*Unless a different written warranty is included with product documentation or sales agreement, we warrant to you that our products will conform to the technical specifications for such products as provided in technical documentation and marketing materials accompanying the products until their respective expiration dates, or up to their respective number of uses as the case may be, however no longer than the expiration dates. THIS WARRANTY IS EXCLUSIVE, AND WE MAKE NO OTHER REPRESENTATIONS OR WARRANTIES OF ANY KIND WHATSOEVER, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE, OF NON-INFRINGEMENT, OR REGARDING RESULTS OBTAINED THROUGH THE USE OF ANY PRODUCT, WHETHER ARISING FROM A STATUTE OR OTHERWISE IN LAW OR FROM A COURSE OF PERFORMANCE, DEALING OR USAGE OF TRADE, ALL OF WHICH ARE EXPRESSLY DISCLAIMED.

Product Line Genomtec® SARS-CoV-2 laboratory kits

All Genomtec® products (GA00Ar1, GA00B) are of the higehst quality laboratory genetic tests that may be used interchangeably pending on local rules and diagnostic guidelines.

Product No.Product NameUnitStorageNet price, EXW,
Czestochowa, Poland
PI & IFU
GA00Ar1Genomtec® SARS CoV-2
RT-LAMP/N Laboratory Kit
50 tests (1 box)-22° C to -15° C
(-7,6° F to +5° F)
* PLN 3150; bez VAT
EUR 750;
USD 825
Product Insert

IFU
* cena w PLN wyłącznie dla odbiorców z Polski (price in PLN only for PL customers)
If you have any question about using SARS-CoV-2 products, please refer to FAQ
Note: it is forbidden to re-export and conduct diagnostic testing with use of Genomtec® SARS-CoV-2 RT-LAMP Kits to:
EU: DE, ES, FR, GB, IT, NL, SE || EUROPE:CH, UK, Turkey || ASIA: Malaysia , China, Hong Kong, JP, Iraq || NORTH AMERICA: USA || SOUTH AMERICA:Brasil
Product No.Product NameUnitStorageNet price, EXW,
Czestochowa, Poland
PI & IFU
GA00Ar1Genomtec® SARS CoV-2
RT-LAMP/N Laboratory Kit
50 tests (1 box)-22° C to -15° C
(-7,6° F to +5° F)
* PLN 3150; bez VAT
EUR 750;
USD 825
Product Insert

IFU
* cena w PLN wyłącznie dla odbiorców z Polski (price in PLN only for PL customers)
If you have any question about using SARS-CoV-2 products, please refer to FAQ
Note: it is forbidden to re-export and conduct diagnostic testing with use of Genomtec® SARS-CoV-2 RT-LAMP Kits to:
EU: DE, ES, FR, GB, IT, NL, SE || EUROPE:CH, UK, Turkey || ASIA: Malaysia , China, Hong Kong, JP, Iraq || NORTH AMERICA: USA || SOUTH AMERICA:Brasil

PRODUCT INFORMATION

Qualitative identification of SARS-CoV-2 RNA in clinical samples can be performed by:

  • Genomtec® SARS-CoV-2 RT-LAMP/N Laboratory Kit – recognising specific sequence on the gene N SARS-CoV-2

Genomtec® RT-LAMP Kit contains assay enough to perform 50 reactions (including controls and assay mixes) required for the RT-LAMP detection of RNA from the SARS-CoV-2 virus.

Features of the newly developed RT-LAMP diagnostic kit:

  • Detection using Real-Time RT-LAMP with amplification cycle of nucleic acid below 30 minutes
  • Assays target distinct genomic region of the gene N SARS-CoV-2 that is unique for SARS-CoV-2, although the gene N is present in other coronaviruses (e.g. SARS, MERS)
  • Highly specific – set of at least five primers recognise at least 7 specific genomic sequences encompassing targeted SARS-CoV-2 gene
  • Instrument run and diagnostic report generated using laboratory standard Real-Time PCR system (equipped with FAM [green fluorescence] channel detection)
  • Superb diagnostic parameters (including Limit of Detection (LOD), Inclusivity, Sensitivity, Accuracy)
  • Primers are validated not to cross-react with other pathogens that might be present in the sample (100% specific)

Intended Use

Genomtec is pleased to offer RT-LAMP/N CE-IVD Laboratory Kit adding the qualitative detection of specific gene from SARS-CoV-2 in individuals suspected of COVID-19 in various sample types, including:

  • throat swab
  • nasopharyngeal swabs

Note : Nasal swabs, nasopharyngeal aspirate, mid-turbinate swabs and bronchoalveolar lavage (BAL) specimens might also be considered acceptable specimen types, but performance with these specimen types has not been established.

Testing with the Genomtec® SARS-CoV-2 RT-LAMP Kits is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and / or LAMP and in vitro diagnostic procedures.

