AUMED a.s. is involved in the fight against the Covid-19 pandemic. In cooperation with Protean s.r.o. and Institute of Molecular and Translational Medicine, AUMED a.s. launched a modern diagnostics of SARS-CoV-2 virus under the name AUMED test RT-LAMP Assay SARS-CoV-2. It is a diagnostic using the RT – LAMP Assay method. The test uses the so-called LAMP reaction, which is isothermal amplification of nucleic acids. Unlike the polymerase chain reaction (PCR, qPCR), in which the reaction is performed using temperature cycles, isothermal amplification is performed at a constant temperature so there is no require for any expensive equipment. The results are reliably read based on the color change with the naked eye.
WHY LAMP REACTION?
Molecular amplification technique RT-LAMP (Reverse transcription – Loop mediated isothermal amplification) allows the amplification of nucleic acids with high specificity, efficiency and speed under isothermal conditions – i.e. at a constant temperature, achievable in incubators, hybridization ovens or dryers.
Main advantages of AUMED test RT – LAMP Assay SARS-CoV-2:
• No need for expensive laboratory equipment – can be performed in any laboratory, no PCR cycler required.
• Results are available within one hour – the possibility of reading with the naked eye.
• Hundreds of samples can be analyzed at once.
• Reduced costs compared to conventional PCR tests with the same sensitivity and reliability.
• The entire test can be performed in a small or mobile laboratory, possibly connected directly to the sampling site.
• Ideal solution for airport terminals, large companies, border crossings, homes for the elderly…
• The use of natural amplification enzymes guarantees high reliability of the test results, so that even if the incubation time is accidentally exceeded, false positive results do not occur. Competitive LAMP assays that use genetically engineered enzymes with higher processivity suffer from this problem. These tests are slightly faster, but there is a risk of false positive results.
AUMED, a.s. also launches its own self-sampling set based on the principle of gargling of the oral cavity and pharynx. The new sampling set was named PCR GARGLING KIT. The self-sampling device is intended for collecting samples, which are then tested in a professional laboratory for the presence of viruses infecting the oral cavity and upper respiratory tract. The kit was primarily developed for the detection of SARS-CoV-2 virus, which causes covid-19. The evaluation is performed in the laboratory by detection based on nucleic acid amplification such as RT-PCR and RT-LAMP methods. The kit is fully validated and meets CE IVD certification. The kit is registered by the State Institute for Drug Control (SÚKL) under registration number 00959967 (issued by SIDC-CZ).The sampling kit was developed and manufactured by a Czech pharmaceutical company AUMED, a.s.. Company production capacity is up to 100,000 kits per day.
The new collection is therefore much more pleasant and completely painless. Instead of pushing the sticks into the nose, it is enough to gargle a sip of ordinary water for 20-30 seconds and then empty this content from the mouth into the enclosed collection container containing the transport powder. The user then closes the tube and packs it according to the instructions. The user will perform this procedure either at the sampling point or at home, from where he will then deliver the sample to the sampling point, to the laboratory or, for example, to his doctor.
1. Irrigation of the oral cavity and the pharynx by gargling is a reliable method of self-sampling for virological testing, including the SARS-CoV-2 virus.
2. This new method of diagnostic self-collection is functionally comparable and does not differ statistically from the collection performed by healthcare professionals using nasopharyngeal swabs.
3. Self-sampling by gargling is safe, simple, and easy to do, even by an instructed layman.
4. There is no need for assistance from medical staff during self-sampling.
5. It is a completely painless way of sampling from the pharynx and oral cavity which does not irritate the mucosa, even when a repeated sampling is performed.
6. The collected sample is stabilized with a special buffer and storage or transport to laboratories at a reduced temperature is not necessary.
7. Viruses remain stable in the solution for a long period of time over a wide range of temperatures (from 4–37 °C) for at least 1 week.
The combination of the newPCR GARGLING KIT and the AUMED test RT-LAMP Assay SARS-CoV-2 test kit creates completely new possibilities for the detection of new coronavirus in the population. Painless and fast collection without queues is followed by fast and reliable diagnostics!