CMC - Guidance on diagnosis of coronavirus testing kits
6 April 2020
The following information is taken from the Gov.uk website and is aimed to satisfy the number of questions around antibody testing.
Some manufacturers are selling products for the diagnosis of coronavirus (COVID-19) infection in community settings, such as pharmacies.
The current view of Public Health England is that use of these products is not advised.
We can confirm that there are no CE-marked tests for home use, and it is illegal to supply such products.
- some of these products look for virus while others look for the body’s immune response to the virus. Such tests are very rapid and can work on a range of specimens including serum, plasma or finger-prick whole blood
- there is little information on the accuracy of the tests, or on how a patient’s antibody response develops or changes during COVID-19 infection. It is not known whether either a positive or negative result is reliable
- currently there is no published evidence about the suitability of these tests for diagnosing COVID-19 infection in a community setting
This was the advice issued on April 2nd 2020. This situation is forever changing and the MHRA are working to approve tests used in a professional environment. We will update you with information as soon as it becomes available.
We wish you all well at this difficult time
Centennial Medical Care
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Elstree
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