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Genetic Analysis

Solution Provider

Genetic Analysis AS

Contact person

Bruno Mainnemard Øijordsbakken, Key Account Manager, Clinical research

Phone

+47 905 39 055

Regulatory Status

The test is CE-marked and In-vitro Diagnostic (IVD) Use for stool samples

About:

Genetic Analysis AS is a fast-growing Norwegian molecular diagnostic company which uses its unique, patented and documented GA-map® technology to map gut microbiota by detecting and characterizing imbalance in the gut microbiota (Dysbiosis) from human faecal samples. We have core competence in detecting microorganisms as bacteria and viruses in the gut and have ability to develop In Vitro Diagnostic tests in all diseases where microbiota is involved. We have been the first in the world to develop, document, clinically validate and commercialize a CE-marked In Vitro Diagnostic test (GA-map® Dysbiosis Test Lx) for diagnosis and characterizing of dysbiosis in IBD and IBS patients. This test has been used in 50 clinical trials and reported in 25+ scientific publications. The GA-map® technology can be developed into several new products that are tailor-made for other diseases and indications for use. In 2020, we have lunched the first CE-marked GA-map® COVID-19 Fecal Test, a Qualitative Real Time PCR test for the detection of the 2019 novel coronavirus (SARS-CoV-2) RNA in stool samples. This test is an important supplement to the current molecular and serological tests already out in the market.

  • Non-invasive test and easy-to-use home sampling, with testing at Genetic Analysis’ service laboratory in Oslo, Norway. Option to directly set-up the testing in any molecular diagnostics laboratory.

Data:

It has been shown that the human gastrointestinal tract serve as an important reservoir for SARS-CoV-2 and that the virus can be detected in fecal samples for up to 40 days after infection (Xu et al. 2020, Wu et al. 2020). SARS-CoV-2 can infiltrate gastrointestinal (GI) cells and may cause GI infection (Xiao et al. 2020). Further, new results indicate that fecal-oral virus transmission is (can be) an important route for COVID-19 spread (Hindson et al. 2020). This means that patients can be SARS-CoV-2 positive and possibly infectious for several weeks despite negative nasopharyngeal results.

  • One third of COVID-19 patients report typical gastrointestinal symptoms (diarrhea, abdominal pain, and vomiting).
  • SARS-CoV-2 has been detected in fecal samples of COVID-19 patients even after respiratory samples were tested negative and for as long as 40 days after infection.
  • SARS-CoV-2 RNA has been found in fecal samples of up to 50% of COVID-19 patients.
  • The detection of SARS-CoV-2 in stool could help in the prevention of the possible fecal-oral transmission route.

Product Information:

  • The CE-marked GA-map® COVID-19 Fecal Test is designed to qualitatively detect SARS-CoV-2 in fecal samples. It constitutes a full workflow from sample collection to result reporting. The test is validated, CE-marked and In-vitro Diagnostic (IVD) Use for stool samples.

Technology:

Viral ribonucleic acid (RNA) is isolated from human faecal samples followed by selective amplification of the target gene using specific primers for two sequences within the SARS-CoV-2 Nucleocapsid gene (N1 and N2). RNA detection probes labeled with a fluorescent dye act as a reporter. Each probe also has a second dye which acts as a quencher. When not bound to the target sequence, the fluorescent signals of the intact probes are suppressed by the quencher dye. The real-time data is recorded in a real-time (RT)-PCR instrument and the results are reported as either positive or negative based on cycle threshold (Ct) recordings.

Key features and Benefits:

  • Developed from and validated with, human stool samples from confirmed COVID-19 positive patients (nasopharyngeal positive tests results) and, stool samples from known COVID-19 negative patients.
  • SARS-CoV-2 target genes and controls selected in accordance with the US Centres for Disease Control and Prevention (CDC) information for molecular detection of SARS-CoV-2.
  • Results available after 5 hours
  • Prolonged detection period of positive samples compared to nasopharyngeal specimens.
  • Instrumental part of the multiple specimens testing strategy.
  • Valuable decision tool for patient management and in surveillance of healthcare workers with frontline exposure.
  • May help with confirmation of Covid-19 clearance and management of social distancing/return to work policies

Suitable for:

  • patients exhibiting signs and symptoms of COVID-19 (confirmation and management)
  • patients in the recovery phase (surveillance)
  • asymptomatic individuals concerned about possessing and transmitting the virus (prevention)
  • Screening faecal microbiota transplant (FMT) donors

Kit: