Biomedical Biomedical Diagnostics 1Diagnostics 1

Ch.1 related dataCh.1 related data

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INTEGRATING LAB DATAINTEGRATING LAB DATAINTO TCM PRACTICEINTO TCM PRACTICE

Healthcare:Healthcare:ComplexComplexDriven by technologyDriven by technologyTests help formulate strategyTests help formulate strategyRecognize Red FlagsRecognize Red FlagsPrepare for evidence based practicePrepare for evidence based practice

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HIPPA AND LAB REPORTSHIPPA AND LAB REPORTSCovers sharing of lab reportsCovers sharing of lab reportsDNA tests?DNA tests?Web based tests?Web based tests?Point of Care (POC) testsPoint of Care (POC) testsCLIA CLIA (Clinical laboratory Improvement Act 1988)(Clinical laboratory Improvement Act 1988)CLIA WaivedCLIA Waived

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USING LABORATORY USING LABORATORY DATADATACLINICIAN’S TASK-CLINICIAN’S TASK-Make reasoned decisions- Make reasoned decisions- In certain situations diagnostic tests are In certain situations diagnostic tests are mandatedmandated

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Categories of testingCategories of testing

ScreeningScreeningDiagnosticDiagnosticPatient Patient managementmanagement

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SCREENINGSCREENINGHelps in identifying risk factors-Helps in identifying risk factors-

In early detection of “occult” In early detection of “occult” diseases-diseases-

Benefits, Costs and Risks must be Benefits, Costs and Risks must be consideredconsidered

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CRITERIA FOR SCREENINGCRITERIA FOR SCREENINGPOPULATION:POPULATION:NATURE OF THE DISEASE:NATURE OF THE DISEASE:TEST CHARACTERISTICS:TEST CHARACTERISTICS:GOOD SENSITIVITY & SPECIFICITYGOOD SENSITIVITY & SPECIFICITYLOW COST AND RISKLOW COST AND RISKHome Test Kits- Txt Book Table 1-4 page 13Home Test Kits- Txt Book Table 1-4 page 13

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0

0.05

0.1

0.15

0.2

0.25

0.3

0.35

0.4

0.45

-3 -2 -1 0 1 2 3

Standardized Score (Z-score)

Heig

ht o

f Cur

ve

Bell Curve and Standard Deviation (SD)

Page 5

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REFERENCE RANGEREFERENCE RANGEMethod and laboratory specificMethod and laboratory specificReflects results found in 95% Reflects results found in 95% of a healthy populationof a healthy populationMeans 5% will have ‘false Means 5% will have ‘false positive’ resultspositive’ resultsTherefore ‘borderline’ results Therefore ‘borderline’ results must be viewed criticallymust be viewed critically

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Main Criteria (page 7-9)Main Criteria (page 7-9)

Sensitivity Sensitivity &&SpecificitySpecificity

SensitivitySensitivity- Sensitivity= TP/(TP Sensitivity= TP/(TP +FN)+FN)

SpecificitySpecificity- Specificity= TN/(TN + Specificity= TN/(TN + FP)FP)

TN= True NegativesTN= True NegativesTP= True PositivesTP= True PositivesFP= False PositivesFP= False Positives

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Sensitivity & SpecificitySensitivity & Specificity

((SSnnNNouts and outs and SSppPPins)ins)DefinitionDefinitionSSeennsitivity refers to the proportion of people:sitivity refers to the proportion of people:with diseasewith disease who have a who have a positivepositive test test result.result.SpSpecificity refers to the proportion of people: ecificity refers to the proportion of people: without diseasewithout disease who have a who have a negativenegative test test result.result.

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SpPins and SnNoutsSpPins and SnNouts

SpPin is a mnemonic applied to the SpPin is a mnemonic applied to the finding that when a sign, test or finding that when a sign, test or symptom has a symptom has a high Specificity, a , a Positive result Positive result rules inrules in (SPin) the (SPin) the diagnosis. diagnosis.

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SpPins and SnNoutsSpPins and SnNouts

SnNoutSnNout is a mnemonic applied to is a mnemonic applied to the finding that when a sign, test or the finding that when a sign, test or symptom has a symptom has a high Sensitivity, a high Sensitivity, a Negative result Negative result rules outrules out (SNout) (SNout)the diagnosisthe diagnosis. .

