Multicenter comparison of nucleic acid amplification tests for the diagnosis of rectal and oropharyngeal Chlamydia trachomatis and Neisseria gonorrhoeae infection.

Research using nucleic acid amplification tests (NAATs) have repeatedly found rectal and oropharyngeal infections with Chlamydia trachomatis and Neisseria gonorrhoeae to be common and potentially more difficult to treat than genital infections. Unfortunately, public health and patient care efforts have been hampered by the lack of FDA-cleared NAATs with claims for anorectal or oropharyngeal samples. At the time of the initiation of this study, no commercially available assays had these claims. We formed a novel partnership among academic institutions and diagnostic manufacturers to address this public health need. From May 2018 through August 2019 we recruited 1108 women, 1256 men and 26 transgender persons each of whom provided 3 anal and 3 oropharyngeal swab specimens. The 3 anal swabs were pooled into a single transport tube as were the 3 oropharyngeal swabs. The performance of each of three study assays was estimated by comparison to the composite result and relative to one another. Percent positivity for chlamydia was 5.9 and 1.2% from anal and oropharyngeal specimens, respectively compared to 4.2 and 4.1% for gonorrhea. Sensitivity for chlamydia detection ranged from 81.0-95.1% and 82.8-100% for anal and oropharyngeal specimens, respectively. Gonorrhea sensitivity ranged from 85.9-99.0% and 74.0-100% for anal and oropharyngeal samples, respectively. Specificity estimates were ≥ 98.9% for all assays, organisms and sample types. Although there was heterogeneity between sensitivity estimates, these assays offer better ability to detect extra genital infections than culture and potential solutions for providing appropriate sexual healthcare for populations in which these infections are of concern.