HOW ACCURATE IS THE TEST?
We have exceeded the minimum sensitivity and specificity required by the FDA for Emergency Use Authorization. Please reference our Product Insert for details. Through ongoing studies and trials, we are continuing our mission to further validate the accuracy of our test.
WHERE CAN I USE THE TESTS?
Testing will be authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform moderate complexity/high complexity tests.
WHERE IS THE TEST MADE?
The test was developed and is manufactured in Springdale, Arkansas by NOWDiagnostics.
WHAT SAMPLE TYPES ARE APPROVED FOR USE WITH THE TEST?
Approved sample types include human whole blood or plasma (EDTA), and serum.
HOW WILL YOU DETERMINE WHO GETS THE ADEXUSDx® COVID-19 TEST?
We are doing everything possible to produce as many tests as we can during this developing situation with the understanding that during a global health pandemic demand may exceed supply at times. We intend to first supply those fighting on the frontlines, especially healthcare employees, police, fire, emergency medical services and military personnel. Next, we intend to supply large-scale screening programs to deliver a reliable, quick, systematic testing option for those who need it most (i.e. essential workers, vulnerable and elderly populations).
Concurrently, we will continue to perform studies to further establish the clinical efficacy of our product with the goal of FDA authorization for Point of Care and over-the-counter use.
In addition, we are scaling up our manufacturing capabilities to maximize volume throughput.
WHO SHOULD BE TESTED?
IS THIS TECHNOLOGY FDA APPROVED?
HOW QUICKLY DOES THE TEST PROVIDE RESULTS?
Our test provides results within 15 minutes.
IS A LAB ANALYZER OR READER REQUIRED TO RUN THE TEST?
No. Our test does NOT require a lab analyzer or a reader or any other technology. Results are qualitative and read visually.
HOW IS YOUR TEST DIFFERENT FROM OTHER ANTIBODY TESTS?
There are many differentiators:
- Unlike many rapid tests on the market, our test was developed and is manufactured in the United States.
- Unlike many rapid tests on the market, our test has been submitted for FDA Emergency Use Authorization.
- Unlike many rapid tests on the market, our test is a total antibody test designed to detect all human immunoglobulins, including IgG, IgM, and IgA, which may indicate recent or prior exposure to SARS-CoV-2 (the virus that causes COVID-19).
Other key differences:
- Due to our patented technology, our test is highly sensitive and specific.
- No transport media, buffers, or in-demand ancillary items are needed.
- Unlike other tests that require expensive lab equipment and specialized training personnel, our test can be administered in-field.
WHY ARE YOU DETECTING TOTAL ANTIBODIES? WHY NOT IGG, IGM SEPARATE?
Current research into the antibody response in COVID-19 patients has indicated that the classical antibody pattern of IgM first then IgG later is not followed. There has been evidence of IgG antibodies first, concurrent development of IgG and IgM antibodies, as well as IgM antibodies first. There is no established clinical utility for distinguishing between IgG and IgM antibodies. Our test is strategically designed to detect total immunoglobulin (IgG + IgM + IgA) in an effort to maximize test sensitivity for identifying people who have been infected with COVID-19.