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KITS AND REAGENTS

Quidel is a leading manufacturer of diagnostic healthcare solutions serving toenhance the health and well-being of people around the globe through the

development of diagnostic solutions that can lead to improved patient

outcomes and provide economic benefits to the healthcare system.

Our product base and technology platforms have continued to expand

through internal development and acquisitions of other products and

technologies allowing for a core competency that includes:

Immuno and molecular assay development

Automated manufacturing lateral flow (LF) technologies

Direct fluorescent antibodies(DFA) production

Monoclonal antibody characterization

Quidel Specialty Products is the option for all your research, biosafety, and

cytotoxicity testing needs. Quidel MicroVue products are a well-established

name in immune system monitoring, assays for the assessment of

Complement activation, as well as biochemical bone markers. Quidel offers

products to meet biosafety testing and Complement dependent cytotoxicity

testing needs, such as normal human sera, cobra venom factor and

Complement fragment assays. ELISA assays, depleted sera, proteins,

monoclonal and polyclonal antibodies, antisera, antigens, controls, and

special reagents are also available to round-out a comprehensive laboratory

portfolio.

Quidel Specialty Products is the option for all yourresearch, biosafety and cytotoxicity testing needs.

Research to RapidsThe Complement System consists of more than 30 fluid and membrane-bound proteins organized into four

primary pathways: the Classical, Alternative, Lectin and Terminal.1 By a series of specific activation steps via

either the classical, alternative, or the lectin pathway, the complement proteins mediate a set of activities

ranging from the initiation of inflammation, clearance of immune complexes, disruption of cell membranes, and

regulation of the immune response. Deficiencies in the complement cascade can predispose individuals to

infection through ineffective opsonization or defects in the ability to lyse invading pathogens. Conversely, the

inflammation promoted by activation of the complement system can lead to tissue damage, such as in ischemia

reperfusion injury, if not kept in check. Complement proteins and fragments are also believed to play a role in

several autoimmune diseases including rheumatoid arthritis, SLE and acute glomerulonephritis.2

DIAGNOSTIC EIA KITSFor In Vitro Diagnostic Use*

Diagnostic kits and controls for assessment of twotypes of circulating immune complexes (CIC),diagnosis of hereditary angioedema (HAE) andmeasurement of total classical pathway activity.

Catalog # Qty Description A001 (CE) 1 kit MicroVue CIC-C1q EIA (Detection

of C1q-binding circulating immunecomplexes)

A002 (CE) 1 kit MicroVue CIC-Raji Cell ReplacementEIA (Detection of C3d-boundcirculating immune complexes)

A013 (CE) 1 set MicroVue ClC-C1q ControlsA018 (CE) 1 kit MicroVue CH50 Eq EIA (Classical

complement pathway activity)A027 (CE) 1 kit MicroVue Bb Plus Fragment EIA A037 (CE) 1 kit MicroVue C1-lnhibitor Plus EIA

(Functional C1-lnhibitor levels)

*All MicroVue Complement IVD products are also CE marked.

EIA KITS FOR COMPLEMENTACTIVITATION ANALYSIS

These kits allow for the analysis of activation of keyproteins and specific pathways of the complementsystem in serum, plasma, and other biological fluids.

Catalog # Qty Description A006 1 kit MicroVue iC3b EIA**

(For C3 activation)A008 1 kit MicroVue C4d Fragment EIA**

(For C4 and classical pathway)A020/A029 (CE) 1 kit MicroVue SC5b-9 Plus EIA**

(For MAC assembly, TCC, C5 andterminal pathway activation)

A021/A025 (CE) 1 kit MicroVue C5a EIA***A031/A032 (CE) 1 kit MicroVue C3a Plus EIA***

(For C3 activation)A033/A034 (CE) 1 kit MicroVue Ba Fragment EIA**A035/A036 (CE) 1 kit MicroVue C4a Fragment EIA**A039/A040 (CE) 1 kit MicroVue Factor H EIA**20261 1 kit MicroVue Pan-Specific C3

Reagent Kit**BP029 1 kit MBL Oligomer EIA**TE1038 1 kit C3a Mouse**

EIA KITS FOR ASSESSMENT OFPREKALLIKREIN ACTIVATOR LEVEL

Assay kits for the determination of PrekallikreinActivator levels in biological fluids.

