The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to LumiraDx’s SARS-CoV-2 Ab test.
The antibody test leverages a combination receptor-binding domain (RBD) and S1 spike SARS CoV-2 antigen to identify total antibody (Ab) induced in response to Covid-19 infection.
The test is indicated for detecting people with an adaptive immune response to the virus, signifying a latest or previous infection.
The LumiraDx SARS-CoV-2 Ab test runs on the company’s platform and requires fingerstick blood to deliver digital results in 11 minutes in the point of care settings.
The test has already received a CE mark and is available in European markets since September 2020.
In clinical trials, the Ab test showed a 100% positive and negative agreement in specimens obtained from eight days after a reverse transcription-polymerase chain reaction test.
Furthermore, the test had 100% sensitivity and specificity in identifying IgM and IgG antibodies against SARS-CoV-2 in serum and plasma samples in a study at National Cancer Institute-sponsored Frederick National Laboratory for Cancer Research.
LumiraDx CEO Ron Zwanziger, “We know providing results at the point of care can make an incredible impact on the control of this virus and the health of our communities.
“Now, with the addition of our antibody test on the LumiraDx point of care platform, we believe we can make it even easier for healthcare providers to provide the best in Covid testing to their patients by providing fast and trusted results to support treatment decisions.”
In a separate development, the FDA granted a EUA to Ortho Clinical Diagnostics’ qualitative VITROS Anti-SARS-CoV-2 Total N antibody test to detect a person’s immune response or total antibodies to the SARS-CoV-2 virus.
With a 99.2% specificity and high sensitivity, the antibody test is the fifth assay to obtain EUA in the Covid-19 testing solutions portfolio of the company.
Last month, the FDA granted EUA to Ortho’s VITROS Anti-SARS-CoV-2 IgG Quantitative Test.