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Clinical diagnostics firm Beckman Coulter has launched its semi-quantitative test, Access SARS-CoV-2 IgG II, which can measure a patient’s relative antibody level in response to a previous Covid-19 infection.
The test helps doctors establish a baseline for analyzing an individual’s immune response to the virus based on a numerical value and assessing relative changes over time.
It can also help researchers estimate the levels of IgG antibodies needed to be considered protective.
By measuring IgG antibodies directed to the binding domain of the coronavirus spike protein receptor in response to a previous infection, the test provides a numerical result in arbitrary units (AU) of 2-450 AU / mL.
The Access SARS-CoV-2 IgG II assay also provides a qualitative result for SARS-CoV-2 IgG antibodies.
Beckman Coulter will submit an application to the US Food and Drug Administration (FDA) for emergency use authorization (EUA) of the test.
The company will begin shipping the tests to its customer base in the United States and will make them available to markets that accept the CE mark later this year.
Beckman Coulter Chief Medical Officer Shamiram Feinglass said, Having a clearer picture of the immune response to SARS-CoV-2 plays an important role in the fight against Covid-19, especially before a vaccine is widely available.
“Although it is not known how long antibodies persist after infection and whether the presence of antibodies confers protective immunity, having a quantifiable baseline is a critical step towards further understanding the adaptive immune response to SARS. CoV-2 in individuals over time “.
In a study with 1,448 samples collected from donors in the United States and France prior to December last year, the test confirmed a 96% positive percentage agreement eight to 14 days after the onset of symptoms.
The test can be used in random access (RAM) mode and easily integrated into existing workflows without batch processing.
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