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CHOL2 - Indiana Blood Center

1. 20 21 22 Greiling H Gressner AM eds Lehrbuch der Klinischen Chemie und Pathobiochemie 3 ed Stuttgart New York Schattauer 1995 Liebermann C Ber Dtsch chem Ges 1885 18 1803 Burchard H Beitr ge zur Kenntnis der Cholesterine Dissertation Rostock 1889 Abell L et al Standard Methods in Clinical Chemistry 1958 26 2 Allain CC et al Clin Chem 1974 20 470 Roeschlau P et al Z Klin Chem Klin Biochem 1974 12 226 Trinder P Ann Clin Biochem 1969 6 24 Siedel J H gele EO Ziegenhorn J et al Clin Chem 1983 29 1075 Wiebe DA Bernert JT Clin Chem 1984 30 352 Cohn JS McNamara JR Schaefer EJ Lipoprotein Cholesterol Concentrations in the Plasma of Human Subjects as Measured in the Fed and Fasted States Clin Chem 1988 34 2456 2459 Pisani T Gebski CP Leary ET et al Accurate Direct Determination of Low density Lipoprotein Cholesterol Using an Immunoseparation Reagent and Enzymatic Cholesterol Assay Arch Pathol Lab Med 1995 119 1127 Recommendations for Improving Cholesterol Measurement A Report from the Laboratory Standardization Panel of the National Cholesterol Education Program NIH Publication No 90 2964 February 1990 Nader R Dufour DR Cooper GR Preanalytical Variation in Lipid Lipoprotein and Apolipoprotein Testing In Rifai N Warnick GR and Dominiczak MH editors Handbook of Lipoprotein Testing 2nd ed Washington AACC press p 176 Tietz NW ed Clinical Guide to Laboratory Tests 31 ed
2. 03039773190V7 CHOL2 Cholesterol Gen 2 Limites inferiores de medici n L mite inferior de detecci n del test 0 1 mmol L 3 86 mg dL El limite inferior de detecci n equivale a la menor concentraci n medible de analito que puede distinguirse de cero Se calcula como el valor situado a tres desviaciones est ndar por encima del est ndar m s bajo est ndar 1 3 DE repetibilidad n 21 Valores te ricos Interpretaci n cl nica seg n las recomendaciones de la Sociedad Europea de Aterosclerosis 20 mmol L mg dL Trastorno del metabolismo Colesterol lt 52 lt 200 de Wis Triglic ridos lt 2 3 lt 200 s S si el colesterol HDL Colesterol 5 2 7 8 200 300 lt 0 9 mmol L lt 35 mg dL Colesterol gt 78 gt 300 si Triglic ridos gt 2 3 gt 200 Valores limites de riesgo para la poblaci n adulta de los EE UU recomendados por el panel de expertos del Programa Nacional de Educaci n de colesterol de los EE UU Nivel ideal de colesterol lt 5 2 mmol L lt 200 mg dL Colesterol elevado l mite 5 2 6 2 mmol L 200 240 mg dL Colesterol alto gt 6 2 mmol L gt 240 mg dL Cada laboratorio deberia comprobar si los intervalos de referencia pueden aplicarse a su grupo de pacientes y en caso necesario establecer sus propios valores Datos especificos de funcionamiento del test A continuaci n se indican los datos representativos de funcionamiento obtenidos en los analizadores Los resultados de ca
3. 15 16 17 18 19 20 21 22 Greiling H Gressner AM eds Lehrbuch der Klinischen Chemie und Pathobiochemie 3 ed Stuttgart New York Schattauer 1995 Liebermann C Ber Dtsch chem Ges 1885 18 1803 Burchard H Beitr ge zur Kenntnis der Cholesterine Dissertation Rostock 1889 Abell L et al Standard Methods in Clinical Chemistry 1958 26 2 Allain CC et al Clin Chem 1974 20 470 Roeschlau P et al Z Klin Chem Klin Biochem 1974 12 226 Trinder P Ann Clin Biochem 1969 6 24 Siedel J H gele EO Ziegenhorn J et al Clin Chem 1983 29 1075 Wiebe DA Bernert JT Clin Chem 1984 30 352 Cohn JS McNamara JR Schaefer EJ Lipoprotein Cholesterol Concentrations in the Plasma of Human Subjects as Measured in the Fed and Fasted States Clin Chem 1988 34 2456 2459 Pisani T Gebski CP Leary ET et al Accurate Direct Determination of Low density Lipoprotein Cholesterol Using an Immunoseparation Reagent and Enzymatic Cholesterol Assay Arch Pathol Lab Med 1995 119 1127 Recommendations for Improving Cholesterol Measurement A Report from the Laboratory Standardization Panel of the National Cholesterol Education Program NIH Publication No 90 2964 February 1990 Nader R Dufour DR Cooper GR Preanalytical Variation in Lipid Lipoprotein and Apolipoprotein Testing En Rifai N Warnick GR and Dominiczak MH editors Handbook of Lipoprotein Testing 2nd ed Washington AACC press p 176 Tietz NW ed Clinical G
