Comparison of a rapid immunochromatographic test with a chemiluminescence immunoassay for detection of anti-SARS-CoV-2 IgM and IgG
Autor: | Luisa Agnello, Caterina Maria Gambino, Marcello Ciaccio, Bruna Lo Sasso, Giulia Bivona, Claudia Colomba, Rosaria Vincenza Giglio |
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Přispěvatelé: | Caterina Maria Gambino, Bruna Lo Sasso, Claudia Colomba, Rosaria Vincenza Giglio, Luisa Agnello, Giulia Bivona, Marcello Ciaccio |
Jazyk: | angličtina |
Rok vydání: | 2020 |
Předmět: |
Male
030213 general clinical medicine Clinical Biochemistry Antibodies Viral medicine.disease_cause Likelihood ratios in diagnostic testing law.invention Serology COVID-19 Testing 0302 clinical medicine law antibodies Medicine Coronavirus Immunoassay 0303 health sciences biology medicine.diagnostic_test Middle Aged antibodie Population Surveillance Female Antibody CLIA Coronavirus Infections Short Communication Concordance Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) Pneumonia Viral Betacoronavirus 03 medical and health sciences immunochromatography Humans Pandemics Aged 030304 developmental biology Chemiluminescence Clinical Laboratory Techniques SARS-CoV-2 business.industry COVID-19 serological test Biochemistry (medical) Reproducibility of Results Immunoglobulin M Immunoglobulin G Luminescent Measurements Immunology biology.protein business |
Zdroj: | Biochemia Medica Volume 30 Issue 3 |
ISSN: | 1330-0962 1846-7482 |
Popis: | Introduction: The 2019 Coronavirus disease (COVID-19) has been characterized as a pandemic, representing a serious global public health emergency. Serological tests have been proposed as reliable tools for detecting Coronavirus SARS-CoV-2 antibodies in infected patients, especially for surveillance or epidemiological purposes. The aim of this study is to evaluate the agreement between the IgM/IgG rapid assays, based on lateral flow immunochromatographic assay, and the fully automated 2019-nCoV IgM and IgG, based on chemiluminescence immunoassay. Materials and methods: SARS-CoV-2 antibodies were measured with the BIOSYNEX COVID-19 BSS IgM/IgG test (BIOSYNEX, Illkirch-Graffenstaden, France) and the MAGLUMI CLIA (IgM and IgG) (SNIBE – Shenzhen New Industries Biomedical Engineering, Shenzhen, China) in 70 serum samples from patients with PCR-confirmed diagnosis. The strength of the agreement of the two methods was calculated by using the Cohen Kappa index. Results: The results showed a good grade of concordance between the two immunoassays with a Cohen’s kappa coefficient of 0.71 (95%CI: 0.54- 0.87) for IgG SARS-CoV-2 antibodies and 0.70 (95%CI: 0.53-0.87) for IgM SARS-CoV-2 antibodies. In addition, the rapid assays BIOSYNEX COVID-19 BSS for detecting SARS-CoV-2 antibodies showed a positive likelihood ratio (LR) of 10.63 (95%CI: 2.79-40.57) for IgG and a LR of 6.79 (95%CI: 2.93- 15.69) for IgM. Conclusion: Our results suggest that the immunochromatographic rapid IgM/IgG test and the chemiluminescence IgM and IgG immunoassay have a good degree of concordance, suggesting that both could be considered as useful tools for epidemiologic surveillance. |
Databáze: | OpenAIRE |
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