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10.1128/JCM.02292-20

http://scihub22266oqcxt.onion/10.1128/JCM.02292-20
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33419947!8092742!33419947
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suck abstract from ncbi


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pmid33419947      J+Clin+Microbiol 2021 ; 59 (4): ä
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  • Performance Characteristics of the Vidas SARS-CoV-2 IgM and IgG Serological Assays #MMPMID33419947
  • Renard N; Daniel S; Cayet N; Pecquet M; Raymond F; Pons S; Lupo J; Tourneur C; Pretis C; Gerez G; Blasco P; Combe M; Canova I; Lesenechal M; Berthier F
  • J Clin Microbiol 2021[Mar]; 59 (4): ä PMID33419947show ga
  • The COVID-19 pandemic, caused by the new severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), continues to spread worldwide. Serological testing for SARS-CoV-2-specific antibodies plays an important role in understanding and controlling the pandemic, notably through epidemiological surveillance. Well-validated and highly specific SARS-CoV-2 serological assays are urgently needed. We describe here the analytical and clinical performance of Vidas SARS-CoV-2 IgM and Vidas SARS-CoV-2 IgG, two CE-marked, emergency use authorization (EUA)-authorized, automated, qualitative assays for the detection of SARS-CoV-2-specific IgM and IgG, respectively. Both assays showed high within-run and within-laboratory precision (coefficients of variation < 11.0%) and very low cross-reactivity toward sera of patients with a past common coronavirus or respiratory virus infection. Clinical specificity determined on up to 989 prepandemic healthy donors was >/=99% with a narrow 95% confidence interval for both IgM and IgG assays. Clinical sensitivity was determined on up to 232 samples from 130 reverse transcriptase PCR (RT-PCR)-confirmed SARS-CoV-2 patients. The positive percent agreement (PPA) with SARS-CoV-2 PCR reached 100% at >/=16 days (Vidas SARS-CoV-2 IgM) and >/=32 days (Vidas SARS-CoV-2 IgG) of symptom onset. Combined IgM/IgG test results improved the PPA compared to each test alone. SARS-CoV-2 IgG seroconversion followed closely that of SARS-CoV-2 IgM and remained stable over time, while SARS-CoV-2 IgM levels rapidly declined. Interestingly, SARS-CoV-2-specific IgM and IgG responses were significantly higher in COVID-19 hospitalized versus nonhospitalized patients. Altogether, the Vidas SARS-CoV-2 IgM and IgG assays are highly specific and sensitive serological tests suitable for the reliable detection of past acute SARS-CoV-2 infections.
  • |*COVID-19[MESH]
  • |*SARS-CoV-2[MESH]
  • |Antibodies, Viral[MESH]
  • |Humans[MESH]
  • |Immunoglobulin G[MESH]
  • |Immunoglobulin M[MESH]
  • |Pandemics[MESH]


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