Abstract
Background This study was aimed to investigate the application of SARS-CoV-2 IgM and IgG antibodies in diagnosis of COVID-19 infection. Method This study enrolled a total of 178 patients at Huangshi Central Hospital from January to February 2020. Among them, 68 patients were SARS-CoV-2 infected, confirmed with nucleic acid test (NAT) and CT imaging. Nine patients were in the suspected group (NAT negative) with fever and other respiratory symptoms. 101 patients were in the control group with other diseases and negative to SARS-CoV-2 infection. After serum samples were collected, SARS-CoV-2 IgG and IgM antibodies were tested by chemiluminescence immunoassay (CLIA) for all patients. Results The specificity of serum IgM and IgG antibodies to SARS-CoV-2 was 99.01% (100/101) and 96.04% (97/101), respectively, and the sensitivity was 88.24% (60/68) and 97.06% (66/68), respectively. The combined detection rate of SARS-CoV-2 IgM and IgG antibodies was 98.53% (67/68). Conclusion Combined detection of serum SARS-CoV-2 IgM and IgG antibodies had better sensitivity compared with single IgM or IgG antibody testing, which can be used as an important diagnostic tool for SARS-CoV-2 infection and a screening tool of potential SARS-CoV-2 carriers in clinics, hospitals, and accredited scientific laboratories.
Highlights
SARS-CoV2 immunoglobulin M (IgM)/Immunoglobulin G (IgG) titers were calculated automatically by the Chemiluminescence immunoassay (CLIA) analyzer based on relative light units (RLU), and the viral antibody titer was positively associated with RLU. e cutoff values for positive SARS-CoV-2 IgM and IgG are both 10 AU/ml
Among the 101 patients in the control group, 100 patients were negative for SARS-CoV-2 IgM antibody, with a clinical specificity of 99.01% (100/101). 97 patients were negative for SARS-CoV-2 IgG antibody, with a clinical specificity of 96.04% (97/101)
SARS-CoV-2 IgM demonstrated a clinical sensitivity of 75.00%, 88.00%, and 93.55%, respectively, and SARS-CoV-2 IgG demonstrated 83.33%, 100.00%, and 100.00%, respectively. e total clinical sensitivity of SARSCoV-2 IgM and IgG to SARS-CoV-2 infection was 88.24% (60/68) and 97.06% (66/68), respectively
Summary
E current standard diagnostic method for diagnosis of COVID-19 is to detect the virus nucleic acid RT-PCR [2]. Erefore, a simple, sensitive, and accurate test was urgently needed to identify SARS-CoV-2-infected patients in a COVID-19 outbreak area. After SARS-CoV-2 infection, the body’s immune system can create immune response to fight against the virus and produce specific antibodies. The immunoglobulin M (IgM) antibody, produced in the early period after the infection, can indicate the current infection or the recent infection. Erefore, the combined detection of IgM and IgG can be used in the early diagnosis of infectious diseases and in the assessment of the stage of infection. Our aim is to investigate the clinical value of CLIA for the diagnosis of SARS-CoV-2 infection.
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