Are we failing because of officialdom and another German go-it-alone?[UK1]

Germany is in danger of squandering billions of taxpayers’ money on a flawed SARS-CoV-2 testing strategy over the next few months.

Imagine there was a test that could be done easily and quickly at any known testing station, at the cost of antigen testing, with results in about 30 minutes, but the accuracy and sensitivity of a biomolecular PCR test. Imagine further that the test would be so sensitive that, if confirmed negative, there would be no risk of infection from the person tested in the next 48h.

Would be great, is also great! All this is also available. VICARE RAPID from the Essen-based VICARE SOLUTION GmbH is a biomolecular test based on RT-LAMP technology for the detection of SARS-CoV-2 RNA.

Although the RT-LAMP method used by VICARE Solution is approved as a biomolecular detection method with a CE marking in addition to the well-known PCR test. Moreover, it is already being used successfully in some European countries such as Austria and Spain.  Can we here in Germany currently not expect a listing as an antigen test – as it is a biomolecular test, but also not get a reimbursement eligibility for test lane providers, as biomolecular tests are allowed under Corona Test and Quarantine Ordinance of one of the only about 50 certified & accredited laboratories.

The facts:

The RT-LAMP method, like the PCR method, is a biomolecular detection of infection by RNA analysis.

Leading European research institutes, such as the Research Institute of Molecular Pathology (IMP) | Institute of Molecular Biotechnology (IMBA), in close cooperation with other researchers worldwide, have succeeded in optimising the procedure for the detection of the SARS-CoV-2 virus several times and making it more robust against contamination.

In terms of sensitivity and specificity of RNA detection, only marginal differences from the gold standard PCR can be observed. This is proven by the extensive studies of the institutes. Here is the link to the protocols

RT-LAMP is cheaper, simpler, faster, scalable, mobile… than the PCR test. We don’t need central labs and can test for PCR – gold standard on site in 35 minutes.

Example:

A mini-lab for a primary school would be operational within 2-3 days for less than €2,500. Pupils would be tested class by class and after 35 minutes the result would be immediately readable on site for each individual pupil. With the PCR procedures, the samples are collected, couriered to one of about 50 laboratories registered nationwide, analysed there within 12-24 hours and the result is then sent to the school.

The costs for this procedure are at least 50 – 70 € – probably more. The costs of the RT-LAMP procedure are far lower, at 6-8 € per pupil. With 35,000 tests per day, there is a tax loss of about 1.5 to 1.75 million €.

What happened

VICARE SOLUTION has been running into walls in ministries and authorities for weeks. First rejected as an antigen test method (because biomolecular) and now [Ga2] [UK3] negotiated again and again with an open outcome. [Ga4] Suitable as an in vitro method, but prevented by the CORONA protection regulation. This is because it only permits PCR testing in accredited laboratories.  VICARE RAPID would fit into both categories. On the one hand, they are more reliable than the commercially available rapid antigen tests. But at around 30 minutes, it would be much quicker and, at 5-8 €, much cheaper.

What else can we do?

We are currently in talks with all authorities. We are trying to move the politicians and are getting nowhere! Getting nowhere – without an outcry of indignation from the business community and society! Yes, the RT-LAMP method is still largely unknown in Germany, although it has been used successfully in a worldwide context for over 2 decades.

You are welcome to take a look at the following internet presentation, which we have produced with heart and soul over the last few weeks. All references to approvals in Germany are OBSOLET!!! The method we prefer can indeed be used because of the CE mark. However, as it is not an antigen test, it cannot be invoiced to the public authorities. VICARE RAPID could also be used anywhere in Germany as a simple, mobile laboratory for the reliable detection of viral RNA – but without the “free test certificate” of a PCR test. So it is worthless!

Of course, the fact that we have invested thousands of hours of time and a huge amount of private capital in this project is painful. That we are now allowed to pull the plug in view of the bureaucratic hurdles and the lack of attention in politics here in Germany. But we have hope, because we are getting sustained support in other countries in Europe, Asia and Latin America. Even the WHO asked us to submit the test procedure for listing and certification by the world community.[Ga6] Only here in Germany we are running up against closed doors with Spahn, Laschet and Co.  Here, at the taxpayers’ expense, the application of a procedure is being dispensed with for no objective reason. A procedure that would have the potential to be a real game changer in the current pandemic.

Or, as we say in the Pott: “Would have, would have – bicycle chain”.

Good luck and thank you for your attention

Your VICARE SOLUTION from Essen. [UK7]

Who are you? [UK1]

don’t understand the sentence. what is the message supposed to be? [Ga2]
goes in the direction of demand and next loop [UK3]
exactly IMP and IMBA, not Uni Vienna, because both are private institutes. If we refer to them, we have to get clearance from you beforehand, in my view. Gladly take the ball, but for that we need the final document [Ga4].

You “only” need a CE certification for the distribution of IVDs. We have this.  [Ga5]

What is required for billing service providers is the BfArM number (for antigen tests) or, in the case of biomolecular tests, the laboratory accreditation “DAkkS Akkreditierung Labor im Qualitätsmanagement ISO / IEC 17025”.
Regulation and Prequalification (who.int) [Ga6]
who is active here right now? [UK7]