A-363 Evaluating the Performance of Emerging STI Point of Care Assays Using Novel, Room Temperature Stable CT/NG/TV/MG Positive Swab Quality Control Materials

Abstract

Abstract Background The emergence of Point of Care tests that detect Sexually Transmitted Infections (STIs) is critical for screening and diagnostic programs in low-resource settings. Point of Care tests that are designed to simultaneously detect Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), Trichomonas vaginalis (TV), and Mycoplasma genitalium (MG) promote rapid diagnosis and early treatment of the most common etiological agents causing STIs. Along with the roll-out and use of these tests, there is a growing need for complex multi-analyte quality control materials that are stable at room temperature and challenge test performance by identifying result deviations, lot-to-lot variability, and routine laboratory workflow errors. Microbix developed a whole-workflow multiplex quality control desiccated on a Copan FLOQSwab® that is stable at 2–30°C and contains inactivated whole-genome target pathogens. The objective of this study is to evaluate sample performance with multiple Point of Care diagnostic platforms that are currently in development and commercial IVD tests that are routinely used in the laboratory. Methods Microbix designed an inactivated STI whole-workflow control that contains whole-genome CT, NG, TV, MG, and human cells to satisfy sample adequacy control requirements. The formulation is desiccated on a Copan FLOQSwab® to mimic patient specimen formats and ensure sample compatibility with all assay workflows and elution buffers. Sample performance was evaluated with Cepheid Xpert® CT/NG assay, Cepheid Xpert® TV assay, Abbott Alinity m STI assay, BD MAX™ CT/GC/TV assay, Seegene Novaplex™ CT/NG/TV/MG assay, EliTechGroup STI PLUS ELITe MGB®Kit, and commercial Point of Care assays currently in development. Results The STI positive swab formulation demonstrated acceptable performance when tested with various nucleic acid amplification tests that detect CT, NG, TV, and MG targets. The formulations also behaved as useful quality management tools by highlighting design limitations for commercial Point of Care assays that are currently in development. Conclusion CT/NG/TV/MG whole-genome multiplex formulation desiccated on a Copan FLOQSwab® is an advantageous prospective quality control material that is stable at room temperature and supports the clinical use and accuracy of emerging STI assays, including the most challenging Point of Care test formats. The formulations showed acceptable performance on multiple platforms, demonstrating excellent commutability. Additionally, the dry swab format offers great practicality for monitoring assay performance in low-resource settings.