GI Effects Collection Pack
GI Effects® GI Effects Collection Pack
The Most Comprehensive Stool Test for Optimal Clinical Utility

Specimen Type: STOOL

Some products not available in New York state.

Only healthcare providers licensed in their state may order laboratory testing. 

Find a Doctor Provider Login / Order

Why choose GI Effects?

GI Effects® is a comprehensive assessment of complete gut health, assessing the root cause of most GI complaints.

Our combination of PCR, culture, and microscopic testing methods ensures any and all relevant organisms are identified.

Data driven analysis is based on our database of hundreds of thousands of complete stool profiles.

The GI Effects Stool Profiles are a suite of advanced stool tests that provide immediate, actionable clinical information for the management of gastrointestinal health. Utilizing cutting-edge technologies and biomarkers, these profiles offer valuable insight into digestive function, intestinal inflammation, and the intestinal microbiome. The overview pages make results interpretation quicker and easier, to prioritize treatment and assess microbiome status.

The GI Effects Stool Profiles can reveal important information about the root cause of many common gastrointestinal symptoms and non-GI conditions including:

  • Gas
  • Bloating
  • Indigestion/ reflux
  • Abdominal pain/ cramps
  • Diarrhea
  • Constipation
  • Inflammatory Bowel Disease (IBD) [1,2]
  • Irritable Bowel Syndrome (IBS) [3,4
  • Atopic dermatitis/ eczema [5,6]
  • Allergies [5]
  • Autoimmune diseases [7,8]
  • Mood disorders (depression) [9,10]
  • Joint aches [11,12]
  • Diabetes [13,14,15]
  • Weight issues [15,16,17,18]

The health of the entire body is dependent on a healthy gut and gut microbiome. Gut microbes are codependent with one another and with their human host, and the health of one affects the other. A sizeable volume of research associates a dysbiotic, or imbalanced gut microbiome with multiple disease states both within and outside of the GI tract. [19,20,21] The diverse metabolic activities of the microbiome ultimately impact the human host, and the activities of the human host ultimately affect the health of their microbiome.

 

 

The biomarkers on the GI Effects Comprehensive Profile (2200) reflect the 3 key functions of gut health arranged in the “DIG” format: Digestion/Absorption, Inflammation/Immunology, and the Gut Microbiome:

Digestion/Absorption:
  • Pancreatic Elastase-1 is a marker of exocrine pancreatic function.
  • Products of Protein Breakdown are markers of undigested protein reaching the colon.
  • Fecal Fat is a marker of fat breakdown and absorption.
Inflammation/Immunology:
  • Calprotectin is a marker of neutrophil-driven inflammation. Produced in abundance at sites of inflammation, this biomarker has been proven clinically useful in differentiating between Inflammatory Bowel Disease (IBD) and Irritable Bowel Syndrome (IBS). [1,2]
  • Eosinophil Protein X is a marker of eosinophil-driven inflammation and allergic response.
  • Fecal Secretory IgA is a marker of gut secretory immunity and barrier function.
  • Fecal Occult Blood Test detects hidden blood; fecal immunochemical testing (FIT) has been recommended by the American College of Gastroenterology as the preferred noninvasive test for colorectal cancer screening/detection.
Gut Microbiome:
  • Genova is the first laboratory to introduce an Inflammation-Associated Dysbiosis score and a Methane Dysbiosis score by incorporating our latest, published microbiome data analysis.22
  • Metabolic indicators, including short-chain fatty acids and beta-glucuronidase, demonstrate specific and vital metabolic functions performed by the microbiota.
  • Commensal Bacteria demonstrate the composition, abundance and patterns of gut organisms.
    • More than 95% of commensal gut organisms are anaerobic and are difficult to recover by traditional (aerobic) culture techniques.
    • GI Effects assesses a set of 24 genera/species that map to 7 major phyla.
    • 16S rRNA gene polymerase chain reaction (qPCR) amplification technique
    • Comprehensive microbiome analysis included
  • Bacterial and mycology cultures demonstrate the presence of specific beneficial and pathogenic organisms.
    • Matrix Assisted Laser Desorption Ionization Time-of-Flight Mass Spectrometry (MALDI-TOF MS) technology is used for limitless bacterial and fungal species identification via culture
  • Bacterial and mycology sensitivities are provided for pathogenic or potentially pathogenic organisms that have been cultured. The report includes effective prescriptive and natural agents.
  • Parasitology includes comprehensive testing for all parasites on every parasitology exam ordered.
    • GI Effects provides microscopic fecal specimen examination for ova and parasites (O&P), the gold standard of diagnosis for many parasites.
    • 6 Real-time Polymerase Chain Reaction (PCR) targets detect common protozoal parasites including Blastocystis spp., Cryptosporidium parvum/hominisCyclospora cayetanensisDientamoeba fragilisEntamoeba histolytica, and Giardia. PCR for organisms is emerging as a highly sensitive method for infectious organism detection.
    • Selection of a one-day or three-day sample collection is based on the clinician's clinical index of suspicion for parasitic infection. If there is no/low suspicion, a one-day sample will likely be adequate. For high suspicion, a three-day sample collection is optimal.
Additional Biomarkers Available:
Additional Microbiome Module:
  • Microbiomix offers metagenomic shotgun/ whole genome sequencing to assess your patient's complete gut microbiome as well as its potential function. Microbiomix complements the information provided on the GI Effects. 

