What is the GA-Map Dysbiosis Test?

What are the indications for use?

With trillions of bacteria residing in the gut, this dynamic community is sensitive to many factors including host lifestyle, diet and immunity, which influence the diversity and abundance of different bacteria colonising the gut. As a result, dysbiosis (i.e. a deviation from a normal and healthy reference microbiome) is common.

In the field of Gastroenterology and digestive health there are many indications for gut microbiota testing. Testing your patients stool samples using GA-map identifies microbiota dysbiosis which supports the diagnosis, treatment and monitoring of numerous digestive diseases.

For those difficult-to-treat conditions such as Irritable Bowel Syndrome (IBS), Inflammatory Bowel Disease (IBD), changes in bowel habits, functional gastrointestinal disorders, diarrhoea, GA-map may help unveil the underlying cause of symptoms and help direct patient-specific treatment.

New indications for microbiota testing are being explored all the time thanks to a vibrant community with great interest in the value of microbiota research. As a result, evidence is emerging at an incredible pace. For example, in the field of gastroenterology alone dysbiosis has been implicated in non-alcoholic fatty liver disease (NAFLD), diabetes, and obesity. Recently it was proposed that Gut microbiota analysis be used to assess the efficacy of faecal microbiota transplants (FMT) in the treatment of Clostridium difficile infection.

In IBS, GA-map Dysbiosis Test has demonstrated how gut microbiota bacterial profiles can be used to predict the efficacy of dietary intervention using traditional IBS and Low-FODMAP diets (Bennet et al). Such findings have led to the exploration of how gut microbiota can predict the outcome of treatments for various gastrointestinal diseases.

Diagnose Dysbiosis
Establish microbiota profiles
Monitor Response
The GA-Map Dysbiosis Test is a gut microbiota DNA analysis tool to identify and characterise dysbiosis. 

 

It is used together with other clinical information to support the diagnosis and management of patients with IBS and IBD. Specifically, GA-Map is classified as an in-vitro diagnostic test for the semi-quantitative measurement of bacterial 16S rRNA in stools from patients with IBS, IBD, and symptomatic non-IBD. It can help in many ways including diagnosis, monitoring and evaluating the response to treatment in a number of digestive diseases.

The technology exploits single nucleotide differences in the 16S rRNA gene to measure the abundance of species and groups of bacteria in a faecal sample. All pre-processing of the data is carried out by the sophisticated GA-Map Analyzer software, and so no bioinformatician resources are needed to analyse results.

Reports containing the microbiota profiles are automatically generated which include information on the dysbiosis index - a measure of how the individual's bacteria profile differs from a reference population. By combining the speed, precision and robustness of RT-PCR applications with the comprehensiveness of next generation sequencing, the GA-Map™ technology dramatically reduces the time from analysis to publication.

Modifying the gut microbiota

The factors that influence gut microbiota and microbial diversity are well documented. Genetics, age, diet, physical activity, mood/stress, medications, age, inflammation, infection all have an affect on the microbial composition in the gut.

The microbiota, and subsequently an indivudal's health, can be modified by manipulating certain factors that influence the microbiota. Current approaches to modulating the microbiota to derive clinical benefit include:

 

  • Diet low in Fermentable Oligosaccharides, Disaccharides, Monosaccharides and Polyols (FODMAP)

  • Fecal microbiota transplantation (FMT)

  • Probiotics

  • Prebiotics

  • Synbiotics (combination of pre- and probiotics)

  • Rifaximin (an antibiotic)

  • Lifestyle changes

GA-Map technology - how it works

The GA-Map dysbiosis test is based on the detection of bacterial DNA using cutting edge techniques that:
  • Significantly increase the number of bacteria species that can be found in a stool sample
  • Dramatically reduce detection time compared to conventional techniques
  • Simplify sample handling – no need for culture or live bacteria
  • Simplify data analysis of the microbes detected

The Bacterial 16S rRNA gene

The patented GA-map™ technology utilises constant and variable DNA sequences within the 16S rRNA gene of the bacteria to identify and characterise the different bacteria. The test enables simultaneous analysis of a large number of gene fragments in one reaction.
probes2.jpg
The GA-map™ Dysbiosis Test is based on advanced DNA profiling techniques to target variable regions (V3 to V7) of amplified bacterial 16S rRNA genes in order to identify and characterise bacteria that make up the gut microbiota.
 
Genomic DNA derived from a single stool sample is the primary sample. The gene targets are identified using a highly specific set of 54 probes in a molecular multiplex assay that utilises the patented Single Nucleotide Primer Extension (SNuPE) technology. A unique algorithm is then employed to reduce all the data generated by the detection of the SnuPE products to determine the dysbiosis level in the sample. The algorithm is incorporated in the GA-map™ Dysbiosis Analyzer software that accompanies the test and so data reduction is made simple.

GA-map Dysbiosis Test comprises eight steps:

  1. Fecal sample collection
  2. Genomic DNA extraction
  3. Amplification od 16S rRNA gene
  4. DNA Quality Control (QC)
  5. End-labelling
  6. Hybridization
  7. Signal detection
  8. Preparation of test report

How does GA-Map compare to Next Generation Sequencing (NGS)?

The main benefit of using GA-Map technology over other applications (e.g. Next Generation Sequencing) comes from the standardisation and consistency of results given which in turn are indexed against a normal control population, giving reassurance to the clinician that the Dysbiotic Index is reliable. As a result, the GA-Map Dysbiosis Test is CE marked for clinical use too with simple data reduction for easy implementation.

 

The results are presented in an easy to read format and include a comprehensive profile of the patient's gut microbiota with a Dysbiosis level between 1 and 5. The Dysbiosis Index is based on the relative abundance of individual bacteria compared to a healthy (control) population.

Next Generation Sequencing (NGS)

GA-map

CE-marked

No

Yes

Normal control population included

No

Yes

Automated report generation

No

Yes

Detection mode

All bacteria present, Relative abundance, Diversity index

Pre-defined bacteria targets, Relative Abundance, Dysbiosis Index

Turnaround time

6 - 14 days

2 days

Detection platform

Illumina, Ion Torrent

Luminex

16s rRNA span

v3 and / or v4 region

v3 - v7

PCR primer pair coverage

200-300 base pairs

1180 base pairs tested against 436 target species

Repeatability

unknown, variable

2.6%*

Reproducibility

unknown, variable

4.2%*

* Dysbiosis Index.

Faecal microbiota analyses requires expert input to get high quality and reproducible data. BIOHIT HealthCare makes accessing a microbiota analytical service simple, but if you prefer to set up the technology to perform your own analyses our experts will bring the technology to you with all the support you need to establish a successful service.

BIOHIT HealthCare can help with research applications that require professional microbiota analysis delivered by experts in the field. We collaborate with researchers to build the evidence needed to bring benefits to patients from diagnostic and therapeutic interventions that involve analysis and manipulation of the microbiome.

FAQs

What kind of treatment can be used to alter the microbiota?

How can a result be non-dysbiotic according to the Dysbiosis index, when several of the bacteria are deviating?

Can the patient be tested again later and test result compared to present results?

How were the bacteria markers in the GA-map® Dysbiosis Test selected?

Can the GA-map Dysbiosis Test be set up in my institution?

Index

© 2018 BIOHIT HealthCare Ltd

Contact Us

BIOHIT HealthCare Ltd

Pioneer House, Pioneer Business Park

North Road

Ellesmere Port

Cheshire CH65 1AD

United Kingdom

Tel: +44 151 550 4 550

Fax: +44 151 550 4 551

cs@biohithealthcare.co.uk

  • Twitter Social Icon