The US Food and Drug Administration (FDA) has authorized two more coronavirus antibody tests for emergency use on Wednesday, April 15. According to a CNN report, antibody tests are being conducted to find the solution in creating the vaccine needed to slow down the spread of the coronavirus.
It was clarified in the CNN report that the antibody tests, known as "Serology tests," are not meant to detect or diagnose active coronavirus infections. These tests are intended to check for the proteins or antibodies produced by the immune system of the human body by observing the blood sample extracted from an individual.
Checking for the presence of antibodies shows whether a virus has infected an individual causing their body to produce these proteins which could fight off the virus. It also shows that the person is somehow immune to a specific virus, but it is not yet confirmed how strong the immunity is and how long will it last.
On the other hand, most medical experts are using a laboratory technique known as the "Polymerase Chain Reaction Test" or PCR test. This test uses a nose swab to extract a nasal secretion sample to check for viral genetic material.
Coronavirus antibody tests are authorized by FDA: 2 new tests are on their way!
According to CNN's report, the US Food and Drug Administration issued an emergency-use authorization on Wednesday, April 15, allowing medical experts to conduct two new coronavirus antibody tests. These tests are conducted to detect previous infections of an individual after they have recovered. However, it was clarified that the information gathered from these tests is not enough to confirm that having antibodies will provide long-term immunity against the coronavirus.
The report of CNN reiterated that using blood samples instead of a swab are limited to authorized laboratories and facilities. This situation pushed medical experts to look for the body's antibodies which is the response of the physical body when it is infected by a virus or disease. However, the FDA gave a warning that these tests may result in false negatives since antibodies may not be detected during the early infection stage.
"A negative result may occur if you are tested early in your illness and your body hasn't had time to produce antibodies to infection," the FDA stated in a fact sheet.
However, experts say that conducting these tests can help them understand how the coronavirus spreads since it can detect past infections even if the individual only had a few or no symptoms.
The newly authorized tests came from Ortho Clinical Diagnostics and Chembio Diagnostic Systems. Meanwhile, Abbott laboratories said that it will release a new antibody test. They expect to ship 1 million antibody tests to its customers as soon as possible and is planning to produce and ship almost 20 million tests by June.