Table 1

HPV test FDA approved for cervical cancer screening16 17 24

Commercial nameAssay typeGenotypesTarget genesAnalytical sensitivitySensitivity
% (95% CI)
Specificity
% (95% CI)
Hybrid Capture System 2*1 Signal amplification13 HR-HPV
5 LR-HPV
Whole viral genome1000–5000 copies/reaction92.7 (85.6 to 97.0)39.4 (33.1 to 46.0)
Cervista-HR*2 14 HR-HPV L1/E6/E7 1250–7500 copies/reaction92.8 (83.9 to 97.6)46,0 (44.2 to 47.0)
Cervista 16/183 16, 18 L1/E6/E7 625–1200 copies/reaction77.3 (56.6 to 89.9)67.3 (63.9 to 70.6)
Cobas HPV Test4 DNA amplification16, 18 +
12 HR-HPV
L1 150–1200 copies/mL93.5 (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/mL91.4 (77.6 to 97.0)62.0 (59.6 to 64.4)
APTIMA HPV assay6 mRNA amplification16, 18, 45 +
11 HR-HPV
E6/E7 19–239 copies/reaction97.7 (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.