Real-Life Head-to-Head Comparison of Performance of Two High-Throughput Automated Assays for the Detection of SARS-CoV-2 RNA in Nasopharyngeal Swabs

Abstract

The Alinity m (Abbott Molecular, Des Plaines, IL) automated molecular analyzer allows continuous loading of samples and sample-to-result molecular detection of several microorganisms. The detection of SARS-CoV-2 by the Alinity m was compared with that of the cobas 6800 (Roche Molecular Systems, Branchburg, NJ; standard comparator) in a manufacturer-independent clinical evaluation on 2157 consecutive nasopharyngeal swab samples. Valid initial results on Alinity m and cobas 6800 were obtained from 2129 (98.7%) and 2157 (100%) samples, respectively. The overall percent agreement (95% CI) was 98.3% (2092/2129 [97.6%–98.7%]); positive percent agreement, 100% (961/961 [99.6%–100%]); negative percent agreement, 96.8% (1131/1168 [95.7%–97.7%]); and high κ value, 0.965 (0.954–0.976). There were 37 discordant results on Alinity m and, based on discordant analyses, including previous and/or follow-up PCR results, 22 could be considered analytically true positive with high probability. Due to a lack of additional information and an inability to perform repeated/further testing, the status of the remaining 15 discordant results remained unresolved. The throughput of the two analyzers was compared using testing on 564 samples in parallel across two 8-hour shifts in clinical practice. The turnaround times were compared using processing of 94 routine samples in parallel on each working day for 5 consecutive days. The two analyzers showed similar performance, with certain differences that have potential importance in some laboratory settings. The Alinity m (Abbott Molecular, Des Plaines, IL) automated molecular analyzer allows continuous loading of samples and sample-to-result molecular detection of several microorganisms. The detection of SARS-CoV-2 by the Alinity m was compared with that of the cobas 6800 (Roche Molecular Systems, Branchburg, NJ; standard comparator) in a manufacturer-independent clinical evaluation on 2157 consecutive nasopharyngeal swab samples. Valid initial results on Alinity m and cobas 6800 were obtained from 2129 (98.7%) and 2157 (100%) samples, respectively. The overall percent agreement (95% CI) was 98.3% (2092/2129 [97.6%–98.7%]); positive percent agreement, 100% (961/961 [99.6%–100%]); negative percent agreement, 96.8% (1131/1168 [95.7%–97.7%]); and high κ value, 0.965 (0.954–0.976). There were 37 discordant results on Alinity m and, based on discordant analyses, including previous and/or follow-up PCR results, 22 could be considered analytically true positive with high probability. Due to a lack of additional information and an inability to perform repeated/further testing, the status of the remaining 15 discordant results remained unresolved. The throughput of the two analyzers was compared using testing on 564 samples in parallel across two 8-hour shifts in clinical practice. The turnaround times were compared using processing of 94 routine samples in parallel on each working day for 5 consecutive days. The two analyzers showed similar performance, with certain differences that have potential importance in some laboratory settings. The coronavirus disease–2019 (COVID-19) pandemic has affected over 135 million individuals, with over 2.9 million COVID-19–related deaths as of April 10, 2021. Highly reliable laboratory diagnostics for COVID-19 are essential for case identification, patient management, and contact tracing. Detecting severe acute respiratory syndrome–coronavirus 2 (SARS-CoV-2) RNA in nasopharyngeal swabs is still considered the COVID-19 reference laboratory diagnostic standard.1Ravi N. Cortade D.L. Ng E. Wang S.X. Diagnostics for SARS-CoV-2 detection: a comprehensive review of the FDA-EUA COVID-19 testing landscape.Biosens Bioelectron. 2020; 165: 112454Crossref PubMed Scopus (292) Google Scholar,2Loeffelholz M.J. Tang Y.W. Laboratory diagnosis of emerging human coronavirus infections—the state of the art.Emerg Microbes Infect. 