We hope you are all staying safe and healthy.
We wanted to let you know that our manufacturer, Pellecome, has secured the Clungene COVID-19 IgM/IgG Rapid Test Cassette and it is currently on its way to the warehouse in NJ. They have received the clearance from the FDA to distribute to HCPs for use at the point-of-care.
With the shortage of testing kits currently available and the current long turn around time, Pellecome has found a test that only takes 15 minutes to get the results.
These kits are currently being used in Italy, Spain and France and now the US. They have a CE mark, which certifies them in Europe. As I said above, Pellecome has notified the FDA that they will be distributing the COVID-19 test under the FDA Emergency guidance and the FDA has now listed them on their website.
The tests are very simple to use. A patient would use a lancet and prick their finger and then put the droplets of blood on to the test strip. A reagent would be then dropped onto the blood and in 15 minutes you would see the results. The test strip looks similar to a home pregnancy test.
The kits have 25 tests in each box along with one bottle of reagent. I am working on getting the best price for the kits, they are currently looking like they will be $25 per test or $625 per box.
These tests can be used when you either have a patient that has symptoms or just simply for every patient coming to your clinic. We know that your patients are going to want to continue to receive all your services, this test can be done before you treat or provide the service for the patient. This will allow you to test your patients before you pellet them, giving you a level of comfort during this time of uncertainty, that you have pelleted a healthy patient.
Please contact us if you would be interested in purchasing these test kits for your clinic or practice. Reach out to us as soon as possible as supplies are limited.