Uncover the Cause of your Gastrointestinal (GI) Symptoms

 

GI Effects stool testing might be right for you if you struggle with:

  • Gas
  • Bloating
  • Abdominal pain/cramps
  • Indigestion/reflux
  • Diarrhea
  • Constipation
  • Food Allergies
  • Inflammatory Bowel Disease (Crohn’s disease, Ulcerative colitis)
  • Irritable Bowel Syndrome (IBS)

 

Genova’s stool profiles provide a more complete evaluation of gut health.

Our testing provides information on inflammation and how well you digest and absorb your food. Stool testing can also uncover imbalances in yeast, parasites, and healthy and unhealthy bacteria that live in the large intestine. This bacterial population is called the microbiome.

Systemic diseases can be linked to the GI tract and improving the health of your gut may improve your overall health. Identifying abnormalities through Genova’s testing allows you and your healthcare provider to develop a personalized treatment plan to improve your symptoms.

Review the Test Preparation tab to learn more about the collection process.

Microbiomix

Genova's Commitment to Innovation Brings You a New Way to Assess the Microbiome

In the era of microbiome research, we are beginning to see that our gut microbiome has more control over our health than we ever knew. Until now, we have only seen the tip of the iceberg. The latest technology and ongoing research shows us that the microbiome is one of the most important health indicators.

 

Introducing the New Metagenomic Microbiomix Stool Analysis

Microbiomix offers metagenomic shotgun/ whole genome sequencing to assess your patient's complete gut microbiome as well as its potential function. Metagenomics is considered the gold standard method to study the gut microbiota.[1]

Microbiomix is available with the GI Effects Comprehensive Profile. Microbiomix complements the information provided on the GI Effects. This additional information may reveal treatable abnormalities that are not seen on GI Effects. Microbiomix is also available as a stand-alone offering. 

microbiomix report pages

 

What Does Microbiomix Offer?

Increased species detection

The Microbiomix platform detects bacteria, fungi, protists, and archaea amounting to over 28,000 species. Each person's microbiome contains over 200 species, all listed in the personalized report.

  • Includes identification of species that may confer pathogenic potential, such as Bacteroides fragilis and the fragilysin toxin - not available on the GI Effects.
  • Microbiomix assesses all methane-producing organisms, including Methanobrevibacter smithii also seen on GI Effects, and others.
  • The Microbiomix platform identifies newly discovered species that may not be well known to science and can see how they may be contributing to overall health.

 

Deeper insight into the microbiome's function

Microbiomix assesses the genetic potential to form unique metabolites such as hexa-LPS, TMA, histamine, vitamin production, branched chain amino acids, urease, GABA, hydrogen sulfide and many others - thus providing MORE information to help understand a patient's condition.

  • Many metabolites can be transported across the intestinal barrier and into the body's circulation. Microbial metabolites interact with our nervous system, immune, and metabolic functions to influence our overall health.
  • Some of these metabolites promote good health while others promote inflammation and disease.

 

Shannon Diversity Index

This metric is well-represented in the literature and is used to assess overall microbiome health. A diverse microbiome is ideal and is associated with greater health.