Genomtec’s recommendation for use Product line Genomtec® SARS-CoV-2 RT-LAMP/N CE-IVD kit (Cat. No. GA00A) is as follows:

  • Where new or suspected cases of COVID-19 disease arise in the population* utilize Genomtec® SARS- CoV-2 RT-LAMP/S or RT-LAMP/N CE-IVD Kit to aid in diagnosis of SARS-CoV2. Positive result (detected targeted gene) and all assay Controls indicate active infection. 
  • False negative result (please refer to Results Interpretation in Instruction for Use) requires patient’s resampling (recommended) subject to nucleic acid purification and test repeat using initial configuration of the Genomtec® SARS-CoV-2 RT-LAMP product line (Cat. No. GA00A and / or GA00B) or other manufacturer’s genetic assay.
  • If the second diagnostic round confirms presence of both SARS-CoV-2 gene(s) and manufacturers  controls, the result is positive. If results are discordant then manufacturer’s confirmatory protocol must be executed. It may include if appropriate, sequencing of the virus from the original specimen or of an amplicon generated from an appropriate NAAT assay, as long as the sequence target is larger or different from the amplicon probed in the NAAT assay(s) used.

*In some cases, it might be recommended to start detection targeting two genes (S and N) simultaneously in each sample, depending on the Local Authority Guideline.

Diagnostic workflow with Genomtec RT-LAMP kits

For details please go to Product Information Sheet

STEP 1 – RNA preparation

The first stage involves extraction of SARS-CoV-2 RNA from investigated samples using commercially available kits. Please follow manufacturer’s instruction. All frozen RNA samples  and reagents must be thawed and kept on ice. Ensure proper mixing of samples and reagents, then centrifuge briefly to collect liquid at the bottom of the tube or sample plate. Proceed to stage 2.

STEP 2 – RT-LAMP preparation

Briefly, make sure all controls (positive, negative, internal control) are prepared and run with samples. Mix adequate reagents of the kit(s) with sample and controls (follow detailed procedure enclosed in the Instruction for Use), seal the plate and centrifuge. The plate is now ready for run on a real time PCR instrument.

STEP 3 – PCR instrument setup and run

You can use any calibrated thermal cycler with FAM channel (green dye) detection that can operate in total reaction volume of 20 µl. The amplification requires 20 minutes at constant temperature, with denaturation at the final step. Please follow setup and run details enclosed in Instruction for Use.

reka & PCR instrument

Please refer to the schematic diagram ‘COVID-19 diagnostic pathway’

    Results obtained identify SARS-CoV-2 RNA in the sample. 

    The positive result of the diagnostic test (Genomtec® SARS-CoV-2 RT-LAMP/S and / or RT-LAMP/S Kit) should be taken into consideration together with patient’s clinical history and other diagnostic results while concluding the final infection status. Positive results are not indicative of lack of bacterial infection or other viral infection that is not subject of the diagnostic assay. Similarly, negative results do not exclude entirely COVID-19 disease and should be accompanied by other diagnostic solution ruling out absence of SARS-CoV-2 in patients.

    The wholistic patient management should carefully consider spectrum of clinical symptoms, patient history, linked to available epidemiological data. Laboratories in European countries* may have to report all positive results to the appropriate Competent Health Authorities. Genomtec stresses the outmost need to seek confirmation of any surprising results in the international WHO reference laboratory or asks for a direct contact with a Scientific & Product Support Team.

    For in vitro diagnostic use. 

    *The following countries require the CE-marked In Vitro Diagnostics: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, UK, Norway, Iceland, Liechtenstein, Switzerland, Turkey.

    Genomtec® SARS-CoV-2 RT-LAMP Kits includes the following reagents:

    • Vial containing Genomtec® SARS-CoV-2 Assay Mix (50 reactions) with primers recognising specific fragment of SARS-CoV-2 gene S (Cat. No. GA00B) or gene N (Cat. No. GA00A)
    • Vial containing Genomtec® SARS-CoV-2 Internal Control Mix with primers specific to human gene target controlling appropriateness of biological sample collection and RNA purification   
    • Vial containing Genomtec® SARS-CoV-2  Positive Control with specific to the SARS-CoV-2 genomic region targeted by the assay
    • Package material – printed Product Information insert provides the basic instructions and the link to download the Instructions for Use. 

    Genomtec recognises difficulties in recognition of a proper epidemiological situation and way of SARS-CoV-2 virus transmission in population, therefore the User is advised to follow the latest guidance provided by World Health Organisation (WHO). The appropriate decision on epidemic status and virus transmission should be provided by each Country’s appropriate Healthcare and / or Epidemiological Agencies. Genomtec will not provide any advice on epidemiological status of any Country or geographical area.    

    Genomtec’s recommendation is as follows:

    • Intra-population transition scenario, where new or suspected cases of COVID-19 disease arise from within the same population (closed system of transition) should at first utilize testing for an individual gene S (Cat. No. GA00B) or gene N (Cat. No. GA00A), to conclude initial results. Positive result (detected gene & controls) indicates an active infection.
    • Inter-population transition scenario, where new or suspected cases of COVID-19 disease arise from outside the population (country level or sudden outbreaks in previously controlled epidemiologically population; open system transition) should at first perform test for two genes (S and N) using Genomtec SARS-CoV-2 RT-LAMP/S and RT-LAMP/S laboratory kits to conclude initial results. Positive result (detected gene S and N) indicates active infection.
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