4. 2010 04 V 7 Espa ol 1 3 sistemas cobas c CHOL2 Cholesterol Gen 2 momento lo cual significa que no fueron analizados todos los tubos de todos los fabricantes Los sistemas de recogida de muestras de diversos fabricantes pueden contener diferentes materiales que en ciertos casos pueden llegar a afectar los resultados de los an lisis Si las muestras se procesan en tubos primarios sistemas de recogida de muestras seguir las instrucciones del fabricante de los tubos Centrifugar las muestras que contienen precipitado antes de efectuar el test Estabilidad 415 7 d as a 15 25 C 7 dias a 2 8 C 3 meses a 15 25 C Material suministrado Consultar los reactivos en la secci n Reactivos Soluciones de trabajo Material requerido no suministrado Consultar la secci n Informaci n de pedido Equipo usual de laboratorio Ejecuci n del test Para garantizar el funcionamiento ptimo del test observar las instrucciones de la presente met dica referentes al analizador empleado Consultar el manual del operador del analizador en cuanto a las instrucciones espec ficas de ensayo Roche no se responsabiliza del funcionamiento de las aplicaciones no validadas por la empresa En su caso el usuario se hace cargo de su definici n Aplicaci n para suero y plasma Definici n del test en el analizador cobas c 311 Tipo de medici n 1 Punto Tiempo de reacci n 10 57 Puntos de medici n Longitud de onda sub
5. cobas Calibrazione Calibratori St H20 S2 C f a s Tipo di calibrazione Lineare Frequenza di calibrazione Calibrazione a 2 punti a cambio di lotto del reattivo e se richiesto dai procedimenti del controllo di qualit Tracciabilita questo metodo stato standardizzato secondo Abell Kendall 2 nonch contro la spettrometria di massa con diluizione isotopica Controllo di qualit Per il controllo di qualit impiegare i materiali di controllo indicati nella sezione Informazioni per ordini In aggiunta possibile utilizzare altro materiale di controllo appropriato Gli intervalli e limiti del controllo dovranno essere conformi alle esigenze individuali di ogni laboratorio valori ottenuti devono rientrare nei limiti definiti Ogni laboratorio deve definire delle misure correttive da attuare nel caso che alcuni valori siano al di fuori dei limiti Per il controllo di qualit attenersi alle normative vigenti e alle linee guida locali Calcolo sistemi Roche Hitachi cobas c effettuano il calcolo automatico della concentrazione dell analita di ciascun campione mmol L x 38 66 mg dL mmol L x 0 3866 g L mg dL x 0 0259 mmol L Fattori di conversione Limiti del metodo interferenze Valutazione recupero entro 10 dei valori iniziali ad una concentrazione di colesterolo di 5 2 mmol L 200 mg dL Ittero nessuna interferenza significativa fino ad un indice di 16 per bilirubina coniugata e di