2020; 20: 1-26Google Scholar Although several commercial SARS-CoV-2 RNA assays have received Emergency-Use Authorization (EUA) from the US Food and Drug Administration (FDA), only a few have been designed for analyzers with high sample throughput to manage the unprecedented demand for SARS-CoV-2 RNA testing and to allow for significant scaling-up due to the fully automated sample-to-result solution.3Arena F. Pollini S. Rossolini G.M. Margaglione M. Summary of the available molecular methods for detection of SARS-CoV-2 during the ongoing pandemic.Int J Mol Sci. 2021; 22: 1298Crossref PubMed Scopus (42) Google Scholar The cobas 6800 and 8800 Systems (Roche Molecular Systems, Branchburg, NJ) are fully integrated and automated analyzers that allow for sample-to-result qualitative and quantitative molecular detection of several microorganisms. The FDA recently approved the use of a range of molecular assays designed for use with the cobas 6800/8800 System (https://www.fda.gov/medical-devices/vitro-diagnostics/nucleic-acid-based-tests, last accessed April 10, 2021), including assays for SARS-CoV-2, which were given FDA EUA on March 12, 2020. Several studies have evaluated the performance of this reliable and robust SARS-CoV-2 assay,4Poljak M. Korva M. Knap Gašper N. Fujs Komloš K. Sagadin M. Uršič T. Avšič Županc T. Petrovec M. Clinical evaluation of the cobas SARS-CoV-2 test and a diagnostic platform switch during 48 hours in the midst of the COVID-19 pandemic.J Clin Microbiol. 2020; 58: e00599-20Crossref PubMed Scopus (104) Google Scholar, 5Lieberman J.A. Pepper G. Naccache S.N. Huang of available and assays for in detection of SARS-CoV-2 in clinical Clin Microbiol. 2020; 58: PubMed Scopus Google Scholar, K. M. M. N. S. S. Clinical evaluation and of molecular in diagnostic assays for the detection of J Clin 2020; PubMed Google Scholar, E. N. T. N. of SARS-CoV-2 detection from nasopharyngeal swab samples by the cobas 6800 SARS-CoV-2 test and a 2020; PubMed Scopus Google Scholar, M.J. K. M. T. M. M. of two for the detection of severe acute respiratory coronavirus Clin Microbiol. 2020; 58: PubMed Scopus Google Scholar, S. of and to cobas for the detection of Clin 2020; PubMed Scopus Google Scholar, N. N. of SARS-CoV-2 by use of the SARS-CoV-2 and cobas SARS-CoV-2 Clin Microbiol. 2020; 58: PubMed Scopus Google Scholar, M. M. of the cobas 6800 System with the for the detection of Clin 2020; PubMed Scopus Google Scholar and has a in performance of SARS-CoV-2 RNA Alinity m (Abbott Molecular, Des Plaines, IL) is recently fully sample-to-result molecular analyzer that allows continuous loading of samples and molecular assays have been for use with Alinity S. F. M. E. M. G. S. K. K. Huang S. N. M.J. K. M. clinical evaluation of Alinity m Clin 2020; PubMed Scopus Google Scholar, S. F. K. M. M. E. G. M. N. M.J. K. S. clinical evaluation of Alinity m Clin 2020; PubMed Scopus Google Scholar, K. M. Alinity m for human test in Clin Microbiol. 58: PubMed Scopus Google Scholar, M. M. F. E. G. M. N. M.J. K. M. clinical evaluation of Alinity m Clin 2020; PubMed Scopus Google Scholar, M. of the Alinity m for the of RNA in a molecular laboratory in Clin 2020; Scopus Google Scholar, S. of the Alinity m and assays for the of and in clinical Clin 2020; PubMed Scopus Google Scholar, the Alinity m platform to RNA in Clin 2020; PubMed Scopus Google Scholar, K. S. of the on and 2021; PubMed Scopus Google Scholar, T. G. and of SARS-CoV-2 performance on the and Alinity m Clin Microbiol. 2021; PubMed Scopus Google Scholar, evaluation of the fully automated molecular Alinity m in a Clin 2021; PubMed Scopus Google Scholar, M. M. Clinical and evaluation of the Alinity m the Clin Microbiol. 2021; PubMed Scopus Google Scholar, K. and Alinity m for detection of and J Clin 2021; of Scopus Google Scholar including an for SARS-CoV-2, which was given FDA EUA on 2020. the cobas SARS-CoV-2 with performance on the Alinity m SARS-CoV-2 only on and T. G. and of SARS-CoV-2 performance on the and Alinity m Clin Microbiol. 