Generating timely molecular diagnostic test results: workflow comparison of the cobas® 6800/8800 to Panther

Abstract

Background: Molecular diagnostic tests for HBV, HCV and HIV-1 and other pathogens are widely used for clinical management. Practical issues related to workflow and labor requirements need to be characterized to inform selection of the most appropriate system. Research design and methods: We compared the workflow of two high-throughput systems: cobas 6800 (Roche) and Panther (Hologic), using average mid-size laboratory test volumes for five different assays (HIV-1, HBV, HCV, HPV or TV, and CT/NG). Results: Set-up time, time to first results, time to last results, and total hands-on time for cobas 6800 was 0.40, 2.47, 7.12, and 0.98 hours, respectively; on the Panther system, these times were 0.75, 2.7, 9.1, and 1.48 hours. Fifty-seven samples had results available at the first time point on cobas 6800 compared to 5 samples on the Panther system. The Panther system required more manual steps including several with potential risks of contamination or error. The number of reagents items required was 5 for cobas 6800 and 40 for the Panther system. Conclusions: Both systems provided a high level of automation. The cobas 6800 platform had shorter start up, time to first result, time to last result and hands-on times than the Panther system. ARTICLE HISTORY

Clinical evaluation of a SARS-CoV-2 RT-PCR assay on a fully automated system for rapid on-demand testing in the hospital setting

“…Incidentally, Roche recently released their own SARS-CoV-2 assay for this system under "Emergency Use Authorization" by the FDA [13]. However, taking into consideration sample registration, pretreatment, preparation of batches, and generating reports, it usually takes more than 5 h before results can be made available to clinicians [14]. Consequently, alternative workflows are required to enable fast-tracking of high-priority samples.…”

Clinical evaluation of a SARS-CoV-2 RT-PCR assay on a fully automated system for rapid on-demand testing in the hospital setting

“…Utilizing this assay, more than 10,000 samples were tested for SARS-CoV-2 during the month of March 2020 while maintaining all other routine diagnostics in our laboratory, proving the potency of rapid automation to cope with massive surges in demand. However, taking into consideration sample registration, pretreatment, preparation of batches, and generating reports, it usually takes more than 5 hours before results can be made available to clinicians (14). Consequently, alternative workflows are required to enable fast-tracking of high-priority samples.…”

Evaluation of the Onclarity HPV assay on the high-throughput COR system

“…HPV 16, 18, and 45 panel members for SurePath and PreservCyt specimens were prepared such that 60-80% of the specimens were near the clinical cutoff (HPV 16: ≥32. 3 and distributed such that 60-80% of the positives were near the cutoff, with the remaining positives covering the analytical range of the assay. Although the testing primarily involved clinical specimens, in some cases, contrived specimens were used to increase certain genotype group numbers.…”

“…Thus, there is an urgent need for large, centralized core facilities that can quickly receive and process specimens, obtain test results, and upload the results into the laboratory information system (LIS) for health care provider review in an efficient and effective manner [1,2]. A number of large systems have been introduced into the marketplace that have the ability to produce several hundred tests in a single shift [2][3][4][5]. However, these systems do not integrate pre-analytical processing (integration of sorting, aliquoting, vortexing, prewarming/cooling, and specimen storage) and thus a bottleneck occurs upstream of the automated analytic system(s) that requires multiple pre-analytic systems and manual intervention steps to 'feed' these higher throughput systems and leverage their assay capacity [2].…”