Covid-19 rapid test manufacturers due diligence | iSTOC News

Published on: 17/05/2020

How does iSTOC ensure the best quality and price?

iSTOC Mobile Diagnostics Solution is used together with lateral flow tests, that detect antibodies for infectious diseases quickly from a small drop of blood. There is great amount of different manufacturers of such rapid tests globally, and lately the public discussion related to rapid testing overall has been focused on the quality of these tests. In this post we describe the iSTOC process for selecting third party manufactures for our solution, and how we ended up choosing Chinese manufacturers for Covid-19 lateral flow tests.

iSTOC maintains the highest international quality standards (CE, US FDA; GDPR; HIPAA) and in order to do so, we have developed a unique three tier due diligence for all lateral flow tests that we consider for OEM (Original Equipment Manufacturing):

  1. Preparation: We review product development clinical tests documentation and production facilities to ensure correctness of CE, ISO, PEUA-FDA submissions which we see as minimum requirements.
  2. Independent Verification: We rely on independent laboratories and national regulatory authorities to confirm quality of all tests.
  3. Continuous PoC Due Diligence: Once tests are delivered and in use at Point of Care (PoC), we are in the unique position to continue quality control and can report to both users and manufacturers if there are any inconsistencies in the performance of the tests.

Using this policy puts us in the advantageous position to be able to select the absolute best price quality ratio for any given diagnosis. In our experience, it is not the difference in quality, but the difference in brand value that explains variations in prices. We know this from empirical field data collected over 8 years with millions of samples. iSTOC possesses the knowledge that allows us to offer our customers the best lateral flow tests at the most affordable prices.

With that, we know more about the actual performance of lateral flow tests outside of controlled trial and laboratory conditions than even the manufacturers of them do. We have concluded that our selection of Chinese manufacturers offer the best quality at the most affordable price, including for COVID-19. Furthermore, we are no alone with this conclusion, as also Abbott, the global leader in lateral flow tests, uses Chinese OEM manufacturing.

Cover picture by mattthewafflecat from Pixabay