Table 4 Diagnostic testing accuracy characteristics.

From: Evaluation of hepatitis C virus antibody assay using dried blood spot samples

 

Disease present

Disease not present

Total

Plasma anti-HCV+ 

Plasma anti-HCV−

DBS test result

Anti-HCV modified assay file

Positive

144 (TP)

0 (FP)

144 (TP + FP)

Negative

0 (FN)

104 (TN)

104 (TN + FN)

Total

144 (TP + FN)

104 (TN + FP)

248

Sensitivity = TP/(TP + FN) = 144/144 × 100% = 100% (95% CI 97.47–100.00)

Specificity = TN/(TN + FP) = 104/104 × 100% = 100% (95% CI 96.52–100.00)

Positive predictive value (PPV) = TP/(TP + FP) = 144/144 × 100% = 100% (95% CI 97.40–100.00), calculated at 58.06% prevalence (144 positive/248 total)

Negative predictive value (NPV) = TN/(TN + FN) = 104/104 × 100% = 100% (95% CI 96.44–100), calculated at 58.06% prevalence

Positive likelihood ratio (LR+) = sensitivity/(1-specificity) = NA

Negative likelihood ratio (LR−) = (1-sensitivity)/specificity = 0

Area under the ROC curve (AUC) = 1.00

DBS test result

Anti-HCV on-market assay file

Positive

131 (TP)

0 (FP)

131 (TP + FP)

Negative

13 (FN)

104 (TN)

117 (TN + FN)

Total

144 (TP + FN)

104 (TN + FP)

248

Sensitivity = TP/(TP + FN) = 131/(131 + 13) × 100% = 90.97% (95% CI 85.06–95.11)

Specificity = TN/(TN + FP) = 104/104 × 100% = 100% (95% CI 96.52–100.00)

Positive predictive value (PPV) = TP/(TP + FP) = 131/131 × 100% = 100% (95% CI 97.22–100.00), calculated at 58.06% prevalence

Negative predictive value (NPV) = TN/(TN + FN) = 104/(104 + 13) = 88.89% (95% CI 81.75–93.95), calculated at 58.06% prevalence

Positive likelihood ratio (LR+) = sensitivity/(1-specificity) = NA

Negative likelihood ratio (LR−) = (1-sensitivity)/specificity = (1–0.9097)/1 = 0.09 (95% CI 0.05–0.15)

Area under the ROC curve (AUC) = 1.00

  1. TP true positive, FN false negative, FP false positive, TN true negative, NA not applicable.