Aumed, a.s., Komořanská 326/63, 143 14 Praha - Modřany, Česká republika

info@aumed.cz+420 603 587 701 English

Diagnostics Covid-19

DIAGNOSTICS OF COVID-19 USING A NEWLY DEVELOPED TEST – AUMED test RT-LAMP Assay SARS-CoV-2

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.

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

dlouhy

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

kit content 2

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

NEW SAMPLING SYSTEM

AUMED, a.s. collaborated on the development of a new self-sampling set based on the principle of gargling of the oral cavity and pharynx. The new sampling set was named GARGTEST and was developed in cooperation with Institute of Molecular and Translational Medicine in Olomouc.

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.

The combination of the new GARGTEST sampling set 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! Mass production of the sampling set has started and it is already being sold through a distributor I.T.A. – Intertact, s.r.o.

 

A new sampling set, including PCR evaluation, can be ordered directly to your door. The courier will then take the sample from you. Chromozoom started offering the service and you can find more information at this link: https://chromozoom.cz/products/gargtest

A similar service is now also offered by Pilulka.cz, more information at https://www.pilulka.cz/pilulka-gargtest-na-covid-vcetne-laboratore

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 GARGTEST 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

The production of the AUMED test RT-LAMP Assay SARS-CoV-2 diagnostic kit was made possible also thanks to the support of the Operational Program for Entrepreneurship and Innovation for Competitiveness. Specifically, AUMED a.s. received support for the project PRODUCTION OF DIAGNOSTIC KIT FOR COVID-19 ON THE LAMP PRINCIPLE within the TECHNOLOGY SUPPORT PROGRAM – CALL XII. COVID 19 (OP: Entrepreneurship and Innovation for Competitiveness 2014-2020, call number: XII, program call: Technology). Part of the project was the purchase of technological equipment needed for the production of this diagnostic kit.

Research projects of Aumed, a.s. are financed by the European Structural Funds:
Research and development of a new pertussis vaccine
Transfer factor — research and development of a new medical form
Production of diagnostic kit for covid-19 on the lamp principle

and with financial support from the state budget through the Ministry of Industry and Trade in the TRIO program:
Research and development of a new oral administration of vaccine

European Union
European Regional Development Fund
OP Enterprise and Innovation for Competitiveness


Tel.: +420 603 587 701, Email: info@aumed.cz
Komořanská 326/63, 143 14 Praha - Modřany, Česká republika
(c) 2017, Aumed a.s