Published May 27, 2020

To our great British public,

we hastened to bring an antibody test to the market in-order to do “our bit” in helping the Governments campaign to “test test test”. This was at great expense to ourselves in additional staffing and creation of “test kits” in a quick turnaround, all of this work was conducted with great diligence and within all Public Health England guidelines and in conjunction with our advisory board and UK laboratory Partners all of which met the very high standards under ISO, UKAS 15189 and the CQC, set for patient safety and reliability.

At 5.00pm GMT on the 26th May we along with all other UK businesses in this market place received a communication as follows – “All laboratories, who carry out SARS-CoV-2 antibody testing on home self-collecting devices have been contacted by the MHRA. There is a national review being carried out by the MHRA on self- collecting devices for blood samples (‘finger prick samples’) for SARS-CoV-2 antibody testing. This review does not affect the testing for SARS-CoV-2 antibody performed on venous drawn samples (SST / Serum or EDTA plasma samples) or for SARS-CoV-2 RT-PCR RNA swab testing. During this review by the MHRA, we will pause testing of blood for SARS-CoV-2 antibody testing obtained by home self-collecting devices.

We will continually be reviewing the status of home collection devices with the MHRA and will advise you when we are able to resume testing for SARS-CoV-2 antibody on blood samples collected by home self-collecting devices. Please accept our apologies for the interruption of your service by circumstances outside of our control.“

This is a U-Turn from the Government and whilst we and our Laboratory Partners are completely satisfied with the efficacy and reliability of the “test” we must and will follow guidelines as you the public are our primary concern whilst the MHRA conduct an additional review. We ask you to be patient with us during this unprecedented time as we are being advised the review process will be quick and should enable us to continue our great service, if however you wish to cancel your test we will of course honour this and please request by emailing covidteam@checkmybodyhealth.com

Our lab has confirmed that all kits that have been despatched to customer and samples that they receive will be processed but there may be a delay getting your results so we are in communication to fully understand what impact this will have to you, the customer.

We’ve tried to answer some of your anticipated questions below:

Does the MHRA block affect my order that I’ve already paid for?
All new orders have been paused pending MHRA UK wide laboratory review, this should be a quick process and we are confident in the outcome of returning to normal business operations shortly.

Does this mean my order is cancelled?
No your order is not cancelled only on hold until MHRA uk wide laboratory review is completed

Will I get a refund?
If you do not wish to wait a short period until we resume operations then of course a full refund is available.

Will I still get my results?
Results will not currently be issued as all laboratories UK wide are undergoing a review. We are confident of this situation being resolved quickly at which point your results will be available and you will be notified by email.

I’ve already sent my blood back to your lab, will I still get my results?
Results will not currently be issued as all laboratories UK wide are undergoing a review. We are confident of this situation being resolved quickly at which point your results will be available and you will be notified by email.

How long will the MHRA processing block last for?
All laboratories have been assured this review will be expedited and we will keep you, our customers updated immediately once we receive further information.

I’ve paid for my kit but it hasn’t arrived yet. What should I do?
All orders that were placed and paid for prior to us receiving the MHRA block (5pm Tuesday 26th May) have been received and shipped. We are at this time pausing all sales and shipping as advised by the MHRA until the UK wide laboratory review is completed. We foresee this to be completed in a timely manner so we ask you to please be patient with us or in urgent circumstances please request a refund by emailing covidteam@checkmybodyhealth.com. Although we have been assured that all kits that had been despatched will still be processed, we recommend you hold onto your kit to allow us to gain more information to the expected timeline MHRA will be conducting their review.

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