When buying pharmaceutical healthcare products like COVID Rapid Virus Tests, doing your research carefully is essential, to ensure that you are buying life-saving best quality products.
Therefore we have put together this FAQ section to answer the most common questions you are likely to have (all information is provided by Acon).
Should you have any further questions, please contact us and we will strive to answer these directly.
Where are the tests made?
Acon Labs are a large global healthcare 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?
All medical devices 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 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 Hughes 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 Hughes Healthcare Flowflex LFD has been submitted for review, the evaluation has not yet been published but we do know of remarkably high results.
When should the tests be used?
The Hughes Flowflex test kits 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.
How often should tests be repeated?
This is difficult to advise as advice differs. Bear in mind that a negative result reflects a moment in time. Some bodies have advised testing twice a week, or perhaps every Monday in a standard five day week. Other guidance has suggested testing every day.
What is the regulatory status of the Flowflex tests?
The pack clearly states, ‘For professional in vitro diagnostic use only’. We take that to mean that all testing should be under the supervision of a healthcare professional. How that supervision should be carried out is a grey area. We know, for example, in schools non-health professional staff receive on line training and are then allowed to carry out the tests. We also know of groups that test multiple people within a single zoom meeting.
One thing is certain; lateral flow antigen tests are not to be sold direct to the public for self-testing. That would require another level of approval. At this stage, there isn’t a lateral flow antigen test on the market that has been approved for self-testing.