Catalog # Qty Description PW30100 1 kit Prekallikrein Activator (PKA)

Assay Kit**PW301EP 1 kit Prekallikrein Activator (PKA)

EP Assay Kit**PW30200 1 kit Prekallikrein Activator (PKA)

Ig Assay Kit**PW302EP 1 kit Prekallikrein Activator (PKA)

Ig EP Assay Kit**PW51005 5 x 0.5 mL Just Positive PKA ControlPW52005 5 x 0.5 mL High Positive PKA Control**For Research Use Only. Not for use in diagnostic procedures.***For Research Use Only in the United States. Not for use indiagnostic procedures. CE marked.

References 1Liszewicki, MK and Atkinson, JP. The Complement System.In: Fundamental Immunology. Paul, WE (ed.) (1993).2Botto, M et al. Complement in human diseases: Lessonsfrom complement deficiencies. Mol. Immunol. 46(4):2774-2783 (2009).

SPECIAL COMPLEMENT REAGENTSCatalog # Vol./Vial Description A100 1.0 mL Human Complement Standard††

(normal human serum)A112 2.5 mL Normal Human Serum ComplementA113 5.0 mL Normal Human Serum ComplementA114 0.2 mL Complement Activator (heat

aggregated gamma globulin)A115 1 Panel Complement Sample Panel (10

Samples x 25 µL)A119 5.0 mL Guinea Pig Serum ComplementA121 2.0 mL Guinea Pig Serum ComplementA600 1.0 mg CVF, Cobra Venom Factor (Naja naja

kaouthia)†A9576 25.0 mL Specimen Stabilizing Solution†>350 units/vial††The Human Complement Standard comes with a data sheetindicating the functional activity and antigen levels of each of themajor complement proteins.

HUMAN COMPLEMENT REAGENTS: ANTISERAFor Research Use OnlyQuidel’s complement antisera are raised in goats andare quality controlled for specificity byimmunochemical analysis. Each contains 0.02%sodium azide.

Catalog # Vol./Vial Description A300 2.0 mL Anti-human C1-lnhibitorA301 2.0 mL Anti-human C1qA302 2.0 mL Anti-human C1sA303 1.0 mL Anti-human C2 (Ig Fraction)A304 2.0 mL Anti-human C3A305 2.0 mL Anti-human C4A306 2.0 mL Anti-human C5A307 2.0 mL Anti-human C6A308 2.0 mL Anti-human C7A309 2.0 mL Anti-human C8A310 2.0 mL Anti-human C9A311 2.0 mL Anti-human Factor BA312 2.0 mL Anti-human Factor HA313 2.0 mL Anti-human Factor I

BIOTINYLATED MONOCLONAL ANTIBODIESFor Research Use OnlyEach monoclonal antibody has been purified fromascites fluid and labeled with biotin. The proteinconcentration of each is approximately 0.2 mg/mL.

Catalog # Vol./Vial Description A700 250 µL Anti-human C1qA701 250 µL Anti-human C3cA702 250 µL Anti-human C3dA703 250 µL Anti-human C4cA704 250 µL Anti-human C4dA705 250 µL Anti-human C5A706 250 µL Anti-human C6A707 250 µL Anti-human C7A708 250 µL Anti-human C8A709 250 µL Anti-human C9A710 250 µL Anti-human iC3b (neoantigen)A711 250 µL Anti-human SC5b-9 (neoantigen)A712 250 µL Anti-human Factor B (Bb)

CUSTOM PRODUCTSFor more information about customized or non-catalog product possibilities, please contact Quidel oryour local representative.

HUMAN COMPLEMENT REAGENTS: PROTEINSFor Research Use OnlyEach complement protein has been tested forfunctional purity in standard hemolytic assays and forbiochemical purity by SDS-polyacrylamide gelelectrophoresis. The concentration of eachcomplement protein, except for Factor D and C3a, isapproximately 1.0 mg/mL.

