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.

DIAGNOSTIC KIT

The kit is fully validated and registered by the State Institute for Drug Control (SÚKL) under registration number 00912050 (issued by SIDC-CZ). Instructions and a valid declaration of conformity can be downloaded from the appendix of this registration.  It is a completely Czech product without dependence on foreign suppliers.

The kit is intended for diagnosis of the presence of SARS-CoV-2 virus in isolated viral RNA samples – for 45 samples. The diagnostic kit involves the detection of SARS-CoV2 virus and the detection of an internal control (IC) to check the correct collection and processing of the sample.

The functional evaluation was successfully performed by the Institute of Molecular and Translational Medicine in Olomouc. Comparison of the kit with the reference RT-PCR assay determined the sensitivity of the assay to be 93% and specificity to 99%. The kit passed all tested parameters and was recommended for use.

Test sensitivity:

• Equivalent sensitivity with qPCR up to Ct 36-38

• Corresponds to 10 copies of virus per ul sample

Kit contents:

• A bag containing a 96-hole PCR plate and a plate of colored caps in a light-tight package. Should be stored at room temperature, caps in the original light-tight package or in the dark.

• Reagent box for 45 tests

IC = internal control; PC = positive control

Material required – not supplied with the kit:

• Automatic and multichannel pipettes

• Appropriate reservoir for the reaction mixture

• Pipette tips with RNAse and DNAse free aerosol filters

• Plate incubation device at 63 °C

DO YOU WANT TO TRY OUR TEST? WE OFFER A COMPREHENSIVE SOLUTION FOR PREVENTIVE TESTING 

The diagnostic kit can be ordered by email at info@aumed.cz. We will reply to your email immediately and you will find out everything important about prices and delivery dates.

AUMED a.s. offers for companies a comprehensive solution for preventive testing of the SARS-CoV-2 virus (COVID-19). We provide sampling and subsequent testing of samples. We perform sampling with the PCR GARGLING KIT self-sampling set, the principle of which is based on gargling of the oral cavity and pharynx. The 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 for half a minute and then empty this contents from the mouth into the enclosed collection tube containing the transport powder. The evaluation is then performed by our newly developed test kit using the RT-LAMP method. The RT-LAMP test is functionally comparable to the RT-PCR test. For long-term and effective protection of the company, therefore, a significantly longer interval of repeated testing will suffice than in the case of antigen tests, where retestation occurs every 5 days! This makes our testing more cost-effective than inaccurate antigen testing. We send the results within 6-8 hours after receiving the samples. If you are interested, please contact us at info@aumed.cz.

For summary information and instructions for use, visit the website www.aumedtest.cz dedicated to this diagnostic kit