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July 12, 2021

FDA grants EUA to Ortho Clinical’s Covid-19 IgG antibody test 

Targeting the S1 spike protein of the virus, the test detects an individual’s adaptive immune response to Covid-19 infection.

The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) to Ortho Clinical Diagnostics’ VITROS Anti-SARS-CoV-2 IgG Quantitative Test.

Targeting the S1 spike protein of the SARS-CoV-2 virus, the antibody test is indicated for detecting people with an adaptive immune response to the virus.

Ortho Clinical noted that the VITROS Anti-SARS-CoV-2 IgG Quantitative Test, which is the first of its kind to obtain the FDA EUA, has a specificity of 100% and significant sensitivity.

Ortho Clinical Diagnostics medical, clinical and scientific affairs head 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.”

The latest test is in line with the World Health Organisation (WHO) International Standard for anti-SARS-CoV-2 IgG antibodies, which offers clinicians and public health experts a tool to assess antibody response to the Covid-19 virus.

In May, Ortho received CE mark for the VITROS Anti-SARS-CoV-2 IgG Quantitative Antibody assay.

Ortho’s VITROS Systems enable high-throughput testing solutions for detecting SARS-CoV-2 infection and antibody testing, the company noted.

The systems can process up to 150 antibody tests or up to 130 antigen tests in one hour.

Currently, VITROS Systems are installed at approximately 1,000 laboratories in the US and more than 5,400 labs globally.

In a separate development, Rite Aid and empowerDX, a subsidiary of Eurofins, have introduced an over-the-counter, at-home Covid-19 PCR Test Kit, which is authorised by the FDA.

Developed by Eurofins Viracor, the at-home test’s mechanism is based on the company’s SARS-CoV-2 RT-PCR assay, another FDA-authorised test.

To be available at all Rite Aid stores in 17 US states, the co-branded Covid-19 test kits will provide users with an option to test for symptomatic and asymptomatic infection in at-home settings.

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