

Smith–Lemli–Opitz syndrome (SLO) 761–762

Smoking 428

Soaking 294

Index Terms Links


Sol particle immunoassays (SPIAs) 68

Solid phase 7 287

antibody capture to 19

binding to 297

covalent attachment of proteins to 290

RIA with 510

separation of surface-coated 287–293

settling of 26

three-dimensional 298–299

Solid-phase immunoassays

ELISA 384–387

kinetic constraints of 54–56 56f–57f

for quantification of antibodies 51–53 51f–55f

special considerations for 53–56

surface immobilization effects of 53–54

Solubilization 294

Soluble ST2 (sST2) 828–829 829f

Solvents, precipitation by 295

Somatostatin (SST) 898–899

SPAs. See Scintillation proximity assay

SPDP. See N-Succinimidyl-3–(2–

pyridyldithio) propionate

Specific activity

sensitivity and 49 49f–50f

of tracer 269

Specificity 7 11 15–20 152

of antibodies 29

with anti-complex immunoassay 62

of digital ELISA 233–234

in immunoassay development 422

of immunoassay product technologies 526



with multiple binding assay system 62

of qualitative immunoassays 140–141

sensitivity and 664–665 665t

Index Terms Links


Specimens

antigen retrieval 362–364

decalcification 361–362

formats for 357–358

storage of 361

Spectroscopy

EPR 70 70f

FCCS 75

FCS 75

Sperm 724

SPIAs. See Sol particle immunoassays

Spin immunoassays 70 70f

Spina bifida 759

SPR. See Screen-positive rate; Surface

plasmon resonance

SPR biosensors 210–213

binding site analysis 213–215

concentration analysis 218–220

direct bindin g assays 218–219 218f–219f

immobilization 212 212f

inhibition assays 219–220 220f

in kinetic analysis 215–217 216f–218f

sensorgrams and report points 210–211 212f

surface activity and 212–213 212f

technology of 210 211f

Squamous cell carcinoma (SCC) antigen 849

SSE. See Sum of squares error

SST. See Somatostatin

sST2. See Soluble ST2

Stability


in SPR biosensors 212

Stability early 211

Stability late 211

Stabilization 294

Stable angina pectoris 817–818 818f

Stable isotope dilution-MRM-MS

(SID-MRM-MS) 193–194

Index Terms Links


Stable isotope standards with capture by

anti-peptide antibodies (SISCAPA) 193–194

Standard curve 9 323

Standard dilution concentrations 329 331f

Standard material 317–318

Standard matrices 321

Standardization 315–320

differences of 318–320

for ELISA 392

of micro- and nanoscale

immunoassays 180

Statistical method 663 663f 664t

Statistical power 663 663f 664t

STEC. See Shiga-toxin producing

E. coli

Stein–Leventhal syndrome 745

Steroids 985–986 986f

Steroid sulfatase (STS) deficiency 762

Steward-Petty plot. See Reciprocal plot

Sticking coefficient 54–56

Stillbirth 760

Stokes’ shift 271

Stored calibration curve 321–322

Stratus CS Acute Care STAT

Fluorometric Analyzer 545–548 546f



assay protocol for 545

calibration of 546




separation for 547


Strength of binding 29

Streptavidin 292

Streptavidin-based macromolecular

complexes 279

Index Terms Links


Streptavidin–biotin 279 280f

Streptococcal toxic shock syndrome (STSS) 929

Streptococcus pyogenes 929–930

Stress

mechanism of 695

in participant preparation 427

Striational antibodies 887

Strongyloides 941

STS. See Steroid sulfatase

STSS. See Streptococcal toxic shock

syndrome

STW mode. See Surface transverse wave mode

Substrate 8

Substrate-linked fluorescence

immunoassay 79

N-Succinimidyl-3-(2-pyridyldithio)