2021; PubMed Scopus Google Scholar the results from a manufacturer-independent of the clinical performance of the Alinity m SARS-CoV-2 the cobas 6800 SARS-CoV-2 as a standard evaluated the clinical performance of two automated assays in the of SARS-CoV-2 RNA in 2157 consecutive nasopharyngeal swab samples in a routine diagnostic throughput of the two analyzers was compared in clinical using testing on 564 samples across two 8-hour were compared using of the 94 samples received in the laboratory on each working day for 5 consecutive days. The clinical performance of the Alinity m and cobas 6800 SARS-CoV-2 assays was compared using testing on a of 2157 nasopharyngeal swab samples, during a in 2021. samples were obtained from the Clinical the and the COVID-19 in with the COVID-19 were in a available from 2157 for COVID-19 testing during the The of samples from the to the laboratory was the swabs were for and two were for Alinity m SARS-CoV-2 testing and for cobas 6800 SARS-CoV-2 The Alinity m SARS-CoV-2 is a for the qualitative detection of SARS-CoV-2 RNA in and swab T. G. and of SARS-CoV-2 performance on the and Alinity m Clin Microbiol. 2021; PubMed Scopus Google Scholar using the allows detection and of two the and as a in and an for the evaluation of sample and in The was on Alinity fully automated molecular analyzer that allows continuous loading of samples and sample PCR and of the Alinity m two is as a is as is and to of the results the laboratory information the results be on the as a this sample were Alinity m on Alinity and the The cobas SARS-CoV-2 is a PCR test for the qualitative detection of SARS-CoV-2 RNA in nasopharyngeal and swab M. Korva M. Knap Gašper N. Fujs Komloš K. Sagadin M. Uršič T. Avšič Županc T. Petrovec M. Clinical evaluation of the cobas SARS-CoV-2 test and a diagnostic platform switch during 48 hours in the midst of the COVID-19 pandemic.J Clin Microbiol. 2020; 58: e00599-20Crossref PubMed Scopus (104) Google Scholar is a to SARS-CoV-2 and the is a in the for detection The RNA as sample and PCR processing and the for the of PCR The is on the cobas 6800 8800 which of the sample processing and is using the which test The results be on the as a to a laboratory information to the a sample was considered SARS-CoV-2 positive cobas showed positive results for the and for the only the case of for the only the was as SARS-CoV-2 this sample were to on the cobas 6800 and the was in negative and positive was for the of percent and negative with The of agreement was using the κ were using and The with the of and was approved by the of the of the throughput of the Alinity m and cobas 6800 in clinical 564 samples were in parallel on across two 8-hour were by on the of 2021. analyzers were the and in parallel samples were and results were The and with each analyzer were by two and of the of the results across the two a from each analyzer was and the obtained were the turnaround times of the two SARS-CoV-2 assays in clinical the 94 routine samples received in the laboratory on each working day for 5 consecutive were in parallel on analyzers by and The testing of each analyzer was by two and and the were for each of the samples sample of sample of and of the and were for each of the samples 2157 nasopharyngeal swab samples initial results from the Alinity m and cobas 6800 SARS-CoV-2 assays were obtained from 2129 (98.7%) and 2157 (100%) samples, respectively. of samples were from due to initial results on Alinity m results were due to a lack of of the and the results from the clinical evaluation of the two assays on 2129 samples with initial results from The diagnostic showed an overall percent agreement (95% CI) of 98.3% (2092/2129 a positive percent agreement of 100% (961/961 a negative percent agreement of 96.8% (1131/1168 and a high κ of 0.965 on 2129 samples with results from of Alinity of Molecular Plaines, cobas of Molecular Systems SARS-CoV-2 m SARS-CoV-2 6800 SARS-CoV-2 agreement (95% (95% of 2129 nasopharyngeal swab samples with initial results on assays were were from due to initial results on Alinity The of 37 discordant results, including positive on Alinity m and on cobas is in in the and of Molecular Plaines, of Molecular Systems in a of 2129 nasopharyngeal swab samples with initial results on assays were were from due to initial