A medical worker wearing personal protective equipment (PPE) inserts a Covid-19 test tube into a box at a drive-through test location at the Alemany Farmers Market in San Francisco, California, United States on Thursday, November 19, 2020.
David Paul Morris | Bloomberg | Getty Images
The FDA on Wednesday approved one of the first Covid-19 tests, which measures the amount of neutralizing antibodies made by the body's immune system after exposure to the virus – a "new generation" coronavirus test that determines should be how well someone is protected against infection.
The body's immune system produces antibodies against viruses and other foreign pathogens that invade the body. When it comes to Covid-19, it remains unclear how much protection antibodies offer and how long it could take, but this test could help researchers better understand the role of Covid antibodies in immune protection.
Unlike many previously authorized Covid antibody tests, which can determine whether or not you had the virus, the COVID SeroKlir test measures your specific levels of Covid-19 neutralizing antibodies. The Food and Drug Administration previously approved some tests that estimate antibody levels, but not specifically designed to neutralize antibodies.
The FDA warned that much unknown is known about the nature of Covid-19 neutralizing antibodies in humans and that high levels of antibodies do not necessarily guarantee immunity to the virus.
However, the new test is important as it can be used by researchers to further study the relationship between Covid-19 antibodies and protection against the virus. This is relevant to the protection created by both previous exposure to Covid-19 and a vaccine after its distribution that could come in the US next month.
The test was developed by Kantaro Biosciences, a joint venture between Mt. Sinai Health System and Renalytix, a diagnostics start-up that went public earlier this year. Through a partnership with Bio-Techne, valued at $ 11.7 billion, the companies currently manufacture approximately 10 million tests per month. Sinai Erik Lium said in a telephone interview.
"It will broadly enable studies of immunity and the relationship between immunity and the level of antibodies an individual has," Lium said, adding that the technology is already being used in studies. "A second use of this test is in vaccination."
Lium says the test could be used to determine who is already high in neutralizing antibodies from previous exposure and may not need the vaccine right away. Lium said he would "postpone public health officials" to decide how to allocate the limited doses, but added that it "would not be inappropriate to focus efforts on those who do not have antibodies to Covid- 19 have ".
Lium says more information will be given to patients and doctors about immunity to the virus, whether someone is recovering from infection or getting vaccinated. For example, he said it could be used to evaluate the effects of a vaccine and whether it creates a robust immune response in someone, he said.
"Since 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 be really reassuring once we understand that relationship in the months ahead," he said.
Kantaro said the test showed a sensitivity of 98.8% and a specificity of 99.6% for the detection of Covid-19 antibodies against two virus antigens, the full-length spike protein and its receptor binding domain, two key elements of this virus . That is, 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 can give individuals and clinicians much better information about whether a person has been infected and has developed an immune response," said Lium, the level of antibodies they have . "
The test uses a blood sample and must be processed in a clinical laboratory, but doesn't require proprietary equipment, Kantaro said. It received a CE mark from European regulators in October and is used in the European Union.
"With this EEA, we are ready to deliver this world-class serological test to doctors in the US immediately," said Chuck Kummeth, CEO of Bio-Techne, in a statement. "We anticipate that COVID-SeroKlir will play an increasingly important role in the decision-making process of healthcare providers and policy makers, and we stand ready to scale up to meet the additional demand."