Idkit Hp One
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Uses
The Exalenz BreathID® Breath Test System is intended for use in the qualitative detection of urease associated with Helicobacter pylori (H. pylori) in the human stomach and as an aid in the initial diagnosis and post treatment monitoring of H. pylori infection in adult patients. This test should be used after at least four weeks of H. pylori eradication therapy. For these purposes, the system utilizes Molecular Correlation Spectrometry (MCS™) for the measurement of the ratio of 13CO2 to 12CO2 in breath samples.
The Exalenz BreathID® System is used to detect and monitor H. pylori infection by measuring changes in the 13CO2 to 12CO2 ratio in a patient’s breath following the ingestion of 13C-urea.The Exalenz BreathID® Breath Test System consists of the IDkit: Hp™ kits containing 13C-urea tablet, 75 mg for oral solution and 4.3 g Citrica Powder (4g citric acid) for oral solution; the BreathID® device and the IDcheck™ system quality control accessory.The device is for use by trained healthcare professionals and the test kit is to be administered under a physician’s supervision.
History
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Other Information
The Exalenz BreathID® non-invasive breath test is a diagnostic test that analyzes a breath sample before and after ingestion of 13C-enriched urea; it is used to identify those patients with H. pylori infection.The Exalenz BreathID® breath test is performed as follows: a 75 mg 13C-urea tablet and 4.3 g Citrica Powder are dissolved in water, and the resulting solution is ingested by the patient. The presence of the Citrica creates an acidic environment in the stomach and also delays the transfer of the ingested solution to the duodenum. These two characteristics facilitate the decomposition of the urea by H. pylori, if present. Thus, in the presence of urease associated with gastric H. pylori, 13C-urea is decomposed to 13CO2 and NH3 according to the following equation:
2 13C-urea + 2 H2O ----------> H. pylori urease----------> 2 13CO2+ 2 NH3
The 13CO2 is absorbed into the blood and then exhaled in the breath. Absorption and distribution of 13CO2 is fast. Therefore, the cleavage of urea by the H. pylori urease that produces the 13CO2 occurs immediately after the solution is ingested and enables immediate detection of increased 13CO2 in the exhaled breath of H. pylori-positive patients.In the case of H. pylori-negative patients, the 13C-urea does not produce 13CO2 in the stomach because there are no human enzymes that can decompose the urea in the stomach.
The diagnostic drug component of the kits is 13C-enriched urea prepared as a tablet. The tablet should be dissolved with Citrica Powder in a glass of water, providing a clear, colorless solution for oral administration.
The 75 mg 13C-urea component is supplied as a tablet in a sealed pouch. The 4.3 g of Citrica Powder (4 g citric acid [3,4,5], aspartame, and Tutti Frutti flavoring) is supplied in a separate sealed pouch.
An average adult body normally contains about 9.0 grams of urea, which is a product of protein metabolism. Urea in the body is referred to as a natural isotopic abundance urea since it is composed of 98.9% 12C-urea and 1.1% 13C-urea.
Greater than or equal to 99% of the carbon molecules in the supplied tablet are in the form of 13C; a stable, naturally occurring, non-radioactive isotope of carbon. 13C-urea is the diamide of 13C carbonic acid and is highly soluble in water (1 gram per ml at 25OC). It has the following chemical formula: 13CH4N2O.
The BreathID® device can be operated in two pre-selected modes of testing. These are the PATIENT MODE and the BAG MODE as described below.
PATIENT MODE
The test begins with the selection of the PATIENT MODE and with the collection of a baseline breath sample. The patient breathes normally while the BreathID® device collects samples through the IDcircuit™ nasal cannula. The IDcircuit™ extracts moisture and patient secretions from the breath samples to provide accurate CO2 readings, and the device measures the 13CO2 / 12CO2 ratio of the baseline measurement. The patient then ingests a test drink consisting of 13C-urea tablet 75 mg and 4.3 g of citric Powder (4g citric acid).
