Article ; Online: Identification of SARS-CoV-2 in a Proficiency Testing Program.
American journal of clinical pathology
2020 Volume 154, Issue 4, Page(s) 475–478
Abstract: Objectives: 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 ... ...
Abstract | Objectives: 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. Methods: 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. Results: 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. Conclusions: 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. |
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MeSH term(s) | Betacoronavirus/genetics ; Betacoronavirus/isolation & purification ; COVID-19 ; COVID-19 Testing ; Clinical Laboratory Services/standards ; Clinical Laboratory Techniques/methods ; Clinical Laboratory Techniques/standards ; Coronavirus Infections/diagnosis ; Humans ; Laboratory Proficiency Testing ; Pandemics ; Pneumonia, Viral/diagnosis ; RNA, Viral/analysis ; RNA, Viral/isolation & purification ; SARS-CoV-2 ; United States |
Chemical Substances | RNA, Viral |
Keywords | covid19 |
Language | English |
Publishing date | 2020-08-10 |
Publishing country | England |
Document type | Journal Article |
ZDB-ID | 2944-0 |
ISSN | 1943-7722 ; 0002-9173 |
ISSN (online) | 1943-7722 |
ISSN | 0002-9173 |
DOI | 10.1093/ajcp/aqaa128 |
Database | MEDical Literature Analysis and Retrieval System OnLINE |
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