KARDIAALSETE TROPONIINIDE MÄÄRAMISE HETKESEIS EESTI LABORITES. Katrin Reimand ELMÜ Suvekool Margusel August 2009
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1 KARDIAALSETE TROPONIINIDE MÄÄRAMISE HETKESEIS EESTI LABORITES Katrin Reimand ELMÜ Suvekool Margusel August 2009
2 KÜSITLUSE ÜLEVAADE (1) Ankeedis küsisime: Määratavat troponiini (troponiin T või troponiin I) ning määramismeetodi nimetust Kasutatavat analüsaatorit Kasutatavat ühikut Referentsisikute 99-ndat protsentiili Väärtust, mida labor kasutab referentspiirina Väärtust, mida labor kasutab müokardi infarkti (MI) otsustuspiirina Analüütilist tundlikkust Taset, mille juures on saavutatud CV 10% (optimaalne kordustäpsus väljendatuna variatsioonikoefitsiendina) ühe lot i piires Taset, mille juures on saavutatud CV 10% (optimaalne kordustäpsus väljendatuna variatsioonikoefitsiendina) eri lot ide vahel Tootja poolt lubatud proovimaterjale Milliseid markereid kasutab labor lisaks troponiinile MI diagnostikas
3 KÜSITLUSE ÜLEVAADE (2) Kokku saatsime välja 26 küsimustikku Neist 22 raviasutuste laboritele, 4 eralaboritele Vastused saime lõpuks kõigist laboritest Kui on olemas veel laboreid, kus määratakse troponiini, kuid kellele pole küsimustikku saadetud, siis palume lahkesti teada anda Järgnevas analüüsis on kasutatud TÜ Kliinikumi, PERH-i, ITKH, LTKH, Ida-Viru Keskhaigla, Pärnu Haigla, Narva Haigla, Lõuna- Eesti Haigla, Rakvere Haigla, Järvamaa Haigla, Läänemaa Haigla, Viljandi Haigla, Kuressaare Haigla, Elva Haigla, Hiiumaa Haigla, Tallinna Lastehaigla, Wismari Haigla, Rapla Haigla, Jõgeva Haigla, Valga Haigla, Tapa Haigla, Põlva Haigla, Tallinna Diagnostikakeskus AS, Quattromed HTI Laborid OÜ, AS Medicumi, Nova Vita Kliinik AS ja Tartu Linna Polikliiniku andmeid. AITÄH KÕIGILE VASTANUTELE!!!
4 KÜSITLUSE TULEMUSED (1) Troponiini määrab üldse 21 laborit, 6 laborit troponiini ei määra Troponiin T-d määrab 17 laborit ning troponiin I-d 4 laborit Ainult (pool)kvantitatiivne (troponiin T Cardiac reader`il või Cobas h232-l) või kvalitatiivne kiirtest (Biocard troponiin I) on kasutusel 9 laboris 2 laboris on kasutusel nii (pool)kvantitatiivne kiirtest kui ka kvantitatiivne määramine 10 laborit määrab troponiini ainult kvantitatiivselt, neist 7 laborit määrab troponiin T-d ja 3 troponiin I-d (kasutusel troponiin T STAT Roche, troponiin I IMMULITE 2500 STAT ja troponiin I Architect i)
5 KÜSITLUSE TULEMUSED (2) Kasutatav ühik oli enamusel juhtudel (19 laborit) ng/ml (nii troponiin T kui ka troponiin I puhul) Üks labor kasutas SI süsteemi ühikut μg/l Kvalitatiivse kiirtesti puhul ühik puudub Küsimus: millist ühikut peaksime kasutama ja kas peaksime kasutatavad ühikud ühtlustama? Rahvusvahelise mõõtühikute süsteemi (SI) põhiühikud, nendest tuletatud ühikud, nende kord- ja osaühikud ning rahvusvaheliselt kehtestatud lisaühikud ja nende kasutamise viis Vabariigi Valitsuse 26. aprilli a määrus nr 120: Kohustuslike mõõtühikute kasutamist kohaldatakse mõõtevahenditele, mõõtetulemustele ja mõõtühikute abil väljendatud suurustele majandustegevuses, rahvatervise ja avaliku ohutuse valdkonnas, haldus- ja õppetegevuses ning standardimisel
6 KÜSITLUSE TULEMUSED (3) Referentsisikute 99-s protsentiil sõltub meetodist ning kuna vastavad uuringud Eesti populatsioonil puuduvad, on ainuke võimalus kasutada tootjapoolseid andmeid, juhul kui need on kättesaadavad. Eestis levinuima meetodi (Troponin T STAT Roche) jaoks on väärtus 0,01ng/mL (μg/l). Referentsväärtus sõltub samuti meetodist, kuid erinevaid vastuseid tuli ka ühe ja sama meetodi kasutajatelt. Näit. sellesama Troponin T STAT puhul kasutati referentsväärtusena järgmisi: <0,01; <0,03; <0,04; <0,06; <0,1; 0,01-0,03; 0,03-0,1 ng/ml (μg/l). Küsimus: kas referentsisikute 99-s protsentiil ja referentsväärtus on kattuvad või tuleb ka siin arvestada, et CV 10%? Või tuleb CV-d arvestada ainult müokardi infarkti otsustuspiiri puhul?
