NOWDiagnostics has announced that its diagnostic ADEXUSDx COVID-19 antibody test demonstrated encouraging test performance based on study results.
According to the latest data, the antibody test delivered 100% sensitivity and 100% specificity in 45 sample panel of Covid-19 positive and negative patient samples.
The Biodefense and Emerging Infections Research Resources Repository (BEI Resources) panel provided the samples.
In May, the company sought emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for the device.
The ADEXUSDx COVID-19 Test is a rapid serology, self-contained assay that measures the presence of SARS-CoV-2 antibodies to provide accurate results in 15 minutes without needing buffers, reagents, or additional equipment.
It only requires a drop of blood, either capillary blood from a simple fingerstick or 40μL venous whole blood, serum, or plasma.
In addition, the test can be used across various healthcare settings such as hospital emergency rooms and clinics and for at-home use by the customers.
The test could potentially reduce the waiting period to receive test results by days as it does not need to be sent to off-site laboratories for analysis.
If FDA authorises emergency use of the device, NOWDiagnostics’ subsidiary C19 Development will initiate distribution of the test for use in CLIA-certified labs in various healthcare settings such as clinics and hospital emergency rooms.
Clinical trials for the over-the-counter (OTC) test use are progressing.
In August, the US Biomedical Advanced Research and Development Authority (BARDA) provided funding and technical support to NOWDiagnostics for delivering a high-quality serological test for SARS-CoV-2 antibodies.
BARDA had recommended analysis of the Covid-19 antibody test with the BEI panel.