qanastek/EMEA-V3 huggingface dataset:
(44-20) 74 18 84 00 Fax (44-20) 74 18 84 16 E-mail: mail@emea. europa. eu http: / /www. emea. europa. eu ©EMEA 2007 Reproduction and/ or distribution of this document is authorised for non commercial purposes only provided the EMEA is acknowledged H. pylori contain enzymes called ureases that make it able to break down urea into carbon dioxide, which is then removed in the breath.
Is- sustanza attiva, 13C- urea, fit- Test Helicobacter INFAI, hija l- urea kimika naturali li ġiet ittikkettjata bil- karbonju- 13 (13C).
When the patient takes Helicobacter Test INFAI, the 13C-urea contained in the test is broken down by H Pylori into carbon dioxide that also contains 13C.
Meta l- pazjent jieħu t- Test Helicobacter INFAI, l- 13C- urea li fih it- test titkisser minn H Pylori f’ dijossidu tal- karbonju li fih ukoll 13C.
This labelled carbon dioxide can be measured by specialised laboratories using a technique called mass spectrometry.
Dan id- dijossidu tal- karbonju ittikkettjat jista ’ jitkejjel minn laboratorji speċjalizzati bl- użu ta ’ teknika msejħa spektometrija tal - massa.
If there is labelled carbon dioxide in the breath sample after 30 minutes (a positive test), this means that the patient is infected with H. pylori.
Jekk wara 30 minuta ikun hemm dijossidu tal- karbonju ittikkettjat fil- kampjun tan- nifs (test pożittiv), dan ifisser li l- pazjent huwa nfettat b’ H. pylori.
If there is no labelled carbon dioxide in the breath, this means there are no bacteria in the stomach or duodenum.
Jekk ma jkunx hemm dijossidu tal- karbonju ittikkettjat fin- nifs, dan ifisser li m’ hemm l- ebda batterju fl- istonku jew fid- duwodenu.
How has Helicobacter Test INFAI been studied?
Kif ġie studjat it- Test Helicobacter INFAI?
Helicobacter Test INFAI has been tested in four studies in adult patients involving a total of 561 patients and one study in 335 children and adolescents.
It- Test Helicobacter INFAI ġie studjat f’ erba ’ studji f’ pazjenti adulti li involvew total ta ’ 561 pazjent u studju bi 335 tifel u tifla u adolexxenti.
All received 75 mg of 13C-urea, except 204 children under the age of 11 who received 45 mg.
Huma kollha irċievew 75 mg ta ’ 13C- urea, ħlief 204 tifel u tifla taħt l- età ta ’ 11- il sena li irċievew 45 mg.
One of the studies in adults was carried out in patients after they had received antibiotics to treat their infection.
Wieħed mill- istudji fl- adulti sar fuq pazjenti wara li kienu ħadu l- antibijotiċi biex jikkuraw l- infezzjoni tagħhom.
In all studies, patients underwent an endoscopy and histology (when a probe is inserted in the stomach to take a sample and the sample is then analysed) as well as a breath test with Helicobacter Test INFAI, and the results of the two tests were compared.
Fl- istudji kollha, il- pazjenti saritilhom endoskopija u istoloġija (meta s- sonda tiddaħħal fl- istonku biex tieħu kampjun u l- kampjun huwa mbagħad analizzat) kif ukoll test tan- nifs bit- Test Helicobacter INFAI, u r- riżultati taż- żewġ testijiet kienu mqabbla.
What benefit has Helicobacter Test INFAI shown during the studies?
X’ benefiċċju wera t- Test Helicobacter INFAI waqt l- istudji?
In all studies, the results of the test done using Helicobacter Test INFAI agreed with the results obtained with the endoscopy and histology in over 95% of cases.
Fl- istudji kollha, ir- riżultati tat- test magħmul bl- użu tat- Test Helicobacter INFAI qablu mar- riżultati miksuba bl- endoskopija u l- istoloġija f’ aktar minn 95% tal- każijiet.
What is the risk associated with Helicobacter Test INFAI?
X’ inhu r- riskju assoċjat mat- Test Helicobacter INFAI?
There are no known side effects of the test.
Ma hemm l- ebda effett sekondarju magħruf ta ’ dan it- test.
However, if the patient vomits during the test, the test will need to be done again, but not until at least the following day.
Madankollu, jekk il- pazjent jirremmetti waqt it- test, it- test ikun jeħtieġ li jerġa ’ jsir, iżda, ta ’ l- anqas, mhux qabel il- jum segwenti.
Helicobacter Test INFAI should not be used in patients who have, or may have gastric (stomach) infection or atrophic gastritis (stomach inflammation that causes the breakdown of the stomach lining), as these might interfere with the breath test.
It- Test Helicobacter INFAI m’ għandux jintuża f’ pazjenti li għandhom, jew jista ’ jkollhom infezzjoni gastrika (ta ’ l- istonku) jew gastrite atrofika (infjammazzjoni ta ’ l- istonku li tikkaġuna tkissir tar- rita ta ’ l- istonku), peress li dawn jistgħu jinterferixxu mat- test tan- nifs.
Why has Helicobacter Test INFAI been approved?
Għalfejn ġie approvat it- Test Helicobacter INFAI?
The Committee for Medicinal products for Human Use (CHMP) decided that Helicobacter Test INFAI’ s benefits are greater than its risks for the in vivo diagnosis of gastroduodenal H. pylori infection in adults, adolescents who are likely to have peptic ulcer disease, and children aged three to 11 years for the evaluation of the success of eradication treatment, or when invasive tests cannot be performed, or when there are discordant results arising from invasive tests.
Il- Kumitat għall- Prodotti Mediċinali għall- Użu mill- Bniedem (CHMP) iddeċieda li l- benefiċċji tat - Test Helicobacter INFAI’ s huma akbar mir- riskji tiegħu għad- dijanjożi in vivo ta ’ infezzjoni H. pylori gastroduwodenali fl- adulti, adolexxenti li x’ aktarx ikollhom mard ta ’ ulċeri peptiċi, u tfal ta ’ etajiet minn tlieta sa 11- il sena għall- evalwazzjoni tas- suċċess tal- kura ta ’ qerda, jew meta testijiet invażivi ma jkunux jistgħu jsiru, jew meta jkun hemm riżultati diskordanti ġejjin minn testijiet invażivi.
The Committee recommended that Helicobacter Test INFAI be given marketing authorisation.
Il - Kumitat irrikkmanda li t- Test Helicobacter INFAI jingħata l- awtorizzazzjoni għat- tqegħid fis- suq.
Other information about Helicobacter Test INFAI:
Tagħrif ieħor dwar T- Test Helicobacter INFAI:
The European Commission granted a marketing authorisation valid throughout the European Union for Helicobacter Test INFAI to INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH on 14 August 1997.
Il- Kummissjoni Ewropea tat awtorizzazzjoni għat- tqegħid fis- suq valida madwar l- Unjoni Ewropea kollha għal Helicobacter Test INFAI lil INFAI, Institut für biomedizinische Analytik & NMR - Imaging GmbH fl- 14 ta ’ Awwissu 1997.
The marketing authorisation was renewed on 14 August 2002 and 14 August 2007.
