Welcome to the CDI Patient Resource Center.
Contact our dedicated patient services team for additional support.

Instructional Guides & Videos

Patients should follow the instructions for use in their kit for additional test instructions and updated return shipping information. Please contact CDI’s dedicated customer service team at 888-258-5966 or customerservice@commdx.com with questions or concerns.

SIBO & IMO
10 Tube Test Kit

Fructose
Malabsorption

Lactose
Malabsorption

Sucrose
Malabsorption

IBSchek®
Capilliary Kit

FAQs and Billing & Insurance

What is Small Intestinal Bacterial Overgrowth (SIBO)?

SIBO is the accumulation of an excessive amount of gut bacteria in the small intestine (at least 100,000 bacteria per ml of fluid). While bacteria naturally exist throughout the digestive tract, with the highest concentrations of bacteria in the colon, a healthy individual should have relatively low levels of bacteria present in the small intestine. Any condition which impairs the normal transit or motion of the small intestine can increase the likelihood of getting SIBO, including lack of adequate stomach acid, damage to the intestine by toxins, or a decrease in the speed at which the small intestine transfers material to the colon. In the U.S., some research studies have demonstrated that up to 80% of the IBS population, or 36 million individuals, suffer from SIBO, and some researchers even hypothesize a connection between SIBO and common skin disorders like acne and rosacea.

What is hydrogen and methane breath testing?

Hydrogen and methane breath testing is based on the concept that bacteria can enter and proliferate in the small intestine and produce trace gases that are not generated by any normal function in the human body. By measuring the levels of these trace gases (hydrogen and methane) in the breath using gas chromatography, the test can aid in the diagnosis of small intestinal bacterial overgrowth (SIBO) and other gastrointestinal disorders like sugar malabsorption

How are patients’ kits returned to CDI?

We provide a pre-paid, pre-addressed shipping label in each kit. Patients will simply take the completed, sealed test kit and return it to us using the shipping label provided.

What is the turnaround time for laboratory results?

When the kit arrives at our laboratory, it will be analyzed within 1 business day. Kits that arrive on Saturdays or Holidays will be analyzed the following business day. Results will be sent to your practice via a secure fax system, secure email, or your office can set up an account with us to receive results via our HIPAA-compliant web-based reporting system.

Are there dietary restrictions involved with taking the test?

Only the following foods are permitted during the 12-hour preparatory diet period:

  • Seafood, chicken, turkey, lean beef, or pork
    • Baked, boiled, broiled, grilled, or pan seared only
  • Eggs
  • Plain white rice
  • Plain coffee or tea or water
  • Minimal oils for cooking, salt and pepper

NOTE: All other foods not listed above are not allowed during the 12-hour preparatory diet. Foods such as, but not limited to: alcohol, dairy, beans, wheat, grains, fruits and vegetables, and high-fiber containing foods are not allowed. Be sure to consult the Instructions for Use included in your kit.

Is fasting required?

Yes. A 12-hour fast is required prior to all breath tests. Water can be consumed during this time and during the test.

Are there any activity restrictions involved with taking the test?
  • Discontinue the use of any antibiotics for 4 weeks prior to taking the test.
  • Discontinue the use of any laxatives and/or promotility drugs for 1 week prior to taking the test.
  • Do not smoke or vape for at least 24 hours prior to the test, or any time during the test.
  • Do not sleep or exercise for at least 1 hour prior to taking the test or at any time during the test.
What if I forgot to collect my baseline sample before consuming the substrate?

If you remembered to collect the baseline sample within 15 minutes of consuming the substrate, the test can be continued as normal. Be sure to collect the second sample 15 minutes after consuming the substrate. If the baseline sample was collected after 15 minutes, the test needs to be repeated.

Will vomiting during the test affect my results?

If the event was within 15-30 minutes after consuming the substrate, the test needs to be repeated. If the event was more than 30 minutes after consuming the substrate, the test can be continued as normal.

Will using the bathroom during the test affect my results?

Your overall results will be affected if you have a bowel movement, but continue with your test and include a note with your samples noting the time/sample during which this occurred. The note will be relayed to your health care provider. Your health care provider may decide a re-test is appropriate after the test is analyzed.

Do I have to drink the entire substrate?

Yes, you must drink the entire substrate mixture, quickly, for the test to be valid. If you do not drink the entire mixture, the test must be repeated.

