Population‐based study of screening test performance indices of three human papillomavirus DNA tests

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Abstract
In order to evaluate three common human papillomavirus (HPV) DNA tests for key performance indices in population‐based cervical screening, we sampled 12,527 women aged 32–38 years who attended invitational, population‐based screening and followed them for 4 years with comprehensive registry linkages. Three different HPV DNA tests (GP5+/6+ general primer PCR (using either AmpliTaq or AmpliTaq Gold DNA polymerase), Amplicor™ PCR and Hybrid Capture IITM were evaluated using baseline samples from women who on follow‐up developed cervical intraepithelial neoplasia grade 2 or worse (CINII+) (n = 197) as well as a representative subsample of the women in the cohort (n = 794). The population‐based HPV prevalence, sensitivity for future cervical intraepithelial neoplasia grade 2 or worse (CINII+), and absolute risk of CINII+ was 7.1%, 87.1%, and 23.2% for AmpliTaq GP5+/6+ PCR, 11.9%, 88.9%, and 11.0% for AmpliTaq Gold GP5+/6+ PCR, 15.7%, 93.4%, and 9.8% for Amplicor, 10.0%, 92.9%, and 15.3% for Amplicor with raised cut‐off, and 7.8%, 79.7%, and 16.9% for Hybrid Capture II. In conclusion, AmpliTaq GP5+/6+ PCR and Amplicor with raised cut‐off value have adequate performance indices for primary screening. J. Med. Virol. 79: 1169–1175, 2007.

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