The First Clinically Validated Blood Test for Irritable Bowel Syndrome with Predominant Diarrhea (IBS-D) and Mixed Symptoms (IBS-M).

IBSchek® Capillary Kit is designed to help patients and physicians quickly and reliably diagnose diarrhea-predominant or mixed-symptom IBS (IBS-D/M). Symptoms of this chronic ailment often occur following an incident of acute gastroenteritis (food poisoning). IBSchek is available with direct patient access, simple and safe sample collection, free shipping, and easy-to-understand results in just a few days.

Clinically validated in 2015 and revalidated internationally, IBSchek is the most reliable diagnostic blood test for IBS in the market, available in the USA as well as UK and Europe via CE marked kits.

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Taking the IBSchek Capillary Collection Test

Before drawing your sample, please read these Instructions For Use in their entirety and remember to handle all blood samples and kit components with care.

The IBSchek Capillary Kit Includes:

(1) BD Microtainer® Tube

(2) BD Microtainer® Contact- Activated Lancets CE

(2) Alcohol Pads

(2) Gauze Pads

(2) Bandages

(1) Cardboard Insert

(1) Specimen Collection Bag with Absorbent Material Inside

(1) Return Shipping Label

(1) Kit Covering with Tear-away Requisition Form

(1) Instructions for Use

(1) Sample Label

 

To avoid possible sample rejection, collections must only be performed Monday – Thursday and must be shipped the same day.

Must collect 500μl of blood or your sample may be rejected.

If packaging of any components are broken, do not use.

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.

Preparing for Sample Collection
  1. Preparate requisition form from kit covering by tearing along the perforations and fully complete the requisition form.
  2. Wash hands thoroughly with soap and warm water.
  3. Select the puncture site. You should be sitting down. Hold your hand in a downward position, allowing gravity to help increase blood flow to the hand. Select either your middle or ring finger and identify the desired puncture site (shaded area). Hold your selected hand in a downward position.
  4. Disinfect the site and allow to air dry. Cleanse the puncture site using an alcohol pad. The site must be allowed to air dry in order to provide effective disinfection and best sample quality.
  5. Remove the protective tab from a lancet. Twist off the tab to break the seal and discard. Do not use lancet if tab is damaged or missing.
  6. Perform the puncture. Position the lancet firmly against the puncture site you selected, as illustrated. To activate, press lancet firmly against the puncture site. Do not remove the lancet from the site until an audible click is heard. Lancets are single use only. Once the audible click is heard it cannot be used again.
  7. Discard used lancet
Performing Sample Collection
  1. Collect the sample. Wipe away the first drop of blood with a sterile gauze pad. Open the microtainer tube and let your arm hang loosely towards the ground. Gently hold the lip of the tube against the tip of your finger, directly beneath the puncture site and allow your sample to drip into the tube.
    • Fill the tube up to the 500 line (500μl). If you are not able to collect enough sample from the first puncture site, please repeat the procedure starting at step 3 on another finger.
    • Place cap securely back on microtainer tube by firmly pressing down until an audible click is heard. These are not twist caps. Invert the tube 8-10 times to mix your sample.
  2. Complete the procedure. Wipe the site dry and apply direct pressure with a sterile gauze pad until the bleeding has stopped, then apply the bandage to the site.
Labeling and Returning Your Sample
  1. Label your sample. Included in your kit is a Sample Label card. Neatly print your first and last name, date of birth, and the date when you collected your sample on the sample label and then apply it to the microtainer tube. In order to process your sample when it arrives at our laboratory, we need you to label it with your first and last name, your date of birth (mm/dd/yyyy), as well as the date you collected your sample. Please write legibly using blue or black ink and place the label on your blood sample as shown.
  2. Prepare your sample for shipment. Included in your kit is a specimen collection bag. Place your sample in the bag and seal the bag closed. Place your completed requisition form back into the kit box along with your sample.

Things to Remember:

  • Place your completed Requisition Form into the kit.
  • Close the box and place the return shipping label on the outside of the box to seal the box shut.
  • Arrange sample return with the carrier indicated on the return shipping label.
  • Use appropriate precautions in the collection, handling, storage, and disposal of all used and unused kit contents.
  • Dispose of all used and unused kit materials.