Can I eat during the test?

No. Eating at any point during the test will make the test results invalid. The test must be repeated.

If I mislabel the tubes can my samples still be analyzed?

If either the times or sample numbers were recorded, then we can process your test. If you do not record the time of the sample, we will include a note to your health care provider with your test results. Your health care provider will determine whether to accept the test results that were not labeled with times for each sample. If neither the time nor sample numbers were recorded, the test will not be analyzed.

What is the difference between glucose and lactulose substrates?

Glucose is absorbed by the digestive tract so it will not be able to detect SIBO that is further along in the small intestine (proximal jejunum/ileum). However, because of this, glucose is considered to be more sensitive than lactulose, providing less false positives with colonic bacteria.

Lactulose is not absorbed by the digestive tract and will travel through the entire gastrointestinal tract, ultimately providing a complete depiction of all intestinal segments, including the colon (large intestine).

What are the ingredients to the sugar substrates?

In the United States, lactulose contains a 10-gram dose of lactulose with less than 1.6-grams of galactose, less than 1.2-grams of lactose, and 1.2- grams of other sugars. If you have a sensitivity to any of the sugars listed, please consult your healthcare provider/nutritionist for a possible alternative substrate he/she can prescribe. (i.e. glucose)

Outside the United States, lactulose contains a 10-gram dose of lactulose with more than 5-grams of lactose/galactose/epilactose. If you have a sensitivity to any of the sugars listed, please consult your healthcare provider/nutritionist for a possible alternative substrate he/she can prescribe. (i.e. glucose)

Glucose is 100% glucose sugar. If you are sensitive and/or have diabetes (Type I or II), please consult with your healthcare provider if this substrate is right for you.

Fructose is 100% fructose sugar.

Lactose is 100% lactose sugar.

Sucrose is 100% sucrose sugar.

How long are my samples stable for?

Your breath samples are stable for up to two weeks and across a wide temperature range (-4°F to 104°F). Samples received after two weeks of collection will be invalid.

When is a sample invalid?

We consider any samples with a Carbon Dioxide (CO2) concentration of less than 2.00% to be an invalid sample.

What if my kit arrives and is missing components?

If there are any components missing from any test kit, we will send out a new test kit to you or health care provider. Please contact our Customer Service Department at 1-888-258-5966 in this instance.

May I take more than one test on the same day?

No. Each test must be taken after fasting for 12 hours and following a subsequent 12-hour preparatory diet. Taking two tests on the same day will produce invalid results.

I tested positive for COVID-19. When can I take and return a CDI breath test?

For any patient that has tested positive for COVID-19, CDI has adopted a corporate policy whereby you should not administer and return your test kit, and CDI will not accept samples from any known COVID-19 positive patient, until thirty days (30) have passed following a negative follow-up test for COVID-19 from your healthcare provider.

We are implementing this policy in an abundance of caution in order to provide for the safest possible environment for our patients as well as our employees and clinical staff. We thank you for your cooperation with our policies, we wish you a speedy recovery and good health, and we look forward to working with you in the near future to help diagnose your gastrointestinal symptoms.

What is IBS?

Irritable bowel syndrome (IBS) is a chronic bowel problem that is associated with bloating, intermittent abdominal discomfort, and changes in bowel frequency and form. Diarrhea and constipation are common symptoms associated with IBS. Until now, the diagnosis of IBS has typically been a diagnosis of exclusion (meaning a diagnosis arrived at by excluding other conditions) because IBS symptoms are similar to those seen for celiac disease, Crohn’s disease, ulcerative colitis, and other chronic bowel diseases.

What is the IBSchek test?

IBSchek is a simple ELISA*-based blood test that is highly predictive of an IBS diagnosis based on the presence of two antibodies—anti-CdtB and anti-vinculin. In a study of more than 2,500 patients conducted in 180 centers around the U.S., IBSchek was found to be more commonly positive in IBS with diarrhea (IBS-D) or IBS with mixed symptoms (IBS-M) compared to patients with Crohn’s disease, ulcerative colitis, and celiac disease. IBSchek is the first clinically validated blood test to confirm a diagnosis of either IBS-D or IBS-M. *ELISA = enzyme-linked immunosorbent assay.

How does IBSchek work?

