Avtor/Urednik		Oštrbenk Valenčak, Anja; Šterbenc, Anja; Seme, Katja; Poljak, Mario
Naslov		Alinity m HR HPV assay fulfils criteria for human papillomavirus test requirements in cervical cancer screening settings
Tip		članek
Vol. in št.		Letnik 58, št. 1
Leto izdaje		2019
ISSN		1098-660X - Journal of clinical microbiology
Jezik		eng
Abstrakt		Alinity m HR HPV is a novel human papillomavirus (HPV) assay that individually identifies genotypes HPV16, HPV18 and HPV45, while reporting 11 other high-risk HPV (hrHPV) genotypes in two aggregates: HPV31/33/52/58 and HPV35/39/51/56/59/66/68. The clinical performance of Alinity for screening of cervical cancer was evaluated in population-based settings. For women aged %30 years, the clinical sensitivity (n=68) and specificity (n=3,077) to detect cervical intraepithelial neoplasia grade 2+ (CIN2+) of Alinity was 100.0% and 92.4%, respectively, and not inferior to that of Hybrid Capture 2 (hc2) (p=0.0006 and p<0.0001, respectively). The intralaboratory reproducibility and interlaboratory agreement of Alinity were 96.7% (kappa, 0.92) and 98.7% (kappa, 0.97), respectively. In the %30 years age group, women who were baseline hrHPV-negative had lower risk for CIN2+ at 3 years using Alinity (0.04%) versus those with normal baseline cytology (0.65%) and comparable risk to that of RealTime (0.04%), hc2 (0.08%) or cobas 4800 HPV (0.04%). HPV16/18 hrHPV infection was associated with a significantly higher baseline and 3-year CIN2+ and CIN3+ risk versus absence of HPV16/18 or presence of hrHPVs at baseline (all p values <0.05). The baseline CIN2+ risk was 8.8% for HPV31/33/52/58 and 2.5% for HPV35/39/51/56/59/66/68, while the 3-year CIN2+ risk was 17.0% and 4.9%, respectively (relative risk 3.4 [p=0.03] and 3.5 [p=0.003]), suggesting that extended genotyping of Alinity may be valuable in improving patient risk stratification. Alinity fulfils international consensus guideline criteria for primary cervical cancer screening and can be considered as clinically validated, demonstrating comparable safety to other clinically validated HPV tests.
Proste vsebinske oznake		cervical cancer human papillomavirus HPV primary screening rak materničnega vratu humani papiloma virus primarni presek HPV