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

OBJECTIVE This study was designed to compare the sensitivity, specificity, efficiency, positive and negative predictive values, and ease of use for 2 commercially available hybridization kits for detecting 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 acceptability based on the presence of epithelial cells and tested for HPV by DB and SB. The results were evaluated 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 13 positive (11.9%). Using SB as the gold standard, we found the sensitivity, specificity, efficiency, and positive and negative predictive values for the ViraType DB to be 100%, 96.9%, 97.3%, 81.3%, and 100%, 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 only significant 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 method for detecting and identifying HPV infections.