Welcome to the CDI Provider Resource Center.
Contact our dedicated provider services team for additional support.

Mid-Year 2021 Functional GI Trends Guide

Patient Instructional Guides & Videos

Patients should follow the instructions for use in their kit for additional test instructions and updated return shipping information. Patients can also 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

Get your free eBook on breath testing and COVID-19's impact on functional GI diagnostic plans.

FAQs and Billing & Insurance

How do I order breath testing kits for my patients?

Our hydrogen and methane breath test kits are available to health care providers at no cost. They are easily accessible through our website’s Ordering page or by contacting your Account Representative. Many of our providers also take advantage of our automatic re-ordering program to proactively account for average monthly usage. Call our Customer Service Department at 1-888-258-5966 for more information about ordering kits.

Where will my patients take the test?

Our patient-centric model allows your patients to administer these tests in the comfort of their own home. Your office will simply fill out the one-page Requisition Form included in every kit and send your patient home to take it. A pre-paid return shipping label is included in the kit for easy patient return to our laboratory. We will take care of the rest.

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.

How is my patient’s insurance billing handled?

Insurance may cover some or all of your patient’s breath test depending on the patient’s insurance plan and benefits. We bill the medical insurance provider specified by patients on their Requisition Form included in each kit. CDI does not accept Medicaid. We offer a patient assistance program for qualified individuals who cannot afford the test. Please call our Customer Service Department at 1-888-258-5966 for more information about billing or our patient assistance program.

Do patients need a pre-authorization before taking the test?

This depends on the patient’s individual health plan. Even within the same medical health insurance company, some plans require pre-authorization and others do not. It is best for the patient to contact the appropriate health insurance representative to inquire about pre-authorization. Your patients’ claim may require an out of network pre-authorization referral. If there is a pre-authorization number, please ask the patient to write it on the Requisition Form he/she will be sending to us with the breath samples.

What if the patient doesn’t have medical insurance?

If your patient has no medical insurance, ask him or her to call our office for information. We do have cash pay options available, and we work with patients individually on a case-by-case basis to determine appropriate payment options. Dial 1-888-258-5966 to reach our Customer Service Department.

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.

My patient tested positive for COVID-19. When can they 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 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). Click to learn more.

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 can place an order online, or via email or fax by completing the IBSchek requisition form. Test kits are shipped within 1-3 business days.

How Is My Patient’s Insurance Billing Handled?

Insurance may cover some or all of your patient’s breath test depending on the patient’s insurance plan and benefits. We bill the medical insurance provider specified by patients on their Requisition Form included in each kit. CDI does not accept Medicaid. We offer a patient assistance program for qualified individuals who cannot afford the test. Please call our Customer Service Department at 1-888-258-5966 for more information about billing or our patient assistance program.

Do Patients Need A Pre-Authorization Before Taking The Test?

This depends on the patient’s individual health plan. Even within the same medical health insurance company, some plans require pre-authorization and others do not. It is best for the patient to contact the appropriate health insurance representative to inquire about pre-authorization. Your patients’ claim may require an out of network pre-authorization referral. If there is a pre-authorization number, please ask the patient to write it on the Requisition Form he/she will be sending to us with the breath samples.

What If The Patient Doesn’t Have Medical Insurance?

If your patient has no medical insurance, ask him or her to call our office for information. We do have cash pay options available, and we work with patients individually on a case-by-case basis to determine appropriate payment options. Dial 1-888-258-5966 to reach our Customer Service Department.

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?

Results are reported within 3-5 business days upon receipt of the sample.

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 online 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 upfront via check sent with the kit or credit card. The maximum out-of-pocket cost per test is $99 for patients that pay promptly in accordance with CDI patient billing policies and programs.

Blood 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 upfront via check sent with the kit or credit card. The maximum out-of-pocket cost per test is $99 for patients that pay promptly in accordance with CDI patient billing policies and programs.

Breath Test FAQs
How do I order breath testing kits for my patients?

Our hydrogen and methane breath test kits are available to health care providers at no cost. They are easily accessible through our website’s Ordering page or by contacting your Account Representative. Many of our providers also take advantage of our automatic re-ordering program to proactively account for average monthly usage. Call our Customer Service Department at 1-888-258-5966 for more information about ordering kits.

Where will my patients take the test?

Our patient-centric model allows your patients to administer these tests in the comfort of their own home. Your office will simply fill out the one-page Requisition Form included in every kit and send your patient home to take it. A pre-paid return shipping label is included in the kit for easy patient return to our laboratory. We will take care of the rest.

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.

How is my patient’s insurance billing handled?

Insurance may cover some or all of your patient’s breath test depending on the patient’s insurance plan and benefits. We bill the medical insurance provider specified by patients on their Requisition Form included in each kit. CDI does not accept Medicaid. We offer a patient assistance program for qualified individuals who cannot afford the test. Please call our Customer Service Department at 1-888-258-5966 for more information about billing or our patient assistance program.

Do patients need a pre-authorization before taking the test?

This depends on the patient’s individual health plan. Even within the same medical health insurance company, some plans require pre-authorization and others do not. It is best for the patient to contact the appropriate health insurance representative to inquire about pre-authorization. Your patients’ claim may require an out of network pre-authorization referral. If there is a pre-authorization number, please ask the patient to write it on the Requisition Form he/she will be sending to us with the breath samples.

What if the patient doesn’t have medical insurance?

If your patient has no medical insurance, ask him or her to call our office for information. We do have cash pay options available, and we work with patients individually on a case-by-case basis to determine appropriate payment options. Dial 1-888-258-5966 to reach our Customer Service Department.

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.

My patient tested positive for COVID-19. When can they 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 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). Click to learn more.

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 can place an order online, or via email or fax by completing the IBSchek requisition form. Test kits are shipped within 1-3 business days.

How Is My Patient’s Insurance Billing Handled?

Insurance may cover some or all of your patient’s breath test depending on the patient’s insurance plan and benefits. We bill the medical insurance provider specified by patients on their Requisition Form included in each kit. CDI does not accept Medicaid. We offer a patient assistance program for qualified individuals who cannot afford the test. Please call our Customer Service Department at 1-888-258-5966 for more information about billing or our patient assistance program.

Do Patients Need A Pre-Authorization Before Taking The Test?

This depends on the patient’s individual health plan. Even within the same medical health insurance company, some plans require pre-authorization and others do not. It is best for the patient to contact the appropriate health insurance representative to inquire about pre-authorization. Your patients’ claim may require an out of network pre-authorization referral. If there is a pre-authorization number, please ask the patient to write it on the Requisition Form he/she will be sending to us with the breath samples.

What If The Patient Doesn’t Have Medical Insurance?

If your patient has no medical insurance, ask him or her to call our office for information. We do have cash pay options available, and we work with patients individually on a case-by-case basis to determine appropriate payment options. Dial 1-888-258-5966 to reach our Customer Service Department.

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?

Results are reported within 3-5 business days upon receipt of the sample.

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 online 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 upfront via check sent with the kit or credit card. The maximum out-of-pocket cost per test is $99 for patients that pay promptly in accordance with CDI patient billing policies and programs.

Blood 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 upfront via check sent with the kit or credit card. The maximum out-of-pocket cost per test is $99 for patients that pay promptly in accordance with CDI patient billing policies and programs.

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