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Comparison of a rapid immunochromatographic test with a chemiluminescence immunoassay for detection of anti-SARS-CoV-2 IgM and IgG.
Biochem Med (Zagreb). 2020 Oct 15; 30(3):030901.BM

Abstract

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.

Authors+Show Affiliations

Department of Biomedicine, Neurosciences and Advanced Diagnostics, Institute of Clinical Biochemistry, Clinical Molecular Medicine and Laboratory Medicine, University of Palermo, Palermo, Italy.Department of Biomedicine, Neurosciences and Advanced Diagnostics, Institute of Clinical Biochemistry, Clinical Molecular Medicine and Laboratory Medicine, University of Palermo, Palermo, Italy. Department of Laboratory Medicine, University Hospital "P. Giaccone", Palermo, Italy.Department of Promoting Health, Maternal-Infant. Excellence and Internal and Specialized Medicine (ProMISE) G. D'Alessandro, University of Palermo, Palermo, Italy.Department of Biomedicine, Neurosciences and Advanced Diagnostics, Institute of Clinical Biochemistry, Clinical Molecular Medicine and Laboratory Medicine, University of Palermo, Palermo, Italy.Department of Biomedicine, Neurosciences and Advanced Diagnostics, Institute of Clinical Biochemistry, Clinical Molecular Medicine and Laboratory Medicine, University of Palermo, Palermo, Italy.Department of Biomedicine, Neurosciences and Advanced Diagnostics, Institute of Clinical Biochemistry, Clinical Molecular Medicine and Laboratory Medicine, University of Palermo, Palermo, Italy.Department of Biomedicine, Neurosciences and Advanced Diagnostics, Institute of Clinical Biochemistry, Clinical Molecular Medicine and Laboratory Medicine, University of Palermo, Palermo, Italy. Department of Laboratory Medicine, University Hospital "P. Giaccone", Palermo, Italy.

Pub Type(s)

Clinical Trial
Comparative Study
Journal Article

Language

eng

PubMed ID

33071558

Citation

Gambino, Caterina Maria, et al. "Comparison of a Rapid Immunochromatographic Test With a Chemiluminescence Immunoassay for Detection of anti-SARS-CoV-2 IgM and IgG." Biochemia Medica, vol. 30, no. 3, 2020, p. 030901.
Gambino CM, Lo Sasso B, Colomba C, et al. Comparison of a rapid immunochromatographic test with a chemiluminescence immunoassay for detection of anti-SARS-CoV-2 IgM and IgG. Biochem Med (Zagreb). 2020;30(3):030901.
Gambino, C. M., Lo Sasso, B., Colomba, C., Giglio, R. V., Agnello, L., Bivona, G., & Ciaccio, M. (2020). Comparison of a rapid immunochromatographic test with a chemiluminescence immunoassay for detection of anti-SARS-CoV-2 IgM and IgG. Biochemia Medica, 30(3), 030901. https://doi.org/10.11613/BM.2020.030901
Gambino CM, et al. Comparison of a Rapid Immunochromatographic Test With a Chemiluminescence Immunoassay for Detection of anti-SARS-CoV-2 IgM and IgG. Biochem Med (Zagreb). 2020 Oct 15;30(3):030901. PubMed PMID: 33071558.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison of a rapid immunochromatographic test with a chemiluminescence immunoassay for detection of anti-SARS-CoV-2 IgM and IgG. AU - Gambino,Caterina Maria, AU - Lo Sasso,Bruna, AU - Colomba,Claudia, AU - Giglio,Rosaria Vincenza, AU - Agnello,Luisa, AU - Bivona,Giulia, AU - Ciaccio,Marcello, PY - 2020/06/09/received PY - 2020/08/11/accepted PY - 2020/10/19/entrez PY - 2020/10/20/pubmed PY - 2020/10/23/medline KW - CLIA KW - COVID-19 KW - antibodies KW - immunochromatography KW - serological test SP - 030901 EP - 030901 JF - Biochemia medica JO - Biochem Med (Zagreb) VL - 30 IS - 3 N2 - 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. SN - 1846-7482 UR - https://www.unboundmedicine.com/medline/citation/33071558/Comparison_of_a_rapid_immunochromatographic_test_with_a_chemiluminescence_immunoassay_for_detection_of_anti_SARS_CoV_2_IgM_and_IgG_ DB - PRIME DP - Unbound Medicine ER -