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Am J Clin Pathol. 2015 Jan;143(1):126-33. doi: 10.1309/AJCP4Q0NSDHWIZGU.

Reliability of the Xpert HPV assay to detect high-risk human papillomavirus DNA in a colposcopy referral population.

Author information

1
From Global Cancer Initiative, Chestertown, MD; castle.philip@gmail.com.
2
Oklahoma University Health Sciences Center, Oklahoma City;
3
Indiana University, Indianapolis;
4
University of Texas, MD Anderson Cancer Center, Houston;
5
Georgia Regents University, Augusta;
6
Medical University of South Carolina, Charleston;
7
University of Mississippi Medical Center, Jackson;
8
University of Virginia, Charlottesville;
9
Columbia University, New York;
10
McGill University and Jewish General Hospital, Montreal, Quebec, Canada; and.
11
Montefiore Medical Center and Albert Einstein College of Medicine, Bronx, NY.

Abstract

OBJECTIVES:

The Xpert HPV Assay (Xpert; Cepheid, Sunnyvale, CA) was developed for the multianalytic GeneXpert platform.

METHODS:

In a colposcopy referral population of 708 women living in the United States, two cervical specimens, A and B, were collected, and both were tested by the Xpert assay for high-risk human papillomavirus (hrHPV) DNA, permitting an evaluation of its test reliability. Specimen B was also tested by Hybrid Capture 2 (hc2; Qiagen, Germantown, MD) and the cobas HPV Test (cobas; Roche Molecular Systems, Pleasanton, CA).

RESULTS:

The Îș and percent agreement for any hrHPV for the two Xpert results were 0.88 and 94.5%, respectively. There was no statistical difference in testing positive on both specimens by Xpert (P = .62). The sensitivity for detection of cervical intraepithelial neoplasia grade 2 or more severe (CIN2+) was 89.0% using specimen A and 90.4% using specimen B for Xpert, 90.4% for cobas, and 81.6% for hc2.

CONCLUSIONS:

The Xpert assay was sensitive and reliable for the detection of hrHPV and the identification of women with CIN2+.

KEYWORDS:

Microbiology; Molecular diagnostics; Virology

PMID:
25511151
DOI:
10.1309/AJCP4Q0NSDHWIZGU
[Indexed for MEDLINE]

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