New Corona rapid test CE certified throughout Europe
In 30 minutes, a coronavirus test, developed at the Donaustadt Hospital in Vienna provides evidence of the virus' genetic makeup. The method has now been brought to market maturity and certified throughout Europe. Klimscha: "This means that nothing stands in the way of commercial application in laboratories, and the legal basis for its use has also been created."
How the test works
As with the PCR test, the previous standard method for detecting the coronavirus, the LAMP test ("loop-mediated isothermal amplification") involves detecting small amounts of the virus' genetic material. Unlike the PCR test, however, no high-tech laboratory equipment is required. In the case of the newly certified test, the sample taken by throat swab is dissolved in saline. Then the LAMP reaction is started without further sample preparation. The genetic material is amplified at a constant temperature of around 63 degrees Celsius. In the PCR test, on the other hand, a complex and precise change of temperature must be maintained, which can only be accomplished with special equipment and takes about three to four hours. The advantage of LAMP tests is therefore their relative simplicity and the significantly shorter time to result.
The method itself has been known for about 20 years, but bioinformatician Armin Robubi and Walter Klimscha, head of the Department of Anesthesiology and Intensive Care Medicine at Donaustadt Hospital, have now further developed it for SARS-CoV-2 detection in collaboration with the Viennese company Ingenetix. "We then refined the test until it worked really well," Klimscha said. That subsequently led to the first in-house certification. From the end of September, the "Cluster Buster Bus" used at Viennese schools with a mobile laboratory on board was also on the road with the new procedure, which brought "a lot of empirical values." Europe-wide certification has been in place since the beginning of December. This is the first RT-LAMP test from Austria with Europe-wide CE certification as an "in vitro diagnostic device" (IVD), according to the Vienna Health Association.
A strong achievement of our medical director in Vienna
Prof. Dr. Walter Klimscha has been the medical director of Air Alliance's air ambulance crews in Austria for many years. In this capacity we would like to express our full appreciation and congratulations to him. The mobile testing capability with high accuracy is a further step towards the containment of Covid-19. Due to the speed and the possibility of direct detection even at quite low viral concentrations of only about 100 pathogens per sample, the test can be useful where people with relatively low viral loads need to be detected quickly. This applies, for example, to nursing homes, hospitals or ambulance flights.
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