Table 2. Comparison of accuracy of the urine Trovagene HPV test, and Linear Array HPV genotyping test (for 15 carcinogenic types) for cervical and urine samples for detection of histology-confirmed CIN2/3 lesions and CIN3 lesions.
| Sampling method | No. of samples | (%, 95 % CI) | Youden's Index (95%CI) | |||||||
|---|---|---|---|---|---|---|---|---|---|---|
| Disease Present | Disease Absent | Sensitivity | Specificity | Positive Predictive Value | Negative Predictive Value | |||||
| CIN2/3=26 | <CIN2=45 | |||||||||
| Total | TP | FN | FP | TN | ||||||
| Urine Trovagene HPV test | 71 | 24 | 2 | 32 | 13 | 92.3 (74.9-99.1) | 28.9 (16.4-44.3) | 42.9 (29.7-56.8) | 86.7 (59.5-98.3) | 0.21 (0.05-0.38) |
| Cervical LA-HPV test | 71 | 25 | 1 | 29 | 16 | 96.2 (80.4-99.9) | 35.6 (21.9-51.2) | 46.3 (32.6-60.4) | 94.1 (71.3-99.9) | 0.32 (0.16-0.48) |
| Urine LA-HPV test | 71 | 21 | 5 | 26 | 19 | 80.8 (60.6-93.4) | 42.2 (27.7-57.8) | 44.7 (30.2-59.9) | 79.2 (57.8-92.9) | 0.23 (0.02-0.44) |
| CIN3=10 | <CIN3=61 | |||||||||
| Total | TP | FN | FP | TN | ||||||
| Urine Trovagene HPV test | 71 | 10 | 0 | 46 | 15 | 100 (69.5-100) | 24.6 (14.5-37.3) | 17.9 (8.9-30.4) | 100 (78.2-100) | 0.25 (0.14-0.35) |
| Cervical LA-HPV test | 71 | 10 | 0 | 44 | 17 | 100 (69.5-100) | 27.9 (17.1-40.8) | 18.5 (9.3-31.4) | 100 (80.5-100) | 0.28 (0.17-0.39) |
| Urine LA- HPV test | 71 | 9 | 1 | 38 | 23 | 90 (55.6-99.7) | 37.7 (25.6-51.0) | 19.1 (9.1-33.3) | 95.8 (78.9-99.9) | 0.28 (0.06-0.5) |
Footnote: HPV: human papillomavirus, LA-HPV: Linear Array HPV genotyping test, CIN: cervical intraepithelial neoplasia. This table uses histology-confirmed cervical diagnoses, which were available in only 71 out of 72 participants who participated in the study.