Identification of SARS-CoV-2 in a Proficiency Testing Program
| Autor: | Daniel C. Edson, Frances P. Downes, Danielle L Casey, Susan E Harmer |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
Laboratory Proficiency Testing
viruses Pneumonia Viral Recombinant virus medicine.disease_cause Microbiology Virus Proficiency testing Betacoronavirus 03 medical and health sciences COVID-19 Testing 0302 clinical medicine Molecular diagnostics Humans Medicine Pandemics Coronavirus biology SARS-CoV-2 CLIA ‘88 Clinical Laboratory Techniques business.industry COVID-19 General Medicine Clinical Laboratory Services biology.organism_classification Quality Virology United States Reverse transcription polymerase chain reaction Capsid 030220 oncology & carcinogenesis RNA Viral Original Article Coronavirus Infections business AcademicSubjects/MED00690 030215 immunology |
| Zdroj: | American Journal of Clinical Pathology |
| ISSN: | 1943-7722 0002-9173 |
| DOI: | 10.1093/ajcp/aqaa128 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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