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Clinical evaluation of the cartridge-based GeneXpert human papillomavirus assay in women referred for colposcopy.

Abstract：

:High-risk human papillomavirus (hrHPV) testing is now being introduced as a potential primary screening test for improved detection of cervical precancer and cancer. Current U.S. Food and Drug Administration-approved tests are batch tests that take several hours to complete. A rapid, non-batch test might permit point-of-care (POC) testing, which can facilitate same-day screen and management strategies. For a non-batch, random-access platform (GeneXpert; Cepheid, Sunnyvale, CA), a prototype hrHPV assay (Xpert) has been developed where testing for 14 hrHPV types can be completed in 1 h. In the first clinical evaluation, Xpert was compared to two validated hrHPV tests, the cobas HPV test (cobas, Roche Molecular Systems) and Hybrid Capture 2 (hc2, Qiagen), and to histologic outcomes using specimens from colposcopy referral populations at 7 clinical sites in the United States (n = 697). The sensitivity of Xpert for cervical intraepithelial neoplasia grade 2 or more severe diagnoses (CIN2+) (n = 141) was equal to that of cobas (90.8% versus 90.8%, P = 1) and greater than that of hc2 (90.8% versus 81.6%, P = 0.004). Xpert was more specific than cobas (42.6% versus 39.6%, P = 0.02) and less specific than hc2 (42.6% versus 47.7%, P < 0.001). Similar results were observed for cervical intraepithelial neoplasia grade 3 or higher (CIN3+) (n = 91). HPV16 detection by Xpert identified 41.8% of the CIN2+ specimens with a positive predictive value (PPV) of 54.6%. By comparison, HPV16 detection by cobas identified 42.6% of the CIN2+ specimens with a PPV of 55.0%. hrHPV detection by the Xpert demonstrated excellent clinical performance for identifying women with CIN2+ and CIN3+ that was comparable to that of currently available clinically validated tests.

journal_name

J Clin Microbiol

journal_title

Journal of clinical microbiology

authors

Einstein MH,Smith KM,Davis TE,Schmeler KM,Ferris DG,Savage AH,Gray JE,Stoler MH,Wright TC Jr,Ferenczy A,Castle PE

doi

10.1128/JCM.00176-14

subject

Has Abstract

pub_date

2014-06-01 00:00:00

pages

2089-95

issue

eissn

0095-1137

issn

1098-660X

pii

JCM.00176-14

journal_volume

pub_type

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Clinical evaluation of the cartridge-based GeneXpert human papillomavirus assay in women referred for colposcopy.