A medical worker wearing personal protective equipment (PPE) inserts a Covid-19 test tube into a compartment at a drive-thru test site at Alemani Farmers Market in San Francisco, California, USA, on Thursday, November 19, 2020.
David Paul Morris | Bloomberg | Getty Images
The FDA on Wednesday authorized one of the first Covid-19 tests that measures the amount of antibodies produced by the body’s immune system after exposure to the virus – a “new pay generation” of coronavirus tests designed to tell anyone how safe it is. Against infection.
The body’s immune system produces antibodies to fight viruses and other foreign pathogens that invade the body. When it comes to Covid-19, it is not clear how much protection antibodies provide and how long it can last, but this test could help research better understand the role of Covid antibodies in immune defense.
Unlike many previous authorized Covid antibody tests that can tell you if you have a virus, the COVID-SeroKlir test measures the exact level of inactivated antibodies to your Covid-19. The Food and Drug Administration has previously authorized some tests that estimate the level of antibodies, but not specifically to inactivate antibodies.
The FDA warned that much remains unknown about the nature of covid-19, which neutralizes antibodies in humans, and that high levels of antibodies do not guarantee immunity to the virus.
But the new test is important because it could be used by researchers to further study the relationship between Covid-19 antibodies and defense against the virus. It relates to defenses created by both previous Covid-19 exposure and by vaccine, once delivered, which may be in the U.S. next month
This test thorn was developed by Bioscience, which mounts. Sinai Health Systems and Renaultics, a diagnostics start-up that went public earlier this year. Through a partnership with Bio-Tech, valued at 11 7 11.7 billion, the companies are now building about 10 million tests per month, said MT’s Chief Commercial Innovation Officer. Sinai Eric Liam said in a phone interview.
“It will enable a wider study of the relationship between the immune system and the levels of the immune system and antibodies,” Liam said, adding that the technology is already being used in the study. “Another use of this test is in vaccinations.”
Lim said the test could be used to determine who already has a neutral level of antibodies due to previous exposure, and does not need a vaccine immediately. Lim said he “postponed public health officials” on the decision on how to allocate the limited dose, but added that “it would not be unreasonable to focus efforts on people who do not have Covid-19 antibodies.”
Lim said he also gives patients and clinicians more information about immunity to the virus whether one recovers from the infection or is immune. For example, he said, it could be used to evaluate the effectiveness of a vaccine and whether it stimulates an immune response in someone, he said.
“When we understand the relationship between the proportion of a person’s antibodies to the virus and these key components of the immune system, this type of test can really begin to provide peace of mind once we understand that relationship in the coming months,” he said. .
Kantaro said the test showed 98.8% susceptibility and 99.6% specificity for detecting Covid-19 antibodies against two virus antigens, the full-length spike protein and its receptor-binding domain, the two main components of the virus. This means that 98.8% is accurate in all positive diagnoses and 99.6% is correct in all negative diagnoses.
“We think our test in the new pay generation of antibody tests is really one that provides more meaningful information to individuals and clinicians about whether a person has developed an immune system,” Lim said, “and then What are the levels of antibodies that they have. “
The test uses a blood sample and must be processed in a clinical laboratory, but it does not require any proprietary instrument, Kantaro said. It received the CE mark from European regulators in October and is used in the European Union.
“With this EU in hand, we are ready to provide this best-in-class serologic asso to clinicians in the US immediately,” Chuck Kummeth, CEO of Bio-Techni, said in a statement. “We expect that Covid-Seroclair will play an increasingly important role in the decision-making of health care providers and policy makers and is ready for the criteria to meet the additional demand.”
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