Agreement of the Point of Care Test (POCT) Boditech iCHROMA™ COVID-19 IgG Antibody Assay with the Abbott Architect SARS-CoV-2 IgG Antibody Assay: An Advanced Study Approach

Abstract

Background: Molecular tests are generally not suited for public health screening, antibody tests are more suited and the more portable, the better. The Boditech iCHROMA™ point of care immunoassay analyser has a Covid-19 antibody assay for the qualitative determination of IgG/IgM antibodies in human whole blood/serum/plasma. It is helpful as an aid in the screening of early mild asymptomatic or acute patients for identifying Covid-19 infection with high sensitivity.

Objectives: To determine the clinical agreement (sensitivity and specificity) of the Boditech iCHROMA™ Covid-19 antibody assay and the Abbott Architect SARS-CoV-2 IgG assay for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma.

Results: Of the 50 plasma samples, 20 (40%) of the plasma samples assayed were reported as positive by both the Abbott Architect SARS-CoV-2 IgG assay and the Boditech iCHROMA™ Covid-19 IgG antibody assay. The remaining 30 (60%) of the plasma samples were reported as negative by Abbott Architect SARS-CoV-2 IgG antibody assay. However, the Boditech iCHROMA™ Covid-19 IgG antibody assay, reported only 27 of the 30 (90%) samples as negative.

Conclusion: There was an overall agreement of 95%, with a sensitivity of 100% and a specificity of 90% of the Boditech iCHROMA™ Covid-19 IgG antibody assay and the Abbott Architect SARS-CoV-2 IgG assay.