7 KÜSITLUSE TULEMUSED (4) Müokardi infarkti otsustuspiir sõltub samuti meetodist, kuid jällegi tuli erinevaid vastuseid ka ühe ja sama meetodi kasutajatelt. Troponiin T puhul oli levinuim väärtus >0,1ng/mL (μg/l) (8 vastanut), esinesid ka väärtused >0,03 (2 vastanut) ja >0,18 (1 vastanu) ning vahemik 0,03-0,1 (1 vastanu). Ühel juhul vastati, et labor ei kasuta MI otsustuspiiri ning neljal juhul oli küsimus jäetud vastamata (neist ühel juhul oli vastus siiski olemas, kuid ebaselge). Väärtus >0,1ng/mL (μg/l) on küll kooskõlas WHO müokardi infarkti kriteeriumidega, kuid mitte ESC/ACCF/AHA/WHF müokardi infarkti uue definitsiooni ja diagnoosi kriteeriumidega. Joint ESC/ACCF/AHA/WHF Task Force for the Redefinition of Myocardial Infarction, Universal Definition of Myocardial Infarction. Eur Heart J 2007; 28 (20): ) MI uue definitsiooniga kooskõlas olev otsustuspiir oli kasutusel vaid kahes troponiin T-d määravas laboris ning ühes troponiin I-d määravas laboris. MI uue definitsiooni kohaselt vajaminev troponiini tase, mille juures on saavutatud CV 10% on IFCC koduleheküljelt ( ) leitav kolme meetodi jaoks (troponiin T STAT Roche, troponiin I IMMULITE 2500 STAT ja troponiin I Architect i). Kõigi ülejäänud meetodite kasutajad ei saagi hetkel paraku uuele definitsioonile vastavat MI otsustuspiiri väljastada, kuni vastavad andmed muutuvad kättesaadavaks.
8 KÜSITLUSE TULEMUSED (5) Lisaks troponiini kontsentratsiooni määramisele kasutab müokardi infarkti diagnostikas 16 laborit vajadusel CK-MB määramist (7 juhul CK-MB mass, 2 juhul CK-MB aktiivsus, 7 juhul täpsustamata) 11 laborit määrab vajadusel lisaks troponiinile müoglobiini Kahel juhul mainiti NT-proBNP määramist, ühel juhul CK üldaktiivuse määramist ning ühel juhul ka transaminaaside määramist
9 NORRAS LÄBIVIIDUD KÜSITLUSE TUTVUSTUS Küsitlus viidi läbi aastal, hs-tnt analüüsi Norra laborites juurutamise raames Küsimustik saadeti 70 laborile Küsimused puudutasid määratava troponiini tüüpi, määramismeetodit, sisemist kvaliteedi kontrolli, madalaimat väljastatavat kontsentratsiooni ning müokardi infarkti otsustuspiiri Vastas 89% laboritest, neist 60% määras troponiin T-d ning 40% troponiin I-d, viis laborit troponiini ei määranud 18% troponiin T-d ning 17% troponiin I-d määravatest laboritest kasutas rahvusvahelistele soovitustele vastavat MI otsustuspiiri ka madalaima väljastatava kontsentratsioonina 82% laboritest väljastas MI otsustuspiiri, kuid 57% troponiin T-d määravatest laboritest ning 79% troponiin I-d määravatest laboritest kasutas kõrgemat otsustuspiiri kui rahvusvahelistes soovitustes ettenähtud Sisemist kvaliteedi kontrolli teostati kõigis laborites, v.a. neis, mis kasutasid POCT aparatuuri (4 laborit), kuid CV polnud sageli arvutatud piisavalt madalatel väärtustel (MI otsustuspiiri juures) K.M.Aakre, S.Landaas, T.A.Hagve Use and Interpretation of Troponin Analysis in Norwegian Laboratories, 18th IFCC-EFCC European Congress of Clinical Chemistry and Laboratory Medicine, Innsbruck, Austria, June 7-11, 2009
