Evaluation of a Digene-recommended algorithm for human papillomavirus low-positive results present in a "retest zone".

Abstract:

:The Digene Hybrid Capture 2 (hc2) high-risk human papillomavirus (HPV) DNA test (Digene, Gaithersburg, MD) is widely used for triage of women with atypical squamous cells of undetermined significance. Results in a "retest zone" (weakly positive tests) are repeated up to 2 times according to the Digene-recommended algorithm. We studied 56 cervical samples in the retest zone. Specimens were tested by a multiplex polymerase chain reaction (PCR)-based genotyping assay, and relevant cytopathologic results were reviewed. Digene results were compared with a reference standard that combined PCR genotyping and cytopathology results. The first repeated Digene assay yielded a sensitivity of 85.2% and a specificity of 62.1% with false-positive and false-negative rates of 40.0% and 15.4%, respectively. The 22 negative samples underwent a second retest and 18 (82%) were negative by the reference standard. The combined first and second retest sensitivity, specificity, and predictive values remained unchanged from the first retest alone. Repeating specimens in the retest zone is necessary, but a second retest does not offer advantages over the first retest.

journal_name

Am J Clin Pathol

authors

Muldrew KL,Beqaj SH,Han J,Lum SH,Clinard V,Schultenover SJ,Tang YW

doi

10.1309/4WCPTUV506HLP06P

subject

Has Abstract

pub_date

2007-01-01 00:00:00

pages

97-102

issue

1

eissn

0002-9173

issn

1943-7722

pii

H352338282787657

journal_volume

127

pub_type

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