This test is to aid in the diagnosis of Lactose Malabsorption.

When the enzyme needed to break down lactose, a sugar commonly found in dairy products, is not present, a condition called Lactose 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.

Taking the Lactose Malabsorption Breath Test

(1) Instructions for Use

(1) Laboratory Requisition Form

(1) Wrapped collection straw

(1) Lactose 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
  1. Carefully open the sealed pack of collection tubes using a pair of scissors.
  2. Unscrew the blue cap from a collection tube.
  3. Unwrap the collection straw and insert the straw about halfway into the tube.
  4. 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.
  5. 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.
  6. Complete and apply the included sample labels with your full name, date of birth, and the date and time the sample was collected.
  7. 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 $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.

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: 82542 x 6 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 Lactose Malabsorption.

Contraindications: Patients with a known lactose 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) Lactose 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 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
  1. Carefully open the sealed pack of collection tubes using a pair of scissors.
  2. Unscrew the blue cap from a collection tube.
  3. Unwrap the collection straw and insert the straw about halfway into the tube.
  4. 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.
  5. 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.
  6. Complete and apply the included sample labels with your full name, date of birth, and the date and time the sample was collected.
  7. 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.

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 $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.

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: 82542 x 6 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 Lactose Malabsorption.

Contraindications: Patients with a known lactose 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 Lactose malabsorption?

Lactose malabsorption is a common condition marked by the inability to fully digest the sugar lactose contained in dairy products like milk and ice cream. This condition often results in a patient exhibiting a variety of gastrointestinal symptoms and discomfort.

A deficiency of lactase — an enzyme produced in your small intestine — is usually responsible for lactose malabsorption. Many people have low levels of lactase but are still able to digest milk products without problems. If you’re actually lactose intolerant, however, your lactase deficiency will lead to symptoms after you eat dairy foods. Most people with lactose malabsorption can manage the condition with dietary modification.

What are the symptoms of lactose malabsorption?

Patients suffering from lactose malabsorption experience a variety of symptoms, including:

  • Diarrhea
  • Abdominal Cramps
  • Bloating
  • Gas
  • Nausea, and sometimes, vomiting
What is a hydrogen and methane breath test for lactose malabsorption?

Following a 12-hour fast and 12-hour dietary preparation period, patients drink a substrate solution that contains high levels of lactose. CDI’s lactose malabsorption breath test then measures the breakdown of lactose over a period of time based on the amount of hydrogen or methane in your breath by capturing breath samples at regular 40-minute intervals. Normally, very little hydrogen or methane is detectable. However, if your body does not properly digest the lactose, it will ferment in the intestines, releasing hydrogen or methane and other gases, which are absorbed by your intestines and eventually exhaled through the lungs. Larger than normal amounts of exhaled hydrogen or methane measured during a breath test indicates that you are not fully digesting and absorbing lactose and may suffer from lactose malabsorption. Our lactose malabsorption hydrogen and methane breath test can be administered in-office or in the comfort of the patient’s own home.