 

Specific, actionable recommendations

Tailored recommendations improve microbiome health which can influence overall health.

  • Easy-to-understand descriptions on how to modify microbiome potential with diet
  • Summary page recommending targeted prebiotics and foods

 

When would I consider ordering Microbiomix with the GI Effects?

Adding Microbiomix to the GI Effects offers a more complete picture of overall gut health.

Gut microbiome research has revealed the impact the gut has on every system in the body. The metabolites produced by the microbiome are bioactive and influence human health. Microbiomix offers a broader look at the microbiome's ability to produce these metabolites and therefore potentially prevent future chronic disease and promote optimal health.

Clinicians often order stool testing to assess GI symptoms such as:

  • Diarrhea
  • Constipation
  • Gas
  • Bloating
  • Abdominal discomfort
  • Indigestion

Additionally, since it is becoming recognized that the gut microbiome influences overall health, clinicians are beginning to look to the gut for numerous other health conditions including:

  • Allergies/asthma
  • Cardiovascular disease
  • Mood disorders (i.e., depression)
  • Autoimmune disease
  • Metabolic diseases (i.e., insulin resistance, diabetes)
  • Nutritional deficiencies

 

How does Microbiomix differ from other profiles?

Genova is the first and only company to offer a stool test of this kind - combining biomarker analysis on the GI Effects Comprehensive Profile with the most comprehensive genotypic microbiome data using Microbiomix.

 

Largest Organism Library

Metagenomic analysis heavily depends on reference databases. The organism library is unmatched in the industry with the ability to detect over 28,000 species.

  • This reference database contains several tens of thousands of microorganisms, many of which do not exist in public databases. This enables Genova to identify at least 25% more DNA than other metagenomic classifiers with access to a faster, more accurate approach than other analysis methods.[2]
  • Our growing microbial genome database uses the most scientifically advanced microbial taxonomy and complete database of bacterial and archaeal genomes currently available.[2]
  • Our world-leading database is regularly updated with new genomes to improve species identification from samples.
  • Whole genome sequencing is a complete microbiome assessment detecting bacteria, fungi, protists, and archaea. While PCR can be helpful for known pathogens, mutations will not be detected. PCR can also be limited in the ability to detect every organism.

 

Superior Analytical Performance

Validity and accuracy studies show superior performance compared to other platforms.[3,4]

  • Depth of sequencing the DNA is important for complete analysis. Reducing the depth of sequencing by performing fewer reads can reduce cost, however, it also compromises the quality. Genova performs a complete analysis of a patient's microbiome to deliver the highest quality information.
  • Metagenomics assesses DNA, whereas metatranscriptomics assesses RNA. DNA is more stable to assess. RNA provides a snapshot in time and may not be indicative of the long-term microbiome status.

 

Built-In Clinical Application

Microbiomix offers the most clinically relevant information about microbiome function and key organisms.

  • Easy-to-understand report
  • Clinically actionable metabolites
  • Evidence-based recommendations
  • Continuous lifetime report updates as the science advances

 

What can I expect when ordering Microbiomix?

Patients with complex illnesses often benefit from the most comprehensive testing — casting a wide net yields more information. GI Effects Comprehensive plus Microbiomix offers the most complete gut health test with actionable results. Dietary changes, supplements and lifestyle changes can all beneficially impact gut health and improve test results. Patients can lead an improved quality of life as their GI concerns are resolved.

Preparing for this Test

Certain medications, supplements, and/or foods may impact test results. Please note that the reference ranges were established based on patients who were taking no medications or supplements. In some instances it is unknown what potential impact a medication may have on test results.

There may be times when a patient may stay on a medication or dietary supplement during testing in order to evaluate its effectiveness. The recommendation to discontinue any substance is intended to establish a baseline finding. Below you will find a list detailing the potential interference or influence of certain substances on the biomarkers.

Genova never recommends that patients discontinue medically necessary medications or supplements in order to complete testing.

