Performance of the Cepheid CT/NG Xpert Rapid PCR Test for Detection of Chlamydia trachomatis and Neisseria gonorrhoeae
Charlotte A Gaydos, Barbara Van Der Pol, Mary Jett-Goheen, Mathilda Barnes, Nicole Quinn, Carey Clark, Grace E Daniel, Paula B Dixon, Edward W Hook 3rd, CT/NG Study Group, Thomas Davis, Preeti Pancholi, Charlotte Gaydos, Edward Hook, Peter Kerndt, Patrick Horner, Jeanne Marrazzo, Andrew de Burgh-Thomas, José Castro, Dorothy Ferguson, Michelle Meyer, Susan Philip, Bobbie Van Der Pol, Melanie Thompson, Stephanie Taylor, David Ronk, Paul Fine, Laura Bachman, Donna Mayne, Craig Dietz, Kim Toevs, Nikole Gettings, Stanley Gall, Rajul Patel, Jonathan Ross, Latina Brooks, Lydie Hazan, Patrick Clarke, Robert Groom, Ronald Ackerman, Eugene Anduczyk, Anakutty Mathews, Stephen Blank, Lisa Harris, Albert Tidings, Philippa Moore, Samuel Alexander, Timothy Spurrell, Charlotte A Gaydos, Barbara Van Der Pol, Mary Jett-Goheen, Mathilda Barnes, Nicole Quinn, Carey Clark, Grace E Daniel, Paula B Dixon, Edward W Hook 3rd, CT/NG Study Group, Thomas Davis, Preeti Pancholi, Charlotte Gaydos, Edward Hook, Peter Kerndt, Patrick Horner, Jeanne Marrazzo, Andrew de Burgh-Thomas, José Castro, Dorothy Ferguson, Michelle Meyer, Susan Philip, Bobbie Van Der Pol, Melanie Thompson, Stephanie Taylor, David Ronk, Paul Fine, Laura Bachman, Donna Mayne, Craig Dietz, Kim Toevs, Nikole Gettings, Stanley Gall, Rajul Patel, Jonathan Ross, Latina Brooks, Lydie Hazan, Patrick Clarke, Robert Groom, Ronald Ackerman, Eugene Anduczyk, Anakutty Mathews, Stephen Blank, Lisa Harris, Albert Tidings, Philippa Moore, Samuel Alexander, Timothy Spurrell
Abstract
Tests for Chlamydia trachomatis and Neisseria gonorrhoeae, which can provide results rapidly to guide therapeutic decision-making, offer patient care advantages over laboratory-based tests that require several days to provide results. We compared results from the Cepheid GeneXpert CT/NG (Xpert) assay to results from two currently approved nucleic acid amplification assays in 1,722 female and 1,387 male volunteers. Results for chlamydia in females demonstrated sensitivities for endocervical, vaginal, and urine samples of 97.4%, 98.7%, and 97.6%, respectively, and for urine samples from males, a sensitivity of 97.5%, with all specificity estimates being ≥ 99.4%. Results for gonorrhea in females demonstrated sensitivities for endocervical, vaginal, and urine samples of 100.0%, 100.0%, and 95.6%, respectively, and for urine samples from males, a sensitivity of 98.0%, with all estimates of specificity being ≥ 99.8%. These results indicate that this short-turnaround-time test can be used to accurately test patients and to possibly do so at the site of care, thus potentially improving chlamydia and gonorrhea control efforts.
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Source: PubMed