IBSchek was developed based on the scientific discovery that irritable bowel syndrome often results from a previous episode of gastroenteritis. IBSchek tests for the presence of antibodies in the blood that were created by alterations in the intestinal microbiota resulting from acute gastroenteritis. It detects levels of an antibody to a toxin called CdtB (cytolethal distending toxin B), as well as vinculin, a human protein commonly found in nerves and the lining of the gut. While the test is more specific for anti-CdtB, the anti-vinculin component suggests that irritable bowel syndrome may be an autoimmune disease. The two levels enable a differential diagnosis of IBS from inflammatory bowel disease (IBD). The test only requires 3mL of patient’s blood which can be drawn in a healthcare provider’s office. For more information on the phlebotomy process refer to the IBSchek Phlebotomy Process.

Does IBSchek work for IBS with diarrhea and mixed symptoms?

IBSchek has been validated in diagnosing irritable bowel syndrome associated with diarrhea and mixed symptoms. Published studies have determined the cost savings—both direct and indirect—to the patient and healthcare system from receiving a faster diagnosis.

How do you order IBSchek?

It’s a simple process. A healthcare provider completes an IBSchek requisition form and submits it to CDI. HCP then completes the patient’s blood draw and returns the specimen according to the instructions provided in the return shipping materials. Results are reported back to the healthcare provider within 24 hours of specimen receipt. For additional details, please refer to the IBSchek Phlebotomy Process overview. In the event the healthcare provider is unable to do the blood draw, you can contact CDI to arrange an alternative method by either visiting a partnering lab or using a mobile phlebotomy service that will draw the blood in the comfort of the patient’s home. Contact CDI customer service for more details on these options – customerservice@commdx.com or (888) 258-5966.

What does a positive IBSchek mean?

This is a very important question. All tests are based on statistics. If the result is positive, it means there is a high degree of medical certainty that there is IBS-D or IBS-M, based on elevated levels of antibodies to Cdtb and/or vinculin. Having a high degree of certainty in irritable bowel syndrome diagnosis can reduce the cost to patients, providers, and the healthcare system as a whole, and can prevent treatment delays. IBSchek may prevent patients from having to undergo more invasive and costly exploratory tests, and, more precisely, it can direct next steps in patient treatment.

What if IBSchek is inconclusive?

Although IBSchek is highly predictive of an IBS-D or IBS-M diagnosis, some patients will still have an inconclusive test result even though they suspect they have IBS. IBSchek tests for a specific mechanism known to cause irritable bowel syndrome. If the result is positive, you know the pathophysiological reason for your patient’s IBS and can determine the optimal approach to treat. However, an inconclusive IBSchek result is simply an indication that additional testing may be required to determine the underlying cause of your patient’s symptoms. One option that may be a viable consideration is the hydrogen and methane breath test for small intestinal bacterial overgrowth (SIBO). The SIBO breath test can identify an over-colonization of bacteria in the small intestine that may be directly contributing to a patient’s symptoms. This allows an accurate, quick diagnosis of common sources of digestive distress. Hydrogen and methane breath tests offer not only a patient-friendly alternative to more invasive diagnostic methods, but once the SIBO is identified, an appropriate antibiotic regimen or other appropriate treatment may be prescribed.

What is the turnaround time for test results?

When the blood specimen arrives at a CDI-affiliated laboratory, the blood will be analyzed within 24 hours of receipt of the specimen. You can receive the results via our secured reporting system. *Please contact us at customerservice@commdx.com for sample report information.

Can medications affect IBSchek results?

Yes, some medications can affect the results of an antibody test. It is important to note that if you are taking steroids, anti-inflammatory medications, biologic agents, or any other immunosuppressive medications, you may not get a true reading, because these medications may change the level of antibodies in the blood. If a patient with suspected IBS has an inconclusive test and is taking any of these medications, repeat testing could be considered at a time when you are no longer taking these medications.

Is there a link between IBS and Small Intestinal Bacterial Overgrowth (SIBO)?

It is now known, based on extensive human and animal research, that acute gastroenteritis leads to IBS. In animal studies, infection with campylobacter jejuni (C. jejuni) caused small intestinal bacterial overgrowth. C. jejuni infection also leads to the production of the anti-CdtB and anti-vinculin antibodies detected by IBSchek. In the same animal studies, antibody levels were related to the number of infections the animals experienced. However, irrespective of the number of infections with C. jejuni, bacterial overgrowth was more closely related to the antibodies than the number of infections.

