LumiraDx SARS-CoV-2 Antibody Test Demonstrates High Sensitivity and Specificity in Point of Care Testing for COVID-19

Evaluation of SARS-CoV-2 Antibody Point of Care Devices in the Laboratory and Clinical Setting

Kirsty McCance, Helen Wise, Jennifer Simpson, Becky Bachelor, Harriet Hale, Lindsay McDonald, Azul Zorzoli, Elizabeth Furrie, Charu Chopra, Frauke Muecksch, Theodora Hatziioannou, Paul D. Bieniasz, Kate Templeton, Sara Jenks medRxiv 2021.12.16.21267703; doi: https://doi.org/10.1101/2021.12.16.21267703

A SARS-CoV-2 antibody test plays an important role in indicating recent or previous COVID-19 infection thereby identifying individuals with an adaptive immune response to SARS-CoV-2.
In contrast to a laboratory-based antibody test which can be costly and time-consuming due to requiring venous sampling and transportation to a lab for analysis, a point of care antibody test offers the advantages of a rapid, cost-effective testing in community care settings.

LumiraDx SARS-CoV-2 Antibody Test – Point of Care Testing

This study evaluated the LumiraDx SARS-CoV-2 Antibody Test, a microfluidic immunofluorescence assay for qualitative detection of total antibodies to SARS-CoV-2 in human whole blood, for sensitivity and specificity in comparison with 13 lateral flow assays. 

In summary, the results from this study highlight a wide variation in performance of SARS-CoV-2 antibody test kits and illustrates the importance of evaluating multiple different  aspects of test performance including checking for batch to batch variation, changes in sensitivity as time from infection increases, correlation with neutralising antibodies and performance on capillary samples. Thorough evaluation of all these aspects is  essential prior to considering the utilisation of these tests for antibody or ‘immunity’ passports and identification of hospitalised patients who would benefit from  monoclonal antibody treatment.