For laboratories

Currently, laboratory genetic diagnostics of SARS-CoV-2 utilizes the RT-PCR method, namely its stype 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 detecting 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.

The Genomtec products listed below have been market authorised (European Union – CE-IVD). For each product there is a downloadable document list (if it is authorized for sale).

The Genetic tests Genomtec SARS-CoV-2 Duo Kit (cat. no. GA00B) and Genomtec SARS-CoV-2 Direct-RT-LAMP Kit (cat. no. GA00C) detect multiple coronavirus variants (B.1.1.7, Breton [hCoV-19/France/BRE-IPP04233/2021], P1, B. 1.351, B.1.525, P.3, B.1.427, B.1.429 and B.1.617).

Genomtec also launched the Genomtec® SARS-CoV-2 EvaGreen® Direct product line. These products do not use standard lab purification of genetic material. This is replaced by a lysis combined with purification due to the application of a special buffer and an increased temperature. Consequently, the nucleic acid isolation stage is replaced by a fast and simple procedure, which saves time and reduces the total diagnostic cost.

Addtionally to Genomtec® RT-LAMP-Direct we offer Saliva Sample Collector Device.

With Genomtec® Direct RT-LAMP we bring multiple benefits for laboratories:

  • rapid biological material processing and 40 minutes isothermal amplification protocol,
  • no thermal-cycling requirement,
  • increased cost effectiveness (no swabs, no extensive RNA purification kit, no doctor’s swabbing),
  • obtained RNA-enriched supernatant directly used for amplification reaction setup,
  • double-well, triple target assay covering highly conserved regions within N & S genes as well as internal control targeting human gene,
  • superb diagnostic performance provided by eleven LAMP primers recognising fifteen conservative fragments of SARS-CoV-2 N & S genes enable specific virus detection.

Instruction how to use the world’s first genetic diagnostic test for the detection of SARS-CoV-2 directly from a saliva sample: Genomtec® SARS-Cov-2 EvaGreen® Direct-RT-LAMP CE-IVD Kit.

Laboratory diagnostics for SARS-CoV-2

PROTOCOL DIRECT KIT – increases throughput by streamlining laboratory processing

1

Sampling

Saliva sample, or throat or nasopharyngeal dry swab is obtained

2

Collected specimen (up to 24hs)

Collected specimen (saliva or dry swab) is transferred to the diagnostic laboratory within 24 hs

3

Lysate total RNA prep (5 minutes)

Add LysBuffer to saliva or dry swab and heat for 5 min. at 95oC to prepare RNA-enriched supernatant. Saliva / dry swab sample preparation stage with LysBuffer takes 5 minutes onto the heat block (pipetting excluded)

4

RT-LAMP amplification (40 minutes)

Purified RNA is simultaneously reverse transcribed to cDNA and amplified in LAMP technology

5

Test result

Positive clinical samples can be detected in as little as 20 minutes – when fluorescence exceeds threshold

The Agency for Health Technology Assessment and Tariff System has issued a 2.0 update of the recommendations “Laboratory diagnostics for SARS-CoV-2”.

The recommendations were prepared by the Scientific Council and the Expert Panel based on the expert consensus, resulting from the current epidemiological situation and reviews of scientific articles on SARS-CoV-2 diagnostic methods.
The document once again indicates that genetic tests offer an advantage when confirming infection at an early stage, before clinical symptoms occur, while antigen tests still show negative results.
The recommendations for molecular diagnostics confirm that “fast RT-PCR genetic tests or isothermal RT-LAMP tests” can be used. The quality of testing is monitored by the laboratory enlisted on the Ministry of Health “COVID laboratories” list.

The entire document can be downloaded here: Download PDF

Documents for Genomtec® SARS-CoV-2 EvaGreen® RT-LAMP CE-IVD Duo Kit

Document name Version Published
Product card PI00BUKrC 2021-07-26 Download
User manual IFU00BUKrC 2021-07-26 Download
Information brochure MM00BrA 2020-11-21 Download

Analysis certificates for Genomtec® SARS-CoV-2 EvaGreen® RT-LAMP CE-IVD Duo Kit

Document name Version Published
Analysis certificate 0000C 2020-12-16 Download
Analysis certificate 0000D 2021-02-05 Download
Analysis certificate 0000E 2021-03-04 Download
Analysis certificate 0000F 2021-05-17 Download
Analysis certificate 0000G 2021-06-09 Download
Analysis certificate 0000H 2021-09-02 Download

Documents for Genomtec® SARS-CoV-2 EvaGreen® Direct-RT-LAMP CE-IVD Kit

Document name Version Published
Product card PI00CUKrC 2021-07-15 Download
User manual IFU00CUKrC 2021-07-15 Download
Information brochure MM00CUKrA 2021-06-10 Download
Fast portable lab 2021-08-02 Download

Analysis certificates Genomtec® SARS-CoV-2 EvaGreen® Direct-RT-LAMP CE-IVD Kit

Document name Version Published
Analysis certificate 0000A 2020-06-01 Download
Analysis certificate 0000B 2021-07-22 Download

Documents for Salive Sample Collector Device

Document name Version Published
User manual 2020-06-29 Download
Certificate CE-IVD 2020-06-29 Download

GENOMTEC S.A. GENERAL TERMS AND CONDITIONS OF SALE AND SERVICES

Document name Version Published
General Terms and Conditions of Sale and Services 01.2020 2020-11-23 Download