Retrospective and prospective evaluation of the Amplicor HPV test for detection of 13 high-risk human papillomavirus genotypes on 862 clinical samples.

摘要: BACKGROUND: Persistent infection with a subgroup of at least 15 high-risk human papillomavirus (HPV) genotypes is considered as necessary although insufficient etiological factor in the development cervical carcinoma. As consequence, HPV testing has recently become an important part carcinoma screening and detection algorithms. AIM OF THE STUDY: To evaluate analytical performance developed polymerase chain reaction (PCR)-based Amplicor test (Roche Molecular Systems) comparison Hybrid Capture 2 DNA (hc2) (Digene Corporation) for 13 genotypes. Inhouse consensus PGMY09/PGMY11 CPI/IIg PCRs targeting two different genes coupled genotyping were used internal reference standard. MATERIALS AND METHODS: In retrospective evaluation, 550 scrape specimens previously established status included. Additionally, 312 tested prospectively presence by both hc2 test. RESULTS: results agreed almost completely standard results. prospective evaluation performed on samples, concordant obtained 85.9% samples tested. CONCLUSION: our hands, demonstrated high sensitivity specificity. The higher specificity to that can be clinically useful. Prospective studies clinical endpoints are urgently needed assess utility primary triaging patients ASC-US.