L- awtorizzazzjoni għat- tqegħid fis- suq ġiet imġedda fl- 14 ta ’ Awwissu 2002 u fl- 14 ta ’ Awwissu 2007.
The full EPAR for Helicobacter Test INFAI is available here.
L- EPAR sħiħ għal Helicobacter Test INFAI huwa disponibbli minn hawn.
This summary was last updated in 09-2007.
Dan is- sommarju ġie aġġornat l- aħħar f’ 09- 2007.
Pharmaceutical form
Għamla farmaċewtika
Content
Kontenut (konċentrazzjoni) 13
Powder for oral solution
Trab għal soluzzjoni orali.
jar (polystyrene)
Vażett (polystyrene)
75 mg 13C-urea
75 mg C urea
1 jar, as part of a multicomponent kit with sample tubes
1 Vażett, reċipjenti għal kampjuni tan - nifs
1 jar, as part of a multicomponent kit with breath bags
1 Vażett, Boroż tan- nifs
EU/ 1/ 97/ 045/ 003
45 mg 13C urea EU 1/ 97/ 045/ 003
50 jars, as part of a multicomponent kit with breath bags
50 vażett, Boroż tan- nifs
Helicobacter Test INFAI 75 mg powder for oral solution
Helicobacter Test INFAI 75 mg trab ta ’ 13C urea għal soluzzjoni orali
One jar contains 75 mg of 13C-urea powder.
Vażett 1 fih 75 mg trab ta ’ 13C- urea għal.
Clear, colourless solution.
Soluzzjoni ċara, mingħajr kulur.
Helicobacter Test INFAI may be used for in vivo diagnosis of gastroduodenal Helicobacter pylori infection in:
Helicobacter Test INFAI jista ’ jintuża għal dijanjosi in vivo ta ’ infezzjoni b’ Helicobacter pylori fl - istonku u l- imsaren f ’:
- adolescents, who are likely to have peptic ulcer disease.
- adoloxxenti, li jista ’ jkollhom mard ta 'l- ulċera fl- istonku.
This medicinal product is for diagnostic use only.
Dan il- prodott mediċinali hu għal użu dijanjostiku biss.
This medicinal product should be administered by a healthcare professional and under appropriate medical supervision.
Dan il- prodott mediċinali għandu jingħata minn professjonist tal- kura tas- saħħa u taħt superviżjoni medika xierqa.
Helicobacter Test INFAI is a breath test for single administration.
Helicobacter Test INFAI huwa test tan- nifs.
Patients from the age of 12 must take the content of 1 jar with 75 mg.
Adoloxxenti mill- età ta ’ 12- il sena 'l fuq u adulti għandhom jieħdu l- kontenut ta ’ vażett b ’ 75 mg.
For performance of the test, 200 ml 100% orange juice or 1 g citric acid in 200 ml water for patients from the age of 12 and older (as a pre-administered test meal), as well as tap water (for dissolving the 13 C-urea powder) are necessary.
Sabiex titwettaq il- proċdura tat- test, 200 ml ta '100% meraq tal- larinġ jew gramma ta ’ aċidu ċitriku f ’ 200 ml ilma għal pazjenti mill- età ta ’ 12- il sena' l fuq (bħala test ta ’ ikla meħuda qabel), kif ukoll bħala ilma tal- vit (sabiex jinħall it- trab 13C- urea) huma meħtieġa.
The patient must have fasted for over 6 hours, preferably overnight.
Il- pazjent irid ikun sajjem għal aktar minn 6 sigħat, preferibilment għal lejl sħiħ.
The test procedure takes approximately 40 minutes.
Il- proċedura tat- test tieħu madwar 40 minuta.
In case it is necessary to repeat the test procedure, this should not be done until the following day.
F' każ li jkun hemm bżonn li tiġi ripetuta l- proċedura tat- test, din għandha ssir fil- ġurnata ta ’ wara.
The suppression of Helicobacter pylori might give false negative results.
It- trażżin ta ’ Helicobacter pylori jista ’ jiriżultati li huma negattivamemt foloz.
Therefore the test shall be used after at least four weeks without systemic antibacterial therapy and two weeks after last dose of acid antisecretory agents.
Għalhekk it- test għandu jintuża wara ta ’ l- anqas erba ’ ġimgħat mingħajr terapija antibatterika sistemika u ġimagħtejn wara l - aħħar doża ta ’ aġenti aċidi li jaħdmu kontra t- tnixxija.
Both might interfere with the Helicobacter pylori status.
It- tnejn jistgħu jinterferixxu ma ’ l- istat ta ’ Helicobacter pylori.
This is especially important after Helicobacter eradication therapy.
Dan hu speċjalment importanti wara terapija ta ’ eradikazzjoni.
It is important to follow the instructions for use adequately (see section 6.6), otherwise the reliability of the outcome will become questionable.
Huwa importanti li l- istruzzjonijiet dwar l- użu jiġu segwiti kif deskritt f' sezzjoni 6. 6, inkella l- validità tar- riżultat ma ’ jkunx konklussiv.
2 4.3 Contraindications
It- test m' għandux jintuża fuq pazjenti li għandhom infezzjoni dokumentata jew suspettata fl- istonku jew għandhom gastritè atrofika, li tista ’ tinterferixxi mat- test tan- nifs ta ’ l- urea (jekk jogħġbok irreferi għal sezzjoni 4. 2 – Pożoloġija u metodu ta ’ amministrazzjoni).
A positive test alone does not constitute indication for eradication therapy.
Test pożittiv waħdu mhux biżżejjed sabiex jistabilixxi indikazzjoni f' terapija ta ’ eradikazzjoni.
Differential diagnosis with invasive endoscopic methods might be indicated in order to examine the presence of any other complicating conditions, e. g. ulcer, autoimmune gastritis and malignancies.
Jista ’ jkun hemm bżonn ta 'dijanjosi differenzjali b' metodi endoskopiċi invażivi sabiex jiġi stabbilit jekk hemmx xi kundizzjonijiet oħrajn preżenti eż. ulċeri, gastrite awtoimmuni u malinni.
There is insufficient data on the diagnostic liability of the Helicobacter Test INFAI to recommend its use in patients with gastrectomy.
Qaghad m' hemmx biżżejjed informazzjoni rigward dispożizzjoni dijanjostika tal- Helicobacter Test INFAI sabiex din tiġi rakkomandata f’ pazjenti b’ gastrektomija u pazjenti li huma iżgħar minn 12- il sena fl- età.
For children from the age of 3, Helicobacter Test INFAI for children aged 3 to 11 is available.
Għal tfal minn 3 snin ’ il fuq, it- test jista ’ jsir bit- test INFAI għal etajiet ta ’ bejn 3 snin sa 11- il sena
In individual cases of A-gastritis (atrophic gastritis) the breath test may have false positive results; other tests may be required to confirm the Helicobacter pylori status.
F’ każijiet individwali ta 'gastrite- A (gastrite atrofika) it- test tan- nifs jista ’ jagħti riżultati pożittivi foloz; jista' jkun hemm bżonn ta ’ testijiet oħrajn biex jikkonfermaw il- preżenza ta ’ l- istat ta ’ Helicobacter pylori.
