Multicenter Clinical Performance Evaluation of the NeuMoDx™ CT/NG Assay 2.0.

Abstract

Background: Given 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.

Methods: The clinical sensitivity and specificity of the assay was 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 to a patient infection status based on US Food and Drug Administration (FDA)-cleared assays.

Results: The 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, sensitivity was 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%).

Conclusions: The NeuMoDx CT/NG Assay 2.0 demonstrated performance similar to currently FDA-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.