Coronavirus Antibody Testing: Response To MHRA Announcement

Ben Starling MSc. |Chief Executive

Last updated: 27 May 2020

You may have heard in yesterday’s press that the government’s Medicines and Healthcare Products Regulatory Agency (MHRA) have temporarily paused the provision of finger-prick-sample Coronavirus Antibody testing to customers, for all providers, including Vitall. 

I want to clarify for all of our customers what this means for you, as follows:

1.    If you have already received test results, you can be assured that your results are valid. We’ll explain why in detail below.

2.    If you have received a kit, or one is in the post, you should return your sample for analysis. The laboratory is continuing to process previously dispatched tests, and has not been asked to stop doing so.

3.    If you’ve placed an order and it has not been marked as dispatched, then we have been asked to pause dispatch until the MHRA review is complete. There may be a small overlap between those marked as dispatched and the MHRA announcement, and we’ll contact you individually if that is the case.

4.    We have been told that the MHRA review is not about the quality of the test, but how antibody tests by all providers have been positioned, and perhaps promoted. As mentioned above, previous tests are being processed and the MHRA is aware of this.

5.    We want to reassure you that Vitall provide the Abbott IgG Antibody test for the analysis of your samples, analysed on Abbott’s ARCHITECT instrumentation. This a CE marked, validated, automated & interfaced laboratory test. The test was evaluated favourably by Public Health England for venous (needle-drawn) samples. Consequently, it is entering routine use in the NHS.

6.    Finger-prick-sample test accuracy was verified in a UKAS accredited, CPA approved and ISO certified laboratory, who have perhaps the most extensive experience with finger-prick blood analysis in the UK. These self-collected samples perform in the same way as those in a larger tube. This data has been submitted to UKAS for accreditation.

7.    Finger-prick-sample testing has been made available to the general public even before antibody testing has been widely rolled out for NHS staff. This is controversial and there may be politics at play here also.

At Vitall we don’t like making promises that we can’t keep, and I’m sorry that we’re not able to deliver our usual level of efficiency here.

As such, we will take the following actions:

1.    Immediate reimbursement of any Special Delivery charges for orders on-hold. These will be processed today.
2.    When orders resume, we will dispatch *all* on-hold orders via Special Delivery at no additional charge

Everything is moving quickly with respect to coronavirus testing and we hope to resume shipping very soon. We will update you as the situation develops.

Thank you for choosing Vitall,

Kind regards,

Ben Starling
CEO & Co-founder

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