It is a special urine test that is used in pre-diagnosis and clinical follow-up of diseases progressing with excretion of substances, which should not be present normally in urine, mainly COVID-19, is performed by foaming of urine and therefore defined as "foaming test".
Laboratory chemical analyses are of great importance in the detection and treatment of Covid19 disease.
The majority of tests are based on the real time polymerase chain reaction (rtPCR). Although this test method has a very high accuracy in the laboratory, of greater than 99%, the problem lies in sample collection.
It has been shown that the swabs are often taken incorrectly. It must be taken into account that the local viral load shifts from the epipharynx to the trachea with increasing duration. This fact is not taken into account in routine swabs, because swabs are always taken from the nose in the epipharynx.
Another problem is the not clearly defined endpoint of the rtPCR. This endpoint can be 30 cycles or 45 cycles, i.e. the detected viral load is 32,768 more accurate with 45 multiplication cycles than with 30 cycles. Overall, the probability of detecting a SARS-CoV-2 positive patient is thus less than 50%. Thus, rtPCR testing is of limited use for broad mass screening of the population and it makes sense to look for alternatives.
This limits the suitability of rtPCR testing for broad mass screening of the population and it makes sense to look for alternatives.
The rapid antigen test systems have the problem of taking a smear and will therefore also have an error rate of over 50%.
The so-called "gargle test systems" have not yet reached practical maturity and are classified as unsafe by the Robert Koch Institute due to possible dilution effects (www.rki.de).
Therefore, the innovative urine foaming test is a promising approach that runs semi-automatically and leads to very fast results.
This test is thus suitable for use by the layperson, providing a test system for mass screening.
The patient puts about 10 ml of his urine into a prepared cup.
A test phenol is then inserted into an opening on the lid of the sealed cup.
The vacuum inside the phenol causes urine to be drawn out of the cup.
Now the phenol is separated from the cup and shaken longitudinally for 15 seconds.
This produces a foam. The height of the foam correlates with the current viral load of the patient.
This semi-automatic test system excludes individual errors.
The test is very easy to perform, delivers a result within 15 seconds and runs semi-automatically.
This makes the test procedure very error-prone and suitable for use in mass screening.
This test can also be carried out safely by laypersons.
Expected and existing mutations of the SARS-COV2 virus are reliably detected by the urine foam test due to its test parameters (serine and arginine).
Our product does not replace medical diagnostics!
In case of foaming from the green area, a medical consultation is necessary.
We are in possession of a study from a large clinic abroad, and we have also had an analysis carried out by Prof. Dr. Dr. Kai-Olaf Henkel, University of Rostock, in order to have a Validation.
Both results come to the same conclusion independently of each other.
EU approval has been granted.
- Approval has already been granted in 2 EU member states.
- Approval in Germany has been applied for.
- FDA approval for USA has been applied for.