Objectives To assess whether pooled sample testing with nucleic acid amplification tests was a potential alternative to three single-site sample testing to screen for Chlamydia trachomatis and Neisseria gonorrhoeae infections in asymptomatic men who have sex with men.
Methods We prospectively compared pooled sample testing with single-site sample testing in asymptomatic MSM. Self-obtained paired rectal samples, one gargle sample and one first-void urine sample were collected from participants to generate two sets of samples: one for pooled sample testing and the other for single-site testing. We used modified pooled sampling, which is defined as the use of gargle samples, instead of swabs, for the pooled sample to test for pharyngeal infection.
Results This study included 513 MSM. The positive rates of C. trachomatis and N. gonorrhoeae were 20.3% and 11.7%, respectively, for single-site sample testing. Compared with the sensitivity of single-site testing as the gold standard, the sensitivities of pooled sample testing for C. trachomatis and N. gonorrhoeae were 94.2% (95% CI 88.0% to 97.3%) and 98.3% (95% CI 90.9% to 99.9%), respectively. The concordance rate and kappa coefficient were 98.3% (95% CI 96.7% to 99.2%) and 0.945 (95% CI 0.859 to 1.000), respectively, for C. trachomatis and 98.8% (95% CI 90.1% to 100%) and 0.943 (95% CI 0.857 to 1.000), respectively, for N. gonorrhoeae.
Conclusions The modified pooled sampling had a comparably high consistency with single-site sample testing. The results strongly suggest that the gargle sample is suitable as a part of pooled sample for STI screening of C. trachomatis and N. gonorrhoeae.
- Chlamydia trachomatis
- Neisseria gonorrhoeae
- sexual health
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Handling editor Henry John Christiaan de Vries
Contributors Conception or design on the work: NA and DM. Data collection: NA, DM, KW, MT, HU, TA, YY, YK, SO and HG. Data analysis and interpretation: NA. Drafting the article: NA. Critical revision of the article: NA, DM, KW, SO and HG. Final approval of the version to be published: NA, DM, SO and HG.
Funding This work was supported by the National Center for Global Health and Medicine (grant numbers 19A1002 and 19A1003) and VIIV Healthcare Supported International Clinical Research (ViiV Ref. 209459).
Competing interests SO has received research grants/materials from Gilead Sciences, MSD KK, CSL Behring and ViiV Healthcare, Co., and has received honorarium for lectures from MSD KK, Gilead Sciences, ViiV Healthcare and Janssen Pharmaceutical, KK.
Patient consent for publication Not required.
Ethics approval This study was approved by the Human Research Ethics Committee of National Centre for Global Health and Medicine (NCGM-G-0 03 350–00) and was conducted according to the principles expressed in the Declaration of Helsinki of 1964 and its later amendments
Provenance and peer review Not commissioned; externally peer reviewed.
Data availability statement All data relevant to the study are included in the article or uploaded as supplementary information.
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