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COVID-19: MHRA asks pharmacies to stop selling finger-prick tests

MHRA: Finger prick sample collection kits “have not yet been validated for home use”
MHRA: Finger prick sample collection kits “have not yet been validated for home use”

Lab-based COVID-19 antibody testing using a finger-prick blood sample should be temporarily halted, the Medicines and Healthcare products Regulatory Agency (MHRA) has said.

The request, made by the MHRA last week (May 29), has prompted Lloydspharmacy to remove the home sampling kits it launched in March from its Online Doctor service.

Superdrug has also “temporarily halted” its sale of COVID-19 antibody tests, just  two weeks after the service launched.

Providers of laboratory-based COVID-19 antibody testing services that use capillary blood collected by a finger prick should “temporarily stop providing this service until home collection of this sample type has been properly assessed and validated for use with these laboratory tests,” the MHRA said.

This does not affect rapid, point-of-care or laboratory test that collect samples from the patient’s vein. According to the latest MHRA guidance, “laboratory tests are CE marked and safe for use on blood drawn from the vein by a healthcare professional, but have not yet been validated by the manufacturer of the test to be used with a finger-prick blood sample”.

The sample collection kits “have not yet been validated for home use”,  the MHR said. It therefore “can’t be sure that people collecting samples at home currently have sufficient support to collect samples in a way that the laboratory can process to give reliable results”, the regulator added.

Kits withdrawn from sale

Following the MHRA guidance, Lloydspharmacy has withdrawn its home-sampling kits from sale, a spokesperson told C+D yesterday (June 1).

The MHRA has requested that Lloydspharmacy’s laboratory partner “further evidences to its satisfaction that blood sampling using a home sampling kit produces the same reliability as when venous blood collected by a healthcare professional is used,” the multiple said.

Llloydspharmacy has “withdrawn the kits from sale pending this outcome,” it added. However, “given the evident consumer demand for such a service, we hope to be able to relaunch it in the next couple of weeks,” the multiple said.  

Superdrug told C+D yesterday that it has “temporarily halted the COVID-19 antibody testing service while conversations with the MHRA are still ongoing”.

1 Comments
Question: 
What do you make of the MHRA's request?

Lucky Ex-Locum, Superintendent Pharmacist

So it looks like the Daily Mail was, for once, right about this! What a turnup for the books.

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