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

Area of Science:

• Clinical diagnostics
• Molecular biology
• Public health

Background:

• Rising rates of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections necessitate improved diagnostic methods.
• The NeuMoDx CT/NG Assay 2.0 was developed to address the need for accessible sexually transmitted infection (STI) testing.

Purpose of the Study:

• To evaluate the clinical performance of the NeuMoDx CT/NG Assay 2.0.
• To assess the assay's accuracy across different specimen types and platforms.

Main Methods:

• Clinical sensitivity and specificity were determined using endocervical swabs, vaginal swabs (self- and clinician-collected), and first-catch urine specimens.
• Assay results were compared against established US Food and Drug Administration-cleared diagnostic tests.
• Performance was evaluated on both the NeuMoDx-96 (moderate-throughput) and NeuMoDx-288 (high-throughput) molecular systems.

Main Results:

• The NeuMoDx CT/NG Assay 2.0 exhibited high sensitivity and specificity for both CT and NG across most specimen types (≥95% sensitivity, >99% specificity).
• Endocervical sample sensitivity was 93.2% for CT and 93.3% for NG.
• Invalid result rates were low (<1%), with no performance differences observed between the NeuMoDx-96 and NeuMoDx-288 platforms.

Conclusions:

• The NeuMoDx CT/NG Assay 2.0 provides performance comparable to existing FDA-cleared assays.
• The assay's availability on moderate- and high-throughput platforms offers flexibility for laboratories of varying volumes.
• This assay can enhance STI testing capacity, potentially reducing reliance on external reference laboratories.