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

Publication/Presentation Date

1-1-1995

Abstract

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.

Volume

2

Issue

6

First Page

255

Last Page

262

ISSN

1064-7449

Disciplines

Obstetrics and Gynecology | Pathology

PubMedID

18475405

Department(s)

Department of Obstetrics and Gynecology, Department of Pathology and Laboratory Medicine

Document Type

Article

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