Reliable high-throughput methods are required for the detection of severe acute respiratory coronavirus 2 (SARS-CoV-2). We evaluated the new research use only (RUO) SpeeDx PlexZyme SARS-CoV-2 components (Plex) compared to the Roche cobas SARS-CoV-2 assay (cobas). A collection of positive ( n = 214) and negative samples ( n = 201) was tested in parallel comparing Plex with cobas. The overall agreement comparing the qualitative outcomes was 96.9%. Using an in-house quantitative PCR method, correlation comparing Plex ORF1ab to cobas ORF1a was r 2 = 0.95. The median Plex ORF1ab change in target copy number compared to cobas ORF1a was +0.48 log 10 copies/mL respectively. Inter- and intra-assay reproducibility of each assay was compared, including a limit-of-detection study. Reproducibility was comparable; however cobas was more sensitive than Plex by 1-log dilution. Throughput was evaluated during a COVID-19 testing surge of 4324 samples in a 30-h period. Plex demonstrated less hands-on time per reportable result (19% decrease) and increased throughput (155% increase of 102 results/hour) compared to cobas (40 results/hour). Our study demonstrates good qualitative and quantitative correlation of Plex compared to cobas and that Plex is well-suited for high throughput testing.
【저자키워드】 SARS-CoV-2, High-throughput, PlexZyme, 【초록키워드】 outcome, COVID-19 testing, Research, correlation, Roche, Quantitative, quantitative PCR, ORF1ab, Dilution, ORF1a, throughput, component, reproducibility, positive, decrease, Respiratory Coronavirus, negative sample, log, evaluated, required, median, less, demonstrated, was tested, 【제목키워드】 COVID-19, Testing, PCR, assessment, throughput,