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10.1111/eci.13357

http://scihub22266oqcxt.onion/10.1111/eci.13357
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32691863!7404380!32691863
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suck abstract from ncbi


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pmid32691863      Eur+J+Clin+Invest 2020 ; 50 (10): e13357
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  • Diagnostic accuracy of Augurix COVID-19 IgG serology rapid test #MMPMID32691863
  • Andrey DO; Cohen P; Meyer B; Torriani G; Yerly S; Mazza L; Calame A; Arm-Vernez I; Guessous I; Stringhini S; Roux-Lombard P; Fontao L; Agoritsas T; Stirnemann J; Reny JL; Siegrist CA; Eckerle I; Kaiser L; Vuilleumier N
  • Eur J Clin Invest 2020[Oct]; 50 (10): e13357 PMID32691863show ga
  • AIMS: To validate the diagnostic accuracy of the Augurix SARS-CoV-2 IgM/IgG rapid immunoassay diagnostic test (RDT) for COVID-19. METHODS: In this unmatched 1:1 case-control study, blood samples from 46 real-time RT-PCR-confirmed SARS-CoV-2 hospitalized cases and 45 healthy donors (negative controls) were studied. Diagnostic accuracy of the IgG RDT was assessed against both an in-house recombinant spike-expressing immunofluorescence assay (rIFA), as an established reference method (primary endpoint), and the Euroimmun SARS-CoV-2 IgG enzyme-linked immunosorbent assays (ELISA) (secondary endpoint). RESULTS: COVID-19 patients were more likely to be male (61% vs 20%; P = .0001) and older (median 66 vs 47 years old; P < .001) than controls. Whole blood IgG-RDT results showed 86% and 93% overall Kendall concordance with rIFA and IgG ELISA, respectively. IgG RDT performances were similar between plasma and whole blood. Overall, RDT sensitivity was 88% (95% confidence interval [95%CI]: 70-96), specificity 98% (95%CI: 90-100), PPV 97% (95%CI: 80-100) and NPV 94% (95%CI: 84-98). The IgG-RDT carried out from 0 to 6 days, 7 to 14 days and > 14 days after the SARS-CoV-2 RT-PCR test displayed 30%, 73% and 100% positivity rates in the COVID-19 group, respectively. When considering samples taken >14 days after RT-PCR diagnosis, NPV was 100% (95%CI:90-100), and PPV was 100% (95%CI:72-100). CONCLUSIONS: The Augurix IgG-RDT done in whole blood displays a high diagnostic accuracy for SARS-CoV-2 IgG in high COVID-19 prevalence settings, where its use could be considered in the absence of routine diagnostic serology facilities.
  • |*Serologic Tests[MESH]
  • |Aged[MESH]
  • |Antibodies, Viral/*immunology[MESH]
  • |Betacoronavirus/*immunology[MESH]
  • |COVID-19[MESH]
  • |COVID-19 Testing[MESH]
  • |COVID-19 Vaccines[MESH]
  • |Case-Control Studies[MESH]
  • |Clinical Laboratory Techniques[MESH]
  • |Coronavirus Infections/*diagnosis[MESH]
  • |Female[MESH]
  • |Fluorescent Antibody Technique[MESH]
  • |Humans[MESH]
  • |Immunoglobulin G/immunology[MESH]
  • |Immunoglobulin M/immunology[MESH]
  • |Male[MESH]
  • |Middle Aged[MESH]
  • |Pandemics[MESH]
  • |Pneumonia, Viral/*diagnosis[MESH]
  • |Reverse Transcriptase Polymerase Chain Reaction[MESH]
  • |SARS-CoV-2[MESH]
  • |Sensitivity and Specificity[MESH]


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