So far, only emergency use has been authorized for the rapid detection of a new coronavirus antibody, the FDA commissioner said
As of 3:30 p.m. on April 8,2020, there had been 399,929 confirmed cases in the United States, including 12,911 deaths and 22,539 cures, according to the Johns Hopkins University.
With the rapid spread of the epidemic in the United States, the United States for the development of COVID-19 diagnostic test method also into the "fast track. ". In less than a month, from March 12 to April 7, the FDA rushed to use 28 authorized in vitro diagnostic tests for the disease. There is only one serological Test available -- A QSARS-COV-2 IGG/IGM Rapid Test from Foshan CELLEX (QSARS-COV-2 IGG/IGM Rapid Test) .
FDA Commissioner Stephen M. Uh, Hahn M. D. In a statement on 7 April, he said:
Serological tests measure the amount of antibodies or proteins in the blood when the body responds to a particular infection, such as COVID-19. In other words, the test measures the body's immune response to a viral infection, not the virus itself. In the early stages of infection, antibodies may not be detected while the body's immune response is still building, which limits the usefulness of the test for diagnosing COVID-19 and therefore can not be used as the sole basis for diagnosing COVID-19.
In March, the FDA issued a policy that allows developers of certain serological tests to sell or use their test kits after making appropriate assessments to determine the accuracy and reliability of their tests. This includes allowing developers to sell their test kits without prior FDA review if certain conditions outlined in the guidance document are met. It is important to note that the FDA has issued this policy to allow certain serological tests to be performed in early patients, but the FDA has not reviewed or approved these tests.
The FDA can also approve tests for COVID-19 under the emergency use authorization (EUA) . So far, the FDA has been urgently using a licensed (EUA) clinical laboratory serological test called QSARS-COV-2 IGG/IGM rapid test.
The FDA director also noted that more than 70 agencies have notified the agency of available serological tests since the agency issued the policy. However, some companies claim that their serological tests are FDA approved or authorized, or falsely claim that they can diagnose COVID-19, and the FDA will take appropriate action in response to such actions.
Rapid detection of QSARS-COV-2 IGG/IGM IN CELLEX
CELLEX QSARS-COV-2 IGG/IGM rapid detection is a lateral flow immunoassay, the aim is to qualitatively detect and identify SARS-CoV-2 IGM and IgG antibodies in blood from patients suspected of being infected with COVID-19, from plasma (EDTA, citrate) or from venipuncture. Combined with clinical manifestations and other laboratory findings, qSARS-CoV-2 IGG/IGM rapid detection is helpful in the diagnosis of patients suspected of SARS-CoV-2 infection.
The results of qSARS-CoV-2 IGG/IGM rapid detection should not be used as the sole basis for diagnosis. Testing is limited to laboratories accredited under the amendment to the Clinical Laboratory Promotion Act 1988(Clia) for moderate and high complexity testing, and the results are used for detection of SARS-CoV-2 antibodies. IGG AND IGM positive results may occur after infection, indicating an acute or recent infection. Laboratories in the United States and its territories are required to report all positive results to the appropriate public health authorities.
Negative results also do not rule out SARS-CoV-2 infection and should not be used as the sole basis for patient diagnostic decision-making. IGM antibodies may not be detectable in the first few days of infection; the sensitivity of rapid detection of IgG/IgM in qSARS-CoV-2 in the early post-infection period is not known.
False positive results for IGM and IGG may result from pre-existing antibody cross-reactivity or other possible causes.
It is not known how long IGM or IGG antibodies can remain in the body after infection. QSARS-COV-2 IGG/IGM rapid detection is only used for prescription, in vitro diagnosis and emergency use authorization.