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10.1093/ajcp/aqaa128

http://scihub22266oqcxt.onion/10.1093/ajcp/aqaa128
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32687172!7454290!32687172
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suck abstract from ncbi


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pmid32687172      Am+J+Clin+Pathol 2020 ; 154 (4): 475-478
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  • Identification of SARS-CoV-2 in a Proficiency Testing Program #MMPMID32687172
  • Edson DC; Casey DL; Harmer SE; Downes FP
  • Am J Clin Pathol 2020[Sep]; 154 (4): 475-478 PMID32687172show ga
  • 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.
  • |*Laboratory Proficiency Testing[MESH]
  • |Betacoronavirus/genetics/*isolation & purification[MESH]
  • |COVID-19[MESH]
  • |COVID-19 Testing[MESH]
  • |Clinical Laboratory Services/*standards[MESH]
  • |Clinical Laboratory Techniques/methods/*standards[MESH]
  • |Coronavirus Infections/*diagnosis[MESH]
  • |Humans[MESH]
  • |Pandemics[MESH]
  • |Pneumonia, Viral/*diagnosis[MESH]
  • |RNA, Viral/analysis/isolation & purification[MESH]
  • |SARS-CoV-2[MESH]


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