Catalog # Vol./Vial Description A400 1.0 mL C1q†A401 250 µL C3A402 250 µL C4A403 250 µL C5A404 250 µL C6A405 250 µL C7A406 250 µL C8A407 250 µL C9A408 250 µL Factor BA409 250 µL Factor D††A410 250 µL Factor HA411 250 µL Factor IA412 250 µL Factor PA413 50 µL C3bA414 100 µL C3aA415 100 µL SC5b-9 Complex

†In phosphate buffered saline containing 40% glycerol.††The protein concentration for Factor D is 0.1 mg/mL.

COMPLEMENT REAGENTS: DEPLETED OR DEFICIENT SERA

For Research Use OnlyExcept for the C3-dpl, C3/C4-dpl and the C4-deficientguinea pig sera, a specific complement protein hasbeen removed immunochemically from each depletedhuman serum reagent. Depleted sera are well suitedfor the detection and quantitation of hemolyticallyactive complement proteins. Except for the specificallydepleted component, the classical and alternativepathways are intact.

Catalog # Vol./Vial Description A500 1.0 mL C2-dplA501 1.0 mL C5-dplA502 1.0 mL C6-dplA503 1.0 mL C7-dplA504 1.0 mL C8-dplA505 1.0 mL C9-dplA506 1.0 mL Factor B-dplA507 1.0 mL C4-deficient (guinea pig)A508 1.0 mL C3-dplA509 1.0 mL C1q*-dplA512 1.0 mL Factor P-dplA521 1.0 mL C3/C4-dplA522 1.0 mL C4-dplA523 1.0 mL Factor I-dplA524 1.0 mL Factor H-dpl

HUMAN COMPLEMENT REAGENTS:MONOCLONAL ANTIBODIES

For Research Use OnlyEach monoclonal antibody has been purified frommouse ascites fluid and tested for purity by SDS-polyacrylamide gel electrophoresis. The proteinconcentration of each is approximately 1 mg/mL inborate buffered saline with 0.1% sodium azide.

Catalog # Vol./Vial Description A201 100 µL Anti-human C1qA203 100 µL Anti-human C3aA205 100 µL Anti-human C3 (C3c)A207 100 µL Anti-human C3 (C3d)A209 100 µL Anti-human iC3b (neoantigen)A211 100 µL Anti-human C4 (C4c)A213 100 µL Anti-human C4 (C4d)A215 100 µL Anti-human C4 binding proteinA217 100 µL Anti-human C5A219 100 µL Anti-human C6A221 100 µL Anti-human C7A223 100 µL Anti-human C9A225 100 µL Anti-human Factor B (Ba)A227 100 µL Anti-human Factor B (Bb)A229 100 µL Anti-human Factor H#1A231 100 µL Anti-human Factor I#2A233 100 µL Anti-human Factor P#1A235 100 µL Anti-human Factor P#2A237 100 µL Anti-human S-Protein (vitronectin)A239 100 µL Anti-human SC5b-9 (TCC neoantigen)A241 100 µL Anti-human Clusterin

(SP40, 40 andApo J)A247 100 µL Anti-human Factor I#1A249 100 µL Anti-human C8A250 100 µL Anti-human C3d (neoantigen)A251 100 µL Anti-human C4d (neoantigen)A252 100 µL Anti-human Bb (neoantigen)A253 0.5 mL Anti-human C4 (C4d)A254 100 µL Anti-human Factor H#2A255 100 µL Anti-human Factor H#3For information on specific monoclonal antibodies and theirapplications, contact Quidel technical service.

CIC-C1q

IVD

Circulating Immune Complex-C1q

A001 (CE)

96 wells

Serum/EDTA Plasma10 µL

1.0 µg Eq/mL

0.1–3.2%

0.3–3.9%

Am, Cm,Rm, B

3

0

2.5 hrs

Normal2.1 µg/Eq/mL

C1-INH Plus

IVD

Functional C1-Inhibitor Protein

A037 (CE)

96 wells


3.3–5.4%

5.7–10%

Rm, B

5

2

2 hrs

Normal≥68% mean normal

Equivocal41–67% mean normal

Abnormal≤40% mean normal

CH50 Eq

IVD

CH50

A018 (CE)

96 wells

Serum 14 µL

3.2–4.5%

5.4–8.7%

Cm

5

2

3.5hrs

Normal133±54 CH50 U

Eq/mL

Bb Plus

IVD

Bb Fragment

A027 (CE)