While the patient continues to breathe normally, the BreathID® device continually and non-invasively samples the patient’s breath (via the cannula) and measures the changes in the 13CO2 / 12CO2 ratio versus the original baseline sample. These changes are displayed as a graph on the large display screen while the test continues. The graph shows multiple points that allow the physician to identify the change in the DOB of the 13CO2 / 12CO2 ratio in response to the administered 13C-urea. Once the BreathID® device has collected enough data to determine whether or not a patient is H. pylori-positive, (i.e. the graph passes the threshold unambiguously), it automatically ends the test and prints out the results.
BAG MODE
The test begins with the collection of normally exhaled breath of the patient into a baseline breath collection bag, which is then sealed. This sample provides the baseline isotope ratio reading. Next, the patient ingests the test drink consisting of dissolved of 13C-urea tablet, 75 mg and 4.3 g of Citrica Powder (4g citric acid), as in the PATIENT MODE. After 20 minutes, the patient exhales into a post-ingestion breath collection bag, which is subsequently sealed.
The test is performed on the BreathID® device. After selecting BAG MODE, the baseline and then the post-ingestion breath collection bags are connected to the BreathID® device, one after the other. Each bag is separately sampled by the BreathID® device to determine the 13CO2 / 12CO2 ratio. The values of the ratios obtained are compared in order to determine the Delta Over Baseline (change in the 13CO2 / 12CO2 ratio between the baseline and the post-ingestion measurements). Once the BreathID® completes measuring the bags, it automatically displays and prints the results. This enables the physician to determine whether a patient is positive or negative for H. pylori, based on whether or not the graph passed the threshold line.
The diagnostic drug component of the kits is 13C-enriched urea prepared as a tablet. The tablet should be dissolved with Citrica Powder in a glass of water, providing a clear, colorless solution for oral administration.
The 75 mg 13C-urea component is supplied as a tablet in a sealed pouch. The 4.3 g of Citrica Powder (4 g citric acid [3,4,5], aspartame, and Tutti Frutti flavoring) is supplied in a separate sealed pouch.
An average adult body normally contains about 9.0 grams of urea, which is a product of protein metabolism. Urea in the body is referred to as a natural isotopic abundance urea since it is composed of 98.9% 12C-urea and 1.1% 13C-urea.
Greater than or equal to 99% of the carbon molecules in the supplied tablet are in the form of 13C; a stable, naturally occurring, non-radioactive isotope of carbon. 13C-urea is the diamide of 13C carbonic acid and is highly soluble in water (1 gram per ml at 25OC). It has the following chemical formula: 13CH4N2O.
DESCRIPTION OF THE MODE OF OPERATION OF THE BREATHID® DEVICEThe BreathID® device can be operated in two pre-selected modes of testing. These are the PATIENT MODE and the BAG MODE as described below.
PATIENT MODE
The test begins with the selection of the PATIENT MODE and with the collection of a baseline breath sample. The patient breathes normally while the BreathID® device collects samples through the IDcircuit™ nasal cannula. The IDcircuit™ extracts moisture and patient secretions from the breath samples to provide accurate CO2 readings, and the device measures the 13CO2 / 12CO2 ratio of the baseline measurement. The patient then ingests a test drink consisting of 13C-urea tablet 75 mg and 4.3 g of citric Powder (4g citric acid).
While the patient continues to breathe normally, the BreathID® device continually and non-invasively samples the patient’s breath (via the cannula) and measures the changes in the 13CO2 / 12CO2 ratio versus the original baseline sample. These changes are displayed as a graph on the large display screen while the test continues. The graph shows multiple points that allow the physician to identify the change in the DOB of the 13CO2 / 12CO2 ratio in response to the administered 13C-urea. Once the BreathID® device has collected enough data to determine whether or not a patient is H. pylori-positive, (i.e. the graph passes the threshold unambiguously), it automatically ends the test and prints out the results.
BAG MODE
The test begins with the collection of normally exhaled breath of the patient into a baseline breath collection bag, which is then sealed. This sample provides the baseline isotope ratio reading. Next, the patient ingests the test drink consisting of dissolved of 13C-urea tablet, 75 mg and 4.3 g of Citrica Powder (4g citric acid), as in the PATIENT MODE. After 20 minutes, the patient exhales into a post-ingestion breath collection bag, which is subsequently sealed.