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EVIDENCE BASED EVIDENCE BASED MEDICINE (page 19)MEDICINE (page 19)FOR SOUND METHODOLOGYFOR SOUND METHODOLOGYCRITICAL APPRAISAL OF RESEARCH CRITICAL APPRAISAL OF RESEARCH DATADATAPUBLISH ACCURATE & CLINICALLY PUBLISH ACCURATE & CLINICALLY USEFUL SUMMARIES OF EVIDENCEUSEFUL SUMMARIES OF EVIDENCE

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POINT OF CARE (POC) POINT OF CARE (POC) TESTSTESTS

URINALYSISURINALYSIS‘‘SCREENING TESTS’(page 2)SCREENING TESTS’(page 2)SIMPLE BLOOD TESTSSIMPLE BLOOD TESTS?HOME TEST KITS?HOME TEST KITSDAT: Direct Access TestingDAT: Direct Access Testing

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Collection TubesCollection Tubes AdditivesAdditives

• PreservativesPreservatives• AnticoagulantsAnticoagulants

Gel separation tubesGel separation tubes

Serum tubesSerum tubes

Plasma tubesPlasma tubes

Trace element-free tubesTrace element-free tubes

Pediatric tubes (3 mL)Pediatric tubes (3 mL)

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B. B. BLOOD BLOOD COLLECTION

SiteSite: Arteries, Veins, : Arteries, Veins,

CapillariesCapillaries Component Types used for testingComponent Types used for testing::

• Whole BloodWhole Blood

PlasmaPlasma

SerumSerum

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PLASMAPLASMA““...... the river in which the blood cells travel.” the river in which the blood cells travel.”

ContainsContains::1.1. Water Water 2.2. Nutrients Nutrients (sugars, amino acids, fats, electrolytes, minerals, etc.) (sugars, amino acids, fats, electrolytes, minerals, etc.) 3. Waste products (CO3. Waste products (CO22, lactic acid, urea, etc.), lactic acid, urea, etc.)4.4. Antibodies (immunoglobulins) Antibodies (immunoglobulins)5. Clotting proteins (called clotting factors)5. Clotting proteins (called clotting factors)6. Hormones6. Hormones7. Complement Proteins 7. Complement Proteins (inflammation, immune response)(inflammation, immune response)8.Transport Proteins (albumin) 8.Transport Proteins (albumin)

60% Total Blood Volume60% Total Blood Volume Plasma = serum + clotting componentsPlasma = serum + clotting components

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LipemiaLipemia ::Can cause factitious Can cause factitious Hyponatremia, Hyponatremia, Hypokalemia, Hypokalemia, HyperchloremiaHyperchloremiaTurbidity Turbidity -- -- Due to lipid particles; causes light to Due to lipid particles; causes light to scatter...interferes with photometryscatter...interferes with photometryPartitioning ErrorPartitioning Error -- -- Analyte can enter lipid…making it Analyte can enter lipid…making it inaccessible for chemical reactioninaccessible for chemical reactionElectrolyte Exclusion EffectElectrolyte Exclusion Effect -- -- Triglycerides > 1500mg/dL (milky Triglycerides > 1500mg/dL (milky serum): Fat replaces serum water, which serum): Fat replaces serum water, which alters distribution & conc. of electrolytesalters distribution & conc. of electrolytes

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Some Lab MethodsSome Lab MethodsMicrobiology- Gram staining- first stain Microbiology- Gram staining- first stain with crystal violet- wash- then second with crystal violet- wash- then second stain with Grams iodine-rinse after stain with Grams iodine-rinse after decolorizing with alcohol-counter stain decolorizing with alcohol-counter stain with safranin and rinse and dry;with safranin and rinse and dry;Gram negative stain pinkGram negative stain pinkGram positive stain purpleGram positive stain purple

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URINEURINE&&RENALRENAL

TESTS

Discuss:Discuss:A.A.Components Components

of Urineof UrineB.B.Collection Collection

of Urineof Urine

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A. A. Urine Components:Urine Components:Color: Color: Yellow, Amber, Red,OrangeYellow, Amber, Red,OrangeClarity: Clarity: Clear, CloudyClear, CloudyMicroscopy: Normal/Abnormal cells, Microscopy: Normal/Abnormal cells, crystals, crystals, Chemistry Testing:Chemistry Testing:ElectrolytesElectrolytesKidney function testingKidney function testingGlucoseGlucoseHeavy metalsHeavy metalsDrug ScreensDrug ScreensProteinProteinUric AcidUric AcidCalciumCalcium… … & more& more

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B. Collection of UrineUrine: Random or timed

Sterile plastic containerWith/without preservatives““Clean Catch”Clean Catch”• Cleanse skin• Collect midstream sampleCatheterCatheter

SuprapubicSuprapubic

ChildrenChildren

2 L collection jug2 L collection jug

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Timing of Urine Collection:Timing of Urine Collection:1.1.Random Random Urine CollectionUrine Collection

Examples:Examples:•First morning void: First morning void: (best for drug analysis) (best for drug analysis) •2- or 3-hour post-prandial: 2- or 3-hour post-prandial: (glucosuria) (glucosuria) •Afternoon:Afternoon:(urobilinogen)(urobilinogen)•Anytime: urinalysis, Anytime: urinalysis, urine pregnancyurine pregnancy

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2.2. Timed Timed Urine Collection:Urine Collection:

• Specified intervals (2-, 12-, 24-hour)Specified intervals (2-, 12-, 24-hour)• Special instructions - diet, drugs, collection Special instructions - diet, drugs, collection technique, preservativestechnique, preservatives• How to collect? How to collect?

