At the beginning of the Covid-19 outbreak, that subsequently led to the WHO to declare it to be a pandemic, medical regulatory bodies around the world provided manufacturers of diagnostic devices with guidance on developing specific tests for the Covid-19 virus. In the UK the MHRA is the single body that governs the distribution and sale of class I-III medical devices.
The basis of the Covid-19 test antibody test would be lateral flow assay (LFA) technology, a tried and tested mechanism for quantitative and qualitative antibody/antigen interaction measurement. Because of the urgency of the situation, throughout the EU, self-certification for the CE mark was allowed as long as manufacturers were already registered with their national regulatory authority.
During the first weeks of the pandemic, a large number of tests from various countries have emerged onto the market. Many are high quality and accurate but there are also some that are of lesser quality and lesser accuracy. Prof Chris Whitty, the chief medical officer for England and Wales, publicly stated two days ago that the NHS would not use inaccurate tests because “a bad test is worse than no test”. Unfortunately, the absolute logic of this position has been confirmed today with the news that Spain bought 650K test kits from a Chinese manufacturer, that have relatively low sensitivity and specificity rates (< 80%) and when the results were checked against other validated tests, many false negative results were identified. Today the Spanish infection rate was reported as having stabilised, but the death rate has sharply increased. It is not clear if these statistics are linked to use of the Chinese test. This sad episode underscores the correct approach taken by the UK authorities.
On Wednesday 25 March 2020, MHRA posted on its website instructions for all manufacturers and distributors of LFA antibody tests for Covid-19 to register their information for evaluation by the regulator and also to assist the UK government’s plans for purchase and deployment of testing to the NHS frontline and further afield. BBL Healthcare Solutions Ltd, as the UK commercialisation partner of Pharmact AG, has submitted all of the relevant information to MHRA.
It is BBL’s understanding that the regulator has been flooded with applications for approval of LFA Covid-19 antibody tests and it is working through those approvals as fast as it can to issue licences for distribution and sale. Manufacturers and distributors attempting to import LFA Covid-19 test kits into the UK without MHRA approval will find their products impounded at the port of entry until approval is granted. If approval is not granted the product will, in all likelihood, be destroyed.
As of today, it is not known when MHRA approval will be granted, however BBL are optimistic that approval for the Pharmact AG test will be forthcoming within the next week given its proven sensitivity and specificity and the urgency of the situation faced by the population of the United Kingdom.
Pending BBL receiving confirmation that they can legally distribute and sell LFA Covid-19 test kits manufactured by Pharmact AG, it will not be able to fulfil large orders in the United Kingdom. Once that confirmation has been achieved it is confident of being able to provide all of its customers with the numbers of test kits required.
Until that time, there is a small chance that a limited number of kits for evaluation will be allowed through customs and can be distributed, but not for retail purposes. The evaluations would need to be carried out by medical professionals and the results of tests logged so that they can later be transmitted to the relevant epidemiological authorities.
BBL and Pharmact AG are working as hard as possible to deliver to customers tests that have already been ordered. They fully understand the frustration that might have arisen due to the delays created by the necessary regulatory oversight. As a result, if customers have prepaid for tests, either directly with BBL or with one of their distribution partners in the UK and Ireland, and they wish to cancel the order and have their payment refunded, reimbursement will be issued immediately upon application.
Nick Birch, Executive Chair, BBL Healthcare Solutions Ltd
19.00 27 March 2020