Comparison of Commercially Available and Laboratory Developed Assays for in vitro Detection of SARS-CoV-2 in Clinical Laboratories
Comparison of Commercially Available and Laboratory Developed Assays for in vitro Detection of SARS-CoV-2 in Clinical Laboratories
Abstract Multiple laboratory developed tests and commercially available assays have emerged to meet diagnostic needs related to the SARS-CoV-2 pandemic. To date, there is limited comparison data for these different testing platforms. We compared the analytical performance of a laboratory developed test (LDT) developed in our clinical laboratory based on CDC primer sets and four commercially available, FDA emergency use authorized assays for SARS-CoV-2 (Cepheid, DiaSorin, Hologic Panther, and Roche Cobas) on a total of 169 nasopharyngeal swabs. The LDT and Cepheid Xpert Xpress SARS-CoV-2 assays were the most sensitive assays for SARS-CoV-2 with 100% agreement across specimens. The Hologic Panther Fusion, DiaSorin Simplexa, and Roche Cobas 6800 only failed to detect positive specimens near the limit of detection of our CDC-based LDT assay. All assays were 100% specific, using our CDC-based LDT as the gold standard. Our results provide initial test performance characteristics for SARS-CoV-2 RT-PCR and highlight the importance of having multiple viral detection testing platforms available in a public health emergency.
Naccache Samia N.、Huang Meei-Li、Greninger Alexander L.、Jerome Keith R.、Pepper Gregory、Lieberman Joshua A.
LabCorp Seattle, Department of MicrobiologyDepartment of Laboratory Medicine, University of Washington Medical Center||Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research CenterDepartment of Laboratory Medicine, University of Washington Medical Center||Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research CenterDepartment of Laboratory Medicine, University of Washington Medical Center||Vaccine and Infectious Disease Division, Fred Hutchinson Cancer Research CenterDepartment of Laboratory Medicine, University of Washington Medical CenterDepartment of Laboratory Medicine, University of Washington Medical Center
医学研究方法基础医学临床医学
Naccache Samia N.,Huang Meei-Li,Greninger Alexander L.,Jerome Keith R.,Pepper Gregory,Lieberman Joshua A..Comparison of Commercially Available and Laboratory Developed Assays for in vitro Detection of SARS-CoV-2 in Clinical Laboratories[EB/OL].(2025-03-28)[2025-08-02].https://www.medrxiv.org/content/10.1101/2020.04.24.20074559.点此复制
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