The test is performed on the BreathID® device. After selecting BAG MODE, the baseline and then the post-ingestion breath collection bags are connected to the BreathID® device, one after the other. Each bag is separately sampled by the BreathID® device to determine the 13CO2 / 12CO2 ratio. The values of the ratios obtained are compared in order to determine the Delta Over Baseline (change in the 13CO2 / 12CO2 ratio between the baseline and the post-ingestion measurements). Once the BreathID® completes measuring the bags, it automatically displays and prints the results. This enables the physician to determine whether a patient is positive or negative for H. pylori, based on whether or not the graph passed the threshold line.
Sources
Idkit Hp One Manufacturers
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Exalenz Bioscience Ltd.
![Idkit Hp One (Citric Acid Anhydrous And 13c Urea) Kit [Exalenz Bioscience Ltd.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Idkit Hp One | Exalenz Bioscience Ltd.
Remind the patient that the Citrica contains 84 mg of phenylalanine per packet of Citrica. Phenylketonurics restrict dietary phenylalanine.The patient should have fasted at least one hour before administering the solution.The patient should not have taken antimicrobials, proton pump inhibitors or bismuth preparations within two weeks prior to administering the test.
PATIENT MODEMaterials
One Tablet of 13C-enriched urea, 75 mg. One Packet of 4.3 g (4 g citric acid, aspartame, Tutti Frutti flavoring) of Citrica Powder. One IDcircuit™ nasal cannula. One straw for stirring and drinking.
A single BreathID® IDkit: Hp™ ONE is provided to perform the Breath Test in the PATIENT MODE.
Each IDkit: Hp™ ONE for the Exalenz BreathID® Breath Test System contains:
SystemCheck
One SystemCheck accessory is supplied for every 25 units of BreathID® kits, IDkit: Hp™ ONE. The SystemCheck accessory supplied with the BreathID® kits provides quality control for the BreathID® system as described in the Quality Control section. The SystemCheck has an expiration date and shouldn't be used beyond this date as stated on the label.
Materials Needed But Not Provided:
A drinking cup with a capacity of eight ounces (236 ml) or greater. Tap water.
1. Before opening the kit, verify that the entire package is intact.
Step-by-Step Procedure for the PATIENT MODE
For more detailed information regarding the step-by-step procedure, on screen instructions, and device operation, refer to the BreathID® Operator’s Manual.
For performing the BreathID® H. pylori test in PATIENT MODE, use the IDkit: Hp™ ONE single-use kit.
2. Ensure that the BreathID® device is activated on PATIENT MODE. The device mode appears on the top corner of the screen.
3. Follow the screen instructions.
4. Connecting the IDcircuit™:
a. Take the IDcircuit™ out of its bag and slide the tubing sleeve down as far as it will go. Gently place the cannula tips into the patient’s nostrils, and place the cannula tubing over the ears, as shown in Figure 1.
b. Slide the tubing sleeve up towards the neck to fit comfortably under the chin.
c. Connect the IDcircuit™ to the BreathID® device by twisting the yellow connector at the free end of the cannula clockwise until it is secured into the dedicated socket of the BreathID® device, as shown in Figure 2.
d. Verify that the IDcircuit™ is not twisted or kinked and that the cannula tips are in the nostrils. Ensure that the IDcircuit™ cannula tips moldings are positioned inwards.
e. Click on the OK button to proceed. The baseline values will be measured by the BreathID® device and the results will be shown on the screen.
5. Preparing the test drink:
Note: Administer the test drink within two hours of preparation, as this is the maximal time for maintaining solution stability.
a. Dissolve the Citrica and the 13C-enriched urea tablet in 150 to 200 ml (5.1 to 6.8 oz) of tap water in a single drinking cup of at least 236 ml (8 oz) in capacity.
b. Stir thoroughly with the provided straw for one to two minutes, until the Citrica Powder and the urea tablet are completely dissolved.
Note: Tiny particles may remain visible after thorough mixing. However, if more substantial particulate matter is still present after five minutes of stirring, discard the solution and repeat the procedure with a new kit.
