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suck abstract from ncbi


10.1016/j.clinbiochem.2020.08.009

http://scihub22266oqcxt.onion/10.1016/j.clinbiochem.2020.08.009
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suck abstract from ncbi


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pmid32858061      Clin+Biochem 2020 ; 86 (ä): 23-27
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  • High clinical performance and quantitative assessment of antibody kinetics using a dual recognition assay for the detection of SARS-CoV-2 IgM and IgG antibodies #MMPMID32858061
  • Mairesse A; Favresse J; Eucher C; Elsen M; Tre-Hardy M; Haventith C; Gruson D; Dogne JM; Douxfils J; Gobbels P
  • Clin Biochem 2020[Dec]; 86 (ä): 23-27 PMID32858061show ga
  • OBJECTIVES: Several serological SARS-CoV-2 immunoassays have been developed recently but require external validation before widespread use. This study aims at assessing the analytical and clinical performance of the iFlash(R) anti-SARS-CoV-2 chemiluminescence assay for the detection of both IgM and IgG antibodies. The kinetics of the antibody response was also evaluated. DESIGN & METHODS: The precision, carry-over, linearity, limit of blank, detection and quantification were assessed. Sensitivity analysis was performed by using 178 sera collected from 154 RT-PCR confirmed COVID-19 patients. The specificity analysis was performed from 75 selected non-SARS-CoV-2 sera with a potential cross-reaction to the SARS-CoV-2 immunoassay. RESULTS: This iFlash(R) SARS-CoV-2 assay showed excellent analytical performance. After 2 weeks since symptom onset, the sensitivities for IgM and IgG were 62.2% (95% CI: 52.3-71.2%) and 92.9%% (95% CI: 85.7-96.7%), respectively by using the cut-off provided by the manufacturer. After cut-off optimization (i.e. >2.81 for IgM and >4.86 for IgG), the sensitivity for IgM and IgG were 81.6 (95% CI: 72.7-88.1%) and 95.9% (95% CI: 89.4-98.7%), respectively. Optimized cut-off for IgG improved the sensitivity to reach 100% (95%CI: 87.6-100) from 28 days since symptom onset. CONCLUSIONS: This study shows that the iFlash(R) SARS-CoV-2 assay from YHLO biotechnology, has satisfactory analytical performance. Nevertheless, the sensitivity of the IgM is limited for a proper clinical use compared to IgG. The determination of anti-SARS-CoV-2 IgG antibodies from 28 days since symptom onset was associated with high sensitivity, especially using optimized cut-offs (i.e. 100%).
  • |*COVID-19 Serological Testing[MESH]
  • |*SARS-CoV-2[MESH]
  • |Adult[MESH]
  • |Antibodies, Viral/*blood[MESH]
  • |COVID-19/*blood[MESH]
  • |Female[MESH]
  • |Humans[MESH]
  • |Immunoglobulin G/*blood[MESH]
  • |Immunoglobulin M/*blood[MESH]
  • |Male[MESH]
  • |Middle Aged[MESH]


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