Comparison of Commercial Assays and Laboratory Developed Tests for Detection of SARS-CoV-2.

Comparison of Commercial Assays and Laboratory Developed Tests for Detection of SARS-CoV-2. J Virol Methods. 2020 Sep 10;:113970 Authors: Dust K, Hedley A, Nichol K, Stein D, Adam H, Karlowsky JA, Bullard J, Van Caeseele P, Alexander DC Abstract The global COVID-19 pandemic has led to the rapid development of tests for detection of SARS-CoV-2. Studies are required to assess the relative performance of different assays. Here, we compared the performance of two commercial assays, the cobas® SARS-CoV-2 (Roche Diagnostics) and Xpert® Xpress SARS-CoV-2 (Cepheid®) tests, and a laboratory developed RT-PCR test adapted for use on the Hologic® Panther Fusion® (Hologic®) instrument as well as Bio-Rad and QIAGEN real-time PCR detection systems. Performance characteristics for each test were determined by testing clinical specimens and reference material. All assays detect the pan-Sarbecovirus E (envelope structural protein) gene plus a SARS-CoV-2-specific target. The limit of detection for the E gene target varied from ∼2 copies/reaction to >30 copies/reaction. Due to assay-specific differences in sample processing and nucleic acid extraction, the overall analytical sensitivity ranged from 24 copies/mL specimen to 574 copies/mL specimen. Despite these differences, there was 100% agreement between the commercial and laboratory developed tests. No false-negative or false-positive SARS-CoV-2 results were observed and there was no cross-...
Source: Journal of Virological Methods - Category: Virology Authors: Tags: J Virol Methods Source Type: research