6. Administering the test drink and starting measurement:
Note: Do not administer the drink until prompted by the screen instructions on the device (this makes certain that the baseline sample has been collected properly).
a. Ensure that the patient drinks the solution through the straw.
b. The patient must drink the solution within two minutes and consume the entire amount.
c. After the patient finishes drinking the solution, press the OK button to proceed.
7. Measurement:
The BreathID® device continually analyzes the trend of measured results. When the BreathID® device determines that the final value will be positive or negative, i.e. greater or less than 5 Delta Over Baseline, it will automatically end the test and print out the results.
8. Removing and discarding the IDcircuit™:
When the measurement is complete, disconnect the IDcircuit™ from both the patient and the device. Dispose of the IDcircuit™ and all other used components of the kit, according to standard operating procedures or local regulations for the disposal of used medical waste.Note: If you do not disconnect the IDcircuit™, instructions will appear on the device screen reminding you to do so. The device will not proceed to the next screen until the IDcircuit™ is disconnected.
9. Printing Results:
a. After the measurement is complete, the device will automatically print the test results. The printout contains the graph as seen on the screen, including the date, time, test number and Delta Over Baseline value of the last point measured.
b. Tear off the printed results and fill in the patient data. Figure 1: Position of the IDcircuit™ Figure 2: Connecting the IDcircuit™ BAG MODEMaterials
One Tablet of 13C-enriched urea, 75 mg One Packet with 4.3 g (4 g citric acid, aspartame, Tutti Frutti flavoring) of Citrica Powder Two differently colored Breath Collection Bags. One bag is silver and marked as BASELINE (T-0) while the other is blue and marked as POST-INGESTION (T-20). One mouthpiece. Two caps, one for sealing each of the collection bags after the breath collections. One straw for stirring and drinking. One abridged User Guide (Instruction for Use - IFU). One patient requisition form. Two labels (stickers) to be completed with patient and clinical institution information. One plastic bag for the filled breath collection bags and the patient requisition form.
A single BreathID® IDkit: Hp™ TWO is provided to perform the Breath Test in the BAG MODE. Each Exalenz IDkit: Hp™ TWO for the Exalenz BreathID® Breath Test System contains:
A drinking cup with a capacity of 8 oz (236 ml) or greater. Tap water.
SystemCheck
One SystemCheck accessory is supplied for every 25 units of BreathID® IDkit: Hp™ TWO. The SystemCheck accessory supplied with IDkit: Hp™ TWO provides quality control for the BreathID® System, as described in the Quality Control section. The SystemCheck has an expiration date and shouldn't be used beyond this date as stated on the label.
Materials Needed But Not Provided:
1. Before opening the kit, verify that the entire package is intact.
Step-by-Step Procedure of the BAG MODE
For detailed information regarding the step-by-step procedure, on screen instructions, and device operation, refer to the BreathID® Operator’s Manual.
For performing the BreathID® H. pylori test in the BAG MODE, use the IDkit: Hp™ TWO single-use kit.
2. Open a single-use test kit and fill in the patient requisition form.
3. Prepare the silver-colored Breath Collection Bag(T-0) for the breath test:
a. Fill in the first label (sticker), marked (T-0).
b. Take out the silver-colored “Breath Collection Bag - BASELINE (T-0)” for the breath test.
c. Affix the label (sticker) on the silver Breath Collection Bag (T-0).
4. Preparing the test drink:
Note: Administer the test drink within two hours of preparation, as this is the maximal time for maintaining solution stability.
a. Dissolve the Citrica and the 13C-enriched urea tablet in 150 to 200 ml (5.1 to 6.8 oz) of tap water in a single drinking cup of at least 236 ml (8 oz) in capacity.
b. Stir thoroughly with the provided straw for one to two minutes until the Citrica Powder and the urea tablet are completely dissolved.
Note: Tiny particles may remain visible after thorough mixing. However, if more substantial particulate matter is still present after five minutes, discard the solution and repeat the procedure with a new kit.
