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Deprecated: Implicit conversion from float 231.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 J+Virol+Methods 2020 ; 285 (ä): 113970 Nephropedia Template TP
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Comparison of commercial assays and laboratory developed tests for detection of SARS-CoV-2 #MMPMID32920028
Dust K; Hedley A; Nichol K; Stein D; Adam H; Karlowsky JA; Bullard J; Van Caeseele P; Alexander DC
J Virol Methods 2020[Nov]; 285 (ä): 113970 PMID32920028show ga
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(R) SARS-CoV-2 (Roche Diagnostics) and Xpert(R) Xpress SARS-CoV-2 (Cepheid(R)) tests, and a laboratory developed RT-PCR test adapted for use on the Hologic(R) Panther Fusion(R) (Hologic(R)) 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 approximately 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-reactivity with common respiratory viruses, including endemic coronaviruses.