 

Collection Pack Instruction Recommended Timeframe to Discontinue Possible Biomarker(s) Impacted
Anti-inflammatory and immune modulating medications
Aspirin and NSAIDs (i.e. ibuprofen, etc.) 2 days May influence inflammation/immune biomarkers (EPX, calprotectin, sIgA)
Steroid (i.e. prednisone, etc.) No recommendation to discontinue
Autoimmune medications (i.e. Humira, etc.)
Digestive tract medications and supplements
Probiotics (beneficial bacteria) 2-4 weeks May influence the beneficial bacteria levels on culture, as well as metabolic markers; the presence of beneficial bacteria may alter the levels of other bacteria, yeast and parasites
Antacids (i.e. proton-pump inhibitors) 2-14 days (if ordering the H. pylori add-on, 14 days is recommended) May result in false negative H. pylori if PPI not discontinued for 14 days (H2 blockers do not interfere); additionally, acid-blocking medications may influence levels of the digestion and absorption markers; PPIs may clear the body relatively quickly, however the antacid effect may linger 3-5 days
Bismuth 2 days; if ordering the H. pylori add-on, 14 days is recommended May result in false negative H. pylori if bismuth not discontinued for 14 days; may affect other bacterial levels
Antacids (i.e. Tums, Rolaids, H2 blockers) 2 days Acid-blocking medication may influence levels of the digestion and absorption markers
Bentonite clay Bentonite clay affects bacteria and parasites that may be identified through microscopic examination and culture growth; this substance is a direct interferent and may result in inaccurate findings
Betaine HCl Hydrochloric acid is intended to improve digestion; therefore, markers of digestion and absorption may be influenced
Digestive enzymes Enzymes are intended to improve digestion; therefore, markers of digestion and absorption may be influenced
Laxatives Laxatives are intended to alter transit time; if laxative use results in normalized transit, there may be no effect on biomarkers. However if transit time is rapid, the markers of digestion and absorption may be influenced
Mineral oil, castor oil
Activated charcoal Activated charcoal can make identification of organisms seen in culture and microscopic examination more difficult; this substance is a direct interferent and may result in inaccurate findings
Rectal suppositories, enemas These agents can alter the density of stool samples resulting in inaccurate biomarker findings
Please note that a period of 4 weeks between a colonoscopy or barium enema and stool testing is recommended. It has been observed that 4 weeks is sufficient time for most patients to resume their previous level of gut function, including the elimination of all traces of barium, dietary/digestive normalization, and re-generation of microflora populations.
 
Antimicrobial Agents
Antibiotics 14 days May influence levels of bacteria, yeast and parasites, as well as metabolic markers; may result in false negative H. pylori if antibiotic not discontinued for 14 days
Antifungals
Antiparasitics

 

 

Illness

We do not suggest collecting during an acute gastrointestinal infectious illness.

Pediatric Patients

We do not generally recommend stool testing in children under the age of two as they are still establishing their gut flora which can impact numerous findings on the test. Inflammatory markers, such as calprotectin and lactoferrin, can also be skewed in younger children, especially if they are still breastfeeding. Reference ranges for many of the markers have not been established for this population.

Genova will not accept add-on testing for Clostridium difficile in individuals less than 2 years old based on recent research indicating non-pathogenic colonization in this age group.1

Fecal Occult Blood Testing

If the patient has a bleeding hemorrhoid(s) or is menstruating, it may interfere with the fecal occult blood test. It is preferred that the patient collect samples when there is not active bleeding.

Colectomy and Colostomy

Genova's stool profiles and reference ranges were not designed with this patient population taken into account. Test results and applicability for a patient who has had a complete or partial colectomy is unknown. Removal of the colon would be expected to impact the microbiome portion of the test, as the colon is the site where the majority of the bacteria reside. The metabolic by-products made by these bacteria may also be impacted. However, there may be clinical value in some of the other biomarkers on the test regarding inflammation and digestion/absorption. It would also be useful to see if there are any pathogenic or potentially pathogenic organisms present.

References
  1. D'Ostroph A, So T. Treatment of pediatric Clostridium difficile infection: a review on treatment efficacy and economic value. Infect Drug Resist. 2017;10:365-375.

The GI Effects Stool Profiles are a suite of advanced stool tests that provide immediate, actionable clinical information for the management of gastrointestinal health. Utilizing cutting-edge technologies and biomarkers, these profiles offer valuable insight into digestive function, intestinal inflammation, and the intestinal microbiome. The overview pages make results interpretation quicker and easier, to prioritize treatment and assess microbiome status.