6. standardizzazione contro Abell Kendall Finalita d uso Test in vitro per la determinazione quantitativa del colesterolo nel siero e nel plasma umani impiegando sistemi Roche Hitachi cobas c Sommario Il colesterolo uno steroide con un gruppo idrossilico secondario nella posizione C3 Sintetizzato in molti tipi di tessuto ma principalmente nel fegato e nella parete intestinale esso origina ca per tre quarti per sintesi endogena e per un quarto dall assunzione alimentare Le determinazioni del colesterolo vengono impiegate nello screening del rischio aterosclerotico e nella diagnosi e nel trattamento di malattie con valori di colesterolo elevati nonch di disturbi a carico del metabolismo lipidico e lipoproteico Il primo metodo per la determinazione del colesterolo fu descritto da Liebermann nel 1885 ed in seguito da Burchard nel 1889 Nella reazione di Liebermann Burchard il colesterolo in presenza di acido acetico di anidride acetica e di acido solforico concentrato forma un colorante verde blu a base dei carboidrati insaturati polimerici Il metodo Abell Kendall bench specifico per il colesterolo utilizza reattivi corrosivi e risulta tuttora tecnicamente complesso Nel 1974 Roeschlau ed Allain descrissero il primo metodo completamente enzimatico Questo metodo basato sulla determinazione del A4 colestenone in seguito alla scissione enzimatica del colesterolo estere da parte della colesterolo esterasi alla trasformazione del
7. 14 per bilirubina non coniugata concentrazione di bilirubina coniugata ca 274 umol L 16 mg dL e concentrazione di bilirubina non coniugata ca 239 umol L 14 mg dL Emolisi nessuna interferenza significativa fino ad un indice H di 700 concentrazione di emoglobina ca 435 umol L 700 mg dL Lipemia Intralipid nessuna interferenza significativa fino ad un indice L di 2000 Non esiste una buona correlazione tra l indice L corrisponde alla torbidit e la concentrazione di trigliceridi Farmaci non si osservata alcuna interferenza a concentrazioni terapeutiche impiegando le pi comuni famiglie di farmaci 18 19 In casi molto rari la gammapatia particolarmente di tipo IgM macroglobulinemia di Waldenstr m pu causare risultati inaffidabili Ai fini diagnostici i risultati devono sempre essere valutati congiuntamente con la storia clinica del paziente con gli esami clinici e con altre evidenze cliniche AZIONI RICHIESTE Programmazione extra lavaggi assolutamente necessario effettuare specifiche fasi di lavaggio se certe combinazioni di test vengono eseguite insieme sui sistemi Roche Hitachi cobas c La versione pi recente dell elenco dei possibili carry over si trova allegata alla metodica NaOHD SMS Multiclean SCCS o alla metodica NaOHD SMS SmpCin1 2 SCCS Per ulteriori istruzioni consultare il manuale d uso Analizzatore cobas c 502 tutte le programmazioni di extra lavaggi richieste per ev
8. 16 cobas Qualit tskontrolle Zur Qualit tskontrolle sind die unter Bestellinformation aufgef hrten Materialien zu verwenden Anderes geeignetes Kontrollmaterial kann zus tzlich verwendet werden Die Kontrollintervalle und Kontrollgrenzen sind den individuellen Anforderungen jedes Labors anzupassen Die Ergebnisse m ssen innerhalb der definierten Bereiche liegen Jedes Labor sollte Korrekturma nahmen f r den Fall festlegen dass Werte au erhalb der Grenzen liegen Bei der Qualit tskontrolle die entsprechenden Gesetzesvorgaben und Richtlinien beachten Berechnung Die Roche Hitachi cobas c Systeme berechnen automatisch die Analytkonzentration der Probe mmol L x 38 66 mg dL mmol L x 0 3866 g L mg dL x 0 0259 mmol L Umrechnungsfaktoren Einschr nkungen des Verfahrens Interferenzen Als Bewertung gilt Wiederfindung 10 vom Ausgangswert bei einer Cholesterinkonzentration von 5 2 mmol L 200 mg dL Ikterus Keine wesentliche Beeiflussung bis zu einem Index von 16 konjugiertes Bilirubin und 14 unkonjugiertes Biliruin entsprechend ca 274 mol L bzw 16 mg dL konjugiertem Bilirubin und ca 239 pmol L bzw 14 mg dL unkonjugiertem Bilirubin Hamolyse Keine wesentliche Beeinflussung bis zum Index H von 700 ca 435 pmol L bzw 700 mg dL Hamoglobin Lipamie Intralipid Keine wesentliche Beeinflussung bis zum Index L von 2000 Es besteht keine zufriedenstellende Ubereinstimmung zwischen dem L Index en