If the patient vomits during the test procedure, necessitating the repetition of the test, this should be done in fasted condition and not before the following day (see section 4.2).
Jekk il pazjent jirremetti waqt il- proċedura tat- test, bil- ħtieġa li t- test għandu jiġi ripetut, dan għandu jsir f’ kondizzjoni ta ’ sawm u mhux qabel il- ġurnata ta ’ wara, kif imniżżel f’ sezzjoni 4. 2.
Helicobacter Test INFAI will be affected by all treatments interfering with Helicobacter pylori status or urease activity.
Helicobacter Test INFAI jiġi affetwat b' kull trattament li jinterferixxi ma ’ l- istat ta ’ Helicobacter pylori jew attività ta ’ urease.
It is not expected that the test procedure may be harmful during pregnancy or lactation.
Mhux mistenni li l- proċedura tat- test tkun ta ’ ħsara waqt it- tqala jew l- irdigħ.
It is recommended to take notice of the product information of eradication therapy products for their use during pregnancy and lactation.
Huwa rakkomandat sabiex tingħata attenzjoni għall- informazzjoni tal- prodott għal prodotti ta ’ terapija fuq l- eradikazzjoni għal l- użu tagħhom waqt it- tqala u irdigħ.
Helicobacter Test INFAI has no influence on the ability to drive and use machines.
Helicobacter Test INFAI m’ għandu l- ebda effett fuq il- ħila ta ’ sewqan u l- użu ta ’ magni.
None known.
Mhux magħrufa.
Due to the fact that only 75 mg of 13C-urea is delivered, an overdose is not expected.
Minħabba li 75 mg ta ’ 13C- urea hija fornuta, mhux mistenni li jkun hemm doża eċċessiva.
Other diagnostic agents, ATC-code:
Kodiċi ATC:
For the amount of 75 mg 13C-urea, which is administered per unit in the course of the breath test, no pharmacodynamic activity is described.
3 Għall- ammont ta ’ 75 mg 13C- urea, mogħti għal kull unità fil- perkors tat- test tan- nifs, l- ebda attività farmakodinamika m’ hija deskritta.
After oral ingestion the labelled urea reaches the gastric mucosa.
Wara li tittieħed mill- ħalq l- urea tikkettjata tilħaq l- mukoża ta ’ l- istonku.
In the presence of Helicobacter pylori the 13C-urea is metabolised by the enzyme urease of Helicobacter pylori.
Fil- preżenza ta ’ Helicobacter pylori l- urea 13C- urea hija metabolizzata bl- enżima urease ta ’ Helicobacter pylori.
Enzyme urease
enżima urease
The carbon dioxide diffuses into the blood vessels.
Id- dijossidu karboniku jnixxi fil- vażi tad- demm.
From there it is transported as bicarbonate into the lung and liberated as 13CO2 with the exhaled air.
Minn hemm jiġi trasportat bħala bikarbonat fil - pulmun u liberat bħala 13CO2 fl- arja minfuħa.
In the presence of bacterial urease the ratio of the 13C/ 12C-carbon isotopes is significantly changed.
Fil- preżenza ta ’ urease batterika l- proporzjon ta ’ l- isotipi 13C/ 12C- carbon huwa sinifikament mibdul.
The portion of 13CO2 in the breath samples is determined by isotope-ratio-mass-spectrometry (IRMS) and stated as an absolute difference (Δδ -value) between the 00-minute- and the 30-minute-values.
Il- porzjon ta ’ 13CO2 fin- nifs huwa stabbilit bi spettrometrija tal- massa- isotopika proporzjonali (IRMS) u mniżżel bħala differenza assoluta (Δδ- value) bejn il- valuri 00- minuti - u t- 30- minuta.
Urease is produced in the stomach only by Helicobacter pylori.
Urease jiġi prodott fl- istonku b’ Helicobacter pylori biss.
Other urease producing bacteria were seldom found in the gastric flora.
Huwa rari li nstabu batterji oħrajn fil- flora gastrika li jipproduċu l- urease.
The cut off point for discriminating Helicobacter pylori-negative and positive patients is determined to be Δδ -value of 4 ‰, which means that an increase of the Δδ -value by more than 4 ‰ indicates an infection In comparison to bioptic diagnostics of an infection with Helicobacter pylori, the breath test achieved in clinical trials on 457 patients, a sensitivity in the range of 96.5% to 97.9% [95 %-CI:
B’ paragun ma ’ dijanjostiċi biotiċi ta ’ infezzjoni b ’ Helicobacter pylori, it- test tan- nifs, waqt provi kliniċi li saru fuq 457 pazjent, kellu sensittività fil medda ta ’ 96. 5% sa 97. 9% [95% - CI:
[95 %-CI:
94. 05% - 99. 72%], u medda ta ’ speċifiċità minn 96. 7% sa 100%. [95% - CI:
94.17 %-103.63%], whereas in clinical trials on 93 adolescents from the age 12– 17, a sensitivity of 97.7% [90 %-CI:
94. 17% - 103. 63%], filwaqt li fi provi kliniċi fuq 93 adoloxxent bejn l- etajiet ta ’ 12 – 17, ġiet miksuba sensittività ta ’ 97. 7% [95% - CI:
91.3%], and a specificity of 96.0% [90 %-CI:
94. 17% - 103. 63%] u speċifiċità ta ’ 96. 0%. [90% - CI:
In the absence of bacterial urease, the whole amount of the administered urea after absorption from the gastrointestinal tract will be metabolised like the endogenous urea.
Fin- nuqqas ta ’ urease batteriku, l- ammont sħiħ ta ’ l- urea amministrata wara assorbiment mill- apparat ta ’ l- istonku u ta ’ l- imsaren għandu jiġi metabolizzat bħal urea endoġena.
Ammonia which is produced as described above by the bacterial hydrolysis is included into the metabolism as NH4+.
Ammonia li tiġi prodotta kif deskritt hawn fuq bl- idroliżi batterika hija inkluża fil- metaboliżmu bħala NH4+.
The orally applied 13C-urea is metabolised to carbon dioxide and ammonia or is integrated into the body’ s own urea cycle.
L- urea 13C meħuda mill- ħalq hija metabolizzata għal dijossidu karboniku u ammonia jew inkella tiġi integrata fiċ- ċiklu uriku tal- ġisem.
Any increase in 13CO2 will be measured by isotopic analysis.
Kull żieda f ’ 13CO2 għandu jiġi mkejjel b’ analiżi isotopika.
Absorption and distribution of 13CO2 is faster than the urease reaction.
L- assorbiment u firxa ta ’ 13CO2 huwa aktar mgħaġġel milli fir- reazzjoni b’ urease.
Therefore, the rate limiting step in the whole process is the cleavage of 13C-urea by Helicobacter's urease.
Għalhekk, l- istadju ristrettiv fil- proċess kollu huwa l- qsim ta ’ 13C- urea b’ urease tal- Helicobacter
Only in Helicobacter pylori- positive patients does the administration of 75 mg labelled urea lead to a significant increase of 13CO2 in the breath sample within the first 30 minutes.
