Population-based study of screening test performance indices of three human papillomavirus DNA tests.
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 II 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.
Wahlström
Cecilia
C
Department of Medical Microbiology, Lund University, University Hospital, Malmö, Sweden.
Iftner
Thomas
T
Dillner
Joakim
J
Dillner
Lena
L
D052685:Alphapapillomavirus / Q000302:isolation & purification*; D004279:DNA, Viral / Q000302:isolation & purification*; D005260:Female; D006801:Humans; D008403:Mass Screening; D030361:Papillomavirus Infections / Q000453:epidemiology* / Q000821:virology; D016133:Polymerase Chain Reaction / Q000379:methods; D011159:Population Surveillance; D013548:Sweden / Q000453:epidemiology
D004279:DNA, Viral