(CNN) The US Food and Drug Administration has issued its first emergency use authorization for a coronavirus test that looks for antibodies in the blood.
That type of test, called a serology test, would be able to identify past coronavirus infections, although it may be less effective at identifying recent ones.
The authorized test, from a manufacturer called Cellex Inc., requires blood to be collected through a vein, and the test itself can only be performed in a certified lab.
Because antibodies can take time to develop, the FDA has previously warned against using antibody tests to definitively diagnose coronavirus.
But in issuing what is known as an Emergency Use Authorization for the new test, the FDA signaled that the benefits of using the new blood test outweighed the risks.
“Based on the totality of scientific evidence available to FDA, it is reasonable to believe that your product may be effective in diagnosing COVID-19,” said the agency, adding that “the known and potential benefits of your product when used for diagnosing COVID-19, outweigh the known and potential risks of your product.”
Unlike most coronavirus tests, which generally require a swab and look for signs of the virus itself, antibody tests look instead for our body’s response to a virus.
The FDA said in its letter that initial antibodies against coronavirus are “generally detectable in blood several days after initial infection,” but the agency cautioned that “levels over the course of infection are not well characterized.”
Suggested reading by Zia H Shah MD, Chief Editor of the Muslim Times
Corona Fear’s Cure: Chanting from the Bible and the Quran
UK coronavirus mass home testing to be made available ‘within days’
Praise be to God for the Miracle of Our Immune System
USA: 15-minute coronavirus test is here
The self isolation for 70 years and older may last up to 4 months
Does the Ordinary Soap Kill Coronavirus?
Islam: China has made eating wild animals illegal after the coronavirus outbreak?
All of humanity are intimate neighbors: Coronavirus proves it once again
Here’s a list of disinfectants you can use against coronavirus
To see the daily new cases and deaths in the top eleven countries go to
When Not Going to Jumma is a Huge Blessing
“We project that roughly 56 percent of our population – 25.5 million people – will be infected with the virus over an eight week period,” Governor Newsom of California wrote on 3/19/2020.
Categories: Health, The Muslim Times
The FDA granted its first emergency authorization for a rapid antibody blood test for COVID-19, developed by Cellex, allowing people to gauge a person’s immune response to the novel coronavirus.
The serological test—which uses a fingerprick of blood and a small strip, similar to a combination of a blood glucose test and a home pregnancy exam—detects two different types of antibodies produced by the body to fight off the infection. Available by prescription, this can be used to determine whether a person has been previously infected and possibly recovered.
It is distinctly different from the nearly two dozen diagnostic tests the FDA has officially authorized so far, which focus on finding active infections by sequencing the genetic material of the virus.
This virtual event will bring together industry experts to discuss the increasing pace of pharmaceutical innovation, the need to maintain data quality and integrity as new technologies are implemented and understand regulatory challenges to ensure compliance.
Cellex—with offices in Shenzhen and Suzhou in China and in North Carolina’s Research Triangle Park—said its CE marked test should deliver a reading in 15 to 20 minutes. However, the test may not work in the first few days of an infection, before enough antibodies are produced as part of the immune system’s response.
Previously, the agency told serological test developers that it would not object to the unreviewed use of these rapid blood tests, describing them as less sophisticated compared to the high-throughput sequencing diagnostics in use nationwide. Companies are required to validate their work and include instructions saying their test must not be used as the sole method of testing a patient for COVID-19, as does Cellex.
Currently, the FDA maintains a public list of nearly 50 other serological test manufacturers, the majority based in China, that have notified the agency of their plans to distribute their products in the U.S. without seeking an Emergency Use Authorization.
That list includes BioMedomics, which has announced plans with medtech giant BD and medical supply company Henry Schein to distribute their version on a large scale. It does not include Hangzhou, China-based Safecare Bio-Tech, maker of tests set to be distributed by BodySphere, which earlier this week incorrectly claimed to have received an FDA authorization.
https://www.fiercebiotech.com/medtech/fda-officially-authorizes-its-first-serological-antibody-blood-test-for-covid-19
So far, the FDA has granted emergency use authorizations to over 20 commercial COVID-19 diagnostic tests, panels and assays. The vast majority detect live infections by searching for specific nucleic acids—or the small pieces of RNA produced by the novel coronavirus—within swabs and respiratory samples.
A separate method, known as a serological test, would search for relevant antibodies in a person’s bloodstream, for evidence that the body produced an immune response to the disease.
This could be able to determine who has had and overcome an infection in the past—and could allow people to exit quarantine early, such as letting a nurse return to work at a hospital, for example.
This virtual event will bring together industry experts to discuss the increasing pace of pharmaceutical innovation, the need to maintain data quality and integrity as new technologies are implemented and understand regulatory challenges to ensure compliance.
Now, BD will begin offering a point-of-care antibody assay, which operates like a combination of a blood glucose test and a home pregnancy test. Using just a fingerstick of blood, the small test strip provides results within 15 minutes, showing multiple lines for a positive reading and a single line for negative.