Does a positive IBSchek tell me what treatment to use?

A positive IBSchek can confirm that your patient has IBS-S or IBS-M and that the disease is an organic condition based on the presence of validated biomarkers. IBSchek does not offer insight into which treatment is best for your irritable bowel syndrome patient. Confidently knowing your patient has IBS based on the presence of biomarkers, however, allows you to immediately initiate therapy without additional invasive and costly testing. You may want to consider a hydrogen and methane breath test for small intestinal bacterial overgrowth (SIBO) to help determine the type of antibiotic therapy to use. Treatment of a patient with methane-positive breath results differs from that of a patient with hydrogen-positive results. Once the SIBO is identified, an appropriate antibiotic regimen can be prescribed for the treatment of irritable bowel syndrome. Alternatively, some healthcare providers treat SIBO using other therapies and dietary modalities, including but not limited to the FODMAP diet.

Who can order IBSchek?

Any healthcare provider who has applicable prescribing rights in his or her state or country of residence can order IBSchek. Patients may also order the test where Direct Access Testing is available and permitted.

Breath Tests

CDI will submit a claim on the patient’s behalf to commercial insurance, Medicare or Tricare. Insurance may cover some or all of the test depending on the patient’s insurance plan and benefits. In the event the patient’s insurance provider denies the insurance claim, or if the patient has not met the deductible or has a coinsurance or co-pay, or if for any reason the insurance does not cover the full amount of the test, the patient is responsible to pay CDI for products and services received.

CDI does not accept any Medicaid plans: therefore any Medicaid patient taking a test will be responsible for the full cost of the test. CDI offers convenient payment plans and financial hardship programs for qualifying patients. Patients may pay up front via check sent with the kit or credit card. The maximum out-of-pocket cost per test is $175 for patients that pay promptly in accordance with CDI patient billing policies and programs. For an updated list of in-network providers, please visit www.commdx.com/insurance.

Blood Tests

IBSchek Capillary Collection Kit is available for $199 via self-pay only. Currently, CDI does not accept, or submit to, any form of insurance for this IBSchek. Patients must elect to self-pay for this service and is responsible for the full cost of these products and services prior to their delivery.

Any healthcare provider who has applicable prescribing rights in his or her state or country of residence can order IBSchek. Patients may also order the test where Direct Access Testing is available and permitted.

Breath Test FAQs
What is Small Intestinal Bacterial Overgrowth (SIBO)?

SIBO is the accumulation of an excessive amount of gut bacteria in the small intestine (at least 100,000 bacteria per ml of fluid). While bacteria naturally exist throughout the digestive tract, with the highest concentrations of bacteria in the colon, a healthy individual should have relatively low levels of bacteria present in the small intestine. Any condition which impairs the normal transit or motion of the small intestine can increase the likelihood of getting SIBO, including lack of adequate stomach acid, damage to the intestine by toxins, or a decrease in the speed at which the small intestine transfers material to the colon. In the U.S., some research studies have demonstrated that up to 80% of the IBS population, or 36 million individuals, suffer from SIBO, and some researchers even hypothesize a connection between SIBO and common skin disorders like acne and rosacea.

What is hydrogen and methane breath testing?

Hydrogen and methane breath testing is based on the concept that bacteria can enter and proliferate in the small intestine and produce trace gases that are not generated by any normal function in the human body. By measuring the levels of these trace gases (hydrogen and methane) in the breath using gas chromatography, the test can aid in the diagnosis of small intestinal bacterial overgrowth (SIBO) and other gastrointestinal disorders like sugar malabsorption

How are patients’ kits returned to CDI?

We provide a pre-paid, pre-addressed shipping label in each kit. Patients will simply take the completed, sealed test kit and return it to us using the shipping label provided.

What is the turnaround time for laboratory results?

When the kit arrives at our laboratory, it will be analyzed within 1 business day. Kits that arrive on Saturdays or Holidays will be analyzed the following business day. Results will be sent to your practice via a secure fax system, secure email, or your office can set up an account with us to receive results via our HIPAA-compliant web-based reporting system.

Are there dietary restrictions involved with taking the test?

