ArticleSexually transmitted diseases2025
Multicenter Clinical Performance Evaluation of the NeuMoDx CT/NG Assay 2.0.
Article in Sexually transmitted diseases, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
backgroundGiven the continued increases in rates of both Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infection, additional diagnostic assays may be useful in increasing access to testing for these sexually transmitted infections. We evaluated the performance of the NeuMoDx CT/NG Assay 2.0 on the NeuMoDx-96 and NeuMoDx-288 Molecular Systems.
methodsThe clinical sensitivity and specificity of the assay were assessed when used with (1) endocervical swabs, (2) self- and clinician-collected vaginal swabs, and (3) first-catch urine specimens (female and male). Results were compared with a patient infection status based on US Food and Drug Administration-cleared assays.
resultsThe NeuMoDx CT/NG Assay 2.0 demonstrated high sensitivity and specificity in both symptomatic and asymptomatic participants. All specimen types other than endocervical swabs had ≥95% sensitivity and >99% specificity for both pathogens. For endocervical samples, sensitivities were 93.2% and 93.3% for CT and NG, respectively. There was no difference in performance based on platform. The frequency of invalid results was low (<1%).
conclusionsThe NeuMoDx CT/NG Assay 2.0 demonstrated performance similar to currently US Food and Drug Administration-cleared assays, with the added choice of a moderate- (96-sample) or a high-throughput (288-sample) platform. The system therefore offers solutions to laboratories running lower volumes of testing that may obviate the need for outsourcing to larger reference laboratories.
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