When the enzyme needed to break down Sucrose, or table sugar, is not present, a condition called Sucrose Malabsorption may occur. The lack of the enzyme allows bacteria normally found in your digestive system to produce hydrogen and/or methane gas which can cause many gastrointestinal symptoms such as bloating, diarrhea, and/or flatulence.
This test is to aid in the diagnosis of Sucrose Malabsorption.
Taking the Sucrose Malabsorption Breath Test
(1) Instructions for Use
(1) Laboratory Requisition Form
(1) Wrapped collection straw
(1) Sucrose substrate packet
(6) Collection tubes in a vacuum-sealed pack
(6) Collection tube labels
(1) Prepaid return shipping label
(2) Bubble wrap bags for packaging of samples
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
Patients should consult with their healthcare provider prior to taking this test. It is okay to drink water while fasting and during the 3-hour and 20-minute testing period. If you are taking more than one breath test, you must perform the preparation prior to each test.
Test Restrictions
- 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.
24-Hour Preparation Period
It may be convenient to begin the 24-hour preparation period in the morning so that you may follow the specific diet during the day, immediately followed by the fasting period during the night (which may include time spent sleeping).
- Start 12-hour diet at 7am
- Start 12-hour fast at 7pm
- Wake up at 6am
- Start performing sample collection at 7am
12-Hour Diet:
Only the foods listed below are permitted during the diet:
- Baked or Broiled: chicken, turkey, lean beef, lean pork, or seafood
- Eggs
- White rice
- Water, plain coffee, or tea
- Minimal fats and seasoning (i.e. salt, pepper, cooking oil)
12-Hour Fasting Period:
Please do not ingest anything other than water while fasting or during the test. You may brush your teeth as you normally would. Please note that you must be awake for at least 1 hour prior to starting your breath test.
Performing Sample Collection
Carefully open the substrate and mix the substrate with 8oz of room temperature water.
DO NOT DRINK YET.
Once collected, your breath samples are only valid for 2 weeks so please return your completed samples back as soon as possible.
Collecting Your Sample
- Carefully open the sealed pack of collection tubes using a pair of scissors.
- Unscrew the blue cap from a collection tube.
- Unwrap the collection straw and insert the straw about halfway into the tube.
- Inhale normally (do not inhale deeply) and then exhale normally through the straw for 5 seconds. You may see condensation on the inside of the tube indicating the presence of your breath.
- Remove the straw and immediately screw the blue cap back on the top of the tube securely but do not over-tighten. The blue cap has a rubber piece which is for laboratory extracting purposes only; it is not for patient use.
- Complete and apply the included sample labels with your full name, date of birth, and the date and time the sample was collected.
- Fully complete the Laboratory Requisition Form by filling in the patient information as well as the insurance/credit card information. Please note if your kit was directly shipped to you, CDI has your provider’s signature and information on file and it does not need to be included on the Laboratory Requisition Form.
Returning Your Sample
After completing your test, place all the labeled collection tubes into the provided bubble bags. Place the filled bubble bags and your completed Laboratory Requisition Form into the kit box, then seal the kit box with the prepaid return shipping label.
You can either take your kit to the nearest drop box or arrange to have your kit picked up by the carrier on the return shipping label. If you need further information on our shipping practices please refer to the terms and conditions on www.CommDX.com.
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 $199 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.
If you wish to see how much your insurance provider will cover before you take your test, it is your responsibility to contact your insurance provider. Please make sure to inform your insurance provider CDI is out of network and provide the following codes:
- CPT code: 91065 x 2 units
- Tax ID #: 47-4725769
- NPI #: 1831625342
Please consult with your healthcare provider if you have any health concerns, are on a specialty diet, and/or are on prescribed medications. Please do not discontinue taking any prescribed or over-the-counter (OTC) medications, including the ones listed in the Test Restrictions section, without consulting with your healthcare provider prior to taking this test.
Indications and Usage: The intended use of this device is for the collection of human breath samples to aid in the diagnosis of Sucrose Malabsorption.
Contraindications: Patients with a known Sucrose allergy should not take this test. Patients with a low galactose diet should discuss with their healthcare provider prior to taking this test. Patients with diabetes should not use this test due to the amount of absorbable sugar and fasting required. Patients should discuss with their healthcare provider prior to ingesting the substrate.
Precautions: Patients with food allergies should take precaution before taking this test as most substrates do not come with food allergy labeling. Contact immediate medical assistance if you have signs of a possible allergic reaction: hives; difficulty breathing; swelling of face, lips, tongue, or throat.
Substrate Warning: The substrate is 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 ingesting this substrate.
- What’s in the Kit?
-
(1) Instructions for Use
(1) Laboratory Requisition Form
(1) Wrapped collection straw
(1) Sucrose substrate packet
(6) Collection tubes in a vacuum-sealed pack
(6) Collection tube labels
(1) Prepaid return shipping label
(2) Bubble wrap bags for packaging of samples
- 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 CollectionPatients should consult with their healthcare provider prior to taking this test. It is okay to drink water while fasting and during the 3-hour and 20-minute testing period. If you are taking more than one breath test, you must perform the preparation prior to each test.
Test Restrictions
- 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.
24-Hour Preparation Period
It may be convenient to begin the 24-hour preparation period in the morning so that you may follow the specific diet during the day, immediately followed by the fasting period during the night (which may include time spent sleeping).
- Start 12-hour diet at 7am
- Start 12-hour fast at 7pm
- Wake up at 6am
- Start performing sample collection at 7am
12-Hour Diet:
Only the foods listed below are permitted during the diet:
- Baked or Broiled: chicken, turkey, lean beef, lean pork, or seafood
- Eggs
- White rice
- Water, plain coffee, or tea
- Minimal fats and seasoning (i.e. salt, pepper, cooking oil)
12-Hour Fasting Period:
Please do not ingest anything other than water while fasting or during the test. You may brush your teeth as you normally would. Please note that you must be awake for at least 1 hour prior to starting your breath test.
