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10.1002/jcla.23466

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32671890!7404627!32671890
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suck abstract from ncbi


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pmid32671890      J+Clin+Lab+Anal 2020 ; 34 (10): e23466
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  • Serological chemiluminescence immunoassay for the diagnosis of SARS-CoV-2 infection #MMPMID32671890
  • Lijia S; Lihong S; Huabin W; Xiaoping X; Xiaodong L; Yixuan Z; Pin H; Yina X; Xiaoyun S; Junqi W
  • J Clin Lab Anal 2020[Oct]; 34 (10): e23466 PMID32671890show ga
  • OBJECTIVE: Dynamic monitoring of the concentration variation of IgM and IgG in patients with SARS-CoV-2 infections and exploring their diagnostic value for coronavirus disease-19 (COVID-19). METHODS: A total of 15 patients with SARS-CoV-2 infection were enrolled as the COVID-19 group, and 50 patients were enrolled as the control group. The concentrations of SARS-CoV-2-specific antibodies (IgM and IgG) were detected by a chemiluminescence immunoassay (CLIA). RESULTS: According to the cutoff value recommended by the manufacturer (cutoff = 10 AU/mL), the sensitivity, specificity, Youden index (YI), positive predictive value (PPV), and negative predictive value (NPV) of IgM were 60%, 100%, 60%, 100%, and 89.29%, respectively; and 86.67%, 100%, 86.67%, 100%, and 96.15%, respectively, for IgG. We reassessed the cutoff value of IgM. When the cutoff value for SARS-CoV-2 IgM was 1.83 AU/mL, the sensitivity, specificity, YI, PPV, and NPV were 93.33%, 98%, 91.33%, 93.33%, and 98%, respectively. During dynamic monitoring of the concentrations of IgM and IgG in COVID-19 patients, we found the shortest times before a patient became IgM and IgG seropositive after symptom onset were 1.5 and 2 days, respectively. The longest times were 7 and 8 days, respectively. The positive rates of SARS-CoV-2 IgM and IgG both reached 100% in 8-14 days after symptom onset. CONCLUSION: The IgM cutoff value of 1.83 AU/mL for the diagnosis of COVID-19 was much better than the cutoff suggested by the manufacturer. SARS-CoV-2 infection can be ruled out if antibodies against SARS-CoV-2 are still undetectable 14 days after symptom onset.
  • |Adult[MESH]
  • |Aged[MESH]
  • |Aged, 80 and over[MESH]
  • |Antibodies, Viral/*blood[MESH]
  • |Betacoronavirus[MESH]
  • |COVID-19[MESH]
  • |COVID-19 Testing[MESH]
  • |Clinical Laboratory Techniques/*methods[MESH]
  • |Coronavirus Infections/*diagnosis[MESH]
  • |Female[MESH]
  • |Humans[MESH]
  • |Immunoassay/*methods[MESH]
  • |Immunoglobulin G/blood[MESH]
  • |Immunoglobulin M/blood[MESH]
  • |Luminescent Measurements/*methods[MESH]
  • |Male[MESH]
  • |Middle Aged[MESH]
  • |Pandemics[MESH]
  • |Pneumonia, Viral/*diagnosis[MESH]


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