The GI Effects Stool Profiles can reveal important information about the root cause of many common gastrointestinal symptoms and non-GI conditions including:

  • Gas
  • Bloating
  • Indigestion/ reflux
  • Abdominal pain/ cramps
  • Diarrhea
  • Constipation
  • Inflammatory Bowel Disease (IBD) [1,2]
  • Irritable Bowel Syndrome (IBS) [3,4
  • Atopic dermatitis/ eczema [5,6]
  • Allergies [5]
  • Autoimmune diseases [7,8]
  • Mood disorders (depression) [9,10]
  • Joint aches [11,12]
  • Diabetes [13,14,15]
  • Weight issues [15,16,17,18]

The health of the entire body is dependent on a healthy gut and gut microbiome. Gut microbes are codependent with one another and with their human host, and the health of one affects the other. A sizeable volume of research associates a dysbiotic, or imbalanced gut microbiome with multiple disease states both within and outside of the GI tract. [19,20,21] The diverse metabolic activities of the microbiome ultimately impact the human host, and the activities of the human host ultimately affect the health of their microbiome.

 

 

The biomarkers on the GI Effects Comprehensive Profile (2200) reflect the 3 key functions of gut health arranged in the “DIG” format: Digestion/Absorption, Inflammation/Immunology, and the Gut Microbiome:

Digestion/Absorption:
  • Pancreatic Elastase-1 is a marker of exocrine pancreatic function.
  • Products of Protein Breakdown are markers of undigested protein reaching the colon.
  • Fecal Fat is a marker of fat breakdown and absorption.
Inflammation/Immunology:
  • Calprotectin is a marker of neutrophil-driven inflammation. Produced in abundance at sites of inflammation, this biomarker has been proven clinically useful in differentiating between Inflammatory Bowel Disease (IBD) and Irritable Bowel Syndrome (IBS). [1,2]
  • Eosinophil Protein X is a marker of eosinophil-driven inflammation and allergic response.
  • Fecal Secretory IgA is a marker of gut secretory immunity and barrier function.
  • Fecal Occult Blood Test detects hidden blood; fecal immunochemical testing (FIT) has been recommended by the American College of Gastroenterology as the preferred noninvasive test for colorectal cancer screening/detection.
Gut Microbiome:
  • Genova is the first laboratory to introduce an Inflammation-Associated Dysbiosis score and a Methane Dysbiosis score by incorporating our latest, published microbiome data analysis.22
  • Metabolic indicators, including short-chain fatty acids and beta-glucuronidase, demonstrate specific and vital metabolic functions performed by the microbiota.
  • Commensal Bacteria demonstrate the composition, abundance and patterns of gut organisms.
    • More than 95% of commensal gut organisms are anaerobic and are difficult to recover by traditional (aerobic) culture techniques.
    • GI Effects assesses a set of 24 genera/species that map to 7 major phyla.
    • 16S rRNA gene polymerase chain reaction (qPCR) amplification technique
    • Comprehensive microbiome analysis included
  • Bacterial and mycology cultures demonstrate the presence of specific beneficial and pathogenic organisms.
    • Matrix Assisted Laser Desorption Ionization Time-of-Flight Mass Spectrometry (MALDI-TOF MS) technology is used for limitless bacterial and fungal species identification via culture
  • Bacterial and mycology sensitivities are provided for pathogenic or potentially pathogenic organisms that have been cultured. The report includes effective prescriptive and natural agents.
  • Parasitology includes comprehensive testing for all parasites on every parasitology exam ordered.
    • GI Effects provides microscopic fecal specimen examination for ova and parasites (O&P), the gold standard of diagnosis for many parasites.
    • 6 Real-time Polymerase Chain Reaction (PCR) targets detect common protozoal parasites including Blastocystis spp., Cryptosporidium parvum/hominisCyclospora cayetanensisDientamoeba fragilisEntamoeba histolytica, and Giardia. PCR for organisms is emerging as a highly sensitive method for infectious organism detection.
    • Selection of a one-day or three-day sample collection is based on the clinician's clinical index of suspicion for parasitic infection. If there is no/low suspicion, a one-day sample will likely be adequate. For high suspicion, a three-day sample collection is optimal.
Additional Biomarkers Available:
Additional Microbiome Module:
  • Microbiomix offers metagenomic shotgun/ whole genome sequencing to assess your patient's complete gut microbiome as well as its potential function. Microbiomix complements the information provided on the GI Effects. 