96 wells

Serum 25 µLEDTA Plasma 50 µL

0.018 µg/mL

0.033 µg/mL

0.836 µg/mL

2.4–4.0%

6.2–9.1%

P, Cm, Rm

5

2

1.5 hrs

Serum0.0–7.6 µg/mL

EDTA Plasma0.3–1.7 µg/mL

iC3b

RUO

iC3b Fragment

A006

96 wells

Serum/EDTA or Heparin Plasma

100 µL

None

3

2

1.5 hrs

None

CIC-Raji

IVD

Circulating Immune Complex-Raji Cell

Replacement

A002 (CE)

96 wells

Serum/Plasma10 µL

4.0 µg Eq/mL

3–9%

4–30%

None

5

2

2.5 hrs

Normal5.0 µg Eq/mL

SLE15.8 µg Eq/mL

RA13.7 µg Eq/mL

Marker

Cat. No.

Tests Per Kit

Specimen Volume

Limit of Detection

Lower Limit ofQuantitation

Upper Limit ofQuantitation

Intra-AssayVariation (CV)

Inter-AssayVariation (CV)

Animal Crossreactivity†

No. of Standards

No. of Controls

Total Assay Time

Sample Values

†Crossreactivity: (R) Rat, (M) Mouse, (Gp) Guinea Pig, (Rb) Rabbit, (Cm) Cynomolgous monkey, (Rm) Rhesus monkey, (B) Baboon, (P) Pig, (D) Dog, (S) Sh

Ba

RUO

Ba Fragment

A033 / A034 (CE)

96 wells

Serum 10 µLEDTA Plasma 25 µL

Urine 10 µL

0.011 ng/mL

0.033 ng/mL

3.239 ng/mL

2.2–3.3%

2.4–8.1%

Am, Cm, Rm, D

5

2

2.5 hrs

Serum436–3362 ng/mL

EDTA Plasma226–2153 ng/mL

Urine0.6–27 ng/mL

C4d

RUO

C4d Fragment

A008

96 wells


0.001 µg/L

0.022 µg/L

6.1–9.7%

8.5–11.2%

B

5

2

1.5 hrs

Serum0.0–9.7 µg/mL

EDTA Plasma0.0–7.7 µg/mL

C3a Plus

RUO

C3a Fragment(Anaphylatoxin)

A031 / A032 (CE)

96 wells


0.012 ng/mL

0.023 ng/mL

2.531 ng/mL

4.5–5.3%

5.9–19.6%

Am, Cm, Rm

5

2

2.5 hrs

Serum71–589.2 ng/mL

Plasma33.8–268.1 ng/mL

SC5b-9 Plus

RUO

SC5b-9

A020 / A029 (CE)

96 wells

Serum 10 µLEDTA or Citrated

Plasma 50 µL

3.7 ng/mL

8.8 ng/mL

1.6–6.8%

5.0–13.1%

Rm, B, Cm, Rb, Am, Pm

5

2

2 hrs

None

C5a

RUO


A021 / A025 (CE)

96 wells

Serum 10 µLEDTA or Citrated

Plasma 20 µL

0.01 ng/mL

0.05 ng/mL

3.5–3.9%

7.1–13%

None

5

2

2.5 hrs

Serum13.4–179 ng/mL

Plasma0.37–74.33 ng/mL

C4a

RUO


A035 / A036 (CE)

96 wells


0.29 ng/mL

5.0 ng/mL

61 ng/mL

3.7–4.3%

4.0–4.4%

Am, Cm, Rm

5

2

2.5 hrs

Serum20.9–4437 ng/mL

Plasma384–8168 ng/mL

Pan-Specific C3

RUO

Depletion of C3

20261

96 wells

Serum/Plasma20 µL

Bv, Ck, D, Gp,P, H, Mp, Rb,

R, S, T, M

0

1

3 hrs

None

heep, (G) Goat, (C) Cow, (H) Horse, (Ct) Cat, (Ck) Chicken, (Bv) Bovine, (Mp) Mini pig, (T) Turkey, (Am) African green monkey, (Pm) Pigtail monkey

Biochemical markers of bone resorption and formation reflect the underlying process of bone turnover and may

be useful in supplementing the information from bone mineral density (BMD) testing. Many studies have

confirmed the importance of various biochemical bone markers both in clinical monitoring and assessment of

patients at risk for osteoporosis and related diseases as well as in research into the nature of these states.