Huwa biss f’ pazjenti li għandhom Helicobacter pylori li t- teħid ta ’ 75 mg urea ttikkettata jwassal għal żieda sinifikanti ta ’ 13CO2 fil- kampjun tan- nifs fi żmien nofs siegħa.
No concerns in relation to the clinical use of the product.
M' hemm l- ebda kawża ta ’ ansjetà dwar l- użu kliniku tal- prodott.
6.3 Shelf-life
4 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
4 6.4 Special precautions for storage
6. 4 Prekawzjonijiet speċjali għall- ħażna
Do not store above 25°C.
Taħżinx f' temperatura 'l fuq minn 25 °C.
A test set contains the following parts:
Is- sett tat- test huwa magħmul mill- biċċiet li ġejjin:
No.
Nru.
Quantity
Kwantità
Jar (10 ml volume, polystyrene with polyethylene snap cap)
Vażett (volum ta ’ 10 ml, tap li jinqasam tal- polystyrene ma ’ polyethylene) li jkun fih 75 mg 13C trab tal- urea għal soluzzjoni li tittieħed mill- ħalq.
containing 75 mg 13C-urea powder for oral solution Labelled sample glass or plastic containers for sampling, storing and transporting the breath samples for analysis:
Reċipjenti bit- tikketta tal- ħġieġ – jew plastik - għal kampjunar, ħażna u ġarr tal- kampjuni tan- nifs għal analiżi:
Sampling time:
Ħin ta ’ kampjunar:
00-minute-value Sampling time:
00- minuti- valur Ħin ta ’ kampjunar:
30-minute-value Bendable straw for collection of the breath samples into the
30- minuta- valur
corresponding sample containers
Strô li jitgħawweġ għal ġbir ta ’ kampjuni tan- nifs fir- reċipjenti relattivi għal kampjunar
Data sheet for patient documentation Package leaflet Page of barcode labels and sticker
Fuljett ta ’ tagħrif Paġna bit- tikketti ta ’ kodiċi żbarrati u stiker
The test is to be performed in the presence of a qualified person.
It- test għandu jitwettaq fil- preżenza ta 'persuna kkwalifikata.
Each patient should be documented according to the provided data sheet.
Kull pazjent għandu jkun dokumentat skond il- folja ta ’ informazzjoni provduta.
It is recommended to perform the test with the patient being in a resting position.
Huwa rakkomandat li t- test jitwettaq bil- pazjent f’ pożizzjoni ta ’ serħan.
The test starts with the collection of samples for the determination of baseline-value (00-minute-value):
It- test jibda bil- ġbir ta ’ kampjuni sabiex jiġi stabbilit il- valur ta ’ referenza bażi (00- minuta- valur):
Take the straw and the two sample tubes with the label “Sampling time:
Ħu l- istrô u ż- żewġ tubi ta ’ kampjunar bit- tikketta: “ Ħin ta ’ kampjunar:
00-minute-value” out of the test set.
00- minuti- valur ” barra mis- sett tat- test.
Remove the stopper from one of the sample tubes, unwrap the straw and place the straw into the container.
Neħħi t- tapp minn wieħed mit- tubi ta ’ kampjunar, neħħi t- tgeżwir ta ’ l- istrô u qiegħed l - istrô fir- reċipjent.
Now the patient breathes gently through the straw until the inner surface of the sample tube steams up.
Issa ħu n- nifs bil- mod minn ġos- strô sakemm il- wiċċ ta ’ ġewwa tat- tubu tal- kampjun ifawwar.
By continuously breathing the patient must pull out the straw and immediately close the sample tube with its stopper.
Waqt li qiegħed tieħu n- nifs b' mod kontinwu, wieħed għandu jiġbed l- istrô l- barra u jagħlaq it- tubu tal- kampjun bit- tapp tiegħu.
(If the sample tube remains open for more than 30 seconds, the test result might be falsified.)
(Kemm- il darba t- tubu tal- kampjun jibqa ’ miftuħ għal aktar minn 30 sekonda, ir- riżultat tat- test jista ’ jkun falz)
Hold the sample tube upright and stick the bar-code label marked “00-minute-value” round the sample tube, so that the lines of the bar-code are horizontal.
Żomm il- borża tan- nifs 'l fuq u waħħal t- tikketta tal- kodiċi żbarrati mmarkata "00- minuti - valur" madwar it- tubu tal- kampjun sabiex il- linji tal- kodiċi żbarrati jkunu oriżżontali.
Fill up the second sample tube (Label “Sampling time:
Imla t- tieni tubu bil- kampjun (Tikketta: “ Ħin ta ’ kampjunar:
00-minute-value”) with breath by following the same procedure.
00- minuta- valur ”) bin- nifs billi tuża l- istess proċedura.
Now 200 ml of 100% orange juice or 1 g citric acid in 200 ml water must be drunk by the patient without delay.
Issa 200 ml ta ’ 100% meraq tal- larinġ jew 1 g ta ’ aċidu ċitriku f ’ 200 ml ilma għandu jinxtorob mingħajr dewmien.
Now the preparation of the test solution follows:
Issa jmiss il- preparazzjoni tas- soluzzjoni tat- test:
The jar labelled “13C-urea powder” is taken from the test set, opened, and filled up to three quarters of its volume with tap water.
Il- vażett bit- tikketta “ 13C trab tal- urea ” jiġi meħud mis- sett tat- test, jinfetaħ u jimtela sa • tlett kwarti minnu b' ilma tal- vit.
Close the jar and shake it carefully until all the powder is dissolved.
Agħlaq il- vażett u ħallat b’ attenzjoni sakemm it- trab kollu jkun inħall.
Pour the contents into a drinking glass.
Ferragħ il - kontenut f’ tazza.
Fill the 13C-urea jar to the brim with water for a second and third time and add these contents to the drinking glass (total volume of tap water should be approximately 30 ml).
Imla l- vażett 13C- urea sax- xifer b’ ilma għat- tieni u tielet darba u żid il- kontenut ta ’ dawn • fit- tazza (volum totali ta ’ ilma tal- vit għandu jkun madwar 30 ml).
This test solution must now be drunk immediately by the patient, and the time of application must be noted.
Is- soluzzjoni tat- test għandha tinxtorob minnufih mill- pazjent, u l- ħin ta ’ applikazzjoni għandu jitniżżel.
30-
Tletin minuta wara t- teħid tas- soluzzjoni tat- test, iġbor il- kampjuni ta ’ 30 minuta- valur li jinsabu fiż- żewġ reċipjenti li fadal fil- pakkett tat- test (Tikketta: “ Ħin ta 'kampjunar:
Use the bar-code labels marked “30-minute- value” for these samples.
30- minuta - valur ”), kif deskritt fl- istadji 3 u 4. Uża t- tikketti tal- kodiċi żbarrati mmarkati “ 30- minuta- valur ” għal dawn il- kampjuni.
Put the relevant bar-code label on the data sheet for patient documentation.
Qiegħed it- tikketta rilevanti bil- kodiċi żbarrata fuq il- folja tal- informazzjoni għad - dokumentazzjoni tal- pazjent.
Finally seal the package with the sticker.
Fl- aħħar issiġġilla l- pakkett bl- istiker.
