(P192) Usability Assessment of a High-Throughput Molecular Microbiology Diagnostic Instrument

Background: As clinical laboratories continue to consolidate into larger, more centralized core facilities, the need for efficient diagnostic platforms, in order to standardize specimen processing and provide accurate test results, grows. This need is exacerbated by staffing shortages across the clinical laboratory arena. To address these and other common problems, automation can be employed to streamline and standardize laboratory workflows. Here, we assess the throughput capabilities of the BD COR™ System, a fully automated and integrated high-throughput molecular diagnostic system that consists of a central, preanalytical module (BD COR™ PX module; “PX”) that can be configured with one or two different analytical modules (BD COR™ GX or BD COR™ MX modules; “GX” and “MX,” respectively).



Methods: BD COR™ Systems, utilizing either one or two MX analytical modules, were used to measure throughput, walk-away time (WAT), user interactions, and testing capacity, using the CE-cleared BD CTGCTV2™ (“CTGCTV2”) assay. Mock samples that represent either urine or vaginal swab specimens were used for this study.



Results: The BD COR™ System with a single MX module took approximately 13.5 minutes to load reagents for 1632 tests. With this, 288 samples were processed and tested with zero user interaction. Walk-away time for these 288 samples was approximately 8 hours; after a second user interaction, this time only taking 7.5-min., an additional 278 samples were processed and tested in an 8-hour shift (8 hrs. of work time plus standard breaks) resulting in a total of 648 samples. Over a 24-hour period, a total of 936 samples were processed and tested. COR with dual MX analytical modules increased the 8-hour and 24-hour throughputs to 1248 and 1872, respectively.



Conclusion: BD COR™ System, utilizing either single or dual MX analytical modules, efficiently automates the processing and molecular testing of clinical samples with minimal staff interaction. This, in turn, results in more standardized and streamlined clinical laboratory workflows, while still providing both fast and accurate patient results.