Examples of specific serum and urine markers that reflect overall bone turnover include total pyridinolines, and

free and total deoxypyridinolines, as well as newer markers like helical peptide. Formation markers include bone

specific alkaline phosphatase, carboxyterminal propetide of Type 1 collagen (CICP, PICP) and osteocalcin.

The Specialty Products Group at Quidel manufactures a variety of enzyme immunoassays or biochemical

markers of bone turnover that may be useful as independent predictors of fracture risk and rate of bone loss.

Branded under the MicroVue name, additional information regarding the breadth of tools and reagents for

bone health research can be found on our website.

Research to Rapids

DIAGNOSTIC EIA KITSFor In Vitro Diagnostic Use*

Diagnostic kits for assessment of bone/joint activity.

Catalog # Qty Description 8007 (CE) 1 kit MicroVue DPD EIA

Deoxypyridinoline crosslinks (urine)8010 (CE) 1 kit MicroVue PYD EIA

Pyridinium crosslinks (urine)8012 (CE) 1 kit MicroVue BAP EIA Bone

Alkaline Phosphatase8043 (CE) 1 kit MicroVue Calcitonin EIA

Calcitonin (1-32)8044 (CE) 1 kit MicroVue Intact PTH EIA

Intact Parathyroid Hormone (1-84) 8046 (CE) 1 kit MicroVue 25-OH Vitamin D EIA

Total 25-OH Vitamin D

*All MicroVue Bone IVD products are also CE marked

REAGENTSCatalog # Quantity Description 4634 1 each Streptavidin Coated 96-well Plate

(for biotinylated molecules)**4703 55 mL Wash Buffer Concentrate**4704 55 mL Assay Buffer**4838 1 each Hydrolysis Unit — 96-well heating

block with lid for use with 8032**4935 40/bag 30k MWCO Spinfilters**

ImmutopicsDiluent30-2531 10 mL Rat PTH Sample Diluent**30-3131 10 mL Human PTH Sample Diluent**30-6631 10 mL Human FGF-23 Sample Diluent**

CONTROLSCatalog # Quantity Description 4818 set of 4 CICP Controls – serum**4819 set of 4 Osteocalcin Controls – serum**4820 set of 4 BAP Controls – serum**4821 set of 4 YKL-40 Controls**4822 set of 4 Dpd Controls – urine**4823 set of 4 Pyridinoline Controls – urine**4824 set of 4 Pyridinoline Controls – serum**4936 set of 4 Helical Peptide Controls – urine** 8004 750 µL Pyd/Dpd HPLC Calibrator** 8006 5 mL HPLC Internal Standard**

EIA KITS FOR MARKERS OF DIABETESAND OBESITY

These kits allow for the assessment of markers fordiabetes and obesity.

Catalog # Quantity Description TE1011 1 kit Human Intact Proinsulin ELISA**

Proinsulin (intact)TE1016 1 kit Human Leptin ELISA** LeptinTE1014 1 kit Total Human Adiponectin ELISA**

Adiponectin (total)

EIA KITS FOR MARKERS OF BONE ANDTISSUE REMODELING

These kits allow for the analysis of bone markers andtissue remodeling in serum, plasma and otherbiological fluids.

Catalog # Qty Description 8002 1 kit MicroVue Osteocalcin EIA**

Osteocalcin (intact)8003 1 kit MicroVue CICP EIA** C-Terminal

Propeptide of type I Collagen8009 1 kit MicroVue Creatinine EIA**8019 1 kit MicroVue Serum PYD EIA**

Pyridinoline crosslinks (serum)8020 1 kit MicroVue YKL-40 EIA** YKL-408022 1 kit MicroVue Helical Peptide EIA**

Helical Peptide a1(I) 620-6338032 1 kit MicroVue tDPD EIA**

Total Deoxypyridinoline8033/8036 (CE) 1 kit MicroVue TRAP5b EIA**

Tartrate-resistant acid phosphatase 5b (TRAcP5b)

8034 1 kit MicroVue OPG EIA**Osteoprotegerin

TE1023HS 1 kit Human Sclerostin HS EIA**Sclerostin High Sensitivity

TE1018-2 1 kit Human Hyaluronic Acid Plus ELISA**Hyaluronic Acid (HA)

