FDA clears ‘new generation’ of Covid antibody test designed to determine how protected a person is from the virus

The FDA on Wednesday cleared one of the first Covid-19 tests that measure the amount of neutralizing antibodies produced by the body’s immune system after exposure to the virus – a “new generation” of coronavirus test designed to tell how well a person is protected from infection.

The body’s immune system produces antibodies to fight viruses and other foreign pathogens that invade the body. Regarding Covid-19, it’s still unclear how many protective antibodies provide and how long it could last, but this test could help researchers better understand the role of Covid antibodies in immune protection.

Unlike many previously licensed Covid antibody tests that can tell whether you have had the virus or not, the COVID-SeroKlir test measures your specific levels of Covid-19 neutralizing antibodies. The Food and Drug Administration has previously authorized certain tests that estimate the level of antibodies, but not specifically for neutralizing antibodies.

The FDA has warned that the nature of neutralizing antibodies to Covid-19 in humans remains unknown and that a high level of antibodies does not necessarily guarantee immunity against the virus.

But the new test is important because it can be used by researchers to further study the relationship between Covid-19 antibodies and protection against the virus. This is relevant for the protection generated both by previous exposure to Covid-19 and by a vaccine, once a vaccine is distributed, which could be next month in the United States.

The test was developed by Kantaro Biosciences, a joint venture between the Mt. Sinai Health System and Renalytix, a diagnostic start-up that went public earlier this year. Through a partnership with Bio-Techne, which is worth $ 11.7 billion, the companies currently manufacture around 10 million tests per month, director of business innovation at Mt. Sinai Erik Lium said in an interview. telephone.

“This will largely enable studies on immunity and the relationship between an individual’s immunity and antibody level,” Lium said, adding that the technology is already being used in studies. “A second use for this test is for vaccination.”

Lium said the test could be used to determine who already has high levels of neutralizing antibodies due to previous exposure and who may not need the vaccine immediately. Lium said he would “defer to public health officials” on decisions on how to allocate the limited doses, but added that it would “not be unreasonable to focus efforts on those who do not. ‘have no antibodies against Covid-19 “.

Lium said it also gives patients and clinicians more information about immunity to the virus, whether someone is recovering from an infection or getting vaccinated. For example, he said, it could be used to assess the effect of a vaccine and whether it elicited a robust immune response in someone, he said.

“As we understand the relationship between the amount of antibodies an individual has against these key components of the virus and immunity, a test like this can really begin to bring peace of mind once we understand this. relationship in the coming months, ”he said. .

Kantaro said the test demonstrated 98.8% sensitivity and 99.6% specificity for the detection of Covid-19 antibodies against two viral antigens, the full-length spike protein and its receptor binding domain, two key elements of this virus. This means that 98.8% of all positive diagnoses are correct and 99.6% of all negative diagnoses are correct.

“We believe our test is truly one of the first in a new generation of antibody tests that provide much more meaningful information to individuals and clinicians about whether an individual has been infected and has developed an immune response,” Lium said. level of antibodies they have. “

The test uses a blood sample and must be processed in a clinical laboratory, but it does not require any proprietary equipment, Kantaro said. It received the CE mark from European regulators in October and is used in the European Union.

“With this EUA in hand, we are ready to immediately deliver this best-in-class serological test to clinicians across the United States,” Chuck Kummeth, CEO of Bio-Techne, said in a statement. “We anticipate that COVID-SeroKlir will play an increasingly important role in the decision-making of healthcare providers and policy makers and are ready to evolve to meet additional demand.”