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Genomtec - SARS-Cov-2 EvaGreen Direct-RT-LAMP CE-IVD Kit

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Genomtec® SARS-CoV-2 EvaGreen® Direct-RT-LAMP CE-IVD Kit is Real-Time Reverse Transcription Loop-Mediated Isothermal Amplification (RT-LAMP) test for qualitative detection of nucleic acid from two genes of SARS-CoV-2 virus with a streamlined biological sample processing that is CE-IVD labelled for diagnostic use in the EU.* It features rapid RNA isolates preparation in conjugation with the simultaneous RNA transcription and cDNA amplification utilizing standard Real-Time PCR instrument workflow (detection in FAM channel), with sample to result time in approx. 50 minutes of which amplification stage takes only 40 minutes.

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CLINICAL EVALUATION

93,75% sensitivity and 100% specificity confirmed when compared to Real-Time RT-PCR CE-IVD test.
Validated specimen types include saliva, nasopharyngeal and oropharyngeal dry-swabs. Clinical validation was performed on saliva samples (as per IFU Section 9.5; dry swab processing is described in Section 6.2 of IFU).

VARIANTS RECOGNIZED

Genomtec ® Direct-RT-LAMP Kit can detect the wild type virus as well as mutant strains of SARS-CoV-2 including but not limited to:

Accession number: EPI_ISL_723044 / variant B.1.1.7 / Alfa (WHO classification)
Accession number: EPI_ISL_825139 / variant B. 1.351 / Beta (WHO classification)
Accession number: EPI_ISL_792680 / variant P.1 / Gamma (WHO classification )
Accession number: EPI_ISL_2650470 / variant B.1.617.2 / Delta (WHO classification)
Accession number: EPI_ISL_2631197 / variant B.1.427 / B.1.429 / Epsilon (WHO classification)
Accession number: EPI_ISL_2614193 / wariant P.2 / Zeta (WHO classification)
Accession number: EPI_ISL_1563854 / variant B.1.525 / Eta (WHO classification)
Accession number: EPI_ISL_1122452 / variant P.3 (version: 2021-04-01) / Theta (WHO classification)
Accession number: EPI_ISL_2647531 / variant B.1.526 / Iota (WHO  classification)
Accession number: EPI_ISL_1415353 / variant B.1.617.1 / Kappa (WHO classification)
Accession number: EPI_ISL_2536799 / variant C.37 / Lambda (WHO classification)
Accession number: EPI_ISL_6811664 / variant B.1.621 / Mu (WHO classification)
Accession number: EPI_ISL_6590782 / variant B.1.1.529 / Omicron (WHO classification)
Accession number: EPI_ISL_1259297 / variant Breton (hCoV-19/France/ BREIPP04233/2021).

Genomtec® RT-LAMP Direct offers multiple benefits:

  • Comfort, accuracy and speed for patients testing.
  • Increased level of safety for medical personnel.
  • Faster, easier and cost effective process for laboratories.
  • Increased efficiency and lower cost of laboratory work for healthcare system.

For Patients our test means:

  • greater comfort due to lack of swabbing e.g. from the nasopharynx
  • test performance regardless of SARS-CoV-2 variant present
  • faster results

For Medical Personnel it means:

  • decreased risk of exposure to infectious agent
  • no specialized skills and equipment required while sampling

For Laboratory our test means:

  • 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

For Healthcare System our test means:

  • quicker laboratory turnaround time increases outbreak surveillance
  • wider population acceptance for testing due to non-invasive sampling
  • less expensive and more robust method for SARS-CoV-2 molecular testing
  • minimal laboratory experience required and possibility for fast re-training for the operator

Sampling

Saliva sample, or throat or nasopharyngeal dry swab is obtained (5 min.)

Collected specimen (up to 24hs)

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

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)

RT-LAMP amplification (40 minutes)

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

Test result

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