Abstract
Hybribio's 14 High-Risk HPV with 16/18 genotyping real-time PCR (HBRT-H14) is a human papillomavirus (HPV) assay with approval from the China Food and Drug Administration that is widely used in China. VALGENT (VALidation of HPV GENotyping Tests) is an established framework for evaluating HPV tests' clinical performance relative to validated comparators. The aim of this study was to assess the clinical accuracy of HBRT-H14 following international validation criteria. Within VALGENT-3, clinical performance of HBRT-H14 was compared with Hybrid Capture 2 (HC2), Linear Array HPV genotyping test (Linear Array), and Cobas 4800 HPV test (Cobas). VALGENT-3 comprised 1,300 consecutive samples and 300 abnormal cytological samples from the Slovenian cervical cancer screening program. Disease was defined as histologically confirmed cervical intraepithelial neoplasia scoring grade 2 or worse (CIN2+) and CIN3+, and two negative cytology results in a row were a proxy for nondisease. In the total study population, relative sensitivity and specificity of HBRT-H14 versus HC2 for detecting CIN2+ were 0.98 (95% confidence interval [CI], 0.94 to 1.03; P noninferiority[P(ni)] < 0.01) and 0.97 (95% CI, 0.96 to 0.99; P(ni) = 0.78), respectively. Applying an optimized a posteriori cutoff, defined using Linear Array and Cobas as bridging tests, yielded relative values of 0.98 (95% CI, 0.94 to 1.03; P(ni) < 0.01) and 1.01 (95% CI, 1.00 to 1.03; P(ni) < 0.01), respectively. In conclusion, HBRT-H14 was as sensitive but less specific than HC2 for detecting cervical precancer at the predefined cutoff. However, HBRT-H14 fulfilled international accuracy criteria for cervical cancer screening when using an optimized cutoff and might be attractive in low-resource settings given its low cost.