The quantitative antibody test will help detect individuals with an adaptive immune response to SARS-CoV-2
Ortho Clinical Diagnostics has secured FDA EUA status for Quantitative COVID-19 IgG Antibody Test. (Credit: Daniel Roberts from Pixabay)
Ortho Clinical Diagnostics has secured an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its Vitros anti-SARS-CoV-2 IgG quantitative test.
The new quantitative Covid-19 IgG antibody test will help target the S1 spike protein. It is designated to detect individuals with an adaptive immune response to SARS-CoV-2.
According to the company, the Vitros anti-SARS-CoV-2 IgG quantitative test provides 100% specificity and better sensitivity.
The new test is said to be calibrated to the World Health Organisation (WHO) International Standard for anti-SARS-CoV-2 IgG antibodies, thereby serving as a standard tool for clinicians and public health leaders to measure antibody response to SARS-CoV-2.
Ortho Clinical Diagnostics medical, clinical and scientific affairs head Dr Ivan Salgo said: “The development of the Vitros Anti-SARS-CoV-2 IgG Quantitative Test shows Ortho’s leadership in response to the need for standardisation of SARS-CoV-2 serological methods currently used.
“Ortho’s quantitative Covid-19 IgG antibody test, which targets the spike protein, is an important tool to help health care and policy teams to understand long-term antibody responses to SARS-CoV-2.”
Ortho’s Vitros Covid-19 testing solutions also consist of Vitros Anti-SARS-CoV-2 Total N Antibody Test, Vitros SARS-CoV-2 Antigen Assay and Vitros Anti-SARS-CoV-2 Total Antibody Test.
The company’s Vitros system has the potential to process up to 150 antibody tests or up to 130 antigen tests.
In March this year, the company secured Ortho Clinical Diagnostics secured CE mark approval for its Vitros Anti-SARS-CoV-2 Total 2 Antibody assay.