9. Biochem 2001 38 376 385 20 Study Group European Atherosclerosis Society Strategies for the prevention of coronary heart disease A policy statement of the European Atherosclerosis Society European Heart Journal 1987 8 77 21 Third Report of the National Cholesterol Education Program NCEP Expert Panel on Detection Evaluation and Treatment of High Blood Cholesterol in Adults Adult Treatment Panel III NIH Publication No 01 3670 May 2001 22 Passing H Bablok W et al A General Regression Procedure for Method Transformation J Clin Chem Clin Biochem 1988 26 783 790 a a o As alterag es ou os acr scimos significativos est o assinalados por uma barra de altera o na margem O 2010 Roche Diagnostics wi Roche Diagnostics GmbH Sandhofer Strasse 116 D 68305 Mannheim www roche com 2010 03 V 7 Portugu s 3 3 sistemas cobas c
10. Europ enne d Ath roscl rose 20 mmol L mg dL Trouble du m tabolisme des lipides Cholest rol lt 5 2 lt 200 Nae Triglyc rides lt 2 3 lt 200 Oui si le cholest rol est Cholest rol 5 2 7 8 200 300 lt 0 9 mmol L lt 35 mg dL Cholest rol gt 7 8 gt 300 Oui Triglyc rides gt 23 200 Seuils de risque pour les USA selon les recommandations de l Adult Treatment Panel du NCEP National Cholesterol Education Program 21 Taux de cholest rol id al lt 5 2mmol L lt 200 mg dL Limite sup rieure 5 2 6 2 mmol L 200 240 mg dL Taux lev s gt 6 2 mmol L gt 240 mg dL Chaque laboratoire devra verifier la validit de ces valeurs et tablir au besoin ses propres domaines de r f rence selon la population examin e Performances analytiques Les performances analytiques indiqu es ci dessous sont repr sentatives Les r sultats obtenus au laboratoire peuvent diff rer de ceux ci Pr cision La pr cision a t d termin e l aide d chantillons humains et de contr les selon un protocole interne R p tabilit n 21 pr cision interm diaire 3 aliquotes par s rie 1 s rie par jour sur 21 jours Les r sultats suivants ont t obtenus R p tabilit Moyenne SD Cv mmol L mg dL mmol L mg dL Precinorm U 2 29 88 5 0 02 0 8 1 1 Precipath U 4 74 183 0 04 2 0 9 S rum humain 1 2 85 110 0 03 1 1 1 S rum humain 2 7 39 286 0 05 2 0 7 Pr cision Moyenne S
11. Precisione intermedia precisione totale precisione fra le serie precisione intergiornaliera Confronto tra metodi valori di colesterolo ottenuti per campioni di siero e di plasma umani su un analizzatore Roche Hitachi cobas c 501 y sono stati confrontati con quelli determinati con lo stesso reagente su un analizzatore Roche Hitachi 917 x Dimensione n del campione 266 Passing Bablok Regressione lineare y 1 002x 0 045 mmol L y 1 012x 0 015 mmol L T 0 953 r 0 997 Le concentrazioni dei campioni erano comprese fra 1 53 e 18 5 mmol L fra 59 1 e 715 mg dL cobas 1 Greiling H Gressner AM eds Lehrbuch der Klinischen Chemie und Pathobiochemie 32 ed Stuttgart New York Schattauer 1995 2 Liebermann C Ber Dtsch chem Ges 1885 18 1803 3 Burchard H Beitr ge zur Kenntnis der Cholesterine Dissertation Rostock 1889 Abell L et al Standard Methods in Clinical Chemistry 1958 26 2 Allain CC et al Clin Chem 1974 20 470 Roeschlau P et al Z Klin Chem Klin Biochem 1974 12 226 Trinder P Ann Clin Biochem 1969 6 24 Siedel J Hagele EO Ziegenhorn J et al Clin Chem 1983 29 1075 Wiebe DA Bernert JT Clin Chem 1984 30 352 Cohn JS McNamara JR Schaefer EJ Lipoprotein Cholesterol Concentrations in the Plasma of Human Subjects as Measured in the Fed and Fasted States Clin Chem 1988 34 2456 2459 11 Pisani T Gebski CP Leary ET et al Accurate Direct Determination of Low density Lipoprotein Chole