Only the following foods are permitted during the 12-hour preparatory diet period:

  • Seafood, chicken, turkey, lean beef, or pork
    • Baked, boiled, broiled, grilled, or pan seared only
  • Eggs
  • Plain white rice
  • Plain coffee or tea or water
  • Minimal oils for cooking, salt and pepper

NOTE: All other foods not listed above are not allowed during the 12-hour preparatory diet. Foods such as, but not limited to: alcohol, dairy, beans, wheat, grains, fruits and vegetables, and high-fiber containing foods are not allowed. Be sure to consult the Instructions for Use included in your kit.

Is fasting required?

Yes. A 12-hour fast is required prior to all breath tests. Water can be consumed during this time and during the test.

Are there any activity restrictions involved with taking the test?
  • Discontinue the use of any antibiotics for 4 weeks prior to taking the test.
  • Discontinue the use of any laxatives and/or promotility drugs for 1 week prior to taking the test.
  • Do not smoke or vape for at least 24 hours prior to the test, or any time during the test.
  • Do not sleep or exercise for at least 1 hour prior to taking the test or at any time during the test.
What if I forgot to collect my baseline sample before consuming the substrate?

If you remembered to collect the baseline sample within 15 minutes of consuming the substrate, the test can be continued as normal. Be sure to collect the second sample 15 minutes after consuming the substrate. If the baseline sample was collected after 15 minutes, the test needs to be repeated.

Will vomiting during the test affect my results?

If the event was within 15-30 minutes after consuming the substrate, the test needs to be repeated. If the event was more than 30 minutes after consuming the substrate, the test can be continued as normal.

Will using the bathroom during the test affect my results?

Your overall results will be affected if you have a bowel movement, but continue with your test and include a note with your samples noting the time/sample during which this occurred. The note will be relayed to your health care provider. Your health care provider may decide a re-test is appropriate after the test is analyzed.

Do I have to drink the entire substrate?

Yes, you must drink the entire substrate mixture, quickly, for the test to be valid. If you do not drink the entire mixture, the test must be repeated.

Can I eat during the test?

No. Eating at any point during the test will make the test results invalid. The test must be repeated.

If I mislabel the tubes can my samples still be analyzed?

If either the times or sample numbers were recorded, then we can process your test. If you do not record the time of the sample, we will include a note to your health care provider with your test results. Your health care provider will determine whether to accept the test results that were not labeled with times for each sample. If neither the time nor sample numbers were recorded, the test will not be analyzed.

What is the difference between glucose and lactulose substrates?

Glucose is absorbed by the digestive tract so it will not be able to detect SIBO that is further along in the small intestine (proximal jejunum/ileum). However, because of this, glucose is considered to be more sensitive than lactulose, providing less false positives with colonic bacteria.

Lactulose is not absorbed by the digestive tract and will travel through the entire gastrointestinal tract, ultimately providing a complete depiction of all intestinal segments, including the colon (large intestine).

What are the ingredients to the sugar substrates?

In the United States, lactulose contains a 10-gram dose of lactulose with less than 1.6-grams of galactose, less than 1.2-grams of lactose, and 1.2- grams of other sugars. If you have a sensitivity to any of the sugars listed, please consult your healthcare provider/nutritionist for a possible alternative substrate he/she can prescribe. (i.e. glucose)

Outside the United States, lactulose contains a 10-gram dose of lactulose with more than 5-grams of lactose/galactose/epilactose. If you have a sensitivity to any of the sugars listed, please consult your healthcare provider/nutritionist for a possible alternative substrate he/she can prescribe. (i.e. glucose)

Glucose is 100% glucose sugar. If you are sensitive and/or have diabetes (Type I or II), please consult with your healthcare provider if this substrate is right for you.

Fructose is 100% fructose sugar.

Lactose is 100% lactose sugar.

Sucrose is 100% sucrose sugar.

How long are my samples stable for?

Your breath samples are stable for up to two weeks and across a wide temperature range (-4°F to 104°F). Samples received after two weeks of collection will be invalid.

When is a sample invalid?

We consider any samples with a Carbon Dioxide (CO2) concentration of less than 2.00% to be an invalid sample.

What if my kit arrives and is missing components?

If there are any components missing from any test kit, we will send out a new test kit to you or health care provider. Please contact our Customer Service Department at 1-888-258-5966 in this instance.

May I take more than one test on the same day?

No. Each test must be taken after fasting for 12 hours and following a subsequent 12-hour preparatory diet. Taking two tests on the same day will produce invalid results.

