COVID-19 Update

Healthcare institutions and laboratories are encouraged to exercise and continue to practice appropriate clinical precautions when handling breath samples from patients. These groups should refer to their own policies on how to handle its COVID-19 response and should respond appropriately as the COVID-19 situation applies to and impacts its breath testing in its facilities.

Judgement on whether or not to test a patient using the BreathTek® UBT for H. pylori Kit should continue to be made by the patient’s prescribing physician and in collaboration with local testing laboratories on an individual patient basis.

While the COVID-19 situation continues to be dynamic, Otsuka sources the components of the BreathTek® UBT in the United States and currently does not foresee disruptions to its supply.

April 202005US20EBP0007

COVID-19 Update

Healthcare institutions and laboratories are encouraged to exercise and continue to practice appropriate clinical precautions when handling breath samples from patients. These groups should refer to their own policies on how to handle its COVID-19 response and should respond appropriately as the COVID-19 situation applies to and impacts its breath testing in its facilities.

Judgement on whether or not to test a patient using the BreathTek® UBT for H. pylori Kit should continue to be made by the patient’s prescribing physician and in collaboration with local testing laboratories on an individual patient basis.

While the COVID-19 situation continues to be dynamic, Otsuka sources the components of the BreathTek® UBT in the United States and currently does not foresee disruptions to its supply.

April 202005US20EBP0007

This site is intended for US Health Care Professionals Only

FAQ

Answers to the most common questions about BreathTek UBT are below.

For more information, contact OAPI customer service at 1.888.637.38351.888.637.3835 or [email protected] so we can have a representative contact you.

Note: While UBiT®-IR300 Infrared Spectrophotometers are no longer for sale, servicing is still available on a limited basis to OAPI customers. Please call OAPI customer service at 1.888.637.38351.888.637.3835 or e-mail [email protected] for more information.

Accessories and Consumable Items

Maintenance and Operation

Caution, Error, and Warning Messages

Measurement Principle Utilized of the POCone Instrument

Warranty Information for the POCone Instrument

Clinical

Patient Preparation

Breath Sample Collection

Product Transport and Storage

Ordering Kits, Instruments, and Supplies

Warnings and Precautions of the BreathTek UBT

Accessories and Consumable Items

How often should the consumable items be replaced?

O-rings should be replaced after analyzing 1000 patient samples. To check the current number of patient samples analyzed on your machine, please refer to POCone Instruction Manual.

Please see instructions on changing the O-rings below:

  1. Remove the sample joints by pushing on the white "ejection" ring. The sample joints should fall out.
  2. Use a sharp razor blade to cut the O-rings off the joints.
  3. Replace both O-rings (black and orange) with new O-rings (the black O-rings on the back slit, the orange O-rings on the front slit). See the POCone Instruction Manual (page 7-3) for correct positioning of O-rings.
  4. Reinsert the sample joints.
  5. For more details, please see pages 9-4 and 9-5 of the POCone Instruction Manual.

Very important! The lifetime of the cartridge will vary depending on the carbon dioxide concentration and humidity level in the vicinity of the instrument. The system will display a caution 3-1 message when it's time to replace the cartridge.

Do not remove the trapping cartridge adapter from the instrument when exchanging the trapping cartridge.

Instructions on replacing the trapping cartridge are located on pages 9-8 and 9-9 of the POCone Instruction Manual.

When mounting the trapping cartridge and adapter onto the instrument, does the orientation matter?

Yes. The word "PUSH" on the back of the adapter and print on the back of the cartridge should be facing inward.

Are there special disposal requirements for any of the consumable items?

Yes. The CO2 trapping cartridge contains approximately 60 to 70 grams of lithium hydroxide; the substance is considered a corrosive and must be disposed of in a heavy metal disposal facility. Please contact OPDC Medical Information at 1-888-637-3835 for a copy of the Safety Data Sheet (SDS) or download in the resources section of this site. Your local hospital's environmental services department may dispose of the CO2 trapping cartridge at no charge.