12. colesterolo mediante la colesterolo ossidasi e alla conseguente misurazione mediante la reazione di Trinder del perossido di idrogeno formatosi Lottimizzazione della scissione dell estere gt 99 5 permette la standardizzazione utilizzando standard primari e secondari e un confronto diretto con i metodi di riferimento dei CDC e del NIST 1 2 3 45 6 7 8 9 risultati dei campioni postprandiali possono essere leggermente inferiori a quelli ottenuti con campioni prelevati a digiuno 10 11 12 La determinazione del colesterolo di Roche conforme agli obiettivi fissati dai National Institutes of Health NIH nel 1992 riguardo ad una performance inferiore o uguale al 3 sia per la precisione che per la deviazione 2 Il test stato standardizzato opzionalmente contro Abell Kendall e contro la spettrometria di massa con diluizione isotopica Le indicazioni ed i dati relativi alla performance riportati nella presente metodica sono indipendenti dalla standardizzazione Metodo enzimatico colorimetrico Gli esteri del colesterolo vengono dissociati per azione della colesterolo esterasi formando colesterolo libero e acidi grassi Poi la colesterolo ossidasi catalizza l ossidazione del colesterolo formando colest 4 en 3 one e perossido d idrogeno In presenza di perossidasi il perossido d idrogeno formatosi influenza sull accoppiamento ossidativo del fenolo e del 4 aminofenazone producendo un colorante chinoneiminico rosso CE Esteri del c
13. de p remption sur l tiquette du cobas c pack Apr s ouverture et r frig r sur l analyseur 4 semaines Diluent NaCl 9 Conservation entre 2 et 8 C voir date de p remption sur l tiquette du cobas c pack Apr s ouverture et r frig r sur l analyseur 12 semaines Pr l vement et preparation des chantillons Pour le pr l vement et la pr paration des chantillons utiliser uniquement des tubes ou r cipients de recueil appropri s Seuls les types d chantillons suivants ont t test s et peuvent tre utilis s S rum Plasma sang total recueilli sur h parinate de lithium ou EDTA dipotassique Ne pas utiliser de citrate d oxalate ou de fluorure Les chantillons pr lev s jeun ou non peuvent tre utilis s pour l analyse Les diff rents types d chantillons indiqu s ci dessus ont t test s l aide d une s lection de tubes de pr l vement disponibles dans le commerce au moment du test les tubes de pr l vement des diff rents fabricants n ont pas 2010 04 V 7 Fran ais 1 3 Systemes cobas c CHOL2 Cholesterol Gen 2 tous t test s Les syst mes de pr l vement du sang de divers fabricants peuvent contenir diff rents mat riaux pouvant dans certains cas influencer le r sultat du test En cas d utilisation de tubes primaires syst mes de pr l vement du sang suivre les instructions donn es par le fabricant Les chantillons qui contiennent un pr cipi
14. establecer medidas correctivas a seguir en caso de que los valores se sit en fuera de los limites Sirvase cumplir con las regulaciones gubernamentales y las normas locales de control de calidad pertinentes C lculo Los analizadores Roche Hitachi cobas c calculan autom ticamente la concentraci n de analito de cada muestra Factores de mmol L x 38 66 mg dL conversi n mmol L x 0 3866 g L mg dL x 0 0259 mmol L Limitaciones Interferencias Criterio Recuperaci n dentro de 10 del valor incial con una concentraci n de colesterol de 5 2 mmol L 200 mg dL Ictericia Sin interferencias significativas hasta un ndice de 16 para la bilirrubina conjugada y de 14 para la bilirrubina sin conjugar lo cual equivale a una concentraci n aproximada de bilirrubina conjugada de 274 umol L 6 16 mg dL y a una concentraci n aproximada de bilirrubina sin conjugar de 239 umol L 6 14 mg dL Hem lisis Sin interferencias significativas hasta un ndice H de 700 concentraci n de hemoglobina aprox 435 umol L 700 mg dL Lipemia Intralipid Sin interferencia significativa hasta un ndice L de 2 000 No existe una concordancia satisfactoria entre el ndice L correspondiente a la turbidez y la concentraci n de triglic ridos F rmacos No se han registrado interferencias con paneles de f rmacos de uso com n en concentraciones terap uticas 18 19 En casos muy raros pueden obtenerse resultados falsos debidos a la gammapat