Performing Sample CollectionCarefully open the substrate and mix the substrate with 8oz of room temperature water.
DO NOT DRINK YET.
Once collected, your breath samples are only valid for 2 weeks so please return your completed samples back as soon as possible.
Collecting Your Sample- Carefully open the sealed pack of collection tubes using a pair of scissors.
- Unscrew the blue cap from a collection tube.
- Unwrap the collection straw and insert the straw about halfway into the tube.
- Inhale normally (do not inhale deeply) and then exhale normally through the straw for 5 seconds. You may see condensation on the inside of the tube indicating the presence of your breath.
- Remove the straw and immediately screw the blue cap back on the top of the tube securely but do not over-tighten. The blue cap has a rubber piece which is for laboratory extracting purposes only; it is not for patient use.
- Complete and apply the included sample labels with your full name, date of birth, and the date and time the sample was collected.
- Fully complete the Laboratory Requisition Form by filling in the patient information as well as the insurance/credit card information. Please note if your kit was directly shipped to you, CDI has your provider’s signature and information on file and it does not need to be included on the Laboratory Requisition Form.
Returning Your SampleAfter completing your test, place all the labeled collection tubes into the provided bubble bags. Place the filled bubble bags and your completed Laboratory Requisition Form into the kit box, then seal the kit box with the prepaid return shipping label.
You can either take your kit to the nearest drop box or arrange to have your kit picked up by the carrier on the return shipping label. If you need further information on our shipping practices please refer to the terms and conditions on www.CommDX.com.
- Billing & Insurance
-
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 $199 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.
If you wish to see how much your insurance provider will cover before you take your test, it is your responsibility to contact your insurance provider. Please make sure to inform your insurance provider CDI is out of network and provide the following codes:
- CPT code: 91065 x 2 units
- Tax ID #: 47-4725769
- NPI #: 1831625342
- Additional Info
-
Please consult with your healthcare provider if you have any health concerns, are on a specialty diet, and/or are on prescribed medications. Please do not discontinue taking any prescribed or over-the-counter (OTC) medications, including the ones listed in the Test Restrictions section, without consulting with your healthcare provider prior to taking this test.
Indications and Usage: The intended use of this device is for the collection of human breath samples to aid in the diagnosis of Sucrose Malabsorption.
Contraindications: Patients with a known Sucrose allergy should not take this test. Patients with a low galactose diet should discuss with their healthcare provider prior to taking this test. Patients with diabetes should not use this test due to the amount of absorbable sugar and fasting required. Patients should discuss with their healthcare provider prior to ingesting the substrate.
Precautions: Patients with food allergies should take precaution before taking this test as most substrates do not come with food allergy labeling. Contact immediate medical assistance if you have signs of a possible allergic reaction: hives; difficulty breathing; swelling of face, lips, tongue, or throat.
Substrate Warning: The substrate is 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 ingesting this substrate.
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Frequently Asked Questions
Here is a list of the most common questions regarding our breath tests. Patients can also contact our dedicated customer service department at 888-258-5966 or customerservice@commdx.com.
What is Sucrose Malabsorption?
Sucrose malabsorption is a disorder characterized by the deficiency or absence of the enzymes sucrase and isomaltase. Lacking this enzyme complex affects a person’s ability to digest certain sugars including sucrose and maltose. Sucrose (a sugar found in fruits, and also known as table sugar) and maltose (the sugar found in grains) are called disaccharides because they are composed of two simple sugars. These disaccharides are normally broken down into simple sugars during digestion. Sucrose is broken down into glucose and another simple sugar called fructose, and maltose is broken down into two glucose molecules. People with congenital sucrase-isomaltase deficiency (CSID) cannot break down the sugars sucrose and maltose, and other compounds made from these sugar molecules (carbohydrates).
CSID usually, but not always, becomes apparent at an early age when a child starts to consume fruits, juices, and grains. After ingestion of sucrose or maltose, an affected individual will typically experience stomach cramps, bloating, excess gas production, and diarrhea. These digestive problems can lead to failure to gain weight and grow at the expected rate (failure to thrive) and malnutrition. Most affected individuals are better able to tolerate sucrose and maltose as they get older, but the condition still affects many adults. The prevalence of congenital sucrase-isomaltase deficiency is estimated to be 1 in 5,000 people of European descent.
What are the symptoms of sucrose malabsorption?
Patients suffering from Genetic Sucrase-Isomaltase Deficiency or Congenital Sucrase-Isomaltase Deficiency experience a variety of symptoms, including:
- Mild to severe chronic, watery, acidic diarrhea
- Bloating
- Abdominal pain
What is a hydrogen and methane breath test for sucrose malabsorption?
CDI’s hydrogen and methane breath test for sucrose malabsorption is the most useful non-invasive test for determining sucrose malabsorption. The test is well validated and widely used. Following a 12-hour fast and 12-hour dietary preparation period, patients ingest a sucrose rich substrate solution. The sucrose malabsorption breath test then measures the breakdown of that specific amount of sucrose over the course of time by capturing breath samples at regular 40-minute intervals. People with a sucrose malabsorption will not breakdown the sugar properly and will exhibit elevated levels of hydrogen or methane gases in their breath samples.
A malabsorption is diagnosed based on exhibited symptoms and following a test with elevated gas concentrations in the collected breath samples. Expert dietary advice may be helpful for the identification of trigger foods and drinks containing sucrose. Our sucrose malabsorption hydrogen and methane breath test can be administered in-office or in the comfort of the patient’s own home.