GA-map® Dysbiosis Test Lx

Product code: 2156

Identify and characterise dysbiosis

The GA-map® Dysbiosis Test Lx is a pioneering clinical test that utilises faecal specimens to identify and characterise dysbiosis, an imbalance in the gut microbiota linked to several health conditions such as inflammatory bowel disease, irritable bowel syndrome, and other autoimmune disorders. Dysbiosis occurs when there is a permanent or transient imbalance in the gut microbiota composition due to an increase in potentially harmful bacteria and/or a decrease in commensal bacteria. This imbalance can lead to dysfunction of the intestinal immune system and trigger a variety of gastrointestinal disorders.

The test employs 48 highly specific probes that target pre-determined multiplex targets and exploit single nucleotide differences in the 16S rRNA gene – a gene common to all bacteria. By leveraging cutting-edge high-throughput technology, the test can identify over 300 species of bacteria at different taxonomic levels in one reaction, making it an efficient and accurate diagnostic tool for characterising the microbiota.

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Key Advantages

Validated gut microbiota and dysbiosis indicator

Fast throughput for hundreds of samples with simple result interpretation

Multiplex technology suitable for any molecular laboratory

Relative abundance profiles compared to healthy populations

Microbiota profiling with species level resolution and targeting of relevant bacteria

Specifications

RT-PCR + 16s rRNA analysis

96 wells

Storage: -15 °C

Stool sample

More Details

The GA-map® Dysbiosis Test Lx is a faecal gut microbiota analysis tool to identify and characterise dysbiosis in adults. The test provides a Dysbiosis Index, which highlights changes in the relative abundance of the different probes compared to their abundance in a healthy normal cohort. The approach to indexing results to healthy reference populations is one of the most important features of the GA-map Dysbiosis Test. This way, clinicians and researchers don’t need to include their own control group. Over the years, several healthy normal cohort studies in many countries have secured the validity of the results in different populations. At BIOHIT, we believe this will be crucial in both research and routine settings that employ microbiota tests going forward. GA-map Dysbiosis Test has been validated using independent cohorts of clinically validated healthy volunteers, IBS and IBD patients.

GA-map Dysbiosis Test can help transfer microbiota testing from research to routine with a standardised workflow, strong documentation, reproducible production, and regulatory compliance as a CE-IVD certified product.

The comprehensive diagnostic tool can:

Determine whether a patient is dysbiotic or non-dysbiotic, according to a cut-off, and indicate the degree of dysbiosis
Establish a gut microflora profile by comparing bacterial levels to a normobiotic reference
Monitor dysbiosis during treatment for conditions such as IBS or IBD

The test is fully standardised, documented and CE marked, and is simple to perform in any molecular laboratory. It is also fast, easy to use and has simple result interpretation without the need for biostatistics.

How is the GA-map® Dysbiosis Test performed?

To perform the GA-map® Dysbiosis Test Lx, a stool sample is collected from the patient and sent to a laboratory for analysis. Genomic DNA is extracted from the sample and the 16s rRNA gene – a gene common to all bacteria, is amplified. After quantifying and cleaning up the PCR product, the preselected probes are labelled, hybridised, and detected. Using clinically relevant probe sets the technology analyses almost the entire length of the 16s gene (variable regions V3 to V9) to identify and quantify the bacterial species present in the gut microbiota. The probe markers within the panel distinguish between a healthy balanced microbiota and a state of dysbiosis, commonly observed in gastrointestinal disorders.

The raw data are processed through a clinically validated software algorithm and compared to a healthy reference population to obtain clinically meaningful results and generate a report. Each GA-map Dysbiosis Test report includes a dysbiosis index, and a list of bacterial species that are overrepresented or underrepresented in the gut microbiota.

GA-map® Dysbiosis Test Lx results & analysis

Results are generated using the GA-map clinically validated software algorithm, which delivers fast, consistent results without the need for bioinformatics input. The test results from GA-map® Dysbiosis Test Lx, include three main sections: dysbiosis index, functional bacteria profiles, and a bacteria abundance table. The report also includes a supplement that gives a concise explanation about each section of the report.

Armed with detailed information about their patient’s microbiota profile, including the abundance of bacteria that have proven to be of high importance and clinical relevance for gut health and disorders, clinicians are able to personalise therapies and dietary recommendations from the literature and evidence base to help restore the balance of the gut microbiota.

How can the GA-map® Dysbiosis Test Lx benefit patients?

The GA-map® Dysbiosis Test Lx is a valuable tool to supplement patient treatment regimens and advance clinical research. Understanding profiles of a person’s gut microbiota, before, during, and after treatment, and mapping those profiles to a patient’s health conditions, can support the understanding and management of gastrointestinal disorders such as Irritable bowel syndrome (IBS), inflammatory bowel disease (IBD), and other functional gastrointestinal disorders.

It can also help understand extra-gastrointestinal symptoms and conditions such as diabetes and health-related lifestyle factors, that are related to the microbial composition in the gut. GA-map Dysbiosis Test has demonstrated value in individuals who experience gastrointestinal symptoms, such as bloating, constipation, diarrhoea, or abdominal pain and has been used in dietary and faecal microbiota transplant (FMT) interventional trials. Analysing the gut microbiota with GA-map Dysbiosis Test can help identify the underlying cause of these symptoms and provide personalised therapy and dietary recommendations to restore gut health.

What’s more, the test can be useful for individuals who have been diagnosed with certain health conditions, such as inflammatory bowel disease or irritable bowel syndrome. By identifying the bacterial species that are overrepresented or underrepresented in the gut microbiota, the test can help develop targeted interventions aimed at restoring gut health and improving overall well-being.