*Must collect 500μl of blood or your sample may be rejected.

*Sample must be shipped same day of draw.

*Any samples received on Friday, Saturday, or a holiday will be analyzed on the next business day from the time of receipt by our laboratory.

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.

  • Remember to place your completed Requisition Form into the kit.
  • Close the box and place the return shipping label on the outside of the box to seal the box shut.
  • Arrange sample return with the carrier indicated on the return shipping label.
  • Use appropriate precautions in the collection, handling, storage, and disposal of all used and unused kit contents.
  • Dispose of all used and unused kit materials.

*Sample must be shipped same day of draw.

*Any samples received on Friday, Saturday, or a holiday will be analyzed on the next business day from the time of receipt by our laboratory.

Indications and Usage: This device is intended to be used by patients and healthcare providers for the collection of capillary whole-blood samples to aid in the diagnosis of Irritable Bowel Syndrome (IBS-M and IBS-D).

Sample Collection: Current test users can still perform standard sample collection and shipping. See the reverse side of the Requisition Form for details on standard test protocols. Sample return shipping materials are available upon request.

Results Interpretation: Result data should be interpreted with the help of a qualified health care provider and all clinical decisions should consider other symptoms and health factors in disease diagnosis and management. CDI’s highly trained laboratorians are available during normal business hours for interpretation questions.

THIS KIT AND ITS COMPONENTS ARE PROVIDED “AS IS” AND CDI MAKES NO REPRESENTATIONS OR WARRANTIES, WHATSOEVER, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. PATIENTS SHOULD CONSULT WITH THEIR HEALTHCARE PROVIDER BEFORE USING THIS KIT.

What’s in the Kit?

Before drawing your sample, please read these Instructions For Use in their entirety and remember to handle all blood samples and kit components with care.

The IBSchek Capillary Kit Includes:

(1) BD Microtainer® Tube

(2) BD Microtainer® Contact- Activated Lancets CE

(2) Alcohol Pads

(2) Gauze Pads

(2) Bandages

(1) Cardboard Insert

(1) Specimen Collection Bag with Absorbent Material Inside

(1) Return Shipping Label

(1) Kit Covering with Tear-away Requisition Form

(1) Instructions for Use

(1) Sample Label

 

To avoid possible sample rejection, collections must only be performed Monday – Thursday and must be shipped the same day.

Must collect 500μl of blood or your sample may be rejected.

If packaging of any components are broken, do not use.

Instructions for Use

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.

Preparing for Sample Collection
  1. Preparate requisition form from kit covering by tearing along the perforations and fully complete the requisition form.
  2. Wash hands thoroughly with soap and warm water.
  3. Select the puncture site. You should be sitting down. Hold your hand in a downward position, allowing gravity to help increase blood flow to the hand. Select either your middle or ring finger and identify the desired puncture site (shaded area). Hold your selected hand in a downward position.
  4. Disinfect the site and allow to air dry. Cleanse the puncture site using an alcohol pad. The site must be allowed to air dry in order to provide effective disinfection and best sample quality.
  5. Remove the protective tab from a lancet. Twist off the tab to break the seal and discard. Do not use lancet if tab is damaged or missing.
  6. Perform the puncture. Position the lancet firmly against the puncture site you selected, as illustrated. To activate, press lancet firmly against the puncture site. Do not remove the lancet from the site until an audible click is heard. Lancets are single use only. Once the audible click is heard it cannot be used again.
  7. Discard used lancet
Performing Sample Collection
  1. Collect the sample. Wipe away the first drop of blood with a sterile gauze pad. Open the microtainer tube and let your arm hang loosely towards the ground. Gently hold the lip of the tube against the tip of your finger, directly beneath the puncture site and allow your sample to drip into the tube.
    • Fill the tube up to the 500 line (500μl). If you are not able to collect enough sample from the first puncture site, please repeat the procedure starting at step 3 on another finger.
    • Place cap securely back on microtainer tube by firmly pressing down until an audible click is heard. These are not twist caps. Invert the tube 8-10 times to mix your sample.
  2. Complete the procedure. Wipe the site dry and apply direct pressure with a sterile gauze pad until the bleeding has stopped, then apply the bandage to the site.
Labeling and Returning Your Sample
  1. Label your sample. Included in your kit is a Sample Label card. Neatly print your first and last name, date of birth, and the date when you collected your sample on the sample label and then apply it to the microtainer tube. In order to process your sample when it arrives at our laboratory, we need you to label it with your first and last name, your date of birth (mm/dd/yyyy), as well as the date you collected your sample. Please write legibly using blue or black ink and place the label on your blood sample as shown.
  2. Prepare your sample for shipment. Included in your kit is a specimen collection bag. Place your sample in the bag and seal the bag closed. Place your completed requisition form back into the kit box along with your sample.