results on Alinity The of 37 discordant results, including positive on Alinity m and on cobas is in in the and discordant results were samples were positive using Alinity m SARS-CoV-2 and positive on cobas 6800 SARS-CoV-2, and were positive using Alinity m SARS-CoV-2 and negative on cobas 6800 SARS-CoV-2 Alinity m SARS-CoV-2, and positive samples were and to and 37 samples with discordant results, and to respectively. of of samples with Alinity 6800 the status of samples with results, previous and follow-up testing results from the 37 with results in the laboratory information were of 37 individuals, previous and/or follow-up SARS-CoV-2 PCR were of a previous SARS-CoV-2 in samples on 10, and to the sample in this was previous samples the positive sample was considered for each and of a positive on follow-up SARS-CoV-2 PCR in samples on and 2 to the sample in this was follow-up samples the positive follow-up sample was considered for each with Alinity 6800 results, previous and/or follow-up SARS-CoV-2 PCR results were in the laboratory information individuals, were Alinity m SARS-CoV-2 6800 SARS-CoV-2 positive for 2 and 15 were Alinity m SARS-CoV-2 6800 SARS-CoV-2 on the discordant of 37 samples with Alinity m 6800 results, 22 samples could be considered Alinity m SARS-CoV-2 analytically true positive with high probability. Due to the lack of additional information and the inability of repeated/further testing, the status of the remaining 15 discordant samples unresolved. the with the Alinity m and cobas 6800 with the of the results from testing 564 samples in parallel across two 8-hour The results were with Alinity m with the cobas 6800 the results were hours Alinity m results in of 12, and 564 results and hours the the cobas 6800 System hours from to the of 94 the cobas 6800 System results in of and 564 results and hours respectively. The times of testing 564 samples were similar the two with Alinity m and with the cobas 6800 the cobas 6800 System Alinity m the cobas 6800 System laboratory during similar to Alinity m during to parallel routine processing of the 94 samples received in the laboratory on each working day for 5 consecutive the of samples were with Alinity m to in to with the cobas 6800 System to Although the of were similar the two analyzers to cobas 6800 to the of of samples to cobas 6800 to The demand for SARS-CoV-2 diagnostics has been and has to the of a range of molecular assays designed for use with analyzers that high sample throughput allows for significant scaling-up due to the fully automated sample-to-result SARS-CoV-2 RNA assays are cobas M. Korva M. Knap Gašper N. Fujs Komloš K. Sagadin M. Uršič T. Avšič Županc T. Petrovec M. Clinical evaluation of the cobas SARS-CoV-2 test and a diagnostic platform switch during 48 hours in the midst of the COVID-19 pandemic.J Clin Microbiol. 2020; 58: e00599-20Crossref PubMed Scopus (104) Google Scholar, 5Lieberman J.A. Pepper G. Naccache S.N. Huang of available and assays for in detection of SARS-CoV-2 in clinical Clin Microbiol. 2020; 58: PubMed Scopus Google Scholar, K. M. M. N. S. S. Clinical evaluation and of molecular in diagnostic assays for the detection of J Clin 2020; PubMed Google Scholar, E. N. T. N. of SARS-CoV-2 detection from nasopharyngeal swab samples by the cobas 6800 SARS-CoV-2 test and a 2020; PubMed Scopus Google Scholar, M.J. K. M. T. M. M. of two for the detection of severe acute respiratory coronavirus Clin Microbiol. 2020; 58: PubMed Scopus Google Scholar, S. of and to cobas for the detection of Clin 2020; PubMed Scopus Google Scholar, N. N. of SARS-CoV-2 by use of the SARS-CoV-2 and cobas SARS-CoV-2 Clin Microbiol. 2020; 58: PubMed Scopus Google Scholar, M. M. of the cobas 6800 System with the for the detection of Clin 2020; PubMed Scopus Google Scholar Alinity m T. G. and of SARS-CoV-2 performance on the and Alinity m Clin Microbiol. 2021; PubMed Scopus Google Scholar SARS-CoV-2 J.A. Pepper G. Naccache S.N. Huang of available and assays for in detection of SARS-CoV-2 in clinical Clin Microbiol. 2020; 58: PubMed Scopus Google M.J. K. M. T. M. M. of two for the detection of severe acute respiratory coronavirus Clin Microbiol. 