Table 1.
The value of p16/Ki-67 dual-staining in the triage of high-grade squamous intraepithelial lesion and its comparison with HPV testing and cytology
| Studies | Subjects* | Sensitivity % | Specificity % | PPV % | NPV % | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Dual | Cyto | HPV | Dual | Cyto | HPV | Dual | Cyto | HPV | Dual | Cyto | HPV | |||||
| Ikenberg et al. 2013 | 181 CIN2+/25577 screening | 86.7 | 68.5 | 93.3 | 95.2 | 95.4 | 93.0 | 15.6 | 13.3 | 9.3 | 99.9 | 99.7 | 99.9 | |||
| 100 CIN3+/25577 screening | 87.4 | 73.6 | 96.2 | 94.8 | 95.1 | 92.7 | ||||||||||
| Wentzensen et al. 2015 | 175 CIN2+/1509 HPV+ | 83.4 | 76.6 | 58.9 | 49.6 | 21.0 | 16.6 | 96.4 | 94.2 | |||||||
| 99 CIN3+/1509 HPV+ | 86.9 | 83.8 | 56.9 | 48.7 | 12.4 | 10.3 | 98.4 | 97.7 | ||||||||
| 41 CIN2+/703 HPV+, Cyto- | 70.7 | 70.8 | 13.1 | 97.5 | ||||||||||||
| 16 CIN3+/703 HPV+, Cyto- | 81.3 | 69.6 | 5.9 | 99.4 | ||||||||||||
| Yu et al. 2016 | 20 CIN2+/1079 screening | 75.0 | 65.0 | 100.0 | 79.5 | 76.2 | 76.9 | 6.5 | 4.9 | 7.5 | 99.4 | 99.1 | 100.0 | |||
| 6 CIN3+/1079 screening | 83.3 | 83.3 | 100.0 | 78.8 | 75.8 | 75.9 | 2.2 | 1.9 | 2.3 | 99.9 | 99.9 | 100.0 | ||||
| 218 CIN2+/463 HPV+ | 92.7 | 94.5 | 52.7 | 53.5 | 63.5 | 64.4 | 89.0 | 91.6 | ||||||||
| 178 CIN3+/463 HPV+ | 95.0 | 98.3 | 47.7 | 49.1 | 53.1 | 54.7 | 93.8 | 97.9 | ||||||||
| 48 CIN2+/256 ASCUS, LSIL | 87.5 | 91.7 | 66.4 | 55.8 | 37.5 | 32.4 | 95.8 | 96.7 | ||||||||
| CIN3+/256 ASCUS, LSIL | 89.7 | 89.7 | 62.1 | 51.5 | 23.2 | 19.1 | 97,9 | 97.5 | ||||||||
| Wright et al. 2017 | 367 CIN2+/3467 HPV+ | 70.3 | 51.8 | 75.6 | 76.1 | 26.2 | 21.1 | 95.4 | 92.7 | |||||||
| 243 CIN3+/3467HPV+ | 74.9 | 51.9 | 74.1 | 75.0 | 18.5 | 14.0 | 97.4 | 95.2 | ||||||||
| Tay et al. 2017 | 63 CIN2+/97 Cyto+ | 93.7 | 85.7 | 76.5 | 14.7 | 88.1 | 65.1 | 86.7 | 35.7 | |||||||
| 14 CIN2+/44 ASCUS, LSIL | 92.9 | 85.7 | 76.7 | 16.7 | 65.0 | 32.4 | 95.8 | 71.4 | ||||||||
| Schmidt et al. 2011 | 77 CIN2+/361 ASCUS | 92.2 | 90.9 | 80.6 | 36.3 | |||||||||||
| 51 CIN3+ /361 ASCUS | 92.2 | 90.2 | 80.6 | 36.3 | ||||||||||||
| 137 CIN2+/415 LSIL | 94.2 | 96.4 | 68.0 | 19.1 | ||||||||||||
| 72 CIN3+/415 LSIL | 95.8 | 95.8 | 68.0 | 19.1 | ||||||||||||
| Uijterwaal et al. 2014 | 58 CIN2+/256 ASC, LSIL, ASC-H, AGC | 89.7 | 96.6 | 73.1 | 68.1 | 54.7 | 52.3 | 95.1 | 98.2 | |||||||
| 27 CIN3+/256 ASC, LSIL, ASC-H, AGC | 100.0 | 96.3 | 64.4 | 57.6 | 28.4 | 24.3 | 100.0 | 99.1 | ||||||||
| Bergeron et al. 2015 | 18 CIN2+/427 ASCUS | 94.4 | 100.0 | 78.7 | 60.4 | 16.3 | 10.0 | 99.7 | 100.0 | |||||||
| 14 CIN3+/427 ASCUS | 100.0 | 100.0 | 78.2 | 59.8 | 13.5 | 7.8 | 100.0 | 100.0 | ||||||||
| 63 CIN2+/384 LSIL | 85.7 | 98.4 | 53.3 | 15.6 | 26.5 | 18.6 | 95.0 | 98.0 | ||||||||
| 25 CIN3+/384 LSIL | 88.0 | 100.0 | 49.3 | 14.2 | 10.8 | 7.5 | 98.3 | 100.0 | ||||||||
| White et al. 2016 | 138 CIN2+/471 ASCUS, LSIL | 75.4 | 92.8 | 88.3 | 48.9 | |||||||||||
| 48 CIN3+/471 ASCUS, LSIL | 79.2 | 95.8 | 75.2 | 40.4 | 26.6 | 15.4 | 97.0 | 99.8 | ||||||||
| CIN2+/206 ASCUS | 71.9 | 94.7 | 87.9 | 64.4 | ||||||||||||
| CIN3+/206 ASCUS | 71.4 | 100.0 | 78.7 | 56.9 | 17.8 | 14.8 | 96.5 | 100.0 | ||||||||
| CIN2+/265 LSIL | 77.8 | 91.4 | 88.6 | 35.3 | ||||||||||||
| CIN3+/265 LSIL | 85.7 | 94.5 | 72.7 | 28.9 | 30.6 | 15.7 | 97.3 | 97.3 | ||||||||
| Petry et al. 2011 | 37 CIN2+/425 HPV+, Cyto- | 91.9 | 82.1 | |||||||||||||
| 28 CIN3+/425 HPV+, Cyto- | 96.4 | 76.9 | ||||||||||||||
| Uijterwaal et al. 2015 | 48 CIN2+/762 HPV+, Cyto- | 68.8 | 72.8 | 25.2 | 94.6 | |||||||||||
| 15 CIN3+/762 HPV+, Cyto- | 73.3 | 70.0 | 8.7 | 98.5 | ||||||||||||
| Ordi et al. 2014 | 378 HSIL, 18 CC/1123 Colposcopy | 90.9 | 96.0 | 72.1 | 41.4 | 63.9 | 47.1 | 93.6 | 94.9 | |||||||
| HSIL, CC/543 HSIL with Pap | 94.5 | 96.1 | 73.4 | 51.9 | 81.3 | 71.7 | 91.6 | 91.0 | ||||||||
| HSIL, CC/580 ASC, AGC, LSIL, HPV+ | 88.9 | 95.6 | 72.9 | 36.7 | 37.4 | 21.7 | 97.3 | 97.8 | ||||||||
*The application of p16/Ki-67 dual-staining (Dual) in the triage of high-grade squamous intraepithelial lesion was compared with HPV testing (HPV) and cytology (Cyto) from four aspects: sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV). In order to provide more valuable and comparable information, detailed sample data were shown in the table. The information of total subjects under screening or with a specific characteristic was presented after slash and the confirmed subjects with high-grade squamous intraepithelial lesion were shown before slash. AGC, atypical glandular cells; ASC, atypical squamous cells; ASC-H, atypical squamous cells cannot exclude HSIL; ASCUS, atypical squamous cells of undetermined significance; CC, cervical cancer; CIN, cervical intraepithelial neoplasia; HSIL, high-grade squamous intraepithelial lesion; LSIL, low-grade squamous intraepithelial lesion.