5. Baseline bag filing:
a. Take the silver bag marked as "Breath Collection Bag - BASELINE (T-0)".
b. Insert the provided mouthpiece approximately halfway into the BASELINE bag.
c. While holding the bag, instruct the patient to take a deep breath, to hold his breath for 1-2 seconds, and then to forcefully exhale his contained breath into the bag.
d. Lock the bag tightly with one of the provided caps immediately after it is filled with the patient’s breath. Continue to turn the cap until a clicking sound is heard. This will confirm that the cap is secured and the bag is sealed.
6. Administering the test drink:
a. Ensure that the patient drinks the solution through the straw.
b. The patient must drink the solution within two minutes and must consume the entire amount.
7. Prepare the blue “Breath Collection Bag- POST INGESTION (T-20)” for the breath test:
a. Fill in the label (sticker) marked (T-20), including the time that the second breath sample will be collected (which is time of ingestion + 20 minutes).
b. Take out the blue Breath Collection Bag for the breath test.
c. Affix the label (sticker) onto the blue bag.
8. Post-Ingestion bag filling:
a. Exactly twenty minutes after ingestion (as indicated on the sticker), insert the mouthpiece into the blue bag marked "Breath Collection Bag POST-INGESTION (T-20)"
b. While holding the bag, the patient is instructed to take a deep breath, to hold his breath for 1-2 seconds, and then to forcefully exhale his contained breath into the bag.
c. Lock the bag tightly with the remaining cap immediately after it is filled with the patient’s breath. Continue to turn the cap until a clicking sound is heard. This will confirm that the cap is secured and the bag is sealed. Place the two sealed bags and the patient requisition form in the provided plastic bag.
9. Measurement:
a. Ascertain that the BreathID® device is operating in H. pylori BAG MODE.
b. The device's mode of operation appears on the upper corner of the screen. To switch modes of operation, refer to the Operator’s Manual.
c. Open the plastic bag containing the breath collection bags and patient requisition form.
d. Connect the silver bag marked as "Breath Collection Bag BASELINE (T-0)" via the bag adaptor (supplied as part of the accessories kit for IDkit: Hp™ TWO) and the bag connector (supplied as part of the Device’s Accessories Box).
e. Prompt the BreathID® to measure the baseline.
f. Disconnect the first bag when instructed to do so by the device and then connect the blue "Breath Collection Bag POST-INGESTION (T-20)".
g. The BreathID® automatically computes the Delta Over Baseline (DOB), and after the measurement is complete, the device will automatically print the test results. The printout contains the date, time, test number and the Delta Over Baseline value.
h. Tear off the printed results, and attach it to the patient requisition form.
i. Disconnect the Breath Collection Bag.
f. Disconnect the Bag Adaptor. PATIENT MODEMaterials
One Tablet of 13C-enriched urea, 75 mg. One Packet of 4.3 g (4 g citric acid, aspartame, Tutti Frutti flavoring) of Citrica Powder. One IDcircuit™ nasal cannula. One straw for stirring and drinking.
A single BreathID® IDkit: Hp™ ONE is provided to perform the Breath Test in the PATIENT MODE.
Each IDkit: Hp™ ONE for the Exalenz BreathID® Breath Test System contains:
SystemCheck
One SystemCheck accessory is supplied for every 25 units of BreathID® kits, IDkit: Hp™ ONE. The SystemCheck accessory supplied with the BreathID® kits provides quality control for the BreathID® system as described in the Quality Control section. The SystemCheck has an expiration date and shouldn't be used beyond this date as stated on the label.
Materials Needed But Not Provided:
A drinking cup with a capacity of eight ounces (236 ml) or greater. Tap water.
1. Before opening the kit, verify that the entire package is intact.
Step-by-Step Procedure for the PATIENT MODE
For more detailed information regarding the step-by-step procedure, on screen instructions, and device operation, refer to the BreathID® Operator’s Manual.
For performing the BreathID® H. pylori test in PATIENT MODE, use the IDkit: Hp™ ONE single-use kit.
2. Ensure that the BreathID® device is activated on PATIENT MODE. The device mode appears on the top corner of the screen.