propionate (SPDP) 307–308 308f

Sum of squares error (SSE) 325 326f

Supercritical angle fluorescence (SAF) 182

Super-laboratories 520

Surface acoustic wave (SAW) 205–206 205f

Surface activity, of SPR Biosensors 212–213 212f

Surface immobilization effects, of solid-

phase immunoassays 53–54

Surface plasmon resonance (SPR) 209–222

binding site analysis 213–215

biosensor technology 210–213

concentration analysis 218–220

direct binding assays 218–219 218f–219f

inhibition assays 219–220 220f

in kinetic analysis 215–217 216f–218f

in on-chip detection methods 181t 183

protein interactions 209–210

Surface tension 176

in miniaturization 176–177

Surface transverse wave (STW) mode 205–206 205f

Index Terms Links


Surface-coated solid phase separation 287–293

beads 292

covalent attachmen t of proteins 290

electrokinetic 293

glass and plastic particles 290–291

immunochromatography 292–293

magnetizable particles 291

membrane filtration 292

protein binding to plastic surfaces 287–290 289f

tubes, wells, and microtitration plates 291–292


Surface-enhanced laser-desorption/

ionization time-of-fight (SELDI-TOF) MS 193–194

Surface-enhanced Raman scattering (SERS) 76

in on-chip detection methods 181t 182–183

Sweat 439

Swine influenza virus 630–631

Synthetic recombinant antibodies 259

Syphilis 930

Systematic evolution of ligands by

exponential enrichment (SELEX) 99–100

Systemic candidiasis 942

T

T3. See 3,3´5–Triiodothyronine

T4. See Thyroxine

Tacrolimus 960–961

µTAS. See Micro total analysis systems

TBG. See Thyroxine-binding globulin

TDM. See Therapeutic drug monitoring

Technical considerations, for automated

analyzers 467

Technical validation, for POCT 461–462

Test menu considerations, for automated

analyzers 466–467

Test throughput, for random-access

analyzers 512

Index Terms Links


Testosterone

in androgen disorders 746 748–749

in fertility 722 731–733 731f–732f 732t

free 750–751 751f

Tetradroma 255

Tg. See Thyroglobulin

TgAb. See Thyroglobulin antibodies

Thalassemia 761

Theophylline 951 951f

Theoretical models

applicability of 50

experimental performance and 57–58

of optimization 40–41

Therapeutic drug monitoring (TDM) 945–962

antiarrhythmic agents 948–950

antibiotics 951–953

anticonvulsants 953–958

assay technology for 945–947

free drug concentration measurement 947

immunosuppression drugs 958–961

practical aspects of 947–948

respiratory system drugs 951

Thermal enhancement 294

Thermal lens microscope (TLM)-based

detection 181t 182

Thermodynamic principles, of

immunoassay 30

Thiazolidinediones 649

Thickness-shear mode (TSM) 205

Thiols 303 303f

Threatened abortion 757–758 767–768

Three-dimensional solid phase 298–299

Threonine 303

Thrombocytopenia 796

Thrombophilia 805–806

Thrombosis 797 805 805t

Thrombus 818

Thyroglobulin (Tg) 687–689

Index Terms Links


Thyroglobulin antibodies (TgAb) 687 687f

Thyroid 673–694

analytes 679–689


drugs and 677–678

hyperthyroidism 675–676

hypothyroidism 673–675

