Sunday, April 26, 2020

by Aaron Medaris - Publisher, Physicians Office Resource

COVID-19 needs no introduction. This virus, which is 1/1000^th the size of a grain of sand, has singlehandedly bought countries, people and businesses to a complete stop. It fills our news feeds, our thoughts, and dictates our actions. We know that humans are resilient and that we will come out on top, but COVID-19 has brought change and heartbreak along the way. During this time of emergency, we express our sincerest praise to all of you who are constantly putting yourselves in harms way to serve and heal another.

Up to this point, much of the screening for COVID-19 has taken place in hospitals and larger laboratories, but with the emergency situation that we have found ourselves in, COVID-19 testing has reached physician offices and urgent care centers. With this development questions from our community of POLs have come forth such as:

• Are these FDA approved products?
• What tests are available to a POL and how do they work?
• How can a POL get access to COVID-19 rapid tests?

We will address these main questions throughout the remainder of this article.

Are these tests FDA approved?

The first thing to be aware of is that these new rapid point of care tests are NOT FDA cleared or approved. However, these rapid tests have been authorized by the FDA under Emergency Use Authorization (EUA) for the detection of COVID-19. According to the FDA, “The EUA authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies.” Given our current situation and the inability for these tests to make it completely through the FDA’s approval process, manufacturers can create and validate their own COVID-19 tests based off of guidelines laid out by the FDA under the EUA. With that said, it is essential for purchasers of COVID-19 rapid tests to make sure they are obtaining them from a valid and reputable company. There have already been reports of false and ineffective COVID-19 rapid tests hitting the market. To help you access quality tests, we will mention a few companies who you can approach about COVID-19 rapid tests at the end of this article.

What testing methods are available for COVID-19 at the point of care?

IgG/IgM Rapid Screen Antibody Test Cassette

There are several rapid testing methods for physician offices and urgent care centers. Probably the most available option is an IgG/IgM rapid screen antibody test cassette. IgG/IgM rapid test cassettes are a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies in COVID-19 in human whole blood, serum or plasma specimen. Tests will most likely come with a cassette, a buffer, and a dropper. Test protocol is quite simple:

• Collect the specimen
• Use the provided dropper apply the specimen to the appropriate well on the cassette.
• Immediately after, add the buffer to the buffer well.
• Results should appear in about 10 to 15 minutes.

These cassettes are quick and convenient, but please remember to purchase your tests from a reputable source. Some companies have taken advantage of the FDA’s EUA and not fully developed or tested their tests.

Molecular Point-of-Care Tests

Molecular point of care tests for the detection of COVID-19 will need diagnostic device or dock to run the test on. However, many POLs and urgent care centers may already have these molecular devices in place as they are used to run rapid flu, RSV and strep tests. If your facility doesn’t have one of these devices yet, you can reach out to companies such as Abbott and Sekisui Diagnostics to help you get set up. Here’s how these molecular devices work:

• A sample is added to the device.
• Chemical solutions splits open the virus releasing genetic material for the device to read.
• Even if a small amount of COVID-19 is found in the sample, the molecular device is able to replicate the small section of the virus’ genetic material making it detectable.

These molecular tests provide results anywhere from 5 to 30 minutes.

How to access rapid COVID-19 Tests

We’ve all heard the news about how COVID-19 tests are in short supply, and that may be an understatement. However, companies have been ramping up their efforts to supply testing kits. Abbott for example has ramped up their manufacturing efforts and plans on delivering 50,000 of their molecular tests per day. Other companies are following suit, and many have even made this test extremely affordable during this time of crisis.

Here are reputable companies you can contact about obtaining rapid COVID-19 tests:

Carolina Liquid Chemistries, offers the “AllTest^TM” 2019-nCoV IgG/IgM Rapid Screen Antibody Test Cassette. They can be reached at CarolinaChemistries.com or by calling 877-722-8910

Sekisui Diagnostics has an agreement with Mesa Biotech to distribute their Accula^TM SARS-COV-2 Test which is performed on the Silaris Dock - a molecular in vitro diagnostic test utilizing PCR and lateral flow technologies for the qualitative visual detection of the coronavirus SARS-CoV-2 viral RNA. For inquires in to product availability please email covid-19testing@sekisui-dx.com

Abbott, offers the new Abbott ID NOW COVID-10 test which runs on Abbott’s ID NOW^TM molecular platform. For inquiries in to this test and device please visit abbott.com

We hope that this brief article has helped bring some clarity to the questions which we have heard from you. If you have further questions please feel free to reach me directly at amedaris@physiciansofficeresource.com. I may not have all the answers for you, but hopefully I can point you in the right direction. Thank you again for your courage and service during this pandemic.

Aaron Medaris