ImmutopicsHuman60-6600 1 kit Human Intact FGF-23 EIA**60-6100 1 kit Human FGF-23 (C Term) EIA**60-3000 1 kit Human Bioactive PTH (1-84) EIA**60-3100 1 kit Human PTH EIA**60-3900 1 kit High Sensitivity Human PTH

(1-34) EIA**60-4000 1 kit Anti-Human PTH (1-34)

Antibody EIA**Mouse and Rat60-6800 1 kit Mouse/Rat Intact FGF-23**60-6300 1 kit Mouse FGF-23 (C Term) EIA**60-2305 1 kit Mouse PTH 1-84 EIA**60-2700 1 kit Rat Bioactive Intact PTH EIA**60-2500 1 kit Rat Intact PTH EIA**60-1305 1 kit Mouse Osteocalcin EIA**60-1505 1 kit Rat Osteocalcin EIA**Porcine and Bovine60-3305 1 kit Porcine Intact PTH EIA**60-3500 1 kit Bovine Intact PTH EIA**Canine60-3800 1 kit Canine Intact PTH EIA**

ANTIBODIES AND ANTIGENSCatalog # Quantity Description 4817 0.1 mg Mouse Anti-CICP antibody**4807 0.02 mg H-Dpd**4811 0.1 mg Mouse Anti-Dpd antibody**4805 0.02 mg H-Pyd**4809 0.1 mg Mouse Anti-Pyd antibody** 4813 0.1 mg Mouse Anti-YKL-40 antibody** 4815 0.1 mg Rabbit Anti-YKL-40 antibody**A442 25 µg YKL-40 Purified Protein

**Sold in the U.S. for Research Use Only. Not for use in diagnostic procedures.

BAP

IVD

Bone specific alkaline

phosphatase (BAP)

8012 (CE)

96 wells

Formation

Serum 20 µL

0.7 U/L

2 U/L

140 U/L

3.9–5.8%

5.0–7.6%

Rb, Cm, Rm, B, P, D, S, G, C, H

6

2

3.5 hrs

Females(Ages 25–44)11.6–29.6 U/L

Males(Ages ≥25)

15.0–41.3 U/L

OC

RUO

Intact Osteocalcin

8002

96 wells

Formation

Serum 25 µL

0.45 ng/mL

4.8–10.0%

4.8–9.8%

Gp, Rb, Cm, P, S, G, C, H

6

2

3.6 hrs

Adult3.7–10.0 ng/mL

Ty

S

6

11

PYD

IVD

Pyridinoline(PYD)

8010 (CE)

96 wells

Resorption

Urine 50 µL

7.5 nmol/L

15 nmol/L

750 nmol/L

6.6–9.9%

3.9–11.2%

R, M, Gp, Rb, Cm, Rm, P, D, S, H

6

2

4 hrs

Females(Ages >25)

(premenopausal)16.0–37.0 nmol

PYD/mmolCreatinine

Males12.8–25.6 nmol

PYD/mmolCreatinine

Calcitonin

IVD

Calcitonin

8043 (CE)

96 wells

Inhibit Resorption

Serum 100 µL

1.0 pg/mL

2.8–5.7%

6.1–7.4%

None

6

2

5 hrs

Females0.1–10.9 pg/mL

Males0.2–27.7 pg/mL

Intact PTH

IVD

ParathyroidHormone

8044 (CE)

96 wells

Homeostasis

Serum/EDTAPlasma 25 µL

1.57 pg/mL

3.7–6.1%

2.8–3.6%

None

6

2

4 hrs

Adult10.4–66.5 pg/mL

Vitamin D

IVD

25-OH Vitamin D

8046 (CE)

96 wells

Resorption

Serum 50 µL

2.81 ng/mL

4.32 ng/mL

2.5–7.8%

4.3–9.2%

None

6

2

3 hrs

Adult(21–92)

4.9–88.6 ng/mL

DPD

IVD

Deoxypyridinoline (DPD)

8007 (CE)

96 wells

Resorption

Urine 50 µL

1.1 nmol/L

3 nmol/L

300 nmol/L

4.3–8.4%

3.1–4.8%

R, M, Gp, Rb, Cm, Rm, Sm, B, P, D, S, C, H

6

2

3 hrs

Females(Ages 25–44)3.0–7.4 nmol

DPD/nmolCreatinine

Males(Ages 25–55)2.3–5.4 nmol

DPD/nmolCreatinine

Marker

Cat. No.

