评估两种用于检测人乳头瘤病毒的市售DNA检测方法。

Evaluation of two commercially available DNA tests for detection of human papillomavirus.

作者信息

Halstead D C, Pfleger S L, Dupree W

机构信息

Microbiology/Virology Division Lehigh Valley Hospital, Allentown, PA, USA.

出版信息

Infect Dis Obstet Gynecol. 1995;2(6):255-62. doi: 10.1155/S1064744995000147.

DOI:10.1155/S1064744995000147

PMID:18475405

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2364404/

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.

摘要

目的

本研究旨在比较两种市售的用于检测人乳头瘤病毒（HPV）DNA的杂交试剂盒的敏感性、特异性、效率、阳性和阴性预测值以及易用性：Oncor Southern印迹法（SB）（Oncor公司，马里兰州盖瑟斯堡）和Digene ViraType斑点印迹法（DB）（Digene诊断公司，马里兰州银泉）。

方法

基于上皮细胞的存在情况，对总共179份标本（172份宫颈活检标本和7份阴茎活检标本）进行可接受性评估，并通过DB和SB检测HPV。根据巴氏染色的宫颈标本和选定的风险因素对结果进行评估。

结果

109份结果中有106份（97.2%）一致，即93份阴性（85.3%）和13份阳性（11.9%）。以SB作为金标准，我们发现ViraType DB的敏感性、特异性、效率、阳性和阴性预测值分别为100%、96.9%、97.3%、81.3%和100%。将巴氏涂片与SB和DB进行比较，我们发现其敏感性、特异性、效率、阳性和阴性预测值分别为33.3%（SB）对44.4%（DB）、89.5%对87.6%、87.3%对84.2%、11.8%对23.5%以及97.0%对94.9%。预测HPV感染的唯一显著风险因素是性伴侣数量。