Table 2.
Summary of test performance measures.
| Per-test accuracy measures | |||
|---|---|---|---|
| Disease “+” | Disease “−” | Predictive valuea | |
| Test positive | 99 | 5 | PPV = 95.2% (91.1–99.3) |
| Test negative | 8 | 1,264 | NPV = 99.4% (98.9–99.8) |
| Sensitivity and Specificity | Sn = 92.5% (87.5–97.5) | Sp = 99.6% (99.3–99.9) | |
| Per-patient accuracy measures | |||
| Test positive | 55 | 3c | PPV = 94.8% (89.1–100) |
| Test negative | 8b | 495 | NPV = 98.4% (97.3–99.5) |
| Sensitivity and Specificity | Sn = 87.3% (79.1–95.5) | Sp = 99.4% (98.7–100) | |
Note: 95% CI shown in parentheses for respective values.
Abbreviations: NPV, negative predictive value; PPV, positive predictive value; Sn, sensitivity; Sp, specificity.
aOne patient was censored from the PPV calculation as they were non-compliant with follow-up despite a TTMV-HPV DNA score of >800 and subsequently died.
bOnly 2 of the 8 patients with a false negative test had pretreatment or baseline testing results. Therefore, baseline detectability of TTMV-HPV DNA was not confirmed among 6 of the 8 patients.
cIndeterminate test results that prompted clinical action via a biopsy between 1 and 60 days later were considered positive test results, whereas indeterminate results that did not prompt clinical action were considered negative.