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

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.

Comprehensive assessment of vaginal infections using a single swab.

Background: The decision to use a particular test to diagnose patients presenting with symptoms of vaginitis and/or STI is based primarily on the prevailing standards of care in the clinic at which the patient evaluation takes place. As a result, laboratory testing of vaginal samples for these patients often involves either an STI or a vaginitis test, but rarely both options simultaneously, which complicates the diagnosis and management of concurrent infections.

Methods: Using de-identified remnant vaginal specimens from symptomatic patients previously tested for STI ( (CT), (GC) and (TV)) with the Becton Dickinson (BD) CTGCTV2 assay for BD MAX System, positivity for bacterial vaginosis (BV) and spp (associated with vulvovaginal candidiasis (VVC)) were evaluated using the molecular-based BD MAX Vaginal Panel.

Clinical Performance of the BD Respiratory Viral Panel for BD MAX™ System in Detecting SARS-CoV-2, Influenza A and B, and Respiratory Syncytial Virus.

Using a nasopharyngeal (NP) or anterior nasal (NS) swab from prospectively collected or retrospective specimens, we assessed the clinical performance of the BD Respiratory Viral Panel (BD RVP) for BD MAX System against FDA-cleared or authorized comparators. Across prospective and retrospective specimens, positive percent agreement (PPA) was ≥ 98.4% for SARS-CoV-2, ≥ 96.