Where are the tests made?
Acon is a large global diagnostics company. They are based in the US with manufacturing facilities in the US, China and Mexico. The factory in China has been inspected and approved by the FDA. It is very important to us that we know exactly where our tests are made and by whom to ensure consistency of quality and supply.
Are they approved for use in the UK & Ireland?
All medical devises have to follow a standard process before they can be sold in the EU. These tests have been through that process and have a CE mark. They can be sold and used in the UK & Ireland within their intended use.
Are they approved by the MHRA?
The MHRA is the competent authority or regulatory body in the UK. They do not approve tests other than to allow the manufacturers to put a CE mark on the product. The MHRA did, however, produce a target product profile that contains criteria that tests should meet. The Flowflex rapid antigen tests meet all of the target profile.
Are they approved by Public Health England?
Public Health England have been assessing tests in the UK at their labs in Porton Down. Although Flowflex has been submitted for review, it has not yet been called up for evaluation. As and when this happens we will advise our customers.
When should the tests be used?
The Flowflex tests pick up moderate to high viral loads. Patients will have moderate to high viral loads about 3 days before symptoms start until between 7 and 10 days after symptoms start. In this window lateral flow tests, such as Flowflex are very effective. A positive test should be repeated using a RT-PCR test for confirmation and entry into the national test and trace system. A negative test simply reflects a point in time – you do not have active COVID-19 today.
Each test is individually packed for easy distribution to staff without contamination.
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