The sample tubes have to be sent in the original packaging, for analysis, to a qualified laboratory.
It- tubi bil- kampjuni għandhom jintbagħtu fil- pakkett oriġinali, għal analiżi f' laboratorju kkwalifikat.
Analysis of breath samples and testing specification for laboratories
Analiżi ta ’ kampjuni tan- nifs u speċifikazzjoni ta 'l- ittestjar għal- laboratorji.
The breath samples, collected in 10 ml glass- or plastic sample tubes, are analysed by isotope ratio mass spectrometry (IRMS).
Il- kampjuni tan- nifs, miġbura f' tubi tal- ħġieġ – jew plastik jiġu analizzati bi spettrometrija tal- massa isotopika proporzjonali (IRMS).
The analysis of the 13C/12C-ratio in carbon dioxide of breath is an integrated part of the diagnostic test Helicobacter Test INFAI.
L- analiżi tal- proporzjoni 13C/ 12C- ratio ta ’ dijossidu karboniku fin- nifs jagħmel parti integrali mis- sett dijanjostiku Helicobacter Test INFAI.
The accuracy of the test strongly depends on the quality of the breath analysis.
Il- preċiżjoni tat- test tiddependi ħafna fuq il- kwalità tal- analiżi tan- nifs.
The specification of breath analysis parameters like linearity, stability (reference gas precision), and precision of measurement are fundamental for the accuracy of the system.
L- ispeċifikazzjoni ta ’ parametri ta ’ analiżi tan- nifs bħal linearità, stabbilità (preċiżjoni mal - gass ta ’ referenza) u preċiżjoni fil- kejl huma fundamentali fil- preċiżjoni tas- sistema.
It has to be ensured that the analysis is carried out by a qualified laboratory.
Għandu jiġi żgurat li l- analiżi titwettaq minn laboratorju kkwalifikat.
The method validated in the application is as follows:
Il- proċedura validata fl - applikazzjoni hija s- segwenti:
• Sample preparation for (IRMS)
• Preparazzjoni tal- kampjun għal (IRMS)
To determine the 13C/12C-ratio of carbon dioxide in breath by mass spectrometric analysis the carbon dioxide must be separated from the breath and introduced into the mass spectrometer.
L- iffissar tal- proporzjon 13C/ 12C- ratio fid- dijossidu karboniku 13C/ 12C fin- nifs b’ analiżi spettrometrika tal- massa, id- dijossidu karboniku għandu jiġi separat minn nifs u mdaħħal fl- ispettrometru tal- massa.
The automatic preparation system for isotope mass spectrometers which is dedicated for breath test analysis is based on a gas-chromatographic continuous flow separation technique.
Is- sistema ta ’ preparazzjoni awtomatika għal spettrometri tal- massa isotopika li hi magħmula għal analiżi tan- nifs hija msejsa fuq teknika ta ’ separazzjoni ta ’ influss kontinwu b ’ kromatografija bil- gass.
Water is removed from the sample by means of a Nafion water trap or the gas-chromatographic preparation system that separates the individual gases in a gas chromatographic column with Helium as eluent.
L- ilma jiġi mneħħi mis- sistema permezz ta ’ trapp ta ’ l- ilma Nafjon jew permezz tas- sistema ta ’ preparazzjoni bil- kromatografija tal- gass li tissepara l- gassijiet individwali fil- kolonna ta ’ kromatografija b' gass li fiha jintuża Elju bħala eluwent.
Passing the column the separated gas species of breath are detected by an ionisation detector.
Kif ikun għaddej fil- kolonna, l- ispeċijiet tal - gass separati tan- nifs jiġu intraċċati b' intraċċatur ijonizzanti.
The fraction of carbon dioxide gas, identified by its characteristic retention time, is introduced into mass spectrometer.
Dak il- porzjon ta ’ gass ta ’ dijossidu karboniku, identifikat biż- żamma tal- ħin karatteristiku tiegħu, jiġi introdott fl- ispettrometru tal- massa.
• Mass spectrometric analysis
• Analiżi spettrometrika tal- massa
To analyse the separated carbon dioxide sample gas its molecules must be ionised, formed into a beam, accelerated by an electric field, deflected in a magnetic field, and finally detected.
Sabiex jiġi analizzat il- kampjun ta ’ gass ta ’ dijossidu karboniku separat, il- molekuli jridu jiġi ijoniżati, magħmula f’ raġġ, aċċelerati f’ medda elettrika, milwija f' medda manjetika, u fl- aħħar intraċċata.
These five processes take place in the analyser of a mass spectrometer, which consists of three separate sections: the source, flight tube, and collector.
Dawn il- ħames proċessi jsiru fl- analizzatur ta ’ l- ispettrometru tal- massa, li hu magħmul minn tlett partijiet separati: is- sors, it- tubu tat- tajran u l- kolletur.
Ionisation, beam formation and acceleration all occur in the source, magnetic deflection takes place in the flight tube and detection takes place in the collector.
Ijonizzazzjoni, formazzjoni tar- raġġ u aċċelerazzjoni kollha jseħħu fis- sors, liwi manjetiku jseħħ fit- tubu tat- tajran u l- intraċċar jseħħ fil- kolletur.
• Sample inlet
• Introduzzjoni tal- kampjun
For introduction of the carbon dioxide into the analyser many sample inlet systems are available.
Għal introduzzjoni ta ’ dijossidu karboniku fl- analizzatur hemm diversi sistemi ta ’ dħul disponibbli.
For breath test analysis the individual balancing of the carbon dioxide of the sample to a reference standard gas is essential.
Għal analiżi tan- nifs huwa meħtieġ li jkun hemm ekwilibriju individwali tad- dijossidu karboniku tal - kampjun mal- gass ta ’ referenza standard.
This ensures the high accuracy of this system, as calculation of the isotopic content in carbon dioxide is done with respect to an independent standard.
Dan jiżgura preċiżazzjoni għolja ta ’ din is- sistema, billi kalkulazzjoni tal- kontenut isotopiku ta ’ dijossidu karboniku irid jitqabbel ma ’ standard indipendenti.
• Specifications for determining 13 C/ 12C-ratios
Speċifikazzjonijiet sabiex jiġu stabbiliti l- proporzjonijiet 13C/ 12C •
The breath test concept relies on the administration of a specifically 13C-labelled urea whose metabolite utilisation is monitored by measuring 13CO2 in the expired breath gas.
6 Il- kunċett tat- test tan- nifs huwa msawwar fuq it- teħid mill- ħalq speċifiku ta ’ urea ttikkettat 13C li l- użu metaboliku tiegħu jiġi sorveljat bil- kejl ta ’ 13CO2 f’ nifs 'l barra.
6 • The mass spectrometer must be capable of:
• L- ispettrometru tal- massa irid jilħaq dawn l- aspettativi:
Multiple replicate analyses:
Analiżi ripettitivi multipli:
Minimum of 3 replicate analyses on the same sample during operation
Minimu ta ’ 3 analiżi ripettivi fuq l- istess kampjun waqt l- impjieg Ħażna tal- parametri ta ’ ħidma u tar- riżultati taħt aċċess tas- sigurtà sabiex jiġi evitat kull manipulazzjoni 'l quddiem proporzjon 13C/ 12C fir- rigward ta ’ PDB (Pee Dee Beliminate)
Security access:
Ħolqa tal- kampjun:
The principal tests to verify the specifications are linearity, stability (reference gas precision), and precision of measurement.
