B-046 Evaluation of cobas 5800 and cobas 6800 systems performance and turnaround time for HIV, CMV, HPV and CT/NG molecular testing in a high-throughput laboratory in Brazil

Background High-performance molecular tests are critical for improving disease detection and management in Brazil, where diverse health challenges exist. Rapid and accurate identification of pathogens is essential for effective treatment strategies and public health interventions. However, transitioning to a new testing platform in Brazilian high-performance laboratories requires a thorough analysis of key factors affecting test lead time. This study compares the turnaround time, number of unplanned stops, and manual data management time for the automated cobas® 5800 and cobas® 6800 molecular systems with the previous routine using platforms from other suppliers for the detection of infectious diseases (HIV, CMV, HPV, and CT/NG). The findings aim to provide insights for optimizing laboratory workflows and enhancing diagnostic throughput. Methods Laboratory internal performance data were reviewed to collect turnaround time, number of unplanned stops, and manual data management for a total of 81,302 tests, including HIV (n=11,907), CMV (n=2,656), HPV (n=12,233), and CT/NG (n=54,506), on three cobas® 5800 instruments and one cobas® 6800 instrument. The analysis was conducted considering a three-month period between May and July 2024 when the cobas® 5800/6800 was installed at its full automation and integration with lab management through the system*s digital solutions. Comparative data were obtained from the same period in 2023 when 58,788 tests—HIV (n=9,374), CMV (n=2,875), HPV (n=19,801), and CT/NG (n=26,698)—were performed using previous platforms at their full potential. The results were analyzed for both timeframes. Results The average turnaround time for the cobas® 5800/6800 systems was 1.88 days (CI 95 1.73 – 1.95), whereas it was 4.09 days (CI 95 2.79 – 5.39) with the previous molecular routine, marking an average reduction of 2.21 days (p<0.05). These improvements in TAT contributed to enhanced laboratory performance, achieving an average release of 1,662.7 (CI 95 1,518 – 1,806) test results per day with cobas® 5800/6800, compared to 781.2 (CI 95 704 – 858) results per day using the previous systems. The automated functionality of cobas® 5800/6800 also led to fewer unplanned stops, with average stop time reduced to 17.61 (CI 95 10.01 – 25.20) hours from 87.51 (CI 95 42.98 – 132.49) hours previously, resulting in an average decrease of 69.89 hours (p<0.05) in the three months observed. Additionally, post-analytical data management time was significantly reduced due to automation and system integration; the average time for data management was 5.08 (CI 95 0.00 – 12.64) hours over three months versus 51.58 (CI 95 20.92 – 82.24) hours from the previous systems. Conclusion Implementing automated molecular systems such as cobas® 5800/6800 can substantially enhance the performance of high-throughput infectious disease molecular testing in Brazil. Data integration through digital solutions promoted better management of processes and eventual issues and improved the data management of results. The transition results in significant reductions in TAT, unplanned stopping time, and manual data management, all contributing to improved laboratory efficiency and diagnostic capacity. These gains underscore the value of technological advancements in supporting effective disease management in diverse healthcare settings.