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.
Published In/Presented At
Halstead, D. C., Pfleger, S. L., & Dupree, W. (1995). Evaluation of two commercially available DNA tests for detection of human papillomavirus. Infectious Diseases In Obstetrics And Gynecology, 2(6), 255-262.
Obstetrics and Gynecology | Pathology
Department of Obstetrics and Gynecology, Department of Pathology and Laboratory Medicine