10 Company/platform/assay1 99th percentile, µg/l 10% CV, µg/l Acceptance designation Assay designation Abbott AxSYM ADV Not acceptable Level 1 Abbott Architect Clinically usable Level 1 Abbott i-stat Clinically usable Level 1 Beckman Access Accu Clinically usable Level 2 biomerieux Vidas Ultra Not acceptable Level 1 Innotrac Aio! Clinically usable Level 1 Inverness Biosite Triage <0.05 NA2 NA Level 1 Inverness Biosite Triage (r) NA Clinically usable Level 1 Mitsubishi PATHFAST Guideline acceptable Level 1 Ortho-Clinical Diagnostics Vitros ECi ES Guideline acceptable Level 1 Radiometer AQT Clinically usable Level 1 Response Biomedical RAMP < Clinically usable Level 1 Roche Elecsys 2010 < Clinically usable Level 1 Siemens Centaur Ultra Guideline acceptable Level 1 Siemens Dimension RxL Clinically usable Level 1 Siemens Immulite 2500 STAT Not acceptable Level 1 Siemens Stratus CS Guideline acceptable Level 1 Siemens VISTA Guideline acceptable Level 1 Tosoh AIA II < Clinically usable Level 1 Research hs assays3 Beckman Access hs-ctni Guideline acceptable Level 4 Roche Elecsys hs-ctnt Guideline acceptable Level 4 Nanosphere hs-ctni Guideline acceptable Level 3
11 ÄGEDA MÜOKARDI INFARKTI DIAGNOOSIMISE KRITEERIUMID MI diagnoosimiseks on vajalik: Kardiaalsete biomarkerite taseme muutus, kusjuures vähemalt üks väärtustest ületab referentsväärtuse ning kaasuvalt esineb vähemalt üks müokardi isheemiale viitav tunnus (sümptomid, EKG-leid, pilttdiagnostika meetoditega tõendatud uus eluvõimelise müokardi kadu või kontraktsioonihäire). Eelistatuim biomarker on troponiin T või troponiin I. Parim alternatiiv troponiini määramisele on CK-MBmassi määramine. Hinnatakse järgmiste kriteeriumide alusel: troponiini väärtus üle referentsväärtuse ülemise piiri (referentsisikute 99- nda protsentiili) (CV 10%) vähemalt ühel juhul esimese 24 tunni jooksul (vastavad väärtused eri määramismeetodite jaoks on leitavad IFCC koduleheküljel Oct_2008.pdf) CK-MBmass peab ületama soost sõltuva referentsväärtuse kahes järjestikuses proovis (CK-MBmassi väärtused peavad muutuma) Joint ESC/ACCF/AHA/WHF Task Force for the Redefinition of Myocardial Infarction, Universal Definition of Myocardial Infarction. Eur Heart J 2007; 28 (20):
12 ÄGEDA MÜOKARDI INFARKTI DIAGNOOSIMISE KRITEERIUMID järg Markereid hinnatakse kõigil ägeda koronaarsündroomiga patsientidel esmasel pöördumisel ja 6-9 tundi hiljem, referentsväärtuste piires olevate vastuste puhul võib MI kahtluse korral osutuda vajalikuks veelkordne analüüs tundi hiljem. Kui patsient pöördub arsti poole rohkem kui 24 tunni möödudes sümptomite algusest piisab ka ühekordsest analüüsist. Markerite taseme suurenemise/vähenemise jälgimine on oluline, kuna nende taseme tõus võib esineda ka kaasuvate haiguste tõttu (näit. troponiin T taseme tõus kroonilise neerupuudulikkuse korral). Reinfarkti diagnoosimiseks hinnata markereid kohe ja 3-6 tundi hiljem. Reinfarkti võib diagnoosida kui kahte analüüsitulemust võrreldes on teises analüüsis markerite tase 20% suurem (ka siin peab troponiini väärtus ületama referentsisikute 99-nda protsentiili).
13 MUUD TROPONIINIDE TASEME SUURENEMISE PÕHJUSED Ilma ägeda koronaarsündroomita võib troponiinide tase suureneda: trauma (k.a. meditsiinilistest protseduuridest tingituna elustamine, defibrillatsioon, kardiokirurgilised operatsioonid) äge ja krooniline südamepuudulikkus aordiklapi haigused ja hüpertroofiline kardiomüopaatia neerupuudulikkus kriitilises seisundis patsiendid ravimite või toksiinide toime (adriamütsiin, hertseptiin, maomürgid jt.) põletikulised haigused (müokardiit, müokardi haaratus endo-/perikardiidi korral) kopsuarteri trombemboolia sepsis põletused infiltratiivsed haigused (amüloidoos, hemokromatoos, sarkoidoos, sklerodermia) äge neuroloogiline haigus (insult, subarahnoidaalne hemorraagia) IGA TROPONIINI TASEME TÕUS EI TÄHENDA MÜOKARDI INFARKTI!
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