Avtor/Urednik		Xu, Lan; Oštrbenk Valenčak, Anja; Poljak, Mario; Arbyna, Marc
Naslov		Evaluation and Optimization of the Clinical Accuracy ofHybribio's 14 High-Risk HPV with 16/18 Genotyping Assaywithin the VALGENT-3 Framework
Tip		članek
Vol. in št.		Letnik 58, št. 6
Leto izdaje		2020
Obseg		str. 1-8
ISSN		1098-660X - Journal of clinical microbiology
Jezik		eng
Abstrakt		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 ChinaFood and Drug Administration that is widely used in China. VALGENT (VALidation ofHPV GENotyping Tests) is an established framework for evaluating HPV tests' clinicalperformance relative to validated comparators. The aim of this study was to assessthe clinical accuracy of HBRT-H14 following international validation criteria. WithinVALGENT-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 wasdefined as histologically confirmed cervical intraepithelial neoplasia scoring grade 2or worse (CIN2+) and CIN3+, and two negative cytology results in a row were aproxy for nondisease. In the total study population, relative sensitivity and specificityof HBRT-H14 versus HC2 for detecting CIN2+ were 0.98 (95% confidence interval[CI], 0.94 to 1.03; P noninferiority[Pni]<%0.01) and 0.97 (95% CI, 0.96 to 0.99;Pni=0.78), respectively. Applying an optimizeda posterioricutoff, defined using Linear Array and Cobas as bridging tests, yielded relative values of 0.98 (95% CI, 0.94 to1.03;Pni<0.01) and 1.01 (95% CI, 1.00 to 1.03;Pni<0.01), respectively. In conclusion, HBRT-H14 was as sensitive but less specific than HC2 for detecting cervical pre-cancer at the predefined cutoff. However, HBRT-H14 fulfilled international accuracycriteria for cervical cancer screening when using an optimized cutoff and might beattractive in low-resource settings given its low cost.
Proste vsebinske oznake		cervical cancer human papillomavirus HPV genotyping rak materničnega vratu humani papiloma virus genotipizacija HPV