Updated: 9/30/2019

# Evaluating Diagnostic Tests

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 Sensitivity, Specificity, PPV, NPV These 4 measures describe how well diagnostic tests capture the true presence or absence of disease  Sensitivity (SN) % with disease who test positive = a/(a+c) = TP/(TP+FN) Specificity (SP) % without disease who test negative = d/(b+d) = TN/(FP+TN) Positive predictive value (PPV)  % positive test results that are true positives = a/(a+b) = TP/(TP+FP) Negative predictive value (NPV)  % negative test results that are true negatives = d/(c+d) = TN/(FN+TN) Cut-off point may be adjusted to optimize sensitivity and specificity, which are inversely related (cut-off point with decreased sensitivity is associated with increased specificity and vice-versa)    will also affect NPV and PPV  i.e., decrease in sensitivity associated with decrease in NPV in the same population (due to higher false negative rates) Sensitivity and specificity are intrinsic to the diagnostic test  do not change with prevalence PPV and NPV do change with prevalence  Receiver operating characteristic (ROC) curves are a graphical depiction of a test's performance Y axis: sensitivity X axis: 1-specificity The higher the curve, the better the test This is quantified by the AUC (area under the curve); an AUC of 0.5 states that the test performs no better than chance (bad test!), whereas an AUC of 0.9 suggests a better-performing test
 Odds Ratio, Relative Risk, Attributable Risk These measures describe the relationship between a risk factor and a disease Odds Ratio (OR) odds of having disease in expose group / odds of having disease in unexposed group = ad/bc Relative Risk (RR) probability of getting disease in exposed group / probability of getting disease in unexposed group = [a/(a+b)] / [c/(c+d)] If RR = 1, there is no association between exposure and outcome  Dose-reponse increased level of exposure shows an increased relative risk of developing/odds ratio of having a disease can be used in OR or RR to support causality  Attributable Risk (AR) risk in exposed group - risk in unexposed group = a/(a+b) - c/(c+d)