Uncover the Cause of your Gastrointestinal (GI) Symptoms

 

GI Effects stool testing might be right for you if you struggle with:

  • Gas
  • Bloating
  • Abdominal pain/cramps
  • Indigestion/reflux
  • Diarrhea
  • Constipation
  • Food Allergies
  • Inflammatory Bowel Disease (Crohn’s disease, Ulcerative colitis)
  • Irritable Bowel Syndrome (IBS)

 

Genova’s stool profiles provide a more complete evaluation of gut health.

Our testing provides information on inflammation and how well you digest and absorb your food. Stool testing can also uncover imbalances in yeast, parasites, and healthy and unhealthy bacteria that live in the large intestine. This bacterial population is called the microbiome.

Systemic diseases can be linked to the GI tract and improving the health of your gut may improve your overall health. Identifying abnormalities through Genova’s testing allows you and your healthcare provider to develop a personalized treatment plan to improve your symptoms.

Review the Test Preparation tab to learn more about the collection process.

Microbiomix

Genova's Commitment to Innovation Brings You a New Way to Assess the Microbiome

In the era of microbiome research, we are beginning to see that our gut microbiome has more control over our health than we ever knew. Until now, we have only seen the tip of the iceberg. The latest technology and ongoing research shows us that the microbiome is one of the most important health indicators.

 

Introducing the New Metagenomic Microbiomix Stool Analysis

Microbiomix offers metagenomic shotgun/ whole genome sequencing to assess your patient's complete gut microbiome as well as its potential function. Metagenomics is considered the gold standard method to study the gut microbiota.[1]

Microbiomix is available with the GI Effects Comprehensive Profile. Microbiomix complements the information provided on the GI Effects. This additional information may reveal treatable abnormalities that are not seen on GI Effects. Microbiomix is also available as a stand-alone offering. 

microbiomix report pages

 

What Does Microbiomix Offer?

Increased species detection

The Microbiomix platform detects bacteria, fungi, protists, and archaea amounting to over 28,000 species. Each person's microbiome contains over 200 species, all listed in the personalized report.

  • Includes identification of species that may confer pathogenic potential, such as Bacteroides fragilis and the fragilysin toxin - not available on the GI Effects.
  • Microbiomix assesses all methane-producing organisms, including Methanobrevibacter smithii also seen on GI Effects, and others.
  • The Microbiomix platform identifies newly discovered species that may not be well known to science and can see how they may be contributing to overall health.

 

Deeper insight into the microbiome's function

Microbiomix assesses the genetic potential to form unique metabolites such as hexa-LPS, TMA, histamine, vitamin production, branched chain amino acids, urease, GABA, hydrogen sulfide and many others - thus providing MORE information to help understand a patient's condition.

  • Many metabolites can be transported across the intestinal barrier and into the body's circulation. Microbial metabolites interact with our nervous system, immune, and metabolic functions to influence our overall health.
  • Some of these metabolites promote good health while others promote inflammation and disease.

 

Shannon Diversity Index

This metric is well-represented in the literature and is used to assess overall microbiome health. A diverse microbiome is ideal and is associated with greater health.

 

Specific, actionable recommendations

Tailored recommendations improve microbiome health which can influence overall health.

  • Easy-to-understand descriptions on how to modify microbiome potential with diet
  • Summary page recommending targeted prebiotics and foods

 

When would I consider ordering Microbiomix with the GI Effects?

Adding Microbiomix to the GI Effects offers a more complete picture of overall gut health.

Gut microbiome research has revealed the impact the gut has on every system in the body. The metabolites produced by the microbiome are bioactive and influence human health. Microbiomix offers a broader look at the microbiome's ability to produce these metabolites and therefore potentially prevent future chronic disease and promote optimal health.

