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

Your Lactose 6 Tube Kit Includes:

(1) Instructions for Use

(1) Laboratory Requisition Form

(1) Wrapped collection straw

(1) Lactose substrate packet

(6) Collection tubes in a vacuum-sealed pack

(1) Sample label card with 6 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.

Important Reminders
  1. Be sure to check the expiration date of your test kit which is located on the outside of your kit next to the hourglass image displayed as YEAR/MONTH/DAY. Do not take your test if the expiration date has already passed and reach out to CDI to receive a new test kit.
  2. Samples are valid for two [2] weeks from sample collection and must be received at CDI’s lab within this timeframe. Please ship your kit back to CDI immediately after completing the test.
  3. Failure to follow these instructions can lead to an invalid result. You may still be billed for the test if the test is invalid due to patient error.
  4. Please be sure to thoroughly read the billing & insurance policies in these instructions as well as on your requisition form. Additional information can be found here on our website, www.commdx.com/insurance.
  5. If you have multiple test kits, please keep in mind that the full 24-hour preparation will need to be repeated between each test. We recommend spacing test apart by at least 24 hours.
Test Preparation

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 (i.e. anything that helps aid in the movement of your bowels) 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

SUGGESTED SCHEDULE:

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).

12-HOUR DIET: PERMITTED FOODS ONLY

12-HOUR FASTING PERIOD

  • Do not ingest anything other than water while fasting or during the test.
  • You may take necessary prescribed medications cleared by your physician
  • Do not take any vitamins or supplements.
  • You may brush your teeth as you normally would.
  • You must be awake for at least 1 hour prior to starting the test.
8 Simple Steps For Lactose 6 Tube Breath Test

Please read carefully prior to taking your breath test:

  • CDI will submit a claim on your behalf for all commercial insurance plans. Most commercial insurance plans do not consider CDI as an in-network provider, therefore most patients will be responsible for the maximum out-of-pocket cost of $249 per breath test.
  • If your insurance provider is not listed on our website as an in-network provider, your claim will be billed as an out-of-network claim. It is the patient’s responsibility to contact their insurance provider to determine coverage. CPT codes and other information needed to determine coverage can be found on our website. Please note, our lab is separate from your healthcare provider, so if your healthcare provider is in-network, it does not mean that CDI is in-network. Please refer to our website for a list of in-network insurance providers.
  • CDI accepts all Medicare, Medicare Advantage, and Tricare government managed health insurance plans.
  • CDI does not accept Medicaid. If you are a Medicaid patient, you will be billed for the maximum out-of-pocket
    cost of $249 per breath test.
  • CDI offers convenient payment plans and financial hardship programs for those who qualify. Contact CDI’s customer service team at customerservice@commdx.com or visit our website for more information.
  • Insurance payments are applied to the registered cost of our test, $599. All non-covered costs are the patient’s responsibility. The maximum out-of-pocket cost will not exceed $249 per test.

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

Visit www.commdx.com/insurance for important information including a list of our in-network providers and billing & insurance FAQs.

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, and throat. Any serious incident that occurs in relation to this device shall be reported to the manufacturer and the competent authority of the member state in which the patient is established.

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.

* 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?

Your Lactose 6 Tube Kit Includes:

(1) Instructions for Use

(1) Laboratory Requisition Form

(1) Wrapped collection straw

(1) Lactose substrate packet

(6) Collection tubes in a vacuum-sealed pack

(1) Sample label card with 6 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.

Important Reminders
  1. Be sure to check the expiration date of your test kit which is located on the outside of your kit next to the hourglass image displayed as YEAR/MONTH/DAY. Do not take your test if the expiration date has already passed and reach out to CDI to receive a new test kit.
  2. Samples are valid for two [2] weeks from sample collection and must be received at CDI’s lab within this timeframe. Please ship your kit back to CDI immediately after completing the test.
  3. Failure to follow these instructions can lead to an invalid result. You may still be billed for the test if the test is invalid due to patient error.
  4. Please be sure to thoroughly read the billing & insurance policies in these instructions as well as on your requisition form. Additional information can be found here on our website, www.commdx.com/insurance.
  5. If you have multiple test kits, please keep in mind that the full 24-hour preparation will need to be repeated between each test. We recommend spacing test apart by at least 24 hours.
Test Preparation

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 (i.e. anything that helps aid in the movement of your bowels) 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

SUGGESTED SCHEDULE:

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).

12-HOUR DIET: PERMITTED FOODS ONLY

12-HOUR FASTING PERIOD

  • Do not ingest anything other than water while fasting or during the test.
  • You may take necessary prescribed medications cleared by your physician
  • Do not take any vitamins or supplements.
  • You may brush your teeth as you normally would.
  • You must be awake for at least 1 hour prior to starting the test.
8 Simple Steps For Lactose 6 Tube Breath Test

Billing & Insurance

Please read carefully prior to taking your breath test:

  • CDI will submit a claim on your behalf for all commercial insurance plans. Most commercial insurance plans do not consider CDI as an in-network provider, therefore most patients will be responsible for the maximum out-of-pocket cost of $249 per breath test.
  • If your insurance provider is not listed on our website as an in-network provider, your claim will be billed as an out-of-network claim. It is the patient’s responsibility to contact their insurance provider to determine coverage. CPT codes and other information needed to determine coverage can be found on our website. Please note, our lab is separate from your healthcare provider, so if your healthcare provider is in-network, it does not mean that CDI is in-network. Please refer to our website for a list of in-network insurance providers.
  • CDI accepts all Medicare, Medicare Advantage, and Tricare government managed health insurance plans.
  • CDI does not accept Medicaid. If you are a Medicaid patient, you will be billed for the maximum out-of-pocket
    cost of $249 per breath test.
  • CDI offers convenient payment plans and financial hardship programs for those who qualify. Contact CDI’s customer service team at customerservice@commdx.com or visit our website for more information.
  • Insurance payments are applied to the registered cost of our test, $599. All non-covered costs are the patient’s responsibility. The maximum out-of-pocket cost will not exceed $249 per test.

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

Visit www.commdx.com/insurance for important information including a list of our in-network providers and billing & insurance FAQs.

Additional Info

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, and throat. Any serious incident that occurs in relation to this device shall be reported to the manufacturer and the competent authority of the member state in which the patient is established.

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.

* 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 frequently asked questions regarding our Lactose Malabsorption 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 kits can be administered in-office or in the comfort of the patient’s own home.