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10.5858/arpa.2020-0811-SA

http://scihub22266oqcxt.onion/10.5858/arpa.2020-0811-SA
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33461214!8084918!33461214
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suck abstract from ncbi


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pmid33461214      Arch+Pathol+Lab+Med 2021 ; 145 (5): 536-542
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  • Interlaboratory Agreement of Anti-Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Serologic Assays in the Expedited College of American Pathologists Proficiency Testing Program #MMPMID33461214
  • Tacker DH; Bashleben C; Long TC; Theel ES; Knight V; Kadkhoda K; Rhoads DD; Linden MA; Fink SL
  • Arch Pathol Lab Med 2021[May]; 145 (5): 536-542 PMID33461214show ga
  • CONTEXT.-: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a recently emerged, currently pandemic virus, and the etiologic agent of coronavirus disease 2019 (COVID-19). Clinical testing for antibodies to SARS-CoV-2 has rapidly become widespread, but data regarding the interlaboratory performance of these serologic assays are limited. OBJECTIVE.-: To describe the development and initial results of the College of American Pathologists (CAP) SARS-CoV-2 Serology Survey. DESIGN.-: Members from the CAP Microbiology and Diagnostic Immunology and Flow Cytometry Committees formed a working group to support development of a new proficiency testing survey for anti-SARS-CoV-2 antibody assays. Supplemental questions in the survey assessed the state of SARS-CoV-2 serologic testing among participating laboratories as of July 2020. Results were analyzed for agreement by immunoglobulin (Ig) isotype tested, assay manufacturer, and methodology. RESULTS.-: A total of 4125 qualitative results were received from 1110 laboratories participating in the first survey. Qualitative agreement for assays measuring anti-SARS-CoV-2 total antibodies or IgG was greater than 90% for all 3 samples in the survey. Qualitative agreement for IgM and IgA for the negative sample was greater than 95%, but lacked consensus for the other 2 samples. CONCLUSIONS.-: These initial data suggest overall excellent agreement and comparable performance for most qualitative anti-SARS-CoV-2 IgG and total antibody assays across all participating clinical laboratories, regardless of specific target antigen or assay methodology.
  • |*Laboratory Proficiency Testing[MESH]
  • |Antibodies, Viral/*blood[MESH]
  • |COVID-19 Serological Testing/*methods/*standards[MESH]
  • |COVID-19/blood/*diagnosis/immunology/virology[MESH]
  • |Humans[MESH]
  • |Immunoglobulin G/blood[MESH]
  • |Reproducibility of Results[MESH]
  • |SARS-CoV-2/*immunology[MESH]


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