3. Follow the screen instructions.
4. Connecting the IDcircuit™:
a. Take the IDcircuit™ out of its bag and slide the tubing sleeve down as far as it will go. Gently place the cannula tips into the patient’s nostrils, and place the cannula tubing over the ears, as shown in Figure 1.
b. Slide the tubing sleeve up towards the neck to fit comfortably under the chin.
c. Connect the IDcircuit™ to the BreathID® device by twisting the yellow connector at the free end of the cannula clockwise until it is secured into the dedicated socket of the BreathID® device, as shown in Figure 2.
d. Verify that the IDcircuit™ is not twisted or kinked and that the cannula tips are in the nostrils. Ensure that the IDcircuit™ cannula tips moldings are positioned inwards.
e. Click on the OK button to proceed. The baseline values will be measured by the BreathID® device and the results will be shown on the screen.
5. Preparing the test drink:
Note: Administer the test drink within two hours of preparation, as this is the maximal time for maintaining solution stability.
a. Dissolve the Citrica and the 13C-enriched urea tablet in 150 to 200 ml (5.1 to 6.8 oz) of tap water in a single drinking cup of at least 236 ml (8 oz) in capacity.
b. Stir thoroughly with the provided straw for one to two minutes, until the Citrica Powder and the urea tablet are completely dissolved.
Note: Tiny particles may remain visible after thorough mixing. However, if more substantial particulate matter is still present after five minutes of stirring, discard the solution and repeat the procedure with a new kit.
6. Administering the test drink and starting measurement:
Note: Do not administer the drink until prompted by the screen instructions on the device (this makes certain that the baseline sample has been collected properly).
a. Ensure that the patient drinks the solution through the straw.
b. The patient must drink the solution within two minutes and consume the entire amount.
c. After the patient finishes drinking the solution, press the OK button to proceed.
7. Measurement:
The BreathID® device continually analyzes the trend of measured results. When the BreathID® device determines that the final value will be positive or negative, i.e. greater or less than 5 Delta Over Baseline, it will automatically end the test and print out the results.
8. Removing and discarding the IDcircuit™:
When the measurement is complete, disconnect the IDcircuit™ from both the patient and the device. Dispose of the IDcircuit™ and all other used components of the kit, according to standard operating procedures or local regulations for the disposal of used medical waste.Note: If you do not disconnect the IDcircuit™, instructions will appear on the device screen reminding you to do so. The device will not proceed to the next screen until the IDcircuit™ is disconnected.
9. Printing Results:
a. After the measurement is complete, the device will automatically print the test results. The printout contains the graph as seen on the screen, including the date, time, test number and Delta Over Baseline value of the last point measured.
b. Tear off the printed results and fill in the patient data. Figure 1: Position of the IDcircuit™ Figure 2: Connecting the IDcircuit™ BAG MODEMaterials
One Tablet of 13C-enriched urea, 75 mg One Packet with 4.3 g (4 g citric acid, aspartame, Tutti Frutti flavoring) of Citrica Powder Two differently colored Breath Collection Bags. One bag is silver and marked as BASELINE (T-0) while the other is blue and marked as POST-INGESTION (T-20). One mouthpiece. Two caps, one for sealing each of the collection bags after the breath collections. One straw for stirring and drinking. One abridged User Guide (Instruction for Use - IFU). One patient requisition form. Two labels (stickers) to be completed with patient and clinical institution information. One plastic bag for the filled breath collection bags and the patient requisition form.
A single BreathID® IDkit: Hp™ TWO is provided to perform the Breath Test in the BAG MODE. Each Exalenz IDkit: Hp™ TWO for the Exalenz BreathID® Breath Test System contains:
A drinking cup with a capacity of 8 oz (236 ml) or greater. Tap water.
SystemCheck
One SystemCheck accessory is supplied for every 25 units of BreathID® IDkit: Hp™ TWO. The SystemCheck accessory supplied with IDkit: Hp™ TWO provides quality control for the BreathID® System, as described in the Quality Control section. The SystemCheck has an expiration date and shouldn't be used beyond this date as stated on the label.