2020; 58: PubMed Scopus Google E. of molecular in diagnostic assays for the detection of SARS-CoV-2 in nasopharyngeal Clin Microbiol. 2020; 58: PubMed Scopus Google Scholar, S. F. S. of the for SARS-CoV-2 in clinical Clin 2020; PubMed Scopus Google Scholar, E. S. and clinical of for SARS-CoV-2 Clin Microbiol. 2020; 58: PubMed Scopus Google Scholar, Huang N. of the and a test the for detection of Clin 2020; PubMed Scopus Google Scholar SARS-CoV-2 J.A. Pepper G. Naccache S.N. Huang of available and assays for in detection of SARS-CoV-2 in clinical Clin Microbiol. 2020; 58: PubMed Scopus Google M.J. K. M. T. M. M. of two for the detection of severe acute respiratory coronavirus Clin Microbiol. 2020; 58: PubMed Scopus Google E. of molecular in diagnostic assays for the detection of SARS-CoV-2 in nasopharyngeal Clin Microbiol. 2020; 58: PubMed Scopus Google Scholar, S. F. S. of the for SARS-CoV-2 in clinical Clin 2020; PubMed Scopus Google Scholar, E. S. and clinical of for SARS-CoV-2 Clin Microbiol. 2020; 58: PubMed Scopus Google Scholar, Huang N. of the and a test the for detection of Clin 2020; PubMed Scopus Google Scholar SARS-CoV-2 Molecular, K. M. E. M. evaluation of the SARS-CoV-2 Clin 2020; PubMed Scopus Google E. S. of a and performance with the and automated assays for detection of SARS-CoV-2 in respiratory Clin 2020; PubMed Scopus Google Scholar and SARS-CoV-2 Although several of assays have been in to the only a of two SARS-CoV-2 assays was using M.J. K. M. T. M. M. of two for the detection of severe acute respiratory coronavirus Clin Microbiol. 2020; 58: PubMed Scopus Google Scholar that the clinical performance of the cobas and SARS-CoV-2 assays was compared using nasopharyngeal swab the two assays showed a high overall percent agreement of and a high κ of M.J. K. M. T. M. M. of two for the detection of severe acute respiratory coronavirus Clin Microbiol. 2020; 58: PubMed Scopus Google Scholar fully automated analyzers for SARS-CoV-2 RNA testing, Alinity m was recently and as of April molecular assays been and for use with Alinity assays are the quantitative detection of S. F. K. M. M. E. G. M. N. M.J. K. S. clinical evaluation of Alinity m Clin 2020; PubMed Scopus Google S. of the Alinity m and assays for the of and in clinical Clin 2020; PubMed Scopus Google K. S. of the on and 2021; PubMed Scopus Google evaluation of the fully automated molecular Alinity m in a Clin 2021; PubMed Scopus Google the quantitative detection of S. F. M. E. M. G. S. K. K. Huang S. N. M.J. K. M. clinical evaluation of Alinity m Clin 2020; PubMed Scopus Google S. of the Alinity m and assays for the of and in clinical Clin 2020; PubMed Scopus Google the Alinity m platform to RNA in Clin 2020; PubMed Scopus Google evaluation of the fully automated molecular Alinity m in a Clin 2021; PubMed Scopus Google the quantitative detection of M. M. F. E. G. M. N. M.J. K. M. clinical evaluation of Alinity m Clin 2020; PubMed Scopus Google Scholar, M. of the Alinity m for the of RNA in a molecular laboratory in Clin 2020; Scopus Google Scholar, S. of the Alinity m and assays for the of and in clinical Clin 2020; PubMed Scopus Google evaluation of the fully automated molecular Alinity m in a Clin 2021; PubMed Scopus Google the qualitative detection of SARS-CoV-2 T. G. and of SARS-CoV-2 performance on the and Alinity m Clin Microbiol. 2021; PubMed Scopus Google the qualitative detection of human with K. M. Alinity m for human test in Clin Microbiol. 58: PubMed Scopus Google M. M. Clinical and evaluation of the Alinity m the Clin Microbiol. 2021; PubMed Scopus Google the qualitative detection and of and K. and Alinity m for detection of and J Clin 2021; of Scopus Google and the qualitative detection and of SARS-CoV-2, and and respiratory of Alinity m assays are available from the S. F. M. E. M. G. S. K. K. Huang S. N. M.J. K. M. clinical evaluation of Alinity m Clin 2020; PubMed Scopus Google Scholar, S. F. K. M. M. E. G. M. N. M.J. K. S. clinical evaluation of Alinity m Clin 2020; PubMed Scopus Google Scholar, K. M. Alinity m for human test in Clin Microbiol. 