Molecular test for chlamydia and gonorrhoea used at point of care in remote primary healthcare settings: a diagnostic test evaluation

Sexually Transmitted Infections
Louise M CauserJohn M Kaldor

Abstract

A new molecular test for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) (GeneXpert CT/NG) has been demonstrated to be as accurate as conventional nucleic acid amplification tests (NAAT), but performance has not been evaluated in routine primary care, performed at the point of care by clinicians. We aimed to examine its diagnostic performance when used by clinicians in remote community health services in Australia with high prevalences of CT and NG infection. The trial was registered with the Australian and New Zealand Clinical Trials Registry (#12613000808741) METHODS: At 12 health services, training was provided to 99 clinicians in the use of the GeneXpert CT/NG assay who tested specimens from all patients undergoing STI screening. Specimens were also sent in parallel for conventional laboratory-based NAATs and the concordance of results was evaluated. Clinicians conducted 2486 tests: CT concordance was 99.4% (95% CI 99.1 to 99.7) with a positive concordance of 98.6% (95% CI 95.9 to 99.7) and negative concordance of 99.5% (95% CI 99.1 to 99.8); NG concordance was 99.9% (95% CI 99.7 to 100.0) with a positive concordance of 100.0% (95% CI 97.5 to 100.0) and negative concordance of 99.9% (95% CI 99.7 to 100.0). In this...Continue Reading

References

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Citations

Apr 5, 2019·Journal of Clinical Microbiology·Kate CuschieriKate E Templeton
Aug 31, 2019·Journal of the International AIDS Society·Teodora Ec WiMagnus Unemo
Jun 6, 2020·Expert Review of Molecular Diagnostics·Charlotte A Gaydos, Johan H Melendez
Feb 6, 2020·International Journal of STD & AIDS·David Taylor-RobinsonAnna Pallecaros
Oct 28, 2020·Archives of Pathology & Laboratory Medicine·Mark ShephardKelly Andrewartha
Nov 6, 2018·Clinical Microbiology and Infection : the Official Publication of the European Society of Clinical Microbiology and Infectious Diseases·P OakeshottF Reid
May 14, 2021·Science Translational Medicine·Alexander Y TrickTza-Huei Wang
Jun 25, 2021·Brazilian Journal of Microbiology : [publication of the Brazilian Society for Microbiology]·Seema ShettyAngela Brand
Jul 7, 2021·Expert Review of Molecular Diagnostics·Barbara Van Der Pol, Charlotte A Gaydos

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