Rapid diagnostic testing for SARS-CoV-2: Validation and comparison of three point-of-care antibody tests.

With the emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), a need for diagnostic tests has surfaced. Point-of-care (POC) antibody tests can detect immunoglobulin (Ig) G and M against SARS-CoV-2 in serum, plasma or whole blood and give results within 15 minutes. Validation of the performance of such tests is needed if they are to be used in clinical practice. In this study we evaluated three POC antibody tests. Convalescent serum samples from 47 reverse transcription polymerase chain reaction (RT-PCR) verified coronavirus disease 2019 (COVID-19) patients collected at least 28 days post RT-PCR diagnosis as well as 50 negative pre-COVID-19 controls were tested. The three tests (denoted the J-, N- and Z-tests) displayed the sensitivities of 87, 96 and 85 percent, respectively, for the detection of IgG. All tests had the same specificity for IgG (98 percent). The tests did not differ significantly for the detection of IgG. The sensitivities for IgM were lower (15, 67 and 70 percent) and the specificities were 90, 98 and 90 percent, respectively. The positive and negative predictive values were similar among the tests. Our results indicate that these POC antibody tests might be accurate enough to use in routine clinical practice. This article is protected by copyright. All rights reserved.