1) empty bladder & discard (“first void” urine)1) empty bladder & discard (“first void” urine)2) Record time and begin urine collection 2) Record time and begin urine collection 3) Store container @ 43) Store container @ 4C between collections C between collections (preservative may be required)(preservative may be required)4) Record time and volume at the end of 4) Record time and volume at the end of collection intervalcollection interval24-hour24-hourWhy? Why? diurnal variation of analyte diurnal variation of analyte

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Urine test (page 31-32)Urine test (page 31-32)

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Urine Color ChartUrine Color Chart

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3131

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3333

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Crystals Seen in UrineCrystals Seen in UrineNormal: calcium oxalate, triple phosphate crystals Normal: calcium oxalate, triple phosphate crystals and and amorphous phosphates amorphous phosphates Very uncommon crystals include: Very uncommon crystals include: cystine crystals in urine of neonates with congenital cystinuria or cystine crystals in urine of neonates with congenital cystinuria or severe liver disease, severe liver disease, tyrosine crystals with congenital tyrosinosis or marked tyrosine crystals with congenital tyrosinosis or marked liver liver impairment, or impairment, or leucine crystals in patients with severe liver disease or with maple leucine crystals in patients with severe liver disease or with maple syrup urine disease syrup urine disease

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little envelopes little envelopes or tetrahedrons – or tetrahedrons –

Oxalate (common)Oxalate (common)stop signs – stop signs –

Cystine (rare)Cystine (rare)rectangles – rectangles –

triple phosphatestriple phosphates

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‘‘Renal’ TestsRenal’ TestsCreatinine Clearance, page 90Creatinine Clearance, page 90GFR, (198)GFR, (198)CMP, CMP, BUN, (63)BUN, (63)Creatinine, (89)Creatinine, (89)

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GFR SignificanceGFR SignificanceKidney Kidney Damage StageDamage Stage

DescriptionDescription GFRGFR Other findingsOther findings

11 Kidney damage with Kidney damage with normal or high GFRnormal or high GFR

90+90+ Protein or albumin Protein or albumin in urine are high, in urine are high, cells or casts seen cells or casts seen in urinein urine

22 Mild decrease in Mild decrease in GFRGFR

60-8960-89   

33 Moderate decrease Moderate decrease in GFRin GFR

30-5930-59   

44 Severe decrease in Severe decrease in GFRGFR

15-2915-29   

55 Kidney failureKidney failure < 15 < 15   

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Serum assessment of Renal Serum assessment of Renal functionfunction

BUN- 8-25 mg/dL BUN- 8-25 mg/dL Creatinine- 0.6-1.5 mg/dLCreatinine- 0.6-1.5 mg/dL>1.5 = 50% nephron loss>1.5 = 50% nephron loss>4.8 = 75% loss>4.8 = 75% loss~10 = 90% loss (ESRD)~10 = 90% loss (ESRD)

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BUN:Creatinine ratioBUN:Creatinine ratioNormal: 10:1 ~20:1. Normal: 10:1 ~20:1. An increased ratio may be due to a condition that An increased ratio may be due to a condition that causes a decrease in the flow of blood to the causes a decrease in the flow of blood to the kidneys: kidneys: such as congestive heart failure or dehydration, such as congestive heart failure or dehydration, increased protein, from gastrointestinal bleeding, or increased protein, from gastrointestinal bleeding, or increased protein in the diet. increased protein in the diet. The ratio may be decreased with liver disease (due The ratio may be decreased with liver disease (due to decrease in the formation of urea) and to decrease in the formation of urea) and malnutrition.malnutrition.

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?Uric Acid (213)?Uric Acid (213)Produced by the breakdown of purines Produced by the breakdown of purines Purines are chemicals that come from nucleic acids Purines are chemicals that come from nucleic acids (DNA)- source:-cells and food(DNA)- source:-cells and foodMost uric acid is removed by the kidneys and Most uric acid is removed by the kidneys and disposed of in the urine disposed of in the urine Gouty arthritis, also known as gout, is a condition Gouty arthritis, also known as gout, is a condition caused by the deposition and accumulation of needle-caused by the deposition and accumulation of needle-like uric acid crystals in the fluid and tissues of one or like uric acid crystals in the fluid and tissues of one or more joints. more joints. This causes inflammation, swelling, and severe pain This causes inflammation, swelling, and severe pain in the joint. in the joint.

