AdviseDx SARS-CoV-2 IgM lab-based serology test is designed to run Architect and Alinity platforms
Healthcare company Abbott has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its Covid-19 IgM (Immunoglobulin M) antibody blood test.
The EUA status has been granted for AdviseDx SARS-CoV-2 IgM lab-based serology test for use on the Architect and Alinity platforms.
Abbott offers seven tests for Covid-19 testing
Abbott stated that it secured EUA status for seven tests, including molecular tests, a rapid antigen test and an IgG antibody test, since the start of the pandemic.
The company first developed an IgG blood test, which helps in understanding whether a person has recovered from the virus, as well as contact tracing and epidemiological studies.
According to the company, the IgM test has shown high reliability in both its research and external virology laboratory studies, similar to IgG blood test.
In addition, Abbott’s data showed 99.56% specificity and 95.00% sensitivity for patients tested 15 days after symptom onset, said the company.
Abbott president and CEO Robert Ford said: “Abbott has developed tests to detect the virus at each stage of infection so doctors and their patients are equipped with knowledge of how they are responding to the virus and progressing through recovery.
“Antibody tests will continue to play an important role to better understand the virus, the prevalence of Covid-19 in an area and where a patient may be in their recovery.”
In August this year, Abbott secured FDA EUA status for its BinaxNOW Covid-19 Ag Card rapid test.
BinaxNOW COVID-19 Ag Card test is suitable for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in nasal swabs from individuals suspected of Covid-19 by their healthcare provider within the first seven days of symptom onset.