Evaluation of Two Commercially Available DNA Tests for Detection of Human Papillomavirus

摘要

Objective:This study was designed to compare the sensitivity, specificity, efficiency, positive andnegative predictive values, and ease of use for 2 commercially available hybridization kits fordetecting human papillomavirus (HPV) DNA: Oncor Southern blot (SB) (Oncor, Inc., Gaithersburg,MD) and Digene ViraType dot blot (DB) (Digene Diagnostics, Inc., Silver Spring, MD).Methods:A total of 179 specimens (172 cervical and 7 penile biopsies) were assessed for acceptabilitybased on the presence of epithelial cells and tested for HPV by DB and SB. The results wereevaluated based on Papanicolaou-stained cervical specimens and selected risk factors.Results:One hundred six (97.2%) of 109 results were concordant, i.e., 93 negative (85.3%) and 13positive (11.9%). Using SB as the gold standard, we found the sensitivity, specificity, efficiency, andpositive and negative predictive values for the ViraType DB to be 100%, 96.9%, 97.3%, 81.3%, and100%, respectively. Comparing the Papanicolaou smear to SB and DB, we found the sensitivity,specificity, efficiency, and positive and negative predictive values to be 33.3% (SB) vs. 44.4% (DB),89.5% vs. 87.6%, 87.3% vs. 84.2%, 11.8% vs. 23.5%, and 97.0% vs. 94.9%, respectively. The onlysignificant risk factor for predicting an HPV infection was the number of sexual partners.Conclusions:Although SB has been considered the standard model, DB is an acceptable methodfor detecting and identifying HPV infections.