medullary carcinoma of 708–709

normal function of 673 673f

testing strategies for 689–692 690f

Thyroid dysgenesis 674

Thyroid peroxidase antibodies (TPOAb) 686–687 686f

Thyrotoxicosis factitia 676

Thyrotropin 679–681 680f

Thyrotropin receptor antibodies (TRAbs) 684–686 686f 882

Thyrotropin-releasing hormone (TRH), test 728

Thyroxine (T4) 681 681f

See also Free

thyroxine

endogenous antibodies to 678

feline and canine immunoassay

product technologies assessing 640–641

free hormone concentration of 123

FT4 and protein bound 129 129f

measurement of 123

L-Thyroxine replacement therapy 678

Thyroxine-binding globulin (TBG) 123

FT4 and 127 127f

Time-resolved amplified cryptate

emission (TRACE) 72–73

Time-resolved fluorescence (TRF) 275–276 276f 511


identification 648

Time-resolved fluorescence resonance

energy transfer (TR-FRET) 72–73

Timing of sample collection 429–430

Tissue microarray (TMA) 360–361

Tissue plasminogen activator (t-PA) 795–796

Index Terms Links


TK assessment. See Toxicokinetic

assessment

TLM. See Thermal lens microscope

TMA. See Tissue microarray

TMNG. See Toxic multinodular goiter

Tobramycin 952–953 953f

Tolerization 247

Topiramate 957 957f

Total serum IgE 860–861

Tourniquet 431

Toxic adenoma 675–676

Toxic multinodular goiter (TMNG) 675

Toxicokinetic (TK) assessment 650–653 650t–651t

Toxoplasma gondii 939

Toxoplasmosis 939

t-PA. See Tissue plasminogen activator

TPOAb. See Thyroid peroxidase

antibodies

TRAbs. See Thyrotropin receptor

antibodies

TRACE. See Time-resolved amplified

cryptate emission

Tracers 7 35

See also Radioactive labels

Tramadol 983 983f 984t

Transducer 203–204

Transferrin 795 803

receptors 803–804

Transmissible spongiform

encephalopathies (TSE) 634–635

Transplantation monitoring, infectious

disease immunoassay for 153–155

Transport proteins 123

Transthyretin (TTR) 123

TRAP5. See Type 5 tartrate-resistant

acid phosphatase

Treponema pallidum 930

TRF. See Time-resolved fluorescence

Index Terms Links


TR-FRET. See Time-resolved

fluorescence resonance energy

transfer

TRH. See Thyrotropin-releasing

hormone

Triage Meter 543 543f

Triage System 541–544


assay device of 542–543 542f–543f

calibration of 543


fluorescence energy transfer dye

system of 541 542f

multianalyte measurements of 543 544f


quality control of 544

symptom-based diagnostic panels of 544

Triage Meter 543 543f

user protocol for 541

Trichomonas vaginalis 940

Tricyclic antidepressants 961–962

3,3´5–Triiodothyronine (T3) 683 683f

endogenous antibodies to 678

free hormone concentration of 123

Trinitrotoluene, detection of 64f 65

Trioma 255

Trisomy 13 759

Trisomy 18 759

Trisomy 21 758

Tritium labels, detection errors with 12

Troubleshooting guide 469–506

assay drift 481–482

between-assay precision 478–481

for binding 484–491

clinical classification 494–497

commercial controls 472–473

competitive immunoassay 484–491

control bias 470–471

Index Terms Links


Troubleshooting guide (Cont.)