Is it possible to store the data for a long period of time when the data are printed on heat-sensitive paper?

The data on the printer paper do fade over time. It's recommended that copies of all the data are made or sent to a personal computer.

How often do we need to replace the paper?

Thermal paper replacement is dependent upon the number of samples analyzed.

Maintenance and Operation

How often should we calibrate the instrument?

The operator is not required to perform an instrument calibration. The system performs its own internal calibration upon warm-up, once each hour the instrument is on, and before sample analysis.

To ensure proper calibration, always change the trapping cartridge when prompted by the system.

What are the proper environmental conditions for installation and operation?

  • Indoors (protected from direct sunlight).
  • 15°-30°C (free from rapid temperature change).
  • Do not store near a vent or window. If stored near a window be sure to locate the instrument not less than 15 cm away.
  • Dust-free environment.
  • Good ventilation around the exhaust joints (at least 6-inch clearance around all sides).
  • Do not permit vibration of instrument or supporting surface.

What type of preventative maintenance is recommended?

  • Keep the instrument in a dust-free environment, and off the floor.
  • Change the O-rings every 1000 patient samples or when prompted by the system.
  • Change the trapping cartridge when prompted by the system.
  • Turn the system off when not in use.

When we don't use the POCone for a certain period of time, is there anything that we need to be aware of, in terms of the maintenance contract and regular maintenance?

Yes, if the device has been off during the non-use period, when turned on, the unit will go through 2 self-diagnosis routines. During the self-diagnosis routines, the instrument's components are evaluated; if during this time, the components do not meet required specifications, then a warning, caution, or error message will occur. After a warning, caution, or error message is displayed, you will not be able to continue with testing until the problem is resolved. If a repair is needed you should notify OAPI Customer Service for servicing. While in use, regular maintenance should be performed at least once a year.

What is the recommended Quality Control Procedure for the instrument?

It is recommended to run a reproducibility test on the instrument at least once a month. This is a 20-minute test that measures the overall stability of the instrument. Please see pages 7-23 and 11-4 of the POCone Instruction Manual for test specifications. You may also call OAPI Customer Service at 1-888-637-38351-888-637-3835 for more information. See below for evaluation criteria.

Evaluation criteria for the reproducibility tests:

  1. The light intensity ratios are between 1.00 and 1.15
  2. The average delta over baseline (DOB) +/- 0.3‰
  3. The S.D. is less than 0.3

The instrument has internal electronic monitoring systems. During the 10-minute warm-up phase the instrument conducts 2 self-diagnostic routines (tests) to determine the overall stability of the instrument. If one of these tests is judged to be out of specifications, the system will display a warning, caution, or error message, and will not allow the system to measure any samples. In addition, if any abnormalities are found during sample analysis, the system will not continue to measure the sample and will display a warning, caution, or error message.

When using the POCone close to a cellular phone, cordless phone, or X-ray device, does this affect the measurement data?

There is a strong possibility that an X-ray device may affect the instrument, therefore affecting the data. Store the instrument in a place free from strong magnetic or electric fields.

Caution, Error, and Warning Messages

How to prevent them and avoid wasting patient samples.

I received several caution 4-1 messages while running a patient's sample. How can I prevent this from occurring in the future?

Be sure to completely insert the breath sample bags onto the sample joints. The breath sample bags must cover both the black and orange O-rings of the sample joints. If the O-rings are not covered, leakage from the bags could occur and the systems' syringe may not be fully able to extract air from the bag.

The sample joints may not be fully attached to the instrument. To check this, gently pull the sample joints out from the instrument then push the sample joints into the two holes in front of system until the joints snap into place.(page 2-6 of POCOne Manual)

The CO2 concentration in the bag is less than 0.5%. Please recollect the sample from the patient. If it's been more than 20 minutes since post collection, you must retest the patient after 24 hours using a new BreathTek UBT kit. The bags were stored without the caps, causing the breath sample to leak out of the bag.

I received a caution 4-2 (CO2 concentration is less than 1%) message while running the patient's sample. How can I prevent this in the future?