Materials Needed But Not Provided:
1. Before opening the kit, verify that the entire package is intact.
Step-by-Step Procedure of the BAG MODE
For detailed information regarding the step-by-step procedure, on screen instructions, and device operation, refer to the BreathID® Operator’s Manual.
For performing the BreathID® H. pylori test in the BAG MODE, use the IDkit: Hp™ TWO single-use kit.
2. Open a single-use test kit and fill in the patient requisition form.
3. Prepare the silver-colored Breath Collection Bag(T-0) for the breath test:
a. Fill in the first label (sticker), marked (T-0).
b. Take out the silver-colored “Breath Collection Bag - BASELINE (T-0)” for the breath test.
c. Affix the label (sticker) on the silver Breath Collection Bag (T-0).
4. Preparing the test drink:
Note: Administer the test drink within two hours of preparation, as this is the maximal time for maintaining solution stability.
a. Dissolve the Citrica and the 13C-enriched urea tablet in 150 to 200 ml (5.1 to 6.8 oz) of tap water in a single drinking cup of at least 236 ml (8 oz) in capacity.
b. Stir thoroughly with the provided straw for one to two minutes until the Citrica Powder and the urea tablet are completely dissolved.
Note: Tiny particles may remain visible after thorough mixing. However, if more substantial particulate matter is still present after five minutes, discard the solution and repeat the procedure with a new kit.
5. Baseline bag filing:
a. Take the silver bag marked as "Breath Collection Bag - BASELINE (T-0)".
b. Insert the provided mouthpiece approximately halfway into the BASELINE bag.
c. While holding the bag, instruct the patient to take a deep breath, to hold his breath for 1-2 seconds, and then to forcefully exhale his contained breath into the bag.
d. Lock the bag tightly with one of the provided caps immediately after it is filled with the patient’s breath. Continue to turn the cap until a clicking sound is heard. This will confirm that the cap is secured and the bag is sealed.
6. Administering the test drink:
a. Ensure that the patient drinks the solution through the straw.
b. The patient must drink the solution within two minutes and must consume the entire amount.
7. Prepare the blue “Breath Collection Bag- POST INGESTION (T-20)” for the breath test:
a. Fill in the label (sticker) marked (T-20), including the time that the second breath sample will be collected (which is time of ingestion + 20 minutes).
b. Take out the blue Breath Collection Bag for the breath test.
c. Affix the label (sticker) onto the blue bag.
8. Post-Ingestion bag filling:
a. Exactly twenty minutes after ingestion (as indicated on the sticker), insert the mouthpiece into the blue bag marked "Breath Collection Bag POST-INGESTION (T-20)"
b. While holding the bag, the patient is instructed to take a deep breath, to hold his breath for 1-2 seconds, and then to forcefully exhale his contained breath into the bag.
c. Lock the bag tightly with the remaining cap immediately after it is filled with the patient’s breath. Continue to turn the cap until a clicking sound is heard. This will confirm that the cap is secured and the bag is sealed. Place the two sealed bags and the patient requisition form in the provided plastic bag.
9. Measurement:
a. Ascertain that the BreathID® device is operating in H. pylori BAG MODE.
b. The device's mode of operation appears on the upper corner of the screen. To switch modes of operation, refer to the Operator’s Manual.
c. Open the plastic bag containing the breath collection bags and patient requisition form.
d. Connect the silver bag marked as "Breath Collection Bag BASELINE (T-0)" via the bag adaptor (supplied as part of the accessories kit for IDkit: Hp™ TWO) and the bag connector (supplied as part of the Device’s Accessories Box).
e. Prompt the BreathID® to measure the baseline.
f. Disconnect the first bag when instructed to do so by the device and then connect the blue "Breath Collection Bag POST-INGESTION (T-20)".
g. The BreathID® automatically computes the Delta Over Baseline (DOB), and after the measurement is complete, the device will automatically print the test results. The printout contains the date, time, test number and the Delta Over Baseline value.
h. Tear off the printed results, and attach it to the patient requisition form.
i. Disconnect the Breath Collection Bag.
f. Disconnect the Bag Adaptor.
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