FDA gives go ahead to administer COVID-19 tests on those without symptoms
The Food and Drug Administration gave its nod to the first COVID-19 test for asymptomatic individuals.
The Food and Drug Administration (FDA) allows the first COVID-19 test for infected persons who do not show any symptoms.
The FDA granted an emergency use authorisation to LabCorp for it to conduct a test on people without symptoms for coronavirus infection. This marked the first time the federal agency has given its authority to administer such a test to asymptomatic patients.
In the past, a person is first asked to meet certain requirements, such as exhibiting COVID-19 symptoms or had a close contact with someone confirmed to have the infection, to have a coronavirus diagnostic test. "FDA reissued the LabCorp COVID-19 RT-PCR Test EUA to expand the use of the test to anyone after the company provided scientific data showing the test's ability to detect SARS-CoV-2 in a general, asymptomatic population," the FDA said in a statement Friday.
A LabCorp spokesperson, in a statement to NBC News, confirmed receiving the authority from the FDA, adding that the same test will still be conducted. She said the company was simply granted approval for it to expand the test to include those without symptoms.
There is mounting evidence suggesting some similarities in symptomatic and asymptomatic coronavirus patients. In astudy published in MedRxiv, Broad Institute of MIT and Harvard researchers discovered that the viral load, which is the amount of virus in the body of a person, is similar to those who were found to be positive for the coronavirus, both symptomatic and asymptomatic. The study is yet to be peer reviewed.
The scientists examined testing data of some 32,299 residents and personnel at 366 skilled nursing facilities, nursing homes and assisted living facilities located in the state of Massachusetts. Of those who were found positive, 93 percent of the personnel and 71 percent of residents did not show any symptoms during testing. They also discovered the viral load is similar in symptomatic and asymptomatic people.
Researchers suggested that polymerase chain reaction (PCR) tests used for symptomatic individuals are also effective for use in asymptomatic people. A PCR test detects small bits of the genetic material of the virus. Having a bigger virus load makes it easier for the test to detect an infection. If the virus levels are similar in people regardless of whether or not they have symptoms, then the test should be likewise effective.
The findings, according to Dr Eric Topol, were vital as they extend "smaller previous ones as to the similarity in viral load in people without COVID-19 symptoms as compared with those having symptoms." He is the founder and director of the Scripps Research Translational Institute but wasn't involved in the research. Dr Topol warned, however, that despite the viral load similarities, the study does not conclude whether asymptomatic individuals can spread the virus with the same degree as symptomatic persons.
© Copyright IBTimes 2024. All rights reserved.