15. los objetivos sentados en 1992 por los Institutos Nacionales de la Salud de los EE UU NIH que corresponden a valores iguales o inferiores al 3 tanto para la precisi n como para la desviaci n El presente test ha sido estandarizado frente a Abell Kendall as como por diluci n isot pica espectrometr a de masa Los datos del desempe o del test aqu presentados no dependen de la estandarizaci n Principio de test M todo enzim tico colorim trico Los steres de colesterol se desdoblan por la acci n de la colesterol esterasa a colesterol libre y cidos grasos La colesterol oxidasa cataliza entonces la oxidaci n de colesterol a colest 4 en 3 ona y per xido de hidr geno En presencia de peroxidasa el per xido de hidr geno formado produce la uni n oxidativa del fenol y la 4 aminofenazona para formar un colorante rojo de quinona imina CE steres de colesterol H20 gt colesterol RCOOH CHOD colesterol O2 gt colest 4 en 3 ona H202 POD Oni 2 H20 4 AAP fenol colorante de quinona imina 4 H20 La intensidad crom tica del colorante formado es directamente proporcional a la concentraci n de colesterol Se determina midiendo el aumento de la absorbancia Reactivos Soluciones de trabajo R1 Tamp n PIPES 225 mmol L pH 6 8 Mg 10 mmol L colato s dico 0 6 mmol L 4 aminofenazona gt 0 45 mmol L fenol gt 12 6 mmol L ter poliglic lico de alcohol graso 3 colesterol estera
16. princ 700 505 nm Direcci n de reacci n Incremento Unidades mmol L mg dL g L Pipeteo de reactivo Diluyente H20 RI 47 uL 93 pL Volumenes de muestra Muestra Diluci n de muestra Muestra Diluyente NaCl Normal 2 uL Disminuido 2 uL 15 uL 135 uL Aumentado 4 uL Definici n del test en los analizadores cobas c 501 502 Tipo de medici n 1 Punto Tiempo de reacci n 10 70 Puntos de medici n Longitud de onda sub princ 700 505 nm Direcci n de reacci n Incremento Unidades mmol L mg dL g L Pipeteo de reactivo Diluyente H20 Ri 47 pL 93 pL Volumenes de muestra Muestra Diluci n de muestra Muestra Diluyente NaCl Normal 2 uL Disminuido 2 uL 15 L 135 pL Aumentado 4uL Calibraci n Calibradores S1 H20 S2 C f a s Modo de calibraci n Lineal Frecuencia de calibraciones calibraci n a 2 puntos tras cambiar de lote de reactivos y seg n lo requiera el control de calidad cobas Trazabilidad El presente m todo ha sido estandarizado por el m todo de Abell Kendall 2 as como por diluci n isot pica espectrometr a de masa 6 Control de calidad Para el control de calidad emplear el material de control indicado en la secci n Informaci n de pedido Asimismo puede emplearse otro material de control apropiado Los intervalos y l mites de control deben adaptarse a los requerimientos de cada laboratorio en particular Los valores deben situarse dentro de los l mites establecidos Cada laboratorio deberia
17. r actifs Ri 47 uL Volumes chantillon Echantillon Dilution chantillon Echantillon Diluant NaCl Normal 2 uL Diminue 2 uL 15 uL 135 uL Augment 4 uL x Calibration Calibrateurs S1 H20 S2 Cfa s Type calibration Lin aire Fr quence des calibrations Calibration en 2 points a chaque nouveau lot de r actifs et si le contr le de qualit l exige Tra abilit la m thode a t standardis e selon Abell Kendall et par rapport la dilution isotopique spectrom trie de masse 6 cobas Pour le contr le de qualit utiliser les mat riaux de contr le indiqu s dans la section R f rences de commande D autres contr les appropri s peuvent galement tre utilises La fr quence