It- testijiet prinċipali li jivverifikaw l- ispeċifikazzjonijiet huma linearità, stabbilità (preċiżazzjoni tal - gass ta ’ referenza), u preċiżazzjoni tal- kejl.
• All mass spectrometers for breath analysis must comply with the following specifications:
Kull spettrometru tal- gass għal analiżi tan- nifs irid ikun konformi ma ’ l- ispeċifikazzjonijiet li ġejjin:
≤ 0.3 ‰ for 13C at natural abundance using a 10 ml breath sample tube with 3% CO2 breath concentration
≤ 0. 5 ‰ għal kampjuni tan- nifs li jvarjaw minn bejn 1% u 7% tal - Linejarità: konċentrazzjoni ta ’ CO2 ≤ 0. 2 ‰ fuq 10 pulsi konsekkutivi Stabbilità: ≤ 0. 3 ‰ għal 13C f’ abundanza naturali permezz ta ’ tubu ta ’ kampjun Preċiżazzjoni fil- kejl: tan- nifs ta ’ 10ml b 'konċentrazzjoni tan- nifs ta ’ 3% CO2.
Helicobacter pylori infection is present if the difference in 13C/12C of baseline-value and 30-minute- value exceeds 4.0 ‰.
Infezzjoni ta ’ Helicobacter pylori huwa preżenti jekk id- differenza ta ’ valur fir- referenza bażi f ’ 13 12 C / C u 30 minuta - valur jaqbeż 4. 0 ‰.
Alternatively, any other suitable-validated method may be used, carried out by any objectively qualified laboratory.
Alternattivament, kull laboratorju b’ mod oġġettiv ikkwalifikat jista ’ iwettaq kull metodu vvalidat kif suppost.
INFAI, Institut für biomedizinische Analytik & NMR-Imaging GmbH Universitätsstraße 142 D-44799 Bochum Germany
INFAI, Institut für biomedizinische Analytik & NMR- Imaging GmbH Universitätsstraße 142 D- 44799 Bochum Il- Ġermanja
Date of latest renewal:
Data ta ’ l- ewwel awtorizzazzjoni 14/ 08/ 1997 Data ta ’ l- aħħar tiġdid ta ’ l- awwtorazzozzjoni 14/ 08/ 2007
1 jar contains 75 mg of 13C-urea powder.
Vażett 1 fih 75 mg trab ta ’ 13C- urea għal.
Patients from the age of 12 must take the contents of 1 jar with 75 mg.
Adoloxxenti mill- età ta ’ 12- il sena 'l fuq u adulti għandhom jieħdu l- kontenut ta ’ vażett b ’ 75 mg.
For performance of the test, 200 ml 100% orange juice or 1 g citric acid in 200 ml water for patients from the age of 12 and older (as a pre-administered test meal), as well as tap water (for dissolving the 13 C-urea powder) are necessary.
Sabiex titwettaq il- proċedura tat- test, 200 ml ta '100% meraq tal- laring jew gramma ta ’ aċidu ċitriku f ’ 200 ml ilma għal pazjenti mill- età ta ’ 12- il sena' l fuq (bħala test ta ’ ikla meħuda qabel), kif ukoll bħala ilma tal- vit (sabiex jinħall it- trab 13C- urea) huma meħtieġa.
The patient must have fasted for over 6 hours, preferably overnight.
Il- pazjent irid ikun sajjem għal aktar minn 6 siegħat, preferibilment għal lejl sħiħ.
The suppression of Helicobacter pylori might give false negative results.
It- trażżin ta ’ Helicobacter pylori jista ’ jagħti riżultati li huma negattivament foloz.
Therefore the test shall be used after at least four weeks without systemic antibacterial therapy and two weeks after last dose of acid antisecretory agents.
Għalhekk it- test għandu jintuża wara ta ’ l- anqas erba ’ ġimgħat mingħajr terapija antibatterika sistematika u ġimagħtejn wara l- aħħar doża ta ’ aġenti aċidi li jaħdmu kontra t- tnixxija.
The test must not be used in patients with documented or suspected gastric infection or atrophic gastritis, which might interfere with the urea breath test (see section 4.2).
8 It- test m' għandux jintuża fuq pazjenti li għandhom infezzjoni dokumentata jew suspettata fl- istonku jew għandhom gastritè atrofika, li tista ’ tinterferixxi mat- test tan- nifs ta ’ l- urea (jekk jogħġbok irreferi għal sezzjoni 4. 2 – Pożoloġija u metodu ta ’ amministrazzjoni).
Differential diagnosis with invasive endoscopic methods might be indicated in order to examine the presence of any other complicating conditions, e.g. ulcer, autoimmune gastritis and malignancies.
Jista ’ jkun hemm bżonn ta 'dijanjosi differenzjali b' metodi endoskopiċi invażivi sabiex jiġi stabbilit jekk hemmx xi kundizzjonijiet oħrajn preżenti eż. ulċeri, gastrite awtoimmuni u malinni.
In individual cases of A-gastritis (atrophic gastritis) the breath test may have false positive results; other tests may be required to confirm the Helicobacter pylori status.
F’ każijiet individwali ta 'gastrite- A (gastrite atrofika) it- test tan- nifs jista ’ jagħti riżultati pożittivi falzi; jista' jkun hemm bżonn ta ’ testijiet oħrajn biex jikkonfermaw il- preżenza ta ’ l- istat ta ’ Helicobacter pylori.
For the amount of 75 mg 13C-urea, which is administered per unit in the course of the breath test, no pharmacodynamic activity is described.
Għall- ammont ta ’ 75 mg 13C- urea, mogħti għal kull unità fil- perkors tat- test tan- nifs, l- ebda attività farmakodinamika m’ hija deskritta.
9
9 Wara li tittieħed mill- ħalq l- urea tikkettjata tilħaq l- mukosa ta ’ l- istonku.
In the presence of bacterial urease the ratio of the 13C/12C-carbon isotopes is significantly changed.
Fil- preżenza ta ’ urease batterika l- proporzjon ta ’ l- isotipi 13C/ 12C- carbon huwa sinifikament mibdul.
The portion of 13CO2 in the breath samples is determined by non-dispersive infrared spectrometry and stated as an absolute difference (Δδ-value) between the 00-minute- and the 30-minute-values.
Il- porzjon ta ’ 13CO2 fin- nifs huwa stabbilit bi spettrometrija infra- ħamra li ma tinxteredx u mniżżel bħala differenza assoluta (Δδ- value) bejn il- valuri 00- minuti - u t- 30- minuta.
The cut off point for discriminating Helicobacter pylori-negative and positive patients is determined to be Δδ-value of 4 ‰, which means that an increase of the Δδ-value by more than 4 ‰ indicates an infection.
Dan ifisser li żieda fil- valur ta ’ Δδ b’ aktar minn 4% jindika li hemm infezzjoni.