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Lab Values
 Blood, Plasma, Serum Reference Range ALT 8-20 U/L Amylase, serum 25-125 U/L AST 8-20 U/L Bilirubin, serum (adult) Total // Direct 0.1-1.0 mg/dL // 0.0-0.3 mg/dL Calcium, serum (Ca2+) 8.4-10.2 mg/dL Cholesterol, serum Rec: < 200 mg/dL Cortisol, serum 0800 h: 5-23Â Î¼g/dL //1600 h: 3-15 Î¼g/dL 2000 h: â‰¤ 50% of 0800 h Creatine kinase, serum Male: 25-90 U/LFemale: 10-70 U/L Creatinine, serum 0.6-1.2 mg/dL Electrolytes, serum Sodium (Na+) 136-145 mEq/L Chloride (Cl-) 95-105 mEq/L Potassium (K+) 3.5-5.0 mEq/L Bicarbonate (HCO3-) 22-28 mEq/L Magnesium (Mg2+) 1.5-2.0 mEq/L Estriol, total, serum (in pregnancy) 24-28 wks // 32-36 wks 30-170 ng/mL // 60-280 ng/mL 28-32 wk // 36-40 wks 40-220 ng/mL // 80-350 ng/mL Ferritin, serum Male: 15-200 ng/mLFemale: 12-150 ng/mL Follicle-stimulating hormone, serum/plasma Male: 4-25 mIU/mL Female: premenopause: 4-30 mIU/mL midcycle peak: 10-90 mIU/mL postmenopause: 40-250 pH 7.35-7.45 PCO2 33-45 mmHg PO2 75-105 mmHg Glucose, serum Fasting: 70-110 mg/dL2-h postprandial:<120 mg/dL Growth hormone - arginine stimulation Fasting: <5 ng/mLProvocative stimuli: > 7ng/mL Immunoglobulins, serum IgA 76-390 mg/dL IgE 0-380 IU/mL IgG 650-1500 mg/dL IgM 40-345 mg/dL Iron 50-170 Î¼g/dL Lactate dehydrogenase, serum 45-90 U/L Luteinizing hormone, serum/plasma Male: 6-23 mIU/mL Female: follicular phase: 5-30 mIU/mL midcycle: 75-150 mIU/mL postmenopause 30-200 mIU/mL Osmolality, serum 275-295 mOsmol/kd H2O Parathyroid hormone, serume, N-terminal 230-630 pg/mL Phosphatase (alkaline), serum (p-NPP at 30Â° C) 20-70 U/L Phosphorus (inorganic), serum 3.0-4.5 mg/dL Prolactin, serum (hPRL) < 20 ng/mL Proteins, serum Total (recumbent) 6.0-7.8 g/dL Albumin 3.5-5.5 g/dL Globulin 2.3-3.5 g/dL Thyroid-stimulating hormone, serum or plasma .5-5.0Â Î¼U/mL Thyroidal iodine (123I) uptake 8%-30% of administered dose/24h Thyroxine (T4), serum 5-12 Î¼g/dL Triglycerides, serum 35-160 mg/dL Triiodothyronine (T3), serum (RIA) 115-190 ng/dL Triiodothyronine (T3) resin uptake 25%-35% Urea nitrogen, serum 7-18 mg/dL Uric acid, serum 3.0-8.2 mg/dL
 Hematologic Reference Range Bleeding time 2-7 minutes Erythrocyte count Male: 4.3-5.9 million/mm3Female: 3.5-5.5 million mm3 Erythrocyte sedimentation rate (Westergren) Male: 0-15 mm/hFemale: 0-20 mm/h Hematocrit Male: 41%-53%Female: 36%-46% Hemoglobin A1c â‰¤ 6 % Hemoglobin, blood Male: 13.5-17.5 g/dLFemale: 12.0-16.0 g/dL Hemoglobin, plasma 1-4 mg/dL Leukocyte count and differential Leukocyte count 4,500-11,000/mm3 Segmented neutrophils 54%-62% Bands 3%-5% Eosinophils 1%-3% Basophils 0%-0.75% Lymphocytes 25%-33% Monocytes 3%-7% Mean corpuscular hemoglobin 25.4-34.6 pg/cell Mean corpuscular hemoglobin concentration 31%-36% Hb/cell Mean corpuscular volume 80-100Â Î¼m3 Partial thromboplastin time (activated) 25-40 seconds Platelet count 150,000-400,000/mm3 Prothrombin time 11-15 seconds Reticulocyte count 0.5%-1.5% of red cells Thrombin time < 2 seconds deviation from control Volume Plasma Male: 25-43 mL/kgFemale: 28-45 mL/kg Red cell Male: 20-36 mL/kgFemale: 19-31 mL/kg
 Cerebrospinal Fluid Reference Range Cell count 0-5/mm3 Chloride 118-132 mEq/L Gamma globulin 3%-12% total proteins Glucose 40-70 mg/dL Pressure 70-180 mm H2O Proteins, total < 40 mg/dL
 Sweat Reference Range Chloride 0-35 mmol/L Urine Calcium 100-300 mg/24 h Chloride Varies with intake Creatinine clearance Male: 97-137 mL/minFemale: 88-128 mL/min Estriol, total (in pregnancy) 30 wks 6-18 mg/24 h 35 wks 9-28 mg/24 h 40 wks 13-42 mg/24 h 17-Hydroxycorticosteroids Male: 3.0-10.0 mg/24 hFemale: 2.0-8.0 mg/24 h 17-Ketosteroids, total Male: 8-20 mg/24 hFemale: 6-15 mg/24 h Osmolality 50-1400 mOsmol/kg H2O Oxalate 8-40 Î¼g/mL Potassium Varies with diet Proteins, total < 150 mg/24 h Sodium Varies with diet Uric acid Varies with diet Body Mass Index (BMI) Adult: 19-25 kg/m2
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(M2.OMB.18.1) A home drug screening test kit is currently being developed. The cut-off level is initially set at 4 mg/uL, which is associated with a sensitivity of 92% and a specificity of 97%. How might the sensitivity and specificity of the test change if the cut-off level is changed to 2 mg/uL? Review Topic | Tested Concept

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Sensitivity = 90%, specificity = 99%

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Sensitivity = 92%, specificity = 97%

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Sensitivity = 95%, specificity = 98%

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Sensitivity = 97%, specificity = 96%

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Sensitivity = 100%, specificity = 97%

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(M2.OMB.18.1) Health officials are considering a change be made to the interpretation of the tuberculin skin test that will change the cut-off for a positive purified protein derivative (PPD) from 10 mm to 15 mm for healthcare workers. Which of the following can be expected as a result of this change? Review Topic | Tested Concept

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Decrease the sensitivity

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Decrease the specificity

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Increase the precision

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Increase the sensitivity

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No change to the sensitivity or specificity

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