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Identification of SARS-CoV-2 in a Proficiency Testing Program.
- Source :
-
American Journal of Clinical Pathology . Oct2020, Vol. 154 Issue 4, p475-478. 4p. - Publication Year :
- 2020
-
Abstract
- <bold>Objectives: </bold>At the onset of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic in the United States, testing was limited to the Centers for Disease Control and Prevention-developed reverse transcription polymerase chain reaction assay. The urgent and massive demand for testing prompted swift development of assays to detect SARS-CoV-2. The objective of this study was to assess the accuracy of these newly developed tests.<bold>Methods: </bold>The American Proficiency Institute sent 2 test samples to 346 clinical laboratories in order to assess the accuracy of SARS-CoV-2 assays. The positive sample, containing 5,175 viral copies/mL, was fully extractable with SARS-CoV-2 viral capsid protein and RNA. The negative sample, with 3,951 viral copies/mL, contained recombinant virus particles with sequences for targeting human RNAase P gene sequences.<bold>Results: </bold>Of the laboratories submitting results, 97.4% (302/310) correctly detected the virus when present and 98.3% (296/301) correctly indicated when the virus was not present. Among incorrect results reported in this proficiency challenge, 76.9% (10/13) were likely related to clerical error. This accounts for 1.6% (10/611) of all reported results.<bold>Conclusions: </bold>Overall performance in this SARS-CoV-2 RNA detection challenge was excellent, providing confidence in the results of these new molecular tests and assurance for the clinical and public health decisions based on these test results. [ABSTRACT FROM AUTHOR]
Details
- Language :
- English
- ISSN :
- 00029173
- Volume :
- 154
- Issue :
- 4
- Database :
- Academic Search Index
- Journal :
- American Journal of Clinical Pathology
- Publication Type :
- Academic Journal
- Accession number :
- 145733959
- Full Text :
- https://doi.org/10.1093/ajcp/aqaa128