What the Pylobactell tablet contains
- The active substance is 13C-urea. Each tablet contains 100 mg of 13C-urea The other ingredients are povidone E1201, microcrystalline cellulose E460i, colloidal anhydrous silica and sodium benzoate E211.
Each Pylobactell Breath Test kit contains:
- 1 Sachet containing1 tablet.
- 6 glass tubes, 3 with white caps and 3 with red caps.
- 30 ml glass mixing tube with cap.
- 2 straws.
- 1 Analysis Request Form.
- 1 Security Label and 3 additional bar code labels.
The contents of this kit are sufficient for a single test. If you need to repeat the test, a new kit will be required and it should not be carried out until the following day.
Marketing Authorisation Holder
Torbet Laboratories Limited, 14D Wendover Road, Rackheath Industrial Estate, Norwich, NR13 6LH, United KingdomTel. +44 (0)1603 735200
Fax. +44 (0)1603 735217
E-mail. customerservices@typharm.com
Manufacturer
PackPharm Limited, 14D Wendover Road, Rackheath Industrial Estate, Norwich, NR13 6LH, United Kingdom.
This leaflet was last approved in
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The following information is intended for laboratory use only:
Analysis of breath samples and testing specification
The accuracy and precision of the test depends heavily on the quality of the analysis and therefore only laboratories having appropriate certification are considered qualified to analyse the breath samples.
Satisfactory specificity and sensitivity have been demonstrated in clinical studies where breath was analysed using isotope ratio mass spectrometry (IRMS).
Breath samples collected during a test must remain in the original containers before analysis by IRMS.
IRMS instruments may be of continuous flow or dual inlet configuration.
A multi-position autosampler and bar code reader should be used to allow samples to be tracked throughout the analysis.
IRMS source parameters and tuning must be optimised daily.
concentrations typically 1.0 - 6.0. This Instruments must be linear over a wide range of CO2should be checked routinely.
Internal analytical precision must be less than + 0.3 ? ? 13C for 20 replicate analyses of the same reference gas sample and remain within 2 3SD?s of the mean for breath analyses.
Transfer of the breath sample through the analytical system must be accomplished without isotope fractionation.
The IRMS must possess a triple collector to allow the simultaneous detection of the ions at mass/charge ratio 44, 45 and 46 fluctuations in the oxygen isotope content.
There must be provision for correction of instrumental drift during an analysis.
Reference gases must be standardised against an appropriate international standard to allow inter-laboratory comparison of results.
Alternatively, any other suitably-validated method may be used, carried out by any objectively qualified laboratory.
Explanation of results:-
? 13C:- Difference in parts per thousand (?) with respect to an accepted international standard.
Excess 13C- Difference between pre- and post-urea sample measurements.
H. pylori status: -< 3.5 excess ? 13C = Negative> 3.5 excess ? 13C = Positive
ANALYSIS REQUEST FORM:
Pylobactell 13Carbon -UREA BREATH TEST 13C-UBT for Helicobacter pylori
ANALYSIS REQUEST FORM - Please complete in block capitals
Please state clearly address for return of results:
Centre:
Patient Name:
Date of Birth:
Patient Reference:
Date of Test:
Referring Doctor:
AFFIX BAR-CODE LABEL HERE
PLEASE PLACE BAR-CODE LABEL ON PATIENT RECORDS, IF APPLICABLE
M.A. Number: EU/1/98/064/001
Marketing Authorisation Holder: Torbet Laboratories Limited, 14D Wendover Road, Rackheath Industrial Estate, Norwich, NR13 6LH, United Kingdom
TEST CHECK LIST Test Check List MEDICATION RECORD Medical History - has the patient taken Type Date Mins Time
i antibiotics in the last 28 days t 0 Note time patient drinks test meal If so, please indicate type and when last taken t 5 ii proton pump inhibitors PPIs Collect Pre-Urea samples White Caps - 3 times in the last 14 days If so, please indicate type and when last taken.
iii eradication therapy in the last t 10 28 days Patient to drink urea solution, then fill bottle to line again and drink. If so, please indicate when treatment ended t 40 iv other medication if Collect Post-Urea samples Red Caps - 3 times. applicable
v patient fasted for hours Check Please note that i - iii will affect result of test. Bar-code label and all details entered on Analysis Request Form. 1 x PrePost sample reserved in store. 2 x PrePost samples this form for return to a qualified laboratory. Comments Laboratory use only Date received Analytical file reference Laboratory code
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