When will you receive FDA approval?
President Trump asked the FDA to “cut the red tape,” and facilitate approval for new COVID-19 treatment and testing. In order to accelerate the review process, the FDA is providing “Emergency Use Authorization” (EUA) to products that meet requirements. The FDA recently began approving new rapid antibody testing products under the EUA. Our test is a self-contained serological test, with results in 15 minutes, while you wait. We are expecting approval within the next week. Meanwhile, test kits are currently authorized for use in medical facilities.
How does the test work?
Covid-Rapid works by looking for antibodies to the virus in your blood. So there is no uncomfortable swab deep in the nose or throat (PCR test), and more importantly, you know for sure that the sample collected is properly done, which isn’t always true with the swabs. After placing the blood on the strip with the reagent, your blood is carried by capillary action down the strip to where there are pieces of the virus embedded in the paper. If you have the antibodies in your blood, they will react with the pieces of virus and change the color of the paper. Similar to a home pregnancy test, a control line assures that the process has worked correctly. A second and/or third line indicates the presence of one or both of the two types of antibodies produced by your body, called IgM and IgG.
Why is Covid-Rapid better than all the others in the marketplace now?
API has 15 years of experience in rapid diagnostic tests. We did not start just last month. This experience means that we were able to develop a very good test that is highly specific and won’t interact with other viruses or infections in your body. We also have one of the strongest manufacturing capabilities: With our overseas partner, we can manufacture 20 million tests each month, so that we can supply enough tests today and into the future. Finally, our test is available for your doctor to test you today!
You say your test could help with getting people back to work. How does that work?
Unlike the swab (PCR) tests, our test looks for both current and past infections. If both antibodies are positive, you have a current infection. If only the long-lasting antibody (IgG) is positive, then we know that your infection is likely more than three weeks old, and you likely have immunity to getting infected again, at least for the next 12 months. As stay-at-home restrictions are lifted and the economy begins to open up, employers may require antibody tests like Covid-Rapid to determine which employees have probable immunity and are thus more safe to return to work sooner. In addition, we can protect those who haven’t been infected yet by offering employers the opportunity to test anyone with symptoms right there on the spot. Because it’s so cheap and easy, employers such as airlines, restaurants, factories and cruise ships can test employees every time they show up for work, limiting the likelihood that someone who is infected spreads it to their colleagues or customers in the workplace.
If your test is so fast, how is it reliable?
Our test is like a urine pregnancy test or blood sugar finger stick test. Speed and reliability have nothing to do with each other. The swab tests (PCR) can take 2-10 days for results from the lab, leaving too big a window for someone who might not know they are infected to transmit the virus. We need faster tests with results that we can act on in real time if we are going to defeat this pandemic. Our test requires no external equipment, and we also don’t face the same shortages for nasal swabs as PCR tests.
I’ve heard that serological tests are less accurate, so why should we use them now?
Serological tests are somewhat less accurate in the first 5-7 days of infection. Most people develop symptoms at day 6 and will likely seek out testing then, when most people will have already formed antibodies. Swab tests (PCR) are highly sensitive and react to the presence of the virus’s DNA itself. However, the swab must be jammed far back in the nose or throat, and faulty collection frequently leads to false negatives. In addition, the painfully slow turnaround time of the swab tests means that the disease continues to run its course while waiting for results, resulting in reduced standard of care and greater potential for infecting others. If a patient receives a positive result for current infection with the Covid-Rapid test, they likely have COVID-19 and can take action now. If a patient receives a negative result but has COVID-19-like symptoms, then we recommend re-testing again in 48 hours. Since Covid-Rapid can be done anywhere, quickly and cheaply, two tests in 48 hours is still easier and cheaper than one swab that takes days to get results. Plus, Covid-Rapid is almost 100% effective for catching those who have previously been exposed to the virus, so it will help with understanding public immunity.
How is your test different from the at-home rapid tests the FDA warned against recently?
Covid-Rapid is not available for at-home testing at this time. While it is simple enough for individuals to perform themselves and does not require lab testing, the interpretation of results should be left to medical professionals. People may misinterpret the difference between current and past infection, and so we recommend individuals do the test with their healthcare provider who can discuss the results with them in the context of their medical history.
Why should we trust a test from your company?
API has 15 years of experience in rapid diagnostic tests, and we are an American company. We didn’t start just last month. Given our experience in using finger prick tests for other viruses (HIV, hepatitis B and C, influenza, norovirus), we were able to quickly develop an effective test for COVID-19. In addition, tens of thousands of our Covid-Rapid tests have already been performed in Europe in real world conditions, and we have successfully screened people quickly. We expect the same to be the case here in the USA.
How will hospitals get your tests?
Please ask your doctor or hospital to contact us at firstname.lastname@example.org to talk with a sales associate, learn more about the test, read the data themselves, and place an order. We can ship from our Florida warehouse this week!
What does the FDA registration allow you to do? Who should administer the test?
FDA registration will ensure that people have access to the test anywhere and everywhere a licensed medical provider is able to perform the test. For some, this may be at their doctor’s office or hospital. For some, it may mean that the paramedics at the fire station or the nurse at the occupational health clinic can perform the test. We hope that Covid-Rapid can be a part of the solution for getting America back to work.
What is the Emergency Use Authorization (is it really legitimate?) and how is it different from normal FDA approval?
EUA is absolutely legitimate. Results from Europe demonstrate that Covid-Rapid is trustworthy in a real-world setting. As part of EUA, we are obligated to continue with the application process for full FDA approval. Since we expect our test to clear all EUA requirements with significant room to spare, we expect to have complete FDA approval in 3-4 months. In the meantime, rest assured that our data and real-world experience is something that we fully believe in.