A breath sample that contains less than 1% CO2 is not considered a valid sample. If the system determines that the breath sample (S1 or S2) contains insufficient CO2 (<1%), it will report a caution 4-1 message along with the final result. To prevent this from happening in the future the operator should be aware of the following items:

The patient should take a deep breath and pause momentarily before blowing into the blue and pink breath collection bags. This will allow the patient to increase the CO2 in lungs and emit a CO2 concentration that is 1% or greater.

Recap the bags immediately after collection and store them at room temperature, if not analyzed right after collection. The breath bags must be firmly attached to the sample joints, over both the black and orange O-rings of the POCone.

Measurement Principle Utilized of the POCone Instrument

Describe the calculation method for 13CO2 utilized by the instrument:

The instrument determines the amount of light absorbance by each breath/gas sample. The instrument then determines the difference between the 13CO2 / 12CO2 concentration ratios in each breath sample. If the result is found to be equal to or greater than 2.4 ‰ (delta per mils) then the result is considered positive for an adult patient. For more detailed calculation, please refer to page 4-2 of the POCone Instruction Manual.

What is the cutoff value for a positive result for an adult patient?

Delta over baseline (DOB) ≥ 2.4 ‰ (delta per mil).

Can the instrument measure H2 concentrations?

No.

Can the instrument be modified?

No.

Is the POCone compatible with Lab Information System (LIS)?

Currently the POCone is not compatible with a LIS. You'll need to write your own interface for this system.

I need to know the bar code size and the bar code standards which can be used for the breath bag labels and the POC-AS10 Autosampler.

  • Bar Code Reader
  • Type: MS5145-AV
  • Light Source: VLD 650nm +/- 10nm
  • Laser Power: Under 1.0mW (Peak)
  • Bar Code Type: NW-7, ITF, CODE-39
  • Resolution 0.102 mm

Is the testing procedure or calculation different for pediatric patients?

While the testing procedure is the same for both adults and pediatric patients ages 3 to 17, an analysis calculation is needed to calculate the urea hydrolysis rate (UHR) metric for pediatric test results. You or your lab technician will need to use the web-based Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA) to conduct the analysis. For your convenience, you can access this web-based application at BreathTekKids.com. The Delta-over-Baseline result from the POCone or UBiT®-IR300 cannot be used to determine infection status in pediatric patients, and it is used to calculate the UHR metric to provide a positive/negative result.

To complete the analysis, the pUHR-CA requires the following patient information: age* (years), gender, collection date, analysis date, height (inches or centimeters), weight (pounds or kilograms), and patient ID.

*Use the patient’s current age and do not round up.

When visiting the BreathTekKids.com website, first-time users must register. Once registered and access is granted, a user ID and a temporary password will be sent to the requestor. Please enter the following information upon registration:

  • Account Name
  • Account Number
  • Requestor’s Name (First and Last Name)
  • Specialty (Lab Technician, Physician…)
  • City and State
  • Phone Number
  • Business Email Address

Allow some time to ensure processing and account validation for a new user name and password.

Is BreathTek UBT Clinical Laboratory Improvement Amendments (CLIA) nonregulated?

Yes.

Whom do I call for technical assistance with the POCone?

Assistance is available at 1-888-637-38351-888-637-3835.

Warranty Information for the POCone Instrument

What types of warranties are available for the POCone?

New POCone instrument comes with a 1-year seller warranty.* Additional warranties and service agreements are available for purchase. For details, please contact the Customer Service office at 1-888-637-38351-888-637-3835.

* Warranty subject to change without notice.

* If you no longer have the Instruction Manual for your instrument, please contact OAPI Customer Service for a replacement manual at 1-888-637-38351-888-637-3835.

Clinical

If clinical questions arise that are not covered by this website or in the product literature, who should these be referred to?

Contact OAPI Customer Service at 1-888-637-38351-888-637-3835, or by e-mail at [email protected].

Patient Preparation

What instructions need to be given to the patient prior to administration of the BreathTek UBT test?

