Interlaboratory reliability of Hybrid Capture 2.

Abstract	We evaluated the interlaboratory reproducibility of the Hybrid Capture 2 (HC2; Digene, Gaithersburg, MD), a test for oncogenic human papillomavirus (HPV) DNA, using data from 4 clinical center (CC) laboratories and the quality control (QC) laboratory participating in the ASCUS (atypical squamous cells of undetermined significance) and LSIL (low-grade squamous intraepithelial lesion) Triage Study (ALTS). Residual liquid cytology specimens were tested routinely throughout the duration of ALTS at CC laboratories, and a stratified (by time in the study) random sample of specimens was retested by the HPV QC laboratory using equivalent protocols. Of the specimens selected (N = 1,175, 5.50% of all specimens obtained), 1,072 (91.23%) had sufficient specimen volume for retesting. The kappa value between all CC laboratories and the HPV QC laboratory was 0.84 (95% confidence interval, 0.78-0.89), with kappa values for individual CCs and the HPV QC laboratory ranging from 0.79 to 0.89. Agreement between test results was lowest among results for women with negative cytologic findings (0.73); among those with equivocal or abnormal cytologic findings, kappa values were 0.80 or more. These data show that HC2 is a reliable test for detecting clinically relevant oncogenic HPV DNA.
Authors	Philip E Castle, Cosette M Wheeler, Diane Solomon, Mark Schiffman, Cheri L Peyton, ALTS Group
Journal	American journal of clinical pathology (Am J Clin Pathol) Vol. 122 Issue 2 Pg. 238-45 (Aug 2004) ISSN: 0002-9173 [Print] England
PMID	15323141 (Publication Type: Comparative Study, Journal Article, Research Support, U.S. Gov't, P.H.S.)
Chemical References	DNA, Viral
Topics	Cytodiagnosis (methods) DNA, Viral (analysis) False Negative Reactions Female Humans Laboratories, Hospital Mass Screening Papillomaviridae (isolation & purification) Papillomavirus Infections (diagnosis) Polymerase Chain Reaction Quality Assurance, Health Care Reproducibility of Results Sensitivity and Specificity Uterine Cervical Neoplasms (diagnosis, virology) Vaginal Smears Uterine Cervical Dysplasia (diagnosis, virology)

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