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Uric AcidUric AcidPurine metabolismPurine metabolism‘‘Gout’Gout’Diuretics- thiazides/lasixDiuretics- thiazides/lasixPre eclampsia/eclampsiaPre eclampsia/eclampsiaExcessive cell destruction –CCTExcessive cell destruction –CCTProlonged fastingProlonged fastingM- 3.6-8.5 mg/dL ; W- 2.3-6.6 mg/dLM- 3.6-8.5 mg/dL ; W- 2.3-6.6 mg/dL

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Note!:Note!:

Purines are part of Purines are part of nucleic acid nucleic acid metabolismmetabolism

Destruction of DNA Destruction of DNA as it happens in as it happens in cancer cancer chemotherapy can chemotherapy can result in elevated result in elevated serum uric acid serum uric acid levelslevels

FOODS RICH IN PURINESFOODS RICH IN PURINESANCHOVIESANCHOVIESASPARAGUSASPARAGUSKIDNEYSKIDNEYSLIVERLIVERLENTILSLENTILSSARDINESSARDINESSPINACHSPINACHSWEETBREADSSWEETBREADS

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Do NOT Confuse! ListDo NOT Confuse! ListCreatine- Creatine- consumption of high glycemic carbohydrates in conjunction with consumption of high glycemic carbohydrates in conjunction with creatine increases creatine muscle stores and performance. (Cell-Techcreatine increases creatine muscle stores and performance. (Cell-TechⓇⓇ--creatine-carbohydrate-alpha lipoic acid supplementcreatine-carbohydrate-alpha lipoic acid supplement ) )Creatinine- Creatinine- Creatinine is a break-down product of creatine phosphate in Creatinine is a break-down product of creatine phosphate in muscle. Creatinine clearence measures kidney GFRmuscle. Creatinine clearence measures kidney GFRCreatine Kinase (CK)Creatine Kinase (CK)Creatine phosphokinase (CK)- Creatine phosphokinase (CK)- Creatine kinase (CK), also known as Creatine kinase (CK), also known as phosphocreatine kinase or creatine phosphokinase (CPK) is an enzyme expressed by various phosphocreatine kinase or creatine phosphokinase (CPK) is an enzyme expressed by various tissue types. It catalyses the conversion of creatine to phosphocreatine, consuming tissue types. It catalyses the conversion of creatine to phosphocreatine, consuming adenosine triphosphate (ATP) and generating adenosine diphosphate (ADP).adenosine triphosphate (ATP) and generating adenosine diphosphate (ADP).Clinically, creatine kinase is assayed in blood tests as a marker of Clinically, creatine kinase is assayed in blood tests as a marker of myocardial infarction (heart attack), rhabdomyolysis (severe muscle myocardial infarction (heart attack), rhabdomyolysis (severe muscle breakdown), muscular dystrophy and in acute renal failurebreakdown), muscular dystrophy and in acute renal failure..

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Metabolic PanelsMetabolic Panels BASICBASIC-information about the -information about the

current status of kidneys, blood current status of kidneys, blood sugar, and electrolyte and acid/base sugar, and electrolyte and acid/base balance. balance.

1.1. GlucoseGlucose2.2. CalciumCalcium3.3. SodiumSodium4.4. PotassiumPotassium5.5. CO2 (carbon dioxide, CO2 (carbon dioxide,

bicarbonate)bicarbonate)6.6. ChlorideChloride7.7. BUN (blood urea BUN (blood urea

nitrogen)nitrogen)8.8. CreatinineCreatinine

COMPREHENSIVECOMPREHENSIVE1.1. GlucoseGlucose2.2. CalciumCalcium3.3. SodiumSodium4.4. PotassiumPotassium5.5. CO2 (carbon dioxide, CO2 (carbon dioxide,

bicarbonate)bicarbonate)6.6. ChlorideChloride7.7. AlbuminAlbumin8.8. Total ProteinTotal Protein9.9. BUN (blood urea nitrogen)BUN (blood urea nitrogen)10.10. CreatinineCreatinine11.11. ALP (alkaline phosphatase)ALP (alkaline phosphatase)12.12. ALT (alanine amino ALT (alanine amino

transferase, SGPT)transferase, SGPT)13.13. AST (aspartate amino AST (aspartate amino

transferase, SGOT)transferase, SGOT)14.14. BilirubinBilirubin

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ACID BASE BALANCE page 392-393ACID BASE BALANCE page 392-393Renal Failure-462Renal Failure-462Urinalysis in disease states-479Urinalysis in disease states-479