Abstract
Background: There is a need for laboratories to participate in EQA schemes to achieve a harmonization of test results and to improve serological testing and research on COVID-19 and SARS-CoV-2. The Boditech iCHROMA point of care immunoassay analyser has a Covid-19 antibody assay for the qualitative determination of IgG antibodies in human whole blood/serum/plasma. The National Institute for Biological Standards and Control (NIBSC) in the United Kingdom has a portfolio of reference and research reagents, including reagents for EQA that are available to laboratories to help them set up and develop accurate diagnostic tests for SARS-CoV-2 assays. Objectives: To determine the performance of the Boditech iCHROMA Covid-19 IgG antibody assay using the external quality control material provided by the UK NIBSC (National Institute for Biological Standards and Control). Results: The Boditech iCHROMA Covid-19 IgG assay using the cut off index >1.1, reported the results of the 33 positive control samples as positive with index range from 19.50 – 29.00, with a mean of 23.75 and standard deviation of SD of 2.53. It also reported the results of the 33 negative control samples as negative with an index range of 0.00 for all samples. Conclusion: The performance of the Boditech iCHROMA Covid-19 IgG antibody assay using external quality control material from the UK NIBSC was very good, confirming the precision of the Boditech iCHROMA Covid 19 IgG antibody method.
Highlights
The detection of SARS-CoV-2 infection is important in the understanding of this infection and the importance of the External quality assurance (EQA) in harmonizing the various methods of detecting the antibodies is appropriate
The Boditech iCHROMA Covid-19 IgG assay using the cut off index >1.1, reported the results of the 33 positive control samples as positive with index range from 19.50 – 29.00, with a mean of 23.75 and standard deviation of SD of 2.53
The National Institute for Biological Standards and Control (NIBSC) in the United Kingdom has a portfolio of reference and research reagents, including reagents for EQA that are available to laboratories to help them set up and develop accurate diagnostic tests for SARS-CoV-2 assays [5]
Summary
The detection of SARS-CoV-2 infection is important in the understanding of this infection and the importance of the EQA in harmonizing the various methods of detecting the antibodies is appropriate. The first EQA of antibody diagnostic testing for SARS-CoV-2 was carried out in 2004, 45% of the laboratories detected anti-SARS antibodies correctly in serum samples [2], More recently, a pilot EQA scheme was conducted by an accredited international EQA provider on laboratories with methods for detecting anti-SARS-CoV-2 specific antibodies (IgG, IgA and IgM), the overall success rate for the anti-SARS-CoV-2 IgG, IgA, and IgM tests was 80%, 72.7%, and 16.7%, respectively [3] These results highlighted the need for laboratories to participate in EQA schemes to achieve a harmonization of test results and to improve serological testing and research on COVID-19 and SARSCoV-2.
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