tetano
Editor, Senior Moderator
Biochem Med (Zagreb)
. 2020 Oct 15;30(3):030901.
doi: 10.11613/BM.2020.030901.
Comparison of a rapid immunochromatographic test with a chemiluminescence immunoassay for detection of anti-SARS-CoV-2 IgM and IgG
Caterina Maria Gambino[SUP] 1 [/SUP], Bruna Lo Sasso[SUP] 1 2 [/SUP], Claudia Colomba[SUP] 3 [/SUP], Rosaria Vincenza Giglio[SUP] 1 [/SUP], Luisa Agnello[SUP] 1 [/SUP], Giulia Bivona[SUP] 1 [/SUP], Marcello Ciaccio[SUP] 1 2 [/SUP]
Affiliations
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.
Keywords: CLIA; COVID-19; antibodies; immunochromatography; serological test.
. 2020 Oct 15;30(3):030901.
doi: 10.11613/BM.2020.030901.
Comparison of a rapid immunochromatographic test with a chemiluminescence immunoassay for detection of anti-SARS-CoV-2 IgM and IgG
Caterina Maria Gambino[SUP] 1 [/SUP], Bruna Lo Sasso[SUP] 1 2 [/SUP], Claudia Colomba[SUP] 3 [/SUP], Rosaria Vincenza Giglio[SUP] 1 [/SUP], Luisa Agnello[SUP] 1 [/SUP], Giulia Bivona[SUP] 1 [/SUP], Marcello Ciaccio[SUP] 1 2 [/SUP]
Affiliations
- PMID: 33071558
- PMCID: PMC7528641
- DOI: 10.11613/BM.2020.030901
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.
Keywords: CLIA; COVID-19; antibodies; immunochromatography; serological test.