TY - JOUR
T1 - Reliability of the Xpert HPV assay to detect high-risk human papillomavirus DNA in a colposcopy referral population
AU - Castle, Philip E.
AU - Smith, Katherine M.
AU - Davis, Thomas E.
AU - Schmeler, Kathleen M.
AU - Ferris, Daron G.
AU - Savage, Ashlyn H.
AU - Gray, Jermaine E.
AU - Stoler, Mark H.
AU - Wright, Thomas C.
AU - Ferenczy, Alex
AU - Einstein, Mark H.
N1 - Publisher Copyright:
© 2015 American Society for Clinical Pathology.
PY - 2015/1
Y1 - 2015/1
N2 - 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 κ 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+.
AB - 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 κ 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+.
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U2 - 10.1309/AJCP4Q0NSDHWIZGU
DO - 10.1309/AJCP4Q0NSDHWIZGU
M3 - Article
C2 - 25511151
AN - SCOPUS:84923557905
SN - 0002-9173
VL - 143
SP - 126
EP - 133
JO - American journal of clinical pathology
JF - American journal of clinical pathology
IS - 1
ER -