Serological chemiluminescence immunoassay for the diagnosis of SARS‐CoV‐2 infection

Autor: Wang Huabin, Zhu Yixuan, Shan Xiaoyun, Wu Junqi, He Pin, Lu Xiaodong, Shao Lijia, Xu Yina, Xu Xiaoping, Shen Lihong
Rok vydání: 2020
Předmět:
Male
0301 basic medicine
Chemiluminescence immunoassay
Clinical Biochemistry
Youden's J statistic
Antibodies
Viral
Gastroenterology
SARS‐CoV‐2
Serology
COVID-19 Testing
0302 clinical medicine
antibody
Immunology and Allergy
Medicine
Cutoff
Research Articles
Aged
80 and over
Immunoassay
biology
Hematology
Middle Aged
Medical Laboratory Technology
030220 oncology & carcinogenesis
Female
diagnostic value
Antibody
Coronavirus Infections
Research Article
Adult
Microbiology (medical)
medicine.medical_specialty
Coronavirus disease 2019 (COVID-19)
Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2)
Pneumonia
Viral
Betacoronavirus
03 medical and health sciences
COVID‐19
Internal medicine
Humans
In patient
Pandemics
Aged
Biochemistry
medical
Clinical Laboratory Techniques
SARS-CoV-2
business.industry
Biochemistry (medical)
Public Health
Environmental and Occupational Health
COVID-19
030104 developmental biology
Immunoglobulin M
Immunoglobulin G
Luminescent Measurements
biology.protein
business
Zdroj: Journal of Clinical Laboratory Analysis
ISSN: 1098-2825
0887-8013
DOI: 10.1002/jcla.23466
Popis: 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.
The new cutoff of IgM improve the diagnostic value. Considering the high diagnostic efficiency of IgG, we chose the day on which the SARS‐CoV‐2 IgG was close to 10.00 AU/mL. Then, we collected IgM data on the same day to select new cutoff values. When the cutoff value of IgM was 1.83 AU/mL, we obtained the maximum YI.
Databáze: OpenAIRE
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