Furthermore, the GA-map® Dysbiosis Test Lx can be used to monitor the effectiveness of interventions aimed at restoring and maintaining the balance of the gut microbiota, such as changes in diet, lifestyle or the use of therapeutics such as prebiotics, probiotics, antibiotics and FMT products. Regular testing can help track the progress of the gut microbiota and ensure that the interventions are effective in re-establishing gut health compared to a healthy reference population.

In summary, the GA-map® Dysbiosis Test Lx is a cutting-edge diagnostic tool that profiles the gut microbiota and compares it to that obtained from a stable, healthy, reference population, in order to support a personalised approach to evaluating gut health. The test has the potential to improve the management of gastrointestinal and autoimmune disorders and contribute to a greater understanding of personalised nutrition and therapy across multiple areas of human health. Download our brochure for further information and guidance or request a quote from BIOHIT Ltd today.

GA-map® Dysbiosis Test FAQs

What is GA-map® Dysbiosis Test?

GA-map® Dysbiosis Test is a gut microbiota analysis platform that uses DNA analysis to characterise the human gut microbiota and identify imbalances in the microbiome compared to a stable, healthy reference population. It has been validated using independent cohorts of clinically validated healthy volunteers, IBS and IBD patients, and provides a simplified and standardised approach to gut microbiota profiling in research and clinical settings.

How is dysbiosis determined?

Dysbiosis is determined by comparing the relative abundance of bacteria that are clinically relevant in health and disease, to that of healthy individuals. The GA-map Dysbiosis Test does this by deploying 48 bacterial markers, targeting over 300 bacteria on different taxonomic levels, to characterise the gut microbiota from a stool sample. These specific markers have been selected based on their ability to distinguish between a healthy balanced microbiota and a state of dysbiosis. The resulting profile of bacteria (abundance and diversity) is compared to that of a healthy population to determine the presence and degree of dysbiosis.

Can I set up the GA-map® Dysbiosis Test in my lab?

Yes. Our tech-transfer service enables customers to run the GA-map® Dysbiosis Test from their own lab, enabling them to deliver microbiome testing using a robust and documented tool. Our ‘white glove’ service includes a comprehensive, hands-on approach including installation, setup and training led by in-house experts who provide full support through the entire adoption and verification process, significantly reducing the onboarding and set up time. This makes the adoption process smooth, simple and cost effective.

What is the result turnaround time for GA-map® Dysbiosis Test?

The GA-map® Dysbiosis Test typically takes 1-2 days depending on the chosen workflow, and because the test results are generated utilising the clinically validated GA-map® software algorithm, results are immediate without the need for further bioinformatic work.

What information does the GA-map® Dysbiosis Test provide?

The GA-map® Dysbiosis Test provides information on the different types and quantities of bacteria in the gut microbiome. Exploiting the 16S gene (variable regions V3-V9) it enables better recognition of bacteria on low taxonomic levels and covers a range of bacteria (over 300 bacteria on different taxonomic levels). It also identifies imbalances in the Gut microbiota and provides functional profiles based on those relevant bacteria identified.

How can I use the results of the GA-map® Dysbiosis Test to improve my patients’ gut health?

The GA-map® Dysbiosis Test provides a personalised Gut microbiota profile based on the individual’s sample and compares this to a healthy reference population to obtain clinically meaningful results. The results can be used to make personalised recommendations (for example dietary changes, prebiotic, antibiotic and probiotic supplementation, and lifestyle modifications) to restore microbial balance and improve gut health.

Is dysbiosis the same as IBS?

Dysbiosis and Irritable Bowel Syndrome (IBS) are not the same, but they can be related. Dysbiosis refers to an imbalance in the gut microbiome, whereas IBS is a functional gastrointestinal disorder that causes a group of symptoms, including abdominal pain, bloating, and changes in bowel habits. Dysbiosis can be a contributing factor to IBS, but not all people with dysbiosis will develop IBS and vice versa, however studies have shown that around 70% of individuals with IBS have dysbiosis.

What is the difference between dysbiosis and leaky gut?

Dysbiosis refers to an imbalance in the bacteria that make up the gut microbiota, while leaky gut refers to an increase in intestinal epithelium permeability when the barrier function of the gut becomes compromised. There are three components to the epithelium barrier, of which the gut microbiota is the inner-most layer. If this barrier becomes compromised in any way, e.g. as a result of dysbiosis, the highly regulated process of trans-epithelial transport can break down.

What causes gut dysbiosis?

Gut dysbiosis occurs when there is an imbalance in the gut microbiota, which can result from a decrease in beneficial bacteria, and increase in potentially harmful bacteria or an overall reduction in microbial diversity in the gut. These types of gut dysbiosis can be triggered by a variety of factors, including environmental factors such as diet, lifestyle, hygiene and medications, and host-specific factors such as genetics, diseases and infections, and stress.

What are the consequences of dysbiosis?

Gut dysbiosis has been linked to a range of health conditions and it can have mild to serious health implications associated with a range of disorders. Disrupting the balance of bacteria in the gut can cause gastrointestinal disorders, metabolic diseases, autoimmune disease and allergy and psychological disorders. For example, gut microbiota imbalances are associated with digestive and systemic symptoms, including IBS and functional gastrointestinal disorders, alternating bowel habits, inflammation (e.g. inflammatory bowel disease), cancer, obesity, type 2 diabetes, fatigue and mental health disorders.

What diseases are associated with gut dysbiosis?

Some of the diseases associated with gut dysbiosis include inflammatory bowel disease (IBD), irritable bowel syndrome (IBS), colorectal cancer, obesity, and type 2 diabetes.

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