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Novel RT-LAMP - Genetic Tests for Use In Diagnostic Laboratories
As part of this project, Genomtec developed and launched on the market novel laboratory diagnostic kits intended for conducting qualitative tests to detect SARS-CoV-2 RNA in various biological samples from patients with suspected COVID-19 infection. In the future, it will also be possible to detect other pathogens. The test kits include an optimized composition of reagents, specific enzymes and proprietary LAMP reaction primers, while the RNA amplification reaction is conducted using an isothermal method, i.e. RT-LAMP or LAMP. This ensures signal detection for positive clinical samples after only 11 minutes for SARS-CoV-2 in the amplification process (with Duo kit) and its compatibility with standard Real-Time PCR thermal cyclers with green (FAM) fluorescence detection channel.
Currently Genomtec has two types of registered and commercially available two-gene diagnostic kits: Genomtec® SARS-CoV-2 EvaGreen® RT-LAMP CE-IVD Duo-Kit, which has been approved for sale in Europe and can be distributed to other continents, and Genomtec® SARS-Cov- 2 EvaGreen® Direct-RT-LAMP CE-IVD Kit, which enables identification of SARS-CoV-2 infection directly from the patient’s saliva.
The innovative test will provide patients with greater comfort due to lack of swabbing, e.g. from the nasopharynx. The possibility of testing using saliva will also reduce the risk of virus’ contraction by the personnel collecting the sample, additionally sampling does not require specialized skills. Utilization of the Direct-RT-LAMP Kit makes it possible to receive test’s results in just several minutes from the time the sample was received by the laboratory. The ultrafast test for COVID-19, which detects all currently identified SARS-CoV-2 variants.
The value of the market of molecular diagnostics, which is still largely connected to stationary lab testing, is estimated to exceed USD 3.82 billion, with a CAGR of +6.16%. The estimated number of tests for SARS-CoV-2 in 2020 is expected to reach USD 329 billion.
Currently, laboratory genetic diagnostics of SARS-CoV-2 utilizes the RT-PCR method, namely its type Real-Time Reverse Transcription PCR. In this method, virus genetic material (RNA) is transcribed to complementary DNA (so-called cDNA) by an enzyme, reverse transcriptase combined with a cDNA multiplication stage using another enzyme – polymerase. The detection mechanism is usually based on molecular probes or fluorescent dyes. We can assume that the average lab time required for Real-Time RT-PCR reaction for detection of such pathogen as SARS-CoV-2 is 90 minutes, and often can be longer, depending on the applied enzymes and the performance of Real-Time PCR device. The Real-Time RT-LAMP makes it possible to analyze the same sample in around 30 minutes using the same laboratory equipment.
Benefits for testing laboratories with the Genomtec® RT-LAMP Duo Kit:
- fast and economically effective isothermal RNA amplification technology with high specificity
- detection of all variants of the SARS-CoV-2 virus,
- 40% savings in amplification reaction time,
- 11 primers in the kit ensuring its high specificity and speed,
- ease of interpretation – reading the reaction result in one FAM channel.
Sampling
A sample is taken from the saliva, oropharyngeal or nasopharyngeal swabs
Transportation
The properly secured sample is transferred to a diagnostic lab (up to 24 hours)
RNA isolation
RNA is isolated and purified from the biological material, manually or automatically.
Direct-RT-LAMP tests require preparation of the lysate and RNA-enriched supernatant.
RT-LAMP amplification
RNA is transcribed to cDNA with simultaneous amplification by RT-LAMP reaction
Test results
A positive result may be obtained from a clinical sample even just after 11 minutes – when the signal exceeds the fluorescence threshold