American Bio Medica Corp (ABMC)

[Btown]

ABMC/Healgens antibody test validated once again!

https://www.tandfonline.com/doi/full/10.1080/20008686.2020.1754538

There were no false IgM positive samples, indicating a very high specificity of the test.

The specificity and sensitivity for IgG detection of the rapid test evaluated here is well in line with those of a recently reported enzyme-linked immunosorbent assay (ELISA), which had a specificity and a sensitivity of 97.5% [20].

While this study showed a satisfactory performance of the rapid test, it is limited by being compared only to clinical cases and PCR-positivity, and as a next step, it is necessary to compare this assay to other serological tests. In contrast to Li et al. [11], we found less indications for using this test for clinical diagnosis. Nevertheless, it might contribute to detecting potential asymptomatic infections as well as getting a notion of the magnitude of the spread in different geographical areas, which might be a key to taking the appropriate decisions and policies forward. The high negative predictive value indicates that the rapid test will be useful for detecting past infections and possible immunity, which may be crucial for restoring social functions after lockdown.

Acknowledgments

This work was supported by the Swedish Research Council (VR, grant numbers 2016-02596, 2017-05807 and 2018-02569). The rapid tests that have enabled this study were donated to us by the Swedish company Noviral AB (organization number: 559175-7942).