The Food and Drug Administration (FDA) issued an emergency use authorization (EUA) of a diagnostic test for the detection of viruses that cause flu and CCP virus also called COVID-19 on July 2, ahead of the upcoming flu season.
“With the authorization of these tests, the FDA is helping address concerns in anticipation of this upcoming flu season during the COVID-19 pandemic, which might be especially worrying for some Americans. This is another example of the FDA working with test developers to bring important diagnostics to Americans,” said FDA Commissioner Stephen M. Hahn, in a statement.
The Center for Disease Control (CDC) said the “Influenza SARS-CoV-2 (Flu SC2) Multiplex Assay” is a test that differentiates RNA from SARS-CoV-2, influenza A virus, and influenza B virus in upper or lower respiratory specimens.
“The assay provides a sensitive, nucleic-acid-based diagnostic tool for evaluation of specimens from patients in the acute phase of infection,” said the CDC.
The EUA was given to BioFire Diagnostics LLC, a company that develops innovative diagnostic solutions and to QIAGEN GmbH, another company that develops reliable sample technologies and test panels to accurately analyze and identify various diseases.
The FDA officials said the combination tests diagnose multiple respiratory diseases by using a single sample from a patient. For example, it can test a single sample for both flu and COVID-19 since their symptoms are similar.
“With just one swab or sample, combination tests can be used to get answers to Americans faster. This efficiency can go a long way to providing timely information for those sick with an unknown respiratory ailment,” said Hahn.
The test kits are currently under production and will be sent to public health laboratories after production, quality control and assembly is done.
The FDA has asked other developers to work along with it on combination tests so that the health care system can preserve critical testing resources in the upcoming flu season.
“Taking just one sample from a patient may help alleviate the need for multiple samplings, which means less discomfort for the patient with faster and more comprehensive results,” said the FDA.
The agency said the combination tests need fewer supplies, like swabs and personal protective equipment—this reduces overall pressure on the supply chain.
The test kit will be distributed to registered state and local public health laboratories by the International Reagent Resource (IRR). The IRR doesn’t directly supply test kits to the clinicians, hospitals, or healthcare professionals.
“During the COVID-19 pandemic, state public health laboratories can authorize county or city laboratories in their state to perform testing. These laboratories must be certified under the Clinical Laboratory Improvement Amendment (CLIA) to perform high-complexity tests, have appropriate laboratory equipment and training, and demonstrate testing proficiency under their state laboratory’s stewardship to maintain their status as an IRR-registered laboratory,” said the CDC.