In comparison to bioptic diagnostics of an infection with Helicobacter pylori, the breath test achieved, in clinical trials on 457 patients, sensitivity in the range of 96.5% to 97.9% [95 %-CI:
B’ paragun ma ’ dijanjostiċi biotiċi ta ’ infezzjoni b ’ Helicobacter pylori, it- test tan- nifs, waqt provi kliniċi li saru fuq 457 pazjent, kellu sensittività fil medda ta ’ 96. 5% sa 97. 9% [95% - CI:
94.05% - 99.72%], and a specificity range from 96.7% to 100%.
94. 05% - 99. 72%], u medda ta ’ speċifiċità minn 96. 7% sa 100%. [95% - CI:
[95 %-CI:
94. 17% - 103. 63%] u speċifiċità ta ’ 96. 0%. [90% - CI:
94.17% - 103.63%].
89. 7%].
The orally applied 13C-urea is metabolised to carbon dioxide and ammonia or is integrated into the body’s own urea cycle.
L- urea 13C meħuda mill- ħalq hija metabolizzata għal dijossidu karboniku u ammonia jew inkella tiġi integrata fiċ- ċiklu uriku tal- ġisem.
Therefore, the rate-limiting step in the whole process is the cleavage of 13C-urea by Helicobacter's urease.
Għalhekk, l- istadju ristrettiv fil- proċess kollu huwa l- qsim ta ’ 13C- urea b’ urease tal- Helicobacter
6.3 Shelf-life
10 6. 3 Żmien kemm idum tajjeb il- prodott mediċinali
3 years.
Id- data ta ’ skadenza hija għal 3 snin.
10 6.5 Nature and contents of container
6. 5 In- natura tal- kontenitur u ta ’ dak li hemm ġo fih
A test set contains 1 jar with the additional components:
Test jikkonsisti minn vażett 1 bil- komponenti addizzjonali li ġejjin:
containing 75 mg 13C-urea powder for oral solution Breath bags:
Boroż tan- nifs:
corresponding sample bags
Strô li jitgħawweġ għal ġbir ta ’ kampjuni tan- nifs fir- reċipjenti relattivi boroż tan- nifs
Data sheet for patient documentation Package leaflet Page of Barcode labels and sticker
Fuljett ta ’ tagħrif Paġna bit- tikketti ta ’ kodiċi żbarrati u stiker
A test set contains 50 jars with the additional components:
Sett tat- testijiet jikkonsisti minn 50 vażett bil- komponenti addizzjonali li ġejjin:
containing 75 mg 13C-urea powder for oral solution Breath bags:
Vażett (volum ta ’ 10 ml, tap li jinqasam tal- polystyrene ma ’ polyethylene) li jkun fih 75 mg 13C trab tal- urea għal soluzzjoni li tittieħed mill- ħalq.
corresponding sample containers
Strô li jitgħawweġ għal ġbir ta ’ kampjuni tan- nifs fir- reċipjenti relattivi boroż tan- nifs
6.6 Special precautions for disposal and other handling
6. 6 Struzzjonijiet għall- użu u maniġġar u għar- rimi
It is recommended to perform the test with the patient being in a resting position.
Huwa rakkomandat li t- test jitwettaq bil- pazjent f’ pożizzjoni ta ’ mistrieħ.
Take the straw and one breath bag with the label “Sampling time:
Ħu l- istrô u ż- żewġ tubi ta ’ kampjunar borża tan- nifs bit- tikketta: “ Ħin ta ’ kampjunar:
Remove the stopper from one of the breath bags, unwrap the straw and place the straw into the breath bag.
Neħħi t- tapp minn wieħed mill- boroż tan- nifs, neħħi t- tgeżwir ta ’ l- istrô u qiegħed l- istrô fir- reċipjent.
Now the patient breathes gently through the straw.
Issa ħu n- nifs bil- mod minn ġos- strô sakemm il- wiċċ ta ’ ġewwa tat- tubu tal- kampjun ifawwar.
By continuously breathing the patient must pull out the straw and immediately close the breath bag with its stopper.
Waqt li qiegħed tieħu n- nifs b' mod kontinwu, wieħed għandu jiġbed l- istrô l- barra u jagħlaq il- borża tan- nifs bit- tapp tagħha.
(If the breath bag remains open for more than 30 seconds, the test result might be falsified.)
(Jekk il- borża tan- nifs tibqa ’ miftuħa għall- iktar minn 30 sekonda, ir- riżultat tat- test jista ’ jkun falz)
Hold the breath bag upright and stick the bar-code label marked “00-minute-value” on the breath bag.
Żomm il- borża tan- nifs 'l fuq u waħħal t- tikketta tal- kodiċi żbarrati mmarkata "00- minuti - valur" fuq il- borża tan- nifs.
11
Ferragħ il - kontenut f’ tazza.
Fill the 13C-urea jar to the brim with water for a second and third time and add these contents to the drinking glass (total volume of tap water should be approximately 30 ml).
Imla l- vażett 13C- urea sax- xifer b’ ilma għat- tieni u tielet darba u żid il- kontenut ta ’ dawn fit- tazza (volum totali ta ’ ilma tal- vit għandu jkun madwar 30 ml).
Thirty minutes after administration of the test solution (point 6), collect the 30-minute-value samples in the breath bag, which is left in the test package (Label “Sampling time:
Tletin minuta wara t- teħid tas- soluzzjoni tat- test, iġbor il- kampjuni ta ’ 30 minuta- valur li qegħdin fil- boroż tan- nifs li fadal fil pakkett tat- test (Tikketta: “ Ħin ta 'kampjunar:
Use the bar-code labels marked “30-minute-value” for this sample.
30- minuta - valur ”), kif deskritt fl- istadji 3 u 4. Uża t- tikketti tal- kodiċi żbarrati mmarkati “ 30- minuta- valur ” għal dan il- kampjun.
Put the relevant bar-code label on the data sheet for patient documentation.
Qiegħed it- tikketta rilevanti bil- kodiċi żbarrati fuq il- folja tal- informazzjoni għad - dokumentazzjoni tal- pazjent.
The breath bags have to be sent in the original packaging, for analysis, to a qualified laboratory.
Il- boroż tan- nifs għandhom jintbagħtu fil- pakkett oriġinali, għal analiżi f' laboratorju kkwalifikat.
The breath samples, collected in 100 ml breath bags, are analysed by non-dispersive infrared spectrometry (NDIR).
Il- kampjuni tan- nifs, miġbura f’ boroż tan- nifs ta ’ 100 ml, jiġu analizzati b’ spettrometrija infra- red li ma tinxteridx (NDIR).
• Sample preparation for Infrared Spectroscopy (NDIR)
• Preparazzjoni Spettrometrija Infra- red (NDIR)
The determination of 13C/12C-ratio in the carbon dioxide of the breath samples is carried out directly in the breath.
L- iffissar tal- proporzjon 13C/ 12C- ratio fid- dijossidu karboniku tal- kampjuni tan- nifs jiġi mwettaq direttament fuq in- nifs.
The breath from the bags will be introduced into the NDIR spectrometer using a variable gas pump.
In- nifs minn ġol- boroż jiġi mdaħħal fl- ispettrometru NDIR permezz ta ’ pompa tal- gass varjabbli.
