Identification of SARS-CoV-2 in a Proficiency Testing Program.
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.
['Edson|Daniel C|DC|', 'Casey|Danielle L|DL|', 'Harmer|Susan E|SE|', 'Downes|Frances P|FP|']
D000073640:Betacoronavirus D000086382:COVID-19 D000086742:COVID-19 Testing D064790:Clinical Laboratory Services D019411:Clinical Laboratory Techniques D018352:Coronavirus Infections D006801:Humans D059021:Laboratory Proficiency Testing D058873:Pandemics D011024:Pneumonia, Viral D012367:RNA, Viral D000086402:SARS-CoV-2 D014481:United States
SARS-CoV-2 Proficiency testing Coronavirus CLIA ‘88 Microbiology Molecular diagnostics Quality