The Infectious Diseases Society of America guidelines on the diagnosis of COVID-19, released in May 2020, advocate for nucleic acid amplification testing of all symptomatic individuals even when clinical suspicion is low ( Infectious Diseases Society of America, 2020). Food & Drug Administration and 27 nucleic acid technology tests authorized under Interim Order by Health Canada ( Health Canada, 2020, U.S. At the time of writing, there are 175 molecular diagnostic COVID-19 tests approved for Emergency Use Authorization by the U.S. Conclusively, the BioFire COVID-19 Test and RP2.1 are highly sensitive assays that can be effectively used in the clinical laboratory for rapid SARS-CoV-2 testing.Īccurate and timely detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in upper respiratory tract specimens is the cornerstone of the global effort to minimize transmission of the virus ( World Health Organization, 2020). Results showed 100% concordance between the BioFire assays and the laboratory-developed test for all clinical samples tested, and acceptable performance of both BioFire assays at their stated limits of detection. A total of 78 tests were performed using the BioFire COVID-19 Test, including 30 clinical specimens and 48 tests in a limit of detection study 57 tests were performed using the RP2.1 for evaluation of SARS-CoV-2 detection, including 30 clinical specimens and 27 tests for limit of detection. We evaluated the performance characteristics of these tests in comparison to a laboratory-developed real-time PCR assay targeting the viral RNA-dependent RNA polymerase and E genes. Food & Drug Administration and Interim Order authorization from Health Canada for use in clinical laboratories.
Both tests have received emergency use authorization from the U.S. In the case of the RP2.1, an additional 21 viral and bacterial pathogens can be detected. The BioFire® COVID-19 Test and Respiratory Panel 2.1 (RP2.1) are rapid, fully automated assays for the detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in nasopharyngeal swabs.
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