58: PubMed Scopus Google Scholar, M. M. F. E. G. M. N. M.J. K. M. clinical evaluation of Alinity m Clin 2020; PubMed Scopus Google Scholar, M. of the Alinity m for the of RNA in a molecular laboratory in Clin 2020; Scopus Google Scholar, S. of the Alinity m and assays for the of and in clinical Clin 2020; PubMed Scopus Google Scholar, the Alinity m platform to RNA in Clin 2020; PubMed Scopus Google Scholar, K. S. of the on and 2021; PubMed Scopus Google Scholar, T. G. and of SARS-CoV-2 performance on the and Alinity m Clin Microbiol. 2021; PubMed Scopus Google Scholar, evaluation of the fully automated molecular Alinity m in a Clin 2021; PubMed Scopus Google Scholar, M. M. Clinical and evaluation of the Alinity m the Clin Microbiol. 2021; PubMed Scopus Google Scholar, K. and Alinity m for detection of and J Clin 2021; of Scopus Google Scholar only a and clinical evaluation of the Alinity m SARS-CoV-2 in a of samples is to have been to T. G. and of SARS-CoV-2 performance on the and Alinity m Clin Microbiol. 2021; PubMed Scopus Google Scholar that the of a of detection of with the Alinity m SARS-CoV-2 was with clinical evaluation on nasopharyngeal swabs from and with The testing of samples was compared the Alinity m and the SARS-CoV-2 and positive and negative percent agreement the two assays were (95% and (95% respectively. The in positive samples showed high on for were with Alinity m with due to the with the T. G. and of SARS-CoV-2 performance on the and Alinity m Clin Microbiol. 2021; PubMed Scopus Google Scholar performance are by the which compared Alinity m SARS-CoV-2 with an PCR approved for use by FDA on the testing of clinical samples with positive and negative percent the two assays of 100% (95% and (95% with two samples positive on Alinity m SARS-CoV-2, of which a of The performance of the assays was using samples from individuals, of which were percent positive and negative of 100% (95% and in on the detection of SARS-CoV-2 with similar has been that the performance of Alinity m SARS-CoV-2 was by emerging of and the Alinity m SARS-CoV-2 showed and negative agreement with the cobas 6800 SARS-CoV-2, in the testing of 2129 samples, with results with discordant results were the assays was with Alinity m SARS-CoV-2 over cobas 6800 are in agreement with on performance from an FDA SARS-CoV-2 reference of performance FDA that the of Alinity m SARS-CoV-2 was test m SARS-CoV-2 EUA Molecular, Des Scholar compared to with cobas 6800 SARS-CoV-2 last accessed April 10, with Alinity m SARS-CoV-2 have to the compared with that of cobas 6800 that the Alinity m and the cobas 6800 SARS-CoV-2 assays SARS-CoV-2 is a that discordant performance was a of and and has been recently that certain in the SARS-CoV-2 commercial M. S. M. K. of SARS-CoV-2 is with of the quantitative in a commercial diagnostic Clin Microbiol. 2020; 58: PubMed Scopus Google M. N. the molecular diagnosis of 2021; PubMed Scopus Google Scholar a is with the Alinity m and cobas 6800 SARS-CoV-2 given that were designed as results is a for for the of that PCR in with a PCR test for SARS-CoV-2 clinical The of SARS-CoV-2 samples a high have and are positive on assays with an that of standard PCR the clinical be only in a of positive samples a SARS-CoV-2 RNA high due to sample that was that in a of SARS-CoV-2 of samples positive on and negative on be Due to the high of the Alinity m and cobas 6800 SARS-CoV-2 and due to the of samples results the Alinity m and cobas 6800 SARS-CoV-2 assays could be the true SARS-CoV-2 RNA status of samples with results could be only using previous and follow-up testing in were in the laboratory information on from discordant analyses, of 37 with samples that discordant results, 22 could have been considered true positive on with Alinity m SARS-CoV-2, with high probability. of the with Alinity m SARS-CoV-2 compared with that of cobas 6800 SARS-CoV-2 was positive on cobas 6800 SARS-CoV-2 in follow-up samples obtained the initial negative was obtained with cobas 6800 clinical to with Alinity m 6800 positive results in the previous follow-up results The clinical of the with Alinity m SARS-CoV-2 in the remaining