  • Remind the patient that Pranactin-Citric contains phenylalanine (one of the protein components of aspartame). Phenylketonurics restrict dietary phenylalanine
  • The patient should have fasted at least 1 hour before administering the BreathTek UBT
  • The patient should not have taken antibiotics, proton pump inhibitors (PPIs), or bismuth preparations within 2 weeks prior to administering the BreathTek UBT. If PPIs are used within 2 weeks of BreathTek UBT testing, false negative test results may occur, and the test should be repeated 2 weeks after discontinuation of PPI treatment. A positive result for a patient on PPI could be considered positive and be acted upon
  • The effect of histamine 2-receptor antagonists (H2RAs) may reduce urease activity on urea breath tests.1 H2RAs may be discontinued for 24-48 hours before the BreathTek UBT
  • Use of antacids does not appear to affect the accuracy of the BreathTek UBT2
  • For administration by a healthcare professional only. Do not provide this kit to the patient for self-administration
  • If repeat testing is needed, BreathTek UBT can be administered again on the following day3

Breath Sample Collection

After administering Pranactin-Citric drug solution, is the 15-minute timing period important for the second breath sample?

Yes. Breath sample may be collected no later than 30 minutes POST-DOSE.

What are the most common collection errors?

Collecting the sample in the wrong bag. Be sure to Collect the BASELINE sample in the Blue Bag and POST-DOSE sample in the Pink Bag. If you immediately recognize that you have collected the sample in the wrong order/bag, i.e. BASELINE sample in the Pink Bag and POST-DOSE sample in the Blue Bag, immediately document this information on the bags for the lab technician analyzing the samples. Note: There is no substance inside the bags that will interfere with the breath sample; however, collecting the breath sample in the wrong bag may result in an inaccurate reading on the POCone.

How do I prevent this problem from occurring in the future? Be sure to Collect the BASELINE sample in the Blue Bag and POST-DOSE sample in the Pink Bag then place the bags on the instrument in the correct order prior to analysis.

Other common collection issues: Not properly and firmly re-capping the breath collection bag after use. This is important if samples will not be immediately analyzed on the POCone.

Other administration errors: The patient drinks the Pranactin-Citric drug solution before the administrator collects the baseline breath sample. If repeat testing is needed, BreathTek UBT can be repeated again on the following day.

Can physician office staff administer the test?

Yes. Any healthcare professional can be trained to administer the test. The BreathTek UBT is CLIA non-regulated, so no special licensing or personnel are needed. However, all staff administering the BreathTek UBT should thoroughly review the Package Insert for BreathTek UBT before administration.

Can this test be administered to pregnant women?

The safety of using the BreathTek UBT kit during pregnancy and lactation is not established.

If the patient does not drink all of the Pranactin-Citric drug solution, will the test still be valid?

No. The test has been validated based on complete consumption of the Pranactin-Citric drug solution as indicated in the Package Insert.

What is phenylalanine?

Phenylalanine is one of the amino acids that the body cannot manufacture itself. Aspartame, which contains phenylalanine, is used as a sweetener in the Pranactin-Citric drug solution (roughly equivalent to the amount in one diet cola soft drink).

What will happen if I accidentally give the test to a PKU patient?

PKU patients can take the test but must be made aware that the drug solution contains approximately the same amount of phenylalanine as a 12-oz can of typical diet cola soft drink.

If I have a question regarding breath collection, whom should I call?

Call OAPI Customer Service at 1-888-637-38351-888-637-3835.

Product Transport and Storage

How long will the specimen integrity be maintained after collection?

The specimens should be processed within 7 days of collection and be stored at 59°-86°F (15°-30°C) per the Package Insert.

What are the storage requirements needed for the BreathTek UBT kit?

The BreathTek UBT Kit should be stored at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C - 30°C (59°F - 86°F) [see USP Controlled Room Temperature].

Ordering Kits, Instruments, and Supplies

How do I get kits, instruments, or supplies?

Contact OAPI Customer Service at 1-888-637-38351-888-637-3835.