Last month, the FDA said it wouldn’t authorize these types of tests the same way as molecular diagnostics. The agency described them as less complex, and said it would not object to their unreviewed use as long as they were clinically validated and not used as the sole method to diagnose an infection.
“Serology tests are important because they provide an additional piece of information to aid in characterizing possible prior exposure to SARS-CoV-2, especially since many infections are mild or asymptomatic in severity,” said Dave Hickey, president of BD’s integrated diagnostic solutions division.
“Initial evidence suggests that nearly all patients infected with SARS-CoV-2 will have developed a detectable antibody response within days of symptom onset, at which time a negative serologic test, along with molecular diagnostics, could be helpful in ruling out COVID-19,” Hickey said. These antibodies are typically present in the middle to late stages of the infection.
Meanwhile, the FDA granted an Emergency Use Authorization April 2 to BD for its high-throughput RT-PCR molecular diagnostic, developed for its BD MAX platform in collaboration with BioGX.
The company’s handheld serological test, developed by BioMedomics, was previously used by China’s Center for Disease Control. It requires no special equipment, and will be distributed by the medical supply company Henry Schein. BioMedomics has previously notified the FDA of its intention to market the test in the U.S. without seeking an official emergency authorization.
BD said it will make the test available this month and plans to supply more than 1 million tests in the future. BioMedomics described the test’s accuracy as having a sensitivity of 88.66%, and a specificity of 90.63%.
https://www.fiercebiotech.com/medtech/bd-to-offer-fingerstick-antibody-blood-test-for-covid-19
The U.S. Food and Drug Administration (FDA) approved the first blood test that looks for the antibodies against the novel coronavirus that causes COVID-19. This is different than assays that test for presence of the virus—those test to determine if a patient has COVID-19. These new antibody tests determine if the person was exposed to the virus, had COVID-19 and recovered. And it suggests, if positive, that the person is now immune to COVID-19 and can’t get it again.
Research Triangle Park, North Carolina-based Cellex was granted an emergency use authorization (EUA) on its test yesterday.
The test is performed on a blood sample taken from a patient’s vein and can be performed by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), the Health and Human Services division that oversees clinical diagnostic testing in the United States.
The authorization stated, in part, “Results are for the detection of SARS-CoV-2 antibodies, IgM and IgG that are generated as part of the human immune response to the virus. IgM antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although levels over the course of infection are not well characterized. IgG antibodies to SARS-CoV-2 become detectable later following infection. Positive results for both IgG and IgM could occur after infection and can be indicative of acute or recent infection.”
Mayo Clinic is reportedly to begin antibody testing on Monday as well, using an internally developed test. Elitza Theel, director of the Mayo Clinic laboratory testing COVID-19 antibody tests, told Minnesota Public Radio (MPR), “It’s important to know that these types of tests are different than all of the molecular tests that are being done off of nasal swabs or throat swabs. Those tests detect viral genetic material [to show whether the coronavirus has infected that person].”
Theel also pointed out that, in some cases, it takes 10 to 11 days for an individual’s immune system to attack the virus and produce the antibodies. That’s why the tests won’t be used to diagnose patients with COVID-19 that are showing symptoms within the last two or three days.
Theel also says Mayo hopes to have the tests available next week, but because of a limited supply, will be doing a slow roll out and hope that commercial manufacturers will speed production in the next few weeks.
“FDA approval is not needed at this time,” Theel said. “However, laboratories that are offering these tests have to go through a very rigorous verification process to make sure that the tests they’re offering provide the right results.”
Part of the reason these antibody tests would be valuable is it can provide guidance on people potentially returning to work and continuing quarantine.
There is also the potential to use antibodies against the virus for therapy against the disease.
Theel said, “As we wait for antivirals and vaccines to be developed and deployed, we need some sort of bridging therapy. So, the idea here is to identify individuals who have recovered from COVID-19, collect their plasma, make sure that it has the antibodies, and then use that plasma to treat acutely ill patients.”
Of the tests in general, and specifically the Cellex test, Alan Wu, professor of laboratory medicine at the University of California, San Francisco and chief of the clinical chemistry and toxicology laboratories at Zuckerberg San Francisco General Hospital, told USA Today, “Antibody positivity likely means a person has recovered and can’t be reinfected. This test will be extremely valuable, especially for healthcare workers.”
Healthcare workers are, obviously, at the front lines of this battle and at high risk of catching COVID-19.
“We could sort out who among the health care workers has antibodies and assign them to coronavirus patients,” said William Schaffner, a professor of preventive medicine and infectious disease at Vanderbilt University in Nashville, Tennessee. “They’d still use protection, but would have a much greater sense of security.”
https://www.biospace.com/article/fda-approves-1st-covid-19-antibody-test/
It is good news Zia, I appreciate it— after the dark day will emerge the ligh day for sure
Send us more good / hope news