Things to Remember:

  • Place your completed Requisition Form into the kit.
  • Close the box and place the return shipping label on the outside of the box to seal the box shut.
  • Arrange sample return with the carrier indicated on the return shipping label.
  • Use appropriate precautions in the collection, handling, storage, and disposal of all used and unused kit contents.
  • Dispose of all used and unused kit materials.

*Must collect 500μl of blood or your sample may be rejected.

*Sample must be shipped same day of draw.

*Any samples received on Friday, Saturday, or a holiday will be analyzed on the next business day from the time of receipt by our laboratory.

Billing & Insurance

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.

Additional Info
  • Remember to place your completed Requisition Form into the kit.
  • Close the box and place the return shipping label on the outside of the box to seal the box shut.
  • Arrange sample return with the carrier indicated on the return shipping label.
  • Use appropriate precautions in the collection, handling, storage, and disposal of all used and unused kit contents.
  • Dispose of all used and unused kit materials.

*Sample must be shipped same day of draw.

*Any samples received on Friday, Saturday, or a holiday will be analyzed on the next business day from the time of receipt by our laboratory.

Indications and Usage: This device is intended to be used by patients and healthcare providers for the collection of capillary whole-blood samples to aid in the diagnosis of Irritable Bowel Syndrome (IBS-M and IBS-D).

Sample Collection: Current test users can still perform standard sample collection and shipping. See the reverse side of the Requisition Form for details on standard test protocols. Sample return shipping materials are available upon request.

Results Interpretation: Result data should be interpreted with the help of a qualified health care provider and all clinical decisions should consider other symptoms and health factors in disease diagnosis and management. CDI’s highly trained laboratorians are available during normal business hours for interpretation questions.

THIS KIT AND ITS COMPONENTS ARE PROVIDED “AS IS” AND CDI MAKES NO REPRESENTATIONS OR WARRANTIES, WHATSOEVER, EXPRESS OR IMPLIED, INCLUDING WITHOUT LIMITATION ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. PATIENTS SHOULD CONSULT WITH THEIR HEALTHCARE PROVIDER BEFORE USING THIS KIT.

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Frequently Asked Questions

Here is a list of the most common questions regarding IBSchek.  Patients can also contact our dedicated customer service department at 888-258-5966 or customerservice@commdx.com.

What is Irritable Bowel Syndrome (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 IBSchek?

IBSchek is a proprietary blood test for 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.

Is IBSchek clinically validated?

Yes! The following is published clinical data validating IBSchek for diagnosing IBS-D and IBS-M. IBSchek is the only diagnostic test for IBS that has been revalidated internationally and available in the UK and Europe via CE marked kits.

“Development and Validation of a Biomarker for Diarrhea-Predominant Irritable Bowel Syndrome in Human Subjects” Mark Pimentel, Walter Morales, Ali Rezaie, et al. PLoS One. 2015; 10:e0126438.

“Assessment of Anti-vinculin and Anti-cytolethal Distending Toxin B Antibodies in Subtypes of Irritable Bowel Syndrome.” Rezaie A, Park SC, Morales W et al. Dig Dis Sci. 2017 Jun; 62(6):1480-1485.

“Clinical experience with the use of anti-CdtB and anti-vinculin antibodies in patients with diarrhea in Mexico.” Schmulson M, Balbuena R, Corona de Law C. Rev Gastroenterol Mex. 2016 Oct – Dec;81(4):236-239.

“The Utility of Measuring Anti-Cytolethal Distending Toxin B and Anti-Vinculin Antibodies in a Tertiary Care Motility Practice: A Free-Range Experience.” Pourmorady J, Rezaie A, Pimentel M, et al. Gastroenterology. 2016;4 (Suppl1): S-230.

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.

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