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RESEARCH PRODUCT

Comparison of a rapid immunochromatographic test with a chemiluminescence immunoassay for detection of anti-SARS-CoV-2 IgM and IgG

Luisa AgnelloCaterina Maria GambinoMarcello CiaccioBruna Lo SassoGiulia BivonaClaudia ColombaRosaria Vincenza Giglio

subject

Male030213 general clinical medicineClinical BiochemistryAntibodies Viralmedicine.disease_causeLikelihood ratios in diagnostic testinglaw.inventionSerologyCOVID-19 Testing0302 clinical medicinelawantibodiesMedicineCoronavirusImmunoassay0303 health sciencesbiologymedicine.diagnostic_testMiddle AgedantibodiePopulation SurveillanceFemaleAntibodyCLIACoronavirus InfectionsShort CommunicationConcordanceSevere acute respiratory syndrome coronavirus 2 (SARS-CoV-2)Pneumonia ViralBetacoronavirus03 medical and health sciencesimmunochromatographyHumansPandemicsAged030304 developmental biologyChemiluminescenceClinical Laboratory TechniquesSARS-CoV-2business.industryCOVID-19; serological test; antibodies; CLIA; immunochromatographyBiochemistry (medical)Reproducibility of ResultsCOVID-19serological testImmunoglobulin MImmunoglobulin GImmunoassayLuminescent MeasurementsImmunologybiology.proteinbusiness

description

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.

yearjournalcountryeditionlanguage
2020-01-01
10.11613/bm.2020.030901http://hdl.handle.net/10447/436788