Interlaboratory reliability of hybrid capture 2

Philip E. Castle, Cosette M. Wheeler, Diane Solomon, Mark Schiffman, Cheri L. Peyton

Research output: Contribution to journalArticle

94 Scopus citations

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 κ value between all CC laboratories and the HPV QC laboratory was 0.84 (95% confidence interval, 0.78-0.89), with κ 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, κ values were 0.80 or more. These data show that HC2 is a reliable test for detecting clinically relevant oncogenic HPV DNA.

Original languageEnglish (US)
Pages (from-to)238-245
Number of pages8
JournalAmerican journal of clinical pathology
Volume122
Issue number2
DOIs
StatePublished - Aug 2004
Externally publishedYes

Keywords

  • Cervical cancer
  • HPV
  • Human papillomavirus
  • Hybrid Capture 2
  • PCR
  • Polymerase chain reaction
  • Reproducibility

ASJC Scopus subject areas

  • Pathology and Forensic Medicine

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