CDI operates out of our state-of-the-art CLIA-certified laboratory located in Salem, Massachusetts. Our industry-leading functional GI diagnostic lab ensures sample intake efficiency, analytical accuracy, quality assurance, and expedited result turnaround time.

Working with one of the premier manufacturers in the gas chromatography (GC) market, CDI has developed an optimal combination of custom component parts, the use of a two-detector system, and specific method parameters to make our instruments more accurate, precise, and sensitive in detecting all three gases of interest in breath testing: hydrogen (H2), methane (CH4), and carbon dioxide (CO2).
Superior Clinical Sophistication and Laboratory Instrumentation
  • Customized, automated, high-throughput gas chromatography (GC) instrumentation manufactured by Agilent Technologies.
  • Wider linear range than other instrumentation on the market, which spans from 3 to 1000 ppm for hydrogen, 3 to 1000 ppm for methane, and 0.2 to 10% for carbon dioxide. Accuracy maintained across the entire linear range greater than 90% for each trace gas.
  • Consistency of samples through our instrumentation is ± 2 ppm for hydrogen and methane and ± 0.1% for carbon dioxide, which is excellent precision between samples according to GC industry standards.
Industry Leading Clinical Criteria and Reporting
  • Calibration of GC instruments uses National Institute of Standards and Technology (NIST) traceable gas standards to ensure the most accurate sample detection and test results.
  • Clinical guidelines for breath testing pursuant to the North American Consensus for Breath Testing, the only standardized breath testing guidelines agreed to by 17 independent clinical scientists from all over the world.
Industry Leading Quality Management, Accuracy, and Precision
  • Fully automated sample extraction for a higher sample throughput, increased consistency in samples across all patients, and a smaller injection volume which allows for repeat analysis within the same sample if necessary.
  • Exclusive collection tube that ensures the stability of the breath sample is maintained for up to two weeks after collection across a wide range of temperatures (-4 to 104 °F).
  • Assurance that instrument performance and technical staff training are maintained at the highest level of accuracy and consistency across tests analyzed.
  • High-purity reference gases utilized to increase signal-to-noise ratios, which improves sample detection limits.
IBSchek® is a proprietary blood test for Irritable Bowel Syndrome (IBS) based on the scientific findings of a 2500+ patient clinical trial which showed that anti-vinculin and anti-CdtB are effective biomarkers for the diagnosis of diarrhea-predominant or mixed-symptom IBS. Irritable Bowel Syndrome (IBS) is the most common functional gastrointestinal syndrome in the U.S. It is estimated that up to 45 million people, or 10-15% of the American population, suffer from IBS.
Clinically validated in 2015 and revalidated internationally, IBSchek is the most reliable diagnostic blood test for IBS in the market.
IBS Pathophysiologic Sequence Explained
null

Acute Gastroenteritis

  • Studies have demonstrated a direct causal relationship between an episode of acute gastroenteritis and IBS
  • Animal studies confirm the link between food poisoning and bacterial overgrowth

null

Bacterial Toxin

  • Specific bacteria—such as Campylobacter jejuni, Escherichia coli, Salmonella, and Shigella—play an integral role in the pathogenesis
  • These bacteria often generate a toxin called cytolethal distending toxin subunit B (CdtB)

null

Autoimmunity Response

  • The body reacts to CdtB with an immune response— generating antibodies in the bloodstream
  • Because of immunologic similarities, these antibodies cross-react to a protein in the nerves of the gut known as vinculin

null

Gut Nerve Damage

  • This autoimmunity against vinculin affects the function of the gut
  • Loss of function leads to neuronal degradation and reduced motility

null

Bacterial Overgrowth

  • With gut motility reduced, stasis occurs as the natural flow pattern is disrupted
  • This stasis leads to bacterial overgrowth, also known as small intestine bacterial overgrowth (SIBO)

null

IBS

  • The entire process leads to the bloating and abdominal pain that are the initial signs and symptoms of IBS

