Routine molecular diagnostic laboratories can benefit from using GA’s products by choosing one of two options:
- Use of GA map® reagent kit: The routine diagnostic laboratory can implement the GA-map® Technology platform and established the GA-map® Test. Fecal samples are locally collected and analyzed by the laboratory. GA will continuously provide CE-marked and validated reagents kit.
- Use of GA service laboratory: Fecal samples are locally collected, assembled by the routine diagnostic laboratory, and regularly send batchwise for analysis and reporting to Genetic Analysis service laboratory, Oslo Norway. Encrypted reports are sent back to the routine diagnostic laboratory.
The two products GA provides are The GA-map® Dysbiosis Test and the GA-map® COVID-19 Fecal Test. The two tests can be set up in any PCR laboratory and GA provides reagent kit for own use or we do the analysis and reporting of the result at our service laboratory. With more than 10 years of experience in gut microbiota analysis, we provide you with a reproducible, standardized and well-documented, CE-marked service to support your drug development projects, to assess gastrointestinal treatment effect on gut microbiota and measurement of gut microbiota variation in clinical settings.
The GA-map® Dysbiosis Test Lx
Genetic Analysis has developed a CE-marked probe-based gut microbiota test on the Luminex® 200 instrument. . GA-map® Dysbiosis Test Lx is fully validated according to the IVD directive 98/79/EC and is the first CE-marked IVD test on the market providing microbiota profiles and dysbiosis status in IBS and IBD patients.
The GA-map® Dysbiosis Test Lx reagent kit
The reagent kit is produced in our ISO 13485 certified facilities in Oslo, Norway. Included in the product is a software that performs QC on the run file, calculates the dysbiosis index (DI) score and Abundance table and converts each sample result into an easy-to-understand result report.
The GA-map® COVID-19 Fecal Test
The GA-map® COVID-19 Fecal Test is a Qualitative Real Time standardized PCR test for the detection of the 2019 novel coronavirus (SARS-CoV-2) RNA in stool samples and is validated and CE -marked. The test is a valuable tool in patient management and in surveillance of healthcare workers with frontline exposure.