Commercial name | Assay type | Genotypes | Target genes | Analytical sensitivity | Sensitivity % (95% CI) | Specificity % (95% CI) |
Hybrid Capture System 2*1 | Signal amplification | 13 HR-HPV 5 LR-HPV | Whole viral genome | 1000–5000 copies/reaction | 92.7 (85.6 to 97.0) | 39.4 (33.1 to 46.0) |
Cervista-HR*2 | 14 HR-HPV | L1/E6/E7 | 1250–7500 copies/reaction | 92.8 (83.9 to 97.6) | 46,0 (44.2 to 47.0) | |
Cervista 16/183 | 16, 18 | L1/E6/E7 | 625–1200 copies/reaction | 77.3 (56.6 to 89.9) | 67.3 (63.9 to 70.6) | |
Cobas HPV Test4 | DNA amplification | 16, 18 + 12 HR-HPV | L1 | 150–1200 copies/mL | 93.5 (82.5 to 97.8) | 69.3 (66.9 to 71.5) |
BD Onclarity HPV assay5 | 16, 18, 45 + 11 HR-HPV | E6/E7 | 251–2367 copies/mL | 91.4 (77.6 to 97.0) | 62.0 (59.6 to 64.4) | |
APTIMA HPV assay6 | mRNA amplification | 16, 18, 45 + 11 HR-HPV | E6/E7 | 19–239 copies/reaction | 97.7 (92.0 to 99.4) | 52.9 (49.1 to 56.6) |
*Does not determine specific type. 1: Qiagen, USA; 2: Hologic Inc, USA; 3: Hologic Inc, USA; 4: Roche Molecular Systems Inc, USA; 5: Becton Dickinson, USA; 6: Hologic Inc, USA.
FDA, US Food and Drug Administration; HPV, human papillomavirus; HR-HPV, high risk HPV; LR, low risk HPV.