Comparative Evaluation of 2 Nucleic Acid Amplification Tests for the Detection of Chlamydia trachomatis and Neisseria gonorrhoeae at Extragenital Sites

Abstract

Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections are frequently asymptomatic, requiring highly accurate diagnostic tests and proper management to prevent further transmission. We compared two nucleic acid tests, Xpert® CT/NG (Cepheid, Sunnyvale, CA) point-of-care platform and at an offsite clinical laboratory with Aptima Combo 2® (Hologic, Inc., San Diego, CA) assay, for the detection of extragenital infection in patients at an STI clinic in Hollywood, CA. We calculated concordance between the two assays and used the exact binomial method to calculate 95% confidence intervals (CIs) for each specimen type and pathogen. The concordance between the two assays was 97.7% (95% CI: 95.7%,99.0%) for 393 paired CT rectal results, 98.2% (95% CI: 96.4%,99.3%) for 391 paired NG rectal results and 98.4% (95% CI: 96.8%,99.4%) for 448 paired NG pharyngeal results. The performance of Xpert® CT/NG assay in point-of-care testing in extragenital specimens was highly similar to the laboratory-based platform.

Meta-analysis of the Cepheid Xpert® CT/NG assay for extragenital detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections

“…Our search yielded a total of eight publications, 4,20-24,28,29 five [20][21][22][23][24] of which met our inclusion criteria. We excluded three studies because they were not evaluation studies.…”

“…Most studies evaluating extragenital testing performance for CT and NG detection by the Xpert CT/NG show high per cent agreement with comparison assays; however, because of the limited sample sizes of CT-and NG-positive cases, the precision around the positive per cent agreement is low. [20][21][22][23][24] Therefore, we aimed to combine data from all published studies of the performance of extragenital testing with Xpert CT/NG to better assess positive per cent agreement.…”

High prevalence of Chlamydia trachomatis, Neisseria gonorrhoeae and particularly Trichomonas vaginalis diagnosed using US FDA‐approved Aptima molecular tests and evaluation of conventional routine diagnostic tests in Ternopil, Ukraine

“…The present study, for the first time, investigated the prevalence of CT, NG and TV using highly sensitive and specific US FDA-approved NAATs (Aptima Combo 2 and Aptima TV assays (Hologic); (6,7,(16)(17)(18)(19)(20)(21)(22)(23)(24)(25)(26)(27)30)) for consecutive mainly symptomatic sexually active females and males in Ukraine (Ternopil) and evaluated the CDTs used for diagnosis of these non-viral STIs compared to the reference Aptima NAATs.…”

“…For detection of Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV), NAATs have superior sensitivities, high specificities, use non-invasive specimens, are rapid and provide opportunities for automation (8)(9)(10)(12)(13)(14)(15)(16)(17)(18)(19)(20). The sensitivities and specificities of the US FDAapproved Aptima NAATs (Hologic, San Diego, CA, USA) for detection of CT, NG and TV have proven excellent (7,(16)(17)(18)(19)(20)(21)(22)(23)(24), and these NAATs have been frequently used as gold standard diagnostic tests to evaluate other diagnostic assays (6,7,20,25,26). However, in many less-resourced settings, which frequently suffer from the highest prevalences of non-viral STIs, the validated and quality-assured US FDAapproved NAATs are not affordable (4,5,14,27).…”

Community-Based, Point-of-Care Sexually Transmitted Infection Screening Among High-Risk Adolescents in Los Angeles and New Orleans: Protocol for a Mixed-Methods Study (Preprint)

“…The test is FDA approved using urine samples and vaginal swabs. However, it has also been verified in accordance with CLIA using pharyngeal and rectal swabs [35]. Male participants selfcollect pharyngeal and rectal swabs as well as a urine sample, while female participants self-collect pharyngeal, rectal, and vaginal swabs.…”