I tested positive for COVID-19. When can I take and return a CDI breath test?

For any patient that has tested positive for COVID-19, CDI has adopted a corporate policy whereby you should not administer and return your test kit, and CDI will not accept samples from any known COVID-19 positive patient, until thirty days (30) have passed following a negative follow-up test for COVID-19 from your healthcare provider.

We are implementing this policy in an abundance of caution in order to provide for the safest possible environment for our patients as well as our employees and clinical staff. We thank you for your cooperation with our policies, we wish you a speedy recovery and good health, and we look forward to working with you in the near future to help diagnose your gastrointestinal symptoms.

Blood Test FAQs
What is IBS?

Irritable bowel syndrome (IBS) is a chronic bowel problem that is associated with bloating, intermittent abdominal discomfort, and changes in bowel frequency and form. Diarrhea and constipation are common symptoms associated with IBS. Until now, the diagnosis of IBS has typically been a diagnosis of exclusion (meaning a diagnosis arrived at by excluding other conditions) because IBS symptoms are similar to those seen for celiac disease, Crohn’s disease, ulcerative colitis, and other chronic bowel diseases.

What is the IBSchek test?

IBSchek is a simple ELISA*-based blood test that is highly predictive of an IBS diagnosis based on the presence of two antibodies—anti-CdtB and anti-vinculin. In a study of more than 2,500 patients conducted in 180 centers around the U.S., IBSchek was found to be more commonly positive in IBS with diarrhea (IBS-D) or IBS with mixed symptoms (IBS-M) compared to patients with Crohn’s disease, ulcerative colitis, and celiac disease. IBSchek is the first clinically validated blood test to confirm a diagnosis of either IBS-D or IBS-M. *ELISA = enzyme-linked immunosorbent assay.

How does IBSchek work?

IBSchek was developed based on the scientific discovery that irritable bowel syndrome often results from a previous episode of gastroenteritis. IBSchek tests for the presence of antibodies in the blood that were created by alterations in the intestinal microbiota resulting from acute gastroenteritis. It detects levels of an antibody to a toxin called CdtB (cytolethal distending toxin B), as well as vinculin, a human protein commonly found in nerves and the lining of the gut. While the test is more specific for anti-CdtB, the anti-vinculin component suggests that irritable bowel syndrome may be an autoimmune disease. The two levels enable a differential diagnosis of IBS from inflammatory bowel disease (IBD). The test only requires 3mL of patient’s blood which can be drawn in a healthcare provider’s office. For more information on the phlebotomy process refer to the IBSchek Phlebotomy Process.

Does IBSchek work for IBS with diarrhea and mixed symptoms?

IBSchek has been validated in diagnosing irritable bowel syndrome associated with diarrhea and mixed symptoms. Published studies have determined the cost savings—both direct and indirect—to the patient and healthcare system from receiving a faster diagnosis.

How do you order IBSchek?

It’s a simple process. A healthcare provider completes an IBSchek requisition form and submits it to CDI. HCP then completes the patient’s blood draw and returns the specimen according to the instructions provided in the return shipping materials. Results are reported back to the healthcare provider within 24 hours of specimen receipt. For additional details, please refer to the IBSchek Phlebotomy Process overview. In the event the healthcare provider is unable to do the blood draw, you can contact CDI to arrange an alternative method by either visiting a partnering lab or using a mobile phlebotomy service that will draw the blood in the comfort of the patient’s home. Contact CDI customer service for more details on these options – customerservice@commdx.com or (888) 258-5966.

What does a positive IBSchek mean?

This is a very important question. All tests are based on statistics. If the result is positive, it means there is a high degree of medical certainty that there is IBS-D or IBS-M, based on elevated levels of antibodies to Cdtb and/or vinculin. Having a high degree of certainty in irritable bowel syndrome diagnosis can reduce the cost to patients, providers, and the healthcare system as a whole, and can prevent treatment delays. IBSchek may prevent patients from having to undergo more invasive and costly exploratory tests, and, more precisely, it can direct next steps in patient treatment.

What if IBSchek is inconclusive?