Tests Per Kit

Bone/JointActivity

Specimen Volume

Limit of Detection

Lower Limit ofQuantitation

Upper Limit ofQuantitation

Intra-AssayVariation (CV)

Inter-AssayVariation (CV)

Animal Crossreactivity†

No. of Standards

No. of Controls

Total Assay Time

Sample Values

†Crossreactivity: (R) Rat, (M) Mouse, (Gp) Guinea Pig, (Rb) Rabbit, (Cm) Cynomolgous monkey, (Rm) Rhesus monkey, (Sm) Squirrel monkey, (B) Baboon, (P) Pig, (

CICP

RUO

ype I Collagen C-Terminal

8003

96 wells

Collagen Synthesis

Serum 25 µL

0.2 ng/mL

1 ng/mL

80 ng/mL

5.5–6.8%

5–7%

Rb, Cm, Rm,

6

2

4 hrs

Adult69–103 ng/mL

Children10–966 ng/mL

Helical Peptide

RUO

Type I Collagen a1 helical peptide

620-633

8022

96 wells

Resorption

Urine 20 µL

8 µg/L

4.0–8.1%

7.3–16.9%

R, M, Gp, Rb, Cm, Rm, B, P, D, S, G,

C, H, Ct

6

2

19–25 hrs

Adult50.7 µg/mmol

tDPD

RUO

Total Deoxypyridinoline

(DPD)

8032

96 wells

Resorption

Serum 100 µLUrine 50 µL

0.5 nmol/L

1 nmol/L

100 nmol/L

5.3–12.1%

10.1–16.8%

R, M, Gp, Rb, Cm, Rm, B, P, D, S,

C, H, Ct, Sq

6

2

23–25 hrs

Females(Ages 25–44)

2.56–4.79 nmol/L

Males(Ages 25–55)

2.25–4.44 nmol/L

Serum PYD

RUO

Pyridinoline(PYD)

8019

96 wells

Resorption

Serum 25 µL

0.4 nmol/L

6.3–14.8%

8.7–11.6%

R, M, Gp, Rm, B, P, D, C, H, Ct

1

2

20–26 hrs

Adult(25–55)

1.09–2.79 nmol/L

TRAP5b

RUO

Tartrate-resistant acid phosphatase

isoform 5b

8033 / 8036 (CE)

96 wells

Resorption

Serum/Heparin Plasma 50 µL

0.24 U/L

1.9–2.2%

2.0–3.0%

None

5

2

2 hrs

Females(Ages 30–44)

(premenopausal)2.9±1.4 U/L

(Ages ≥50)(postmenopausal)

4.3±1.5U/L

Males(Ages ≥20)4.0±1.4 U/L

OPG

RUO

Osteoprotegerin(OPG)

8034

96 wells

Resorption

Serum/Citrate, EDTA or Heparin Plasma

100 µL

0.13 pmol/L

2.1–3.5%

4.2–6.2%

Rm, B

6

2

3 hrs

Adult5.7±0.42 pmol/L

Sclerostin

RUO

Sclerostin

TE1023HS

96 wells

Formation

Serum/EDTA or Heparin Plasma

25 µL

0.009 ng/mL

0.058 ng/mL

3.5 ng/mL

3.7–4.2%

4.3–4.8%

None

6

2

5 hrs

Females(premenopausal)

0.50 ng/mL

(postmenopausal)0.45 ng/mL

Males0.59 ng/mL

Hyaluronic Acid

RUO

Hyaluronic Acid

TE1018-2

96 wells

Homeostasis

Serum/EDTA Plasma 100 µL

2.7 ng/mL

2.8–2.9%

4.7–6.5%

None

6

2

3 hrs

Females(premenopausal)

20.1 ng/mL

(postmenopausal)50.3 ng/mL

Males42.6 ng/mL

D) Dog, (S) Sheep, (G) Goat, (C) Cow, (H) Horse, (Ct) Cat, (Ch) Chimpanzee, (Sq) Squirrel

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