For calibration and measurement necessary CO2-free air (zero-gas) will be produced via an integrated CO2-absorber in the analysator.
Il- kontenut ta ’ ilma fil- kampjun tan- nifs jinżamm kemmxejn kostanti permezz ta ’ trapp ta 'l- ilma Nafjon. Għal kalibrazzjoni u kejl meħtieġ, arja mingħajr CO2 (gass żero) għandha toħroġ permezz ta ’ assorbitur ta ’ CO2 integrat fl- analizzatur.
• Infrared spectroscopic analysis
• Analiżi spettroskopika infra- red
To analyse the carbon dioxide in breath a broad band infrared radiation bunch emitted by an infrared radiation source is alternately sent through the measuring chamber and a reference chamber by means of a beam chopper.
Sabiex jiġi analizzat id- dijossidu karboniku fin- nifs, faxx wiesgħa ta ’ radjazzjoni infra- red mitfugħa minn sors ta ’ radjazzjoni infra- red jiġi mibgħut b’ alternanza minn ġol- kompartament ta ’ kejl u kompartament ta ’ referenza permezz ta ’ tagħmir li jaqta ’ r- raġġ.
The modulated infrared beams then enter the infrared detectors, which are double layer transmission detectors with a front, and a rear chamber each filled with one of the isotopicly pure gases (13CO2 or 12CO2, respectively) to be measured.
Ir- raġġi infra- red immodulati mbagħad jidħlu fl- intraċċaturi infra- red, li huma intraċċaturi ta ’ trasmissjoni f’ żewġ saffi b’ kompartament fuq quddiem u ieħor fuq wara, li kull wieħed minnhom huwa mimli b’ gassijiet isotopikament puri (13CO2 jew 12CO2, rispettivament) li jridu jiġi mkejla.
The infrared radiation in the measuring chamber is weakened by the gas component to be measured.
B' hekk, l- ekwilibriju
Thus the radiation equilibrium between measuring and comparative beam is disturbed.
12 ta ’ radjazzjoni bejn ir- raġġ ta ’ kejl u r- raġġ komparattiv huwa disturbat.
In consequence there is a temperature fluctuation, which in its turn causes a fluctuating pressure in the front chamber of the infrared detector.
Bħala konsegwenza ta ’ hekk, hemm bidla fit- temperatura, li tikkaġuna bidla fil- pressjoni fil- kompartament ta ’ quddiem ta ’ l - intraċċatur infra- red.
A membrane capacitor connected with this chamber, which is exposed to a high resistance direct voltage, transforms these pressure fluctuations into an alternating voltage, which is a measure of the isotopic composition of breath carbon dioxide.
Kapasiter bir- rita li hu konness ma ’ dan il- kompartament, espost għal vultaġġ dirett b’ reżistenza għolja jittrasforma dawn il- bidliet fil- pressjoni f' vultaġġ li jalterna, li hu kejl tal - kompożizzjoni isotopika tad- dijossidu karboniku fin- nifs.
12 • Sample Inlet
• Introduzzjoni tal- kampjun
A semi-automatic sample inlet system injects the measuring gas in definite amounts into the zero gas circulating in the gas circuit of the infrared spectrometer.
Sistema li tippermetti d- dħul ta ’ kampjun b ’ mod semi- awtomatiku tinjetta l- gass li jrid jitkejjel f’ ammonti stabbiliti fiż- żero gass li jkun qed jiċirkula fiċ- ċirkwit ta ’ l- ispettrometru infra- red.
This enables measurement of the 13C/12C ratio at any CO2 concentration above 1%.
Dan jippermetti l- kejl tal- proporzjon 13C/ 12C f 'kull konċentrazzjoni' l fuq minn 1%.
• Specifications for determining 13C/12C-ratios
Speċifikazzjonijiet sabiex jiġu stabbiliti l- proporzjonijiet 13C/ 12C •
The breath test concept is based upon the oral administration of 13C-labelled urea whose enzymatic hydrolysis is monitored by measuring 13CO2 in breath using non-dispersive infrared spectrometry.
Il- kunċett tat- test tan- nifs huwa msawwar fuq it- teħid mill- ħalq speċifiku ta ’ urea ttikkettat 13C li l- użu metaboliku tiegħu jiġi sorveljat bil- kejl ta ’ 13CO2 f’ nifs bl- użu ta ’ spettrometrija infra- red li ma ’ tinxteredx.
• Infrared spectrometers for breath analysis must comply with the following specifications:
Spettrometri infra- red għal analiżi tan- nifs għandhom jikkonformaw ma 'l- ispeċifikazzjonijiet li ġejjin:
Minimum of 3 replicate analyses of the same sample during operation
Minimu ta ’ 3 analiżi ripettivi fuq l- istess kampjun waqt l- impjieg Ħażna tal- parametri ta ’ ħidma u tar- riżultati taħt aċċess tas- sigurtà sabiex jiġi evitat kull manipulazzjoni 'l quddiem proporzjon 13C/ 12C fir- rigward ta ’ PDB (Pee Dee Beliminate)
Storing of operating parameters and of results under security access to avoid later manipulation
< 200 µl
For verifying the specifications linearity, stability, and precision of measurement have to be tested.
Għal verifikazzjoni ta 'l- ispeċifikazzjonijiet, iridu jiġu ttestjati linearità, stabbilità u preċiżjoni ta' kejl.
Zero point adjustment of the detectors by means of the zero gas generated in the spectrometer.
Aġġustament fil- punt żero ta ’ l- intraċċaturi permezz taż- żero gass li jiġi prodott fl- ispettrometru.
End- point adjustment of the detectors by means of calibration gases of precisely known concentration.
Aġġustament ta ’ l- intraċċaturi tal- punt terminali permezz ta ’ kalibrazzjoni tal- gassijiet ta ’ konċentrazzjoni preċiża magħrufa.
≤ 0.5 ‰ for breath samples varying between 1% and 7% CO2- concentration
≤ 0. 5 ‰ għal kampjuni tan- nifs li jvarjaw minn bejn 1% u 7% tal - Linearità: konċentrazzjoni ta ’ CO2 ≤ 0. 2 ‰ fuq 10 pulsi konsekkutivi Stabbilità: ≤ 0. 5 ‰ għal 13C f’ abbundanza naturali permezz ta ’ borża tan- nifs ta ’ Preċiżazzjoni fil- kejl:
Precision of measurement:
100 ml b ’ 3% CO2 fin- nifs
Helicobacter pylori infection is present if the difference in 13C/12C of baseline-value and 30-minute- value exceeds 4.0 ‰.
Infezzjoni ta ’ Helicobacter pylori huwa preżenti jekk id- differenza ta ’ valur fir- referenza bażi f ’ 13 C/ 12C u 30 minuta - valur jaqbeż 4. 0 ‰.
Alternatively, any other suitable-validated method may be used, carried out by any objectively qualified laboratory.
Alternativament, kull laboratorju oġġetivament ikkwalifikat jista ’ iwettaq kull metodu vvalidat kif suppost.
EU 1/97/045/002 EU 1/97/045/004
EU/ 1/ 97/ 045/ 002 EU 1/ 97/ 05/ 004