I’d like to thank all of our customers for their patience while we wait to dispatch your Coronavirus Antibody sampling kit. I'm as frustrated as anyone that we have had to pause supply with no advance notice, so I'd like to update you on where we are with everything, following my previous update.
The MHRA Review
The validation of antibody tests and sample collection kits using finger-prick blood samples is still being reviewed. All test kit manufacturers are required to make claims about the expected performance of their test kit before service can resume.
Applicable data has been submitted and given the urgency of this test regulatory exemptions may be granted to expedite approval.
I should stress that we have no concerns about the quality of these Coronavirus tests. We are using a very good, fully validated and CE marked lab test. The laboratory is highly experienced with finger-prick blood analysis. Internal verification for finger-prick testing is highly concordant with the manufacturer's validation. The work done to-date is reliable and repeatable.
Crucially, the MHRA are fully aware that customers who already received test kits are having their samples analysed – which has continued all of this week – so they already have a good understanding of the test's performance.
We have every expectation that when the pause is lifted and service resumes, that we will be providing the exact same product to people, with the same level of accuracy and quality.
We also believe that pausing the provision of tests to the public may also be due to concerns over subsequent behaviour when given a positive or negative result. I would note that this was first anticipated in April.
Vitall already make it very clear in our report what the the presence of antibodies to Coronavirus means for you.
However, we anticipate when service resumes that promotion or reports may also include approved guidance regarding this.
We don't think the review will take long, as there is so much public demand and necessity for this critical test to be delivered. However, at this point we cannot specify an exact date on which we can dispatch your kit to you. As we learn more, we'll update you immediately.
So, if you're willing to wait with us, please do. We'll expedite your order immediately when we can, and you will be prioritised over new customer orders since demand is very high.
If you'd like a full refund at any point, then please confirm by return email and we will process accordingly. Refund requests will be processed within 24 hours and payments will be made directly from our payment processor, so may take 5 – 10 days to be visible in your account.
Coronavirus has made many things more difficult, and we recognise how important getting tested is as we all try to return to normality. We will update you on this at soon as we are able.
CEO & Founder
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