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10.1016/j.ijid.2020.11.164

http://scihub22266oqcxt.onion/10.1016/j.ijid.2020.11.164
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33227517!7677675!33227517
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suck abstract from ncbi


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pmid33227517      Int+J+Infect+Dis 2021 ; 103 (ä): 636-641
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  • Clinical performance evaluation of a SARS-CoV-2 Rapid Antibody Test for determining past exposure to SARS-CoV-2 #MMPMID33227517
  • Findeisen P; Stiegler H; Lopez-Calle E; Schneider T; Urlaub E; Hayer J; Zemmrich C
  • Int J Infect Dis 2021[Feb]; 103 (ä): 636-641 PMID33227517show ga
  • OBJECTIVES: Due to the number of asymptomatic infections and limited access to high-performance antibody tests, the true prevalence and seropositivity of SARS-CoV-2 infection remains unknown. To fill this gap, the clinical performance of a point-of-care SARS-CoV-2 Rapid Antibody Assay, a chromatographic immunoassay for detecting IgM/IgG antibodies, in near patient settings was assessed. METHODS: Forty-two anti-SARS-Cov-2 positive (CoV+) and 92 anti-SARS-Cov-2 negative (CoV-) leftover samples from before December 2019 were assessed; the Elecsys(R) Anti-SARS-CoV-2 was used as the reference assay. Analytical specificity was tested using leftover samples collected before December 2019 from patients with common cold symptoms. RESULTS: The SARS-CoV-2 Rapid Antibody Test was 100.0% (95% CI 91.59-100.0) sensitive and 96.74% (95% CI 90.77-99.32) specific, with 0.00% assay failure rate. No cross-reactivity was observed against the common cold panel. Method comparison was additionally conducted by two external laboratories, using 100 CoV+ and 275 CoV- samples, also comparing whole blood versus plasma matrix. The comparison demonstrated 96.00% positive and 96.36% negative percent agreement for plasma with the Elecsys Anti-SARS-CoV-2 and 99.20% percent overall agreement between whole blood and EDTA plasma. CONCLUSION: The SARS-CoV-2 Rapid Antibody Test demonstrated similar performance to the manufacturer's data and a centralised automated immunoassay, with no cross-reactivity with common cold panels.
  • |Antibodies, Viral/*blood[MESH]
  • |COVID-19 Testing[MESH]
  • |COVID-19/*diagnosis[MESH]
  • |Cross Reactions[MESH]
  • |Humans[MESH]
  • |Immunoassay/methods[MESH]
  • |Point-of-Care Systems[MESH]


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