Genetic tests for COVID-19

About tests

Genetic (molecular) laboratory kit for rapid detection of SARS-CoV-2

Genomtec® SARS-CoV-2 RT-LAMP/N CE-IVD

 

Rapid genetic (molecular) tests for COVID-19 diagnosis to be performed and read on any Real-Time thermocycler equipped with FAM (green) detection channel. The amplification protocol takes in total 30 minutes, however, the Mean Time to Result (MTTR) for positive samples is less than 20 minutes.

Genomtec® SARS CoV-2 RT-LAMP/N is a CE-IVD laboratory kit designed for qualitative detection of the SARS-CoV-2 RNA in nasopharyngeal and oropharyngeal swabs. The product consists of all controls and reagents to conduct reverse transcription and amplification of the virus's RNA in an isothermal nucleic acid amplification technology, namely LAMP (Loop-mediated Isothermal Amplification).

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

Do you have questions? Call +48 697 802 241 OR SEND E-MAIL >>

 

Synektik testy genetyczne koronawirus SARS-CoV-2 Genomtec

The main features of Genomtec® SARS-CoV-2 RT-LAMP/N CE-IVD genetic (molecular) test for COVID-19 detection

  • Short test time to positive result: <20 minutes, thanks to unique isothermal technology
  • Compatible with standard equipment of the Molecular Diagnostics Laboratory (including the Real-Time PCR instrument and the wet-prep workflow)
  • Easy to use in both the large and small laboratories
  • The kit contains all ready-to-use reagents
  • Fast delivery time and readily available due to manufacturing in Poland
  • High test sensitivity - LOD (Limit of Detection) is 147 (95% CI: 112-271) gene copies/reaction

Diagnostics

The results obtained allow to identify the presence of SARS-CoV-2 RNA in the sample. A positive result obtained with the diagnostic test should only be taken into account together with the patient's clinical history and other laboratory results (if necessary to obtain a clear clinical guidance on the type of infection) when determining the final state of a disease.

Unique methodology

The test kit contains an optimized composition of reagents, highest quality enzymes and RT-LAMP patent-pending primers. This guarantees signal detection in positive clinical samples in less than 20 minutes, with a maximum response time of 30 minutes (compared to a minimum of 75 minutes for the fastest RT-PCR laboratory tests currently available on the market).

Thanks to utilization of the best enzymes and individual compositions we can offer a rapid yet of unmatched diagnostic parameters genetic test that can be swiftly implemented into your current laboratory workflow, enhancing your throughput and reliability (false negative samples occurrence limited due to use of the LAMP primers).

Medical device for laboratory diagnostics

Genomtec® SARS-CoV-2 RT-LAMP/N CE-IVD test is classified as an in vitro diagnostic medical device (IVD) and comply with all registration requirements. The product is intended for use in molecular diagnostics laboratories by a qualified laboratory personnel. The product is not sterile and do not require in a sterile working environment, but according to manufacturer’s instruction the work must be performed in a PCR laminar chamber to minimize / prevent cross-contamination with a foreign genetic material.

All Genomtec products are of the highest quality laboratory genetic tests that may be used interchangeably with other Nucleic Acid Amplification Technology (NAAT) IVD assays, pending on the local rules and diagnostic guidelines.

Manufacturer

The manufacturer of the test is the Polish company - Genomtec, whereas Synektik is their authorized distributor.

Genomtec logo Synektik2

 

Do you have questions? Call +48 697 802 241 OR SEND E-MAIL >>