Clinicians often order stool testing to assess GI symptoms such as:

  • Diarrhea
  • Constipation
  • Gas
  • Bloating
  • Abdominal discomfort
  • Indigestion

Additionally, since it is becoming recognized that the gut microbiome influences overall health, clinicians are beginning to look to the gut for numerous other health conditions including:

  • Allergies/asthma
  • Cardiovascular disease
  • Mood disorders (i.e., depression)
  • Autoimmune disease
  • Metabolic diseases (i.e., insulin resistance, diabetes)
  • Nutritional deficiencies

 

How does Microbiomix differ from other profiles?

Genova is the first and only company to offer a stool test of this kind - combining biomarker analysis on the GI Effects Comprehensive Profile with the most comprehensive genotypic microbiome data using Microbiomix.

 

Largest Organism Library

Metagenomic analysis heavily depends on reference databases. The organism library is unmatched in the industry with the ability to detect over 28,000 species.

  • This reference database contains several tens of thousands of microorganisms, many of which do not exist in public databases. This enables Genova to identify at least 25% more DNA than other metagenomic classifiers with access to a faster, more accurate approach than other analysis methods.[2]
  • Our growing microbial genome database uses the most scientifically advanced microbial taxonomy and complete database of bacterial and archaeal genomes currently available.[2]
  • Our world-leading database is regularly updated with new genomes to improve species identification from samples.
  • Whole genome sequencing is a complete microbiome assessment detecting bacteria, fungi, protists, and archaea. While PCR can be helpful for known pathogens, mutations will not be detected. PCR can also be limited in the ability to detect every organism.

 

Superior Analytical Performance

Validity and accuracy studies show superior performance compared to other platforms.[3,4]

  • Depth of sequencing the DNA is important for complete analysis. Reducing the depth of sequencing by performing fewer reads can reduce cost, however, it also compromises the quality. Genova performs a complete analysis of a patient's microbiome to deliver the highest quality information.
  • Metagenomics assesses DNA, whereas metatranscriptomics assesses RNA. DNA is more stable to assess. RNA provides a snapshot in time and may not be indicative of the long-term microbiome status.

 

Built-In Clinical Application

Microbiomix offers the most clinically relevant information about microbiome function and key organisms.

  • Easy-to-understand report
  • Clinically actionable metabolites
  • Evidence-based recommendations
  • Continuous lifetime report updates as the science advances

 

What can I expect when ordering Microbiomix?

Patients with complex illnesses often benefit from the most comprehensive testing — casting a wide net yields more information. GI Effects Comprehensive plus Microbiomix offers the most complete gut health test with actionable results. Dietary changes, supplements and lifestyle changes can all beneficially impact gut health and improve test results. Patients can lead an improved quality of life as their GI concerns are resolved.

Preparing for this Test

Certain medications, supplements, and/or foods may impact test results. Please note that the reference ranges were established based on patients who were taking no medications or supplements. In some instances it is unknown what potential impact a medication may have on test results.

There may be times when a patient may stay on a medication or dietary supplement during testing in order to evaluate its effectiveness. The recommendation to discontinue any substance is intended to establish a baseline finding. Below you will find a list detailing the potential interference or influence of certain substances on the biomarkers.

Genova never recommends that patients discontinue medically necessary medications or supplements in order to complete testing.

 

