- The FDA just approved a breakthrough coronavirus antibody test that doesn’t just detect antibodies — it actually measures the amount of neutralizing antibodies that the immune system has produced.
- The test can be used to measure someone’s immunity after a COVID-19 infection or to determine whether the immune response is accurate after vaccination.
- The COVID-SeroKlir test requires a blood sample and has to be performed in a clinical lab. The test has 98.8% sensitivity and 99.6% specificity.
Testing was one of America’s biggest problems at the start of the pandemic. Issues with COVID-19 diagnostic tests hindered the government’s ability to conduct testing campaigns early in the pandemic. Then the FDA had to deal with a flurry of antibody tests that were not reliable. Things have improved significantly since then, with companies developing better, more reliable tests that can actually help manage the pandemic.
The FDA just recently approved a quick at-home test that produces results in just 30 minutes. It has to be prescribed by a physician, and the diagnosis has to be reported to health authorities, but the test might help people isolate themselves earlier after being infected. The agency has just approved another breakthrough test that concerns antibodies. Rather than telling people whether they have COVID-19 antibodies, the test will actually offer details about the number of neutralizing antibodies that are found within the person’s body.
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The test would have more use cases than simply informing doctors whether the patients have mounted a strong response to the infection. They could also allow doctors to measure the immune response to a coronavirus vaccine. Health officials could use the tests to determine whether a person requires a vaccine as soon as possible or whether they can wait a while, as the existing immunity would still offer protection. The first wave of vaccines will be limited, and only at-risk categories of people will qualify for it. The test could also inform patients whether their plasma has the right kind of antibodies to be considered for donation.
The test is called COVID-SeroKlir and comes from Kantaro Biosciences, a joint venture between Mount Sinai Health System and diagnostics start-up Renalytix. The antibody test has a sensitivity of 98.8% and specificity of 99.6%. That means 98.8% of the positive results will be accurate, and 99.6% of the negative results will be accurate. These high figures suggest the test could be highly reliable.
“It’s going to broadly enable studies of immunity and the relationship between immunity and the level of antibodies that an individual has,” Mount Sinai’s chief commercial innovation officer, Erik Lium, told CNBC. “A second use of this test is in vaccination.”
Vaccines aren’t 100% effective, and tests like this one could be used to determine whether an at-risk person has developed an immune response after the vaccine regimen. Several studies so far showed that COVID-19 antibodies could disappear in a few months, although others said that the neutralizing antibodies that actually matter could survive for at least six months.
Some of the COVID-19 survivors won’t develop detectable antibodies, according to previous studies. That might be explained by flawed tests that were not able to pick up antibodies. Next-gen tests like the COVID-SeroKlir might work better and actually tell whether a person has delivered an immune response after infection or vaccination. These tests could be used to reduce the risk of reinfection but also warn individuals that a vaccine might not have worked.
The test detects antibodies against two virus antigens, including the full-length spike protein and its receptor-binding domain. The test requires a blood sample but can’t be performed at home. This “new generation” of tests needs to be processed in a clinical laboratory.