Identification of SARS-CoV-2 in a Proficiency Testing Program.
Am J Clin Pathol
; 154(4): 475-478, 2020 09 08.
Article
in English
| MEDLINE | ID: covidwho-705105
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.Keywords
Full text:
Available
Collection:
International databases
Database:
MEDLINE
Main subject:
Pneumonia, Viral
/
Coronavirus Infections
/
Clinical Laboratory Techniques
/
Laboratory Proficiency Testing
/
Clinical Laboratory Services
/
Betacoronavirus
Type of study:
Diagnostic study
/
Prognostic study
Limits:
Humans
Country/Region as subject:
North America
Language:
English
Journal:
Am J Clin Pathol
Year:
2020
Document Type:
Article
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