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

SARS-CoV-2 Antibody tests have been marketed to diagnose previous SARS-CoV-2 infection and as a test of immune status. There is a lack of evidence on the performance and clinical utility of these tests. We aimed to carry out an evaluation of 14 point of care (POC) SARS-CoV-2 antibody tests.

Serum from participants with previous RT-PCR (Real-Time Polymerase chain reaction) confirmed SARS-CoV-2 infection and pre-pandemic controls were used to determine specificity and sensitivity of each POC device. Changes in sensitivity with increasing time from infection were determined on a cohort of participants. Corresponding neutralising antibody status was measured to establish whether the detection of antibodies by the POC device correlated with immune status. Paired capillary and serum samples were collected to ascertain whether POC devices performed comparably on capillary samples.

Sensitivity and specificity varied between the POC devices and in general did not meet the manufacturers reported performance characteristics signifying the importance of independent evaluation of these tests. The sensitivity peaked at >20 days following symptoms onset however sensitivity of 3 POC devices evaluated at extended time points showed that sensitivity declined with time and this was particularly marked at >140 days post infection onset. This is relevant if the tests are to be used for sero-prevelence studies. Neutralising antibody data showed positive antibody results on POC devices did not necessarily confer high neutralising antibody titres and these POC devices cannot be used to determine immune status to the SARS-CoV-2 virus. Comparison of paired serum and capillary results showed that there was a decline in sensitivity using capillary blood. This has implications in the utility of the test as they are designed to be used on capillary blood by the general population.