a sample that an Alinity m true 6800 a cobas 6800 in previous is the clinical of molecular for follow-up testing in with due to the lack of additional information and the inability of repeated/further testing in 15 of 37 with results discordant Alinity m 6800 SARS-CoV-2, the status of the samples that discordant results unresolved. Alinity m SARS-CoV-2 is a RNA to the SARS-CoV-2 and is each the of the sample The is by PCR to that the testing has in each the of 2157 samples showed initial results on Alinity m SARS-CoV-2, due to a lack of of and for the of only of samples with initial results on Alinity m SARS-CoV-2, and a on Alinity m SARS-CoV-2 was obtained in of the samples The cobas 6800 System was the of and of of 2 and Alinity m was a the of the Although results on SARS-CoV-2 RNA testing were an with the cobas 6800 M. Korva M. Knap Gašper N. Fujs Komloš K. Sagadin M. Uršič T. Avšič Županc T. Petrovec M. Clinical evaluation of the cobas SARS-CoV-2 test and a diagnostic platform switch during 48 hours in the midst of the COVID-19 pandemic.J Clin Microbiol. 2020; 58: e00599-20Crossref PubMed Scopus (104) Google Scholar and were by by the during sample by sample in sample processing the and significant with results on the cobas 6800 System have been during the of routine testing of samples using the cobas 6800 SARS-CoV-2 the was the of results on Alinity m was for the of results on Alinity m SARS-CoV-2 in the remained similar to during the and in to in the the of results were and in 5 to The for the have been a of the of the analyzer and the of the Due to the of of the samples, the of and of the samples with results on Alinity m SARS-CoV-2 are using a that a sample as M. Korva M. Knap Gašper N. Fujs Komloš K. Sagadin M. Uršič T. Avšič Županc T. Petrovec M. Clinical evaluation of the cobas SARS-CoV-2 test and a diagnostic platform switch during 48 hours in the midst of the COVID-19 pandemic.J Clin Microbiol. 2020; 58: e00599-20Crossref PubMed Scopus (104) Google Scholar in the of the samples with results that of available were with Alinity m SARS-CoV-2, and a was obtained in of of samples sample is testing sample is in of samples with results on Alinity m a SARS-CoV-2 RNA only and sample to test and and throughput is a for The Alinity m and the cobas 6800 Systems are fully integrated and automated analyzers that allow for sample-to-result detection of SARS-CoV-2 the throughput showed differences Alinity m the results the cobas 6800 System with the cobas 6800 the testing of 564 samples in parallel was hours with Alinity m the of testing 564 samples was similar the two was with the cobas 6800 System with Alinity during testing of 564 samples in parallel across two 8-hour the cobas 6800 System the of laboratory during similar Alinity m during differences the analyzers were during routine processing of the 94 samples received the laboratory on each working day for 5 consecutive days. this testing of samples, the of of the samples were with Alinity m in to the cobas 6800 was due to differences in the two and due to routine processing of with Alinity m and with the cobas 6800 in laboratory the differences the analyzers in the be and to in using the two analyzers for the routine detection of SARS-CoV-2 laboratory that the of Alinity m were a with and and that the were the for and and sample and of positive and negative The with the cobas 6800 System were a that and and sample the the laboratory the of and was the of sample to during sample due to in the manufacturer-independent of Alinity m SARS-CoV-2 cobas 6800 SARS-CoV-2 in the routine diagnostic testing of 2157 samples, the Alinity m SARS-CoV-2 was reliable in the qualitative detection of SARS-CoV-2 from nasopharyngeal swab samples. showed and negative percent with a high κ with the Alinity m SARS-CoV-2 was in a of samples. throughput and in clinical showed similar performance of the two with performance differences that could be in some laboratory settings. and for laboratory with the cobas 6800 System testing and of the COVID-19 diagnostic have been working for the to SARS-CoV-2

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