LOW FALSE-NEGATIVE RATE OF PCR ANALYSIS FOR DETECTING HUMAN PAPILLOMAVIRUS-RELATED CERVICAL LESIONS

Although PCR analysis is a sensitive test for detection of human papil lomavirus (HPV) in the cervix, the proportion of cases of cervical dys plasia missed, or the false-negative rate, has been unknown. We determ ined the accuracy of PCR analysis for BPV DNA as a predictor of HPV-re lated cervical lesions in a cross-sectional study of sexually active w omen, aged 18 to 50 years, from the University of Michigan Family Medi cine HPV study. Of 133 eligible participants, 41 underwent colposcopy because of a positive result for HPV of the cervix by the PCR method a nd 92 underwent screening colposcopy ni th biopsy prior to knowing the HPV PCR results, Twenty-four of those screened were subsequently foun d to also be HPV DNA positive. In those found to he HPV positive, hist ological studies revealed the presence of condyloma or cervical intrad epithelial neoplasia in 16 women (24.6%) and changes suggestive of con dyloma in 5 (7.6%). No HPV-negative woman had an abnormal biopsy or cy tology report (P = 0.00001) The false-negative rate (1 - sensitivity) for HPV PCR analysis for detection of the presence of a cervical HPV-r elated lesion was 0% (95% confidence interval, 0 to 0.047), and the sp ecificity was 60.7%. In summary, PCR analysis for HPV DNA had a very l ow false-negative sate far predicting HPV-related lesions of the cervi x in a community-based population. This supports the validity of using the absence of HPV at the cervix, as determined by PCR testing, as an inclusion criterion for patients in control groups in studies dealing with low-grade cervical lesions.