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Disease/health condition -
Sexually transmitted infections (STIs), Chlamydial infection, Gonorrhoea
Qualitative Chlamydia trachomatis and Neisseria gonorrhoeae nucleic acid amplification test
Assay format
NAAT
Information History
First added in 2019
Changed in 2020
Purpose type
Diagnosis
Purpose
To diagnose chlamydial and/or gonorrhoeal urogenital disease and extragenital infection.
Specimen types
Urine, Genital specimens (e.g., Endocervical swabs, Urethral swabs, Vaginal swabs), Rectal swab, Oropharyngeal swab, Liquid-based cervical cytology
WHO prequalified or recommended products
N/A
GMDN
50409
Multiple-type sexually transmitted pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acid from multiple types of microorganisms associated with sexually transmitted infections (STI), in a clinical specimen, using a nucleic acid technique (NAT). Microorganisms detected may include (but are not limited to) Chlamydia trachomatis, Neisseria gonorrhoeae, Mycoplasma species, Ureaplasma species, Treponema pallidum, Trichomonas vaginalis, herpes simplex virus 1 and/or herpes simplex virus 2 (HSV1 & 2).
The medical device term(s), code(s) and definition(s) in this section were retrieved from databases external to WHO. As there might be more than one name, definition and “Nomenclature Code” related to the specific medical device, please consult https://gmdnagency.org GMDN ®. © GMDN Agency 2005-2024EMDN
W0105070501
STDS (C.TRACHOMATIS, N.GONORRHOEAE, M.GENITALIUM, T.VAGINALIS…) COMBINATION - MULTIPLEX NA REAGENTS
The code(s) and term(s) in this section were observed and retrieved from public databases and have not been validated by health regulatory authorities. Please consult your regulatory agency and EMDN site: https://webgate.ec.europa.eu/dyna2/emdnWHO supporting publications
World Health Organization. (2023). Laboratory and point-of-care diagnostic testing for sexually transmitted infections, including HIV. World Health Organization. https://iris.who.int/handle/10665/374252
Technical specifications
N/A
Related Medical Devices in MeDevIS
The SAGE IVD recommended inclusion on the EDL of nucleic acid testing for C. trachomatis and N. gonorrhoeae. They noted that the tests are reliable, with high diagnostic accuracy, that appropriate tests with high sensitivity are essential for surveillance of these diseases and that the tests have been on the market for a number of years.
The Group considered that the test should be included only for testing in tertiary laboratories but that it could be considered for use at primary care level in the future.
Recommended test purpose: for the diagnosis and screening of symptomatic or asymptomatic chlamydial and/or gonorrhoeal urogenital disease and extragenital infection.
Although the analytical performance varies by assay, the sensitivity of tests for C. trachomatis is 91–100%, the specificity is 98–100%, the positive predictive value for symptomatic patients is > 90%, and the negative predictive value is > 98.8%; and the sensitivity of tests for N. gonorrhoeae is 97.7–100%, the specificity is 99.6–100%, the positive predictive value for symptomatic patients is 89.4–100%, and the negative predictive value is ≥ 99.9%. The tests are FDA approved or CE-marked, although local vendors might require validation or verification. No evidence was provided of the impacts of these tests in clinical practice. There are UNAIDS/WHO guidelines for the test for N. gonorrhoeae, and both organisms are high priorities for surveillance.
The accuracy of these tests is difficult to assess in the absence of a good reference standard; assessments rely on methods such as latent class analyses or comparison with panels of alternative tests. Systematic reviews of the accuracy of these tests were unavailable. One study with a reasonable sample size supports the claim made in non-systematic reviews that laboratory-based tests are highly accurate (4). Many of the other supporting primary studies are based on very few cases. Additional evaluations, particularly for new cartridge-based methods, would be useful.
World Health Organization. (2019). The selection and use of essential in vitro diagnostics: report of the second meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics (including the second WHO model list of essential in vitro diagnostics). World Health Organization. https://iris.who.int/handle/10665/329527