Collection Pack Instruction Recommended Timeframe to Discontinue Possible Biomarker(s) Impacted
Anti-inflammatory and immune modulating medications
Aspirin and NSAIDs (i.e. ibuprofen, etc.) 2 days May influence inflammation/immune biomarkers (EPX, calprotectin, sIgA)
Steroid (i.e. prednisone, etc.) No recommendation to discontinue
Autoimmune medications (i.e. Humira, etc.)
Digestive tract medications and supplements
Probiotics (beneficial bacteria) 2-4 weeks May influence the beneficial bacteria levels on culture, as well as metabolic markers; the presence of beneficial bacteria may alter the levels of other bacteria, yeast and parasites
Antacids (i.e. proton-pump inhibitors) 2-14 days (if ordering the H. pylori add-on, 14 days is recommended) May result in false negative H. pylori if PPI not discontinued for 14 days (H2 blockers do not interfere); additionally, acid-blocking medications may influence levels of the digestion and absorption markers; PPIs may clear the body relatively quickly, however the antacid effect may linger 3-5 days
Bismuth 2 days; if ordering the H. pylori add-on, 14 days is recommended May result in false negative H. pylori if bismuth not discontinued for 14 days; may affect other bacterial levels
Antacids (i.e. Tums, Rolaids, H2 blockers) 2 days Acid-blocking medication may influence levels of the digestion and absorption markers
Bentonite clay Bentonite clay affects bacteria and parasites that may be identified through microscopic examination and culture growth; this substance is a direct interferent and may result in inaccurate findings
Betaine HCl Hydrochloric acid is intended to improve digestion; therefore, markers of digestion and absorption may be influenced
Digestive enzymes Enzymes are intended to improve digestion; therefore, markers of digestion and absorption may be influenced
Laxatives Laxatives are intended to alter transit time; if laxative use results in normalized transit, there may be no effect on biomarkers. However if transit time is rapid, the markers of digestion and absorption may be influenced
Mineral oil, castor oil
Activated charcoal Activated charcoal can make identification of organisms seen in culture and microscopic examination more difficult; this substance is a direct interferent and may result in inaccurate findings
Rectal suppositories, enemas These agents can alter the density of stool samples resulting in inaccurate biomarker findings
Please note that a period of 4 weeks between a colonoscopy or barium enema and stool testing is recommended. It has been observed that 4 weeks is sufficient time for most patients to resume their previous level of gut function, including the elimination of all traces of barium, dietary/digestive normalization, and re-generation of microflora populations.
 
Antimicrobial Agents
Antibiotics 14 days May influence levels of bacteria, yeast and parasites, as well as metabolic markers; may result in false negative H. pylori if antibiotic not discontinued for 14 days
Antifungals
Antiparasitics

 

 

Illness

We do not suggest collecting during an acute gastrointestinal infectious illness.

Pediatric Patients

We do not generally recommend stool testing in children under the age of two as they are still establishing their gut flora which can impact numerous findings on the test. Inflammatory markers, such as calprotectin and lactoferrin, can also be skewed in younger children, especially if they are still breastfeeding. Reference ranges for many of the markers have not been established for this population.

Genova will not accept add-on testing for Clostridium difficile in individuals less than 2 years old based on recent research indicating non-pathogenic colonization in this age group.1

Fecal Occult Blood Testing

If the patient has a bleeding hemorrhoid(s) or is menstruating, it may interfere with the fecal occult blood test. It is preferred that the patient collect samples when there is not active bleeding.

Colectomy and Colostomy

Genova's stool profiles and reference ranges were not designed with this patient population taken into account. Test results and applicability for a patient who has had a complete or partial colectomy is unknown. Removal of the colon would be expected to impact the microbiome portion of the test, as the colon is the site where the majority of the bacteria reside. The metabolic by-products made by these bacteria may also be impacted. However, there may be clinical value in some of the other biomarkers on the test regarding inflammation and digestion/absorption. It would also be useful to see if there are any pathogenic or potentially pathogenic organisms present.

References
  1. D'Ostroph A, So T. Treatment of pediatric Clostridium difficile infection: a review on treatment efficacy and economic value. Infect Drug Resist. 2017;10:365-375.

How it Works

Consult Doctor

Your doctor will discuss your symptoms and help decide which test is right for you.

Many specimen collections can be completed from the privacy of your home.

chevron_right
Activate Test

Collection packs can be dropshipped directly to your home and everything you need to begin testing is included.

Already have a collection pack? Activate your test and begin today.

chevron_right
Collect Samples

Use a calendar to plan for your collection.

Follow instructions carefully and be sure to add important details about you and your specimens in the Activation portal.

chevron_right
Ship to Lab

Ship your specimens using the prepaid FedEx materials provided.

Results are available online. Schedule time with your physician to review results and create a plan for your health.

FAQ

Review information on the Test Preparation tab above for details on how medications and supplements may impact this test.

We provide a variety of testing services, and some of them may or may not be covered by your insurance plan.

Once your physician has ordered a Genova Diagnostics test for you, you can submit the CPT codes for your test to your commercial insurance plan to determine coverage. For information about billing options, please visit the Billing Information page.

Support guides, charts, and additional aids can be found on the Support Materials tab. Additional educational materials can be found in our Learning Library.

Genova also offers complimentary Medical Education Consultations for healthcare providers. Schedule consults online by signing in to your myGDX account.