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Validation of COBAS Taqman CT for the detection of Chlamydia trachomatis in vulvo-vaginal swabs


Background: Vulvo-vaginal swabs (VVSs) are not validated for use by the manufacturers of two widely used nucleic acid amplification tests (NAAT) for the detection of Chlamydia trachomatis. However, there is evidence that this type of swab is suitable for diagnosis.

Objective: To validate the Cobas Taqman CT assay for the detection of C trachomatis in VVS.

Method: Women aged 18–24 years attending a genitourinary medicine clinic were invited to take part in the study. Participants provided a self-taken VVS and the results obtained with these samples were compared with those obtained with an endocervical swab collected by a healthcare worker. A total of 267 women took part.

Results: 255/267 (96%; 95% CI 92 to 98%) sets of samples gave concordant results. 12/267 (4.5%) VVSs were invalid/inhibitory and so no result was available for these samples. This compared with 2/267 (0.7%) for endocervical swabs.

Conclusion: VVS are suitable samples for detecting C trachomatis.

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