Although IBSchek is highly predictive of an IBS-D or IBS-M diagnosis, some patients will still have an inconclusive test result even though they suspect they have IBS. IBSchek tests for a specific mechanism known to cause irritable bowel syndrome. If the result is positive, you know the pathophysiological reason for your patient’s IBS and can determine the optimal approach to treat. However, an inconclusive IBSchek result is simply an indication that additional testing may be required to determine the underlying cause of your patient’s symptoms. One option that may be a viable consideration is the hydrogen and methane breath test for small intestinal bacterial overgrowth (SIBO). The SIBO breath test can identify an over-colonization of bacteria in the small intestine that may be directly contributing to a patient’s symptoms. This allows an accurate, quick diagnosis of common sources of digestive distress. Hydrogen and methane breath tests offer not only a patient-friendly alternative to more invasive diagnostic methods, but once the SIBO is identified, an appropriate antibiotic regimen or other appropriate treatment may be prescribed.

What is the turnaround time for test results?

When the blood specimen arrives at a CDI-affiliated laboratory, the blood will be analyzed within 24 hours of receipt of the specimen. You can receive the results via our secured reporting system. *Please contact us at customerservice@commdx.com for sample report information.

Can medications affect IBSchek results?

Yes, some medications can affect the results of an antibody test. It is important to note that if you are taking steroids, anti-inflammatory medications, biologic agents, or any other immunosuppressive medications, you may not get a true reading, because these medications may change the level of antibodies in the blood. If a patient with suspected IBS has an inconclusive test and is taking any of these medications, repeat testing could be considered at a time when you are no longer taking these medications.

Is there a link between IBS and Small Intestinal Bacterial Overgrowth (SIBO)?

It is now known, based on extensive human and animal research, that acute gastroenteritis leads to IBS. In animal studies, infection with campylobacter jejuni (C. jejuni) caused small intestinal bacterial overgrowth. C. jejuni infection also leads to the production of the anti-CdtB and anti-vinculin antibodies detected by IBSchek. In the same animal studies, antibody levels were related to the number of infections the animals experienced. However, irrespective of the number of infections with C. jejuni, bacterial overgrowth was more closely related to the antibodies than the number of infections.

Does a positive IBSchek tell me what treatment to use?

A positive IBSchek can confirm that your patient has IBS-S or IBS-M and that the disease is an organic condition based on the presence of validated biomarkers. IBSchek does not offer insight into which treatment is best for your irritable bowel syndrome patient. Confidently knowing your patient has IBS based on the presence of biomarkers, however, allows you to immediately initiate therapy without additional invasive and costly testing. You may want to consider a hydrogen and methane breath test for small intestinal bacterial overgrowth (SIBO) to help determine the type of antibiotic therapy to use. Treatment of a patient with methane-positive breath results differs from that of a patient with hydrogen-positive results. Once the SIBO is identified, an appropriate antibiotic regimen can be prescribed for the treatment of irritable bowel syndrome. Alternatively, some healthcare providers treat SIBO using other therapies and dietary modalities, including but not limited to the FODMAP diet.

Who can order IBSchek?

Any healthcare provider who has applicable prescribing rights in his or her state or country of residence can order IBSchek. Patients may also order the test where Direct Access Testing is available and permitted.

Billing & Insurance

Breath Tests

CDI will submit a claim on the patient’s behalf to commercial insurance, Medicare or Tricare. Insurance may cover some or all of the test depending on the patient’s insurance plan and benefits. In the event the patient’s insurance provider denies the insurance claim, or if the patient has not met the deductible or has a coinsurance or co-pay, or if for any reason the insurance does not cover the full amount of the test, the patient is responsible to pay CDI for products and services received.

CDI does not accept any Medicaid plans: therefore any Medicaid patient taking a test will be responsible for the full cost of the test. CDI offers convenient payment plans and financial hardship programs for qualifying patients. Patients may pay up front via check sent with the kit or credit card. The maximum out-of-pocket cost per test is $175 for patients that pay promptly in accordance with CDI patient billing policies and programs. For an updated list of in-network providers, please visit www.commdx.com/insurance.

Blood Tests

IBSchek Capillary Collection Kit is available for $199 via self-pay only. Currently, CDI does not accept, or submit to, any form of insurance for this IBSchek. Patients must elect to self-pay for this service and is responsible for the full cost of these products and services prior to their delivery.

Any healthcare provider who has applicable prescribing rights in his or her state or country of residence can order IBSchek. Patients may also order the test where Direct Access Testing is available and permitted.