Is there a minimum order?

Yes. Kits are shipped in 5-piece package configurations.

Who should monitor the kit expiration date?

Once a physician's office or lab has received a kit, it is the responsibility of that lab or physician's office to monitor the expiration date.

What if a kit has expired?

Do not use it.

Contact OAPI Customer Service at 1-888-637-38351-888-637-3835.

What if I have a complaint about the kit, such as a missing component? What do I need to do?

Please contact OAPI Customer Service at 1-888-637-38351-888-637-3835.

What is the cost for kits, instruments, and other supplies?

Please contact OAPI Customer Service at 1-888-637-38351-888-637-3835.

Warnings and Precautions of the BreathTek UBT

What Warnings and Precautions of the BreathTek UBT should I be aware of?

Warnings and Precautions for BreathTek UBT are as follows:

  • For in vitro diagnostic use only. The Pranactin®-Citric solution is taken orally as part of the diagnostic procedure and contains Phenylalanine (one of the protein components of Aspartame), 84 mg per dosage unit. (For reference, 12 ounces of typical diet cola soft drinks contain approximately 80 mg of Phenylalanine.)
  • A negative result does not rule out the possibility of H. pylori infection. False negative results do occur with this procedure. If clinical signs are suggestive of H. pylori infection, retest with a new sample or an alternate method.
  • False negative test results may be caused by:
    • Ingestion of proton pump inhibitors (PPIs) within 2 weeks prior to performing the BreathTek UBT. If a negative result is obtained from a patient ingesting a PPI within 2 weeks prior to the BreathTek UBT, it may be a false-negative result and the test should be repeated 2 weeks after discontinuing the PPI treatment. A positive result for a patient on a PPI could be considered positive and be acted upon.
    • Ingestion of antibiotics, or bismuth preparations within 2 weeks prior to performing the BreathTek UBT.
    • Premature POST-DOSE breath collection time for a patient with a marginally positive BreathTek UBT result.
    • Post-treatment assessment with the BreathTek UBT less than 4 weeks after completion of treatment for the eradication of H. pylori.
  • False positive test results may be caused by:
    • Urease associated with other gastric spiral organisms observed in humans such as Helicobacter heilmannii or achlorhydria.
    • Oral contamination associated with urease containing bacteria especially when not using the straw provided in the BreathTek UBT Kit.
  • If particulate matter is visible in the reconstituted Pranactin-Citric solution after thorough mixing, the solution should not be used.
  • Patients who are hypersensitive to mannitol, citric acid or Aspartame should avoid taking the drug solution as this drug solution contains these ingredients. Use with caution in patients with difficulty swallowing or who may be at high risk of aspiration due to medical or physical conditions.
  • The safety of using the BreathTek UBT Kit during pregnancy and lactation is not established.
  • For pediatric test results, the Urea Hydrolysis Rate (UHR) results must be calculated. Delta over Baseline (DOB) results in conjunction with the Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA), provided as a web-based calculation program, is required to obtain pediatric test results. DOB results cannot be used to determine the infection status of pediatric patients. Use the web-based pUHR-CA (BreathTekKids.com) to calculate the UHR.
  • Safety and effectiveness has not been established in children below the age of 3 years.

 

For a complete listing of Warnings, Precautions and Limitations, please see the Package Insert.

References
  • Klein PD, Malaty HM, Martin RF, et al. Noninvasive Detection of Helicobacter pylori Infection in Clinical Practice: The 13C Urea Breath Test. Am J Gastroenterol 1996;91(4):690-694.
  • Chey WD, Wong BCY; Practice Parameters Committee of the American College of Gastroenterology. American College of Gastroenterology guideline on the management of Helicobacter pylori infection. Am J Gastroenterol. 2007;102(8):1808-1825.
  • Graham DY, Opekun AR, Jogi M, et al. False Negative Urea Breath Tests with H2-Receptor Antagonists: Interactions Between Helicobacter pylori Density and pH. Helicobacter. 2004; 9(1):17-27.