HPV genotyping and E6/E7 transcript assays for cervical lesion detection in an Asian screening population-Cobas and Aptima HPV tests.

BACKGROUND: High-risk human papillomavirus (hrHPV) detection and genotyping by Cobas HPV test has become an important technical platform in cervical cancer screening. It may be used as a co-test with cervical cytology or as a standalone test. Aptima HPV assay (AHPV) is another hrHPV test detecting 13 genotypes through qPCR based amplification of viral E6/E7 transcripts. Partial genotyping with Aptima HPV 16 18/45 genotype assay (AHPV GT) on positive samples is possible. Evidence supporting the performance of AHPV in Asian populations is scarce.

OBJECTIVE: To compare the performances of Cobas and AHPV in detection of cervical squamous intraepithelial lesions (SIL) and triage of cytologically equivocal smears in a cohort of Hong Kong women.

STUDY DESIGN: 442 liquid based cytology (LBC) residues with biopsy confirmed diagnoses were evaluated by both AHPV and Cobas HPV tests.

RESULTS: Overall, there was a moderate agreement between AHPV and Cobas (κ = 0.5082, 95% CI: 0.492-0.672). The sensitivities of AHPV and Cobas for detecting biopsy confirmed HSIL or worse lesions (HSIL+) were 96.71% (95% CI: 92.49%-98.92%) and 97.37% (95% CI: 93.40%-99.28%) respectively. AHPV demonstrated significantly higher specificity than Cobas (37.85% vs 23.96%, p < 0.0001). Both tests could identify all ASC-US and AGC cases with HSIL + in follow-up biopsies, but AHPV showed a significantly higher specificity in both settings (ASC-US: 28.81% vs 11.86%, p < 0.0001; AGC: 55.00% vs 20.00%, p = 0.0233).

CONCLUSIONS: Both AHPV and Cobas were equally sensitive in detecting high-grade SIL in both scenarios of screening and ASC-US or AGC triage but AHPV showed a higher specificity.