control value change 471–472

for estimated dose 488–491

for high non-specific binding 491–493

immunometric immunoassay 486–487

for linearity of dilution 493–494

low signal level 482–484

patient sample concentrations 499–501

poor assay sensitivity 503–505

poor correlation 505–506

poor recovery 501–503

proficiency testing 473–476

reference interval 497–499

within-assay precision 476–478

Trypanosoma cruzi 940

Tryptophan 303

TSE. See Transmissible spongiform

encephalopathies

TSM. See Thickness-shear mode

TTR. See Transthyretin

Tuberculosis 635–636

Tularemia 937–938

Turbidimetry 67

Turner’s syndrome 723 759

Two-site immunometric assays 37–38 37f–38f 296

Two-step method. See Back-titration

method

Type 1 diabetes 783

Type 2 diabetes 783

Type 5 tartrate-resistant acid

phosphatase (TRAP5) 718

Tyrosine 303

U

UBT. See Urea breath test

UCP. See Urine C-peptide

Ultrafiltration 312

Unitized random-access systems 513

Index Terms Links


Universal selective antibody system 63–65

applications of 64f–65f 65

components of 63 64f

Unmasking. See Antigen retrieval

Up-conversion 278

Upconverting particles (UPs) 73

Up-Converting Phosphor Technology (UPT) 278

Up-converting phosphors 73

UPs. See Upconverting particles

UPT. See Up-Converting Phosphor

Technology

Urea breath test (UBT) 933

Urine collection 434–435

Urine C-peptide (UCP) 786

User convenience, of immunoassay

product technologies 525–526

V

Vaccination, infectious disease

immunoassay and 153

Vaccine immunity studies 151

Vacuum depression 294

Valence 32

Validation

for ELISA 392

of infectious disease immunoassay 151–152

for POCT 461–462

of qualitative immunoassays 145–146 146f

Validity tests, for free analyte

immunoassay 135–136

Valproic acid 957–958 958f

Vancomycin 953

Varicella 924

Vasoactive intestinal peptide 899

VDJ gene 247

VeraCode 195

Verification, of qualitative

immunoassays 145–146 146f

Index Terms Links


Vertical separation, for LFIAs 97 97f

Veterinary diagnostic testing


used in 623–646 624f 624t 626f

626t 640f

infectious disease diagnosis and

immune status assessment 623–639 624f 624t 626f

626t

reproductive and metabolic status

assessment 639–643 640f

Viral antibody, in qualitative

immunoassays 145

Viral diseases 919–927

Viral IgM testing 140

Viral orchitis 724

Virilization 745



Virus-like particles (VLPs), epitope

mapping of 214

Viscosity 176

in miniaturization 176–177

Vitamin B12 797–801 798f 799t 800f

Vitamin D

disorders of 707–708

metabolites of 709–712 709t

VITROS 350 Chemistry System 585–588 585f








separation for 588


Index Terms Links


VITROS 3600 Immunodiagnostic

System 579–584 579f–580f




calibration of 581



product features of 580–581 581f

separation for 582

signal generation and detection by 582–583

VITROS 4600 Chemistry System 585–588 585f








separation for 588


VITROS 5600 Integrated System 579–588 580f 586f

antibodies used in 582 588

assay principle of 581 582f–583f 586–587 587f

assay protocol of 579–580 580f 586

calibration of 581 587–588

data processing of 583 588

LIS interfacing of 584 588

product features of 580–581 581f 586

separation for 582 588

signal generation and detection by 582–583 588

VITROS ECiQ Immunodiagnostic

System 579–584 579f–580f




calibration of 581


Index Terms Links


VITROS ECiQ Immunodiagnostic

System (Cont.)


product features of 580–581 581f

separation for 582

signal generation and detection by 582–583

VJ gene 247

VLPs. See Virus-like particles

Von Willebrand disease 806

Von Willebrand factor (vWF) 795–796

W

Warfare agents 203

Washing

in ELISA 388–389

of interfering substances 293–294

mechanics of 294

for microarrays 299

for separation 293–294

Weighted least squares regression 327–329

Weighted SSE (wSSE) 325–326

West Nile Virus (WNV) 926


Westgard rules 446 447t

Wettability 176–177

Wetting 176–177

White blood cells 795

Whole blood 432

Wick 90

Within-assay imprecision 399


Within-method precision 13

Within-run precision 12 444 444f

WNV. See West Nile Virus

Worklist, for random-access analyzers 512

WOUNDCHECK 203

wSSE. See Weighted SSE

Index Terms Links


X

xMAP Technology 157 194–195

assay development for 160–165 160t

buffers for 160–161 160t

commercial applications and platforms 172 172t

competitive immunoassay with 169–171 170f

immunometric immunoassays with 165–168 167f

immunometric with competitive 171–172

indirect immunoassays with 168–169 168f

Luminex analyzers 158–160 159f

microspheres 157–158 158f

Z

Zollinger–Ellison syndrome (ZES) 898

Zonisamide 958 958f

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