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.
Highlights
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
These assays are intended for: i) the quantitative detection of hepatitis B virus DNA13,17,19,21; ii) the quantitative detection of hepatitis C virus RNA12,17,18,21; iii) the quantitative detection of HIV-1 RNA15e17,21; iv) the qualitative detection of SARS-CoV-2 RNA20; v) the qualitative detection of 14 high-risk human papillomaviruses coupled with extended genotyping[14,22]; the vi) qualitative detection and differentiation of Chlamydia trachomatis, Trichomonas vaginalis, Mycoplasma genitalium, and Neisseria gonorrhoeae[23]; and vii) the qualitative detection and differentiation of SARSCoV-2, influenza A and B viruses, and respiratory syncytial virus
Twelve evaluations of Alinity m assays are available from the peer-reviewed literature,12e23 but only a single analytical and clinical evaluation of the Alinity m SARS-CoV-2 assay in a limited number of samples is known to have been published to date.[20]
Summary
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 throughput of the two analyzers was compared using testing on 564 samples in parallel across two 8-hour shifts in clinical practice. Detecting severe acute respiratory syndromeecoronavirus 2 (SARS-CoV-2) RNA in nasopharyngeal swabs is still considered the COVID-19 reference laboratory diagnostic standard.[1,2] several commercial SARS-CoV-2 RNA assays have received Emergency-Use Authorization.
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