Breath Testing
Working with one of the premier manufacturers in the gas chromatography (GC) market, CDI has developed an optimal combination of custom component parts, the use of a two-detector system, and specific method parameters to make our instruments more accurate, precise, and sensitive in detecting all three gases of interest in breath testing: hydrogen (H2), methane (CH4), and carbon dioxide (CO2).
Superior Clinical Sophistication and Laboratory Instrumentation
  • Customized, automated, high-throughput gas chromatography (GC) instrumentation manufactured by Agilent Technologies.
  • Wider linear range than other instrumentation on the market, which spans from 3 to 1000 ppm for hydrogen, 3 to 1000 ppm for methane, and 0.2 to 10% for carbon dioxide. Accuracy maintained across the entire linear range greater than 90% for each trace gas.
  • Consistency of samples through our instrumentation is ± 2 ppm for hydrogen and methane and ± 0.1% for carbon dioxide, which is excellent precision between samples according to GC industry standards.
Industry Leading Clinical Criteria and Reporting
  • Calibration of GC instruments uses National Institute of Standards and Technology (NIST) traceable gas standards to ensure the most accurate sample detection and test results.
  • Clinical guidelines for breath testing pursuant to the North American Consensus for Breath Testing, the only standardized breath testing guidelines agreed to by 17 independent clinical scientists from all over the world.
Industry Leading Quality Management, Accuracy, and Precision
  • Fully automated sample extraction for a higher sample throughput, increased consistency in samples across all patients, and a smaller injection volume which allows for repeat analysis within the same sample if necessary.
  • Exclusive collection tube that ensures the stability of the breath sample is maintained for up to two weeks after collection across a wide range of temperatures (-4 to 104 °F).
  • Assurance that instrument performance and technical staff training are maintained at the highest level of accuracy and consistency across tests analyzed.
  • High-purity reference gases utilized to increase signal-to-noise ratios, which improves sample detection limits.
Blood Testing
IBSchek® is a proprietary blood test for Irritable Bowel Syndrome (IBS) based on the scientific findings of a 2500+ patient clinical trial which showed that anti-vinculin and anti-CdtB are effective biomarkers for the diagnosis of diarrhea-predominant or mixed-symptom IBS. Irritable Bowel Syndrome (IBS) is the most common functional gastrointestinal syndrome in the U.S. It is estimated that up to 45 million people, or 10-15% of the American population, suffer from IBS.
Clinically validated in 2015 and revalidated internationally, IBSchek is the most reliable diagnostic blood test for IBS in the market.
IBS Pathophysiologic Sequence Explained
null

Acute Gastroenteritis

  • Studies have demonstrated a direct causal relationship between an episode of acute gastroenteritis and IBS
  • Animal studies confirm the link between food poisoning and bacterial overgrowth

null

Bacterial Toxin

  • Specific bacteria—such as Campylobacter jejuni, Escherichia coli, Salmonella, and Shigella—play an integral role in the pathogenesis
  • These bacteria often generate a toxin called cytolethal distending toxin subunit B (CdtB)

null

Autoimmunity Response

  • The body reacts to CdtB with an immune response— generating antibodies in the bloodstream
  • Because of immunologic similarities, these antibodies cross-react to a protein in the nerves of the gut known as vinculin

null

Gut Nerve Damage

  • This autoimmunity against vinculin affects the function of the gut
  • Loss of function leads to neuronal degradation and reduced motility

null

Bacterial Overgrowth

  • With gut motility reduced, stasis occurs as the natural flow pattern is disrupted
  • This stasis leads to bacterial overgrowth, also known as small intestine bacterial overgrowth (SIBO)

null

IBS

  • The entire process leads to the bloating and abdominal pain that are the initial signs and symptoms of IBS

Combining our instrumentation and methods with a robust QA/QC quality system that was developed in accordance with CLIA high complexity guidelines enables CDI to be more accurate in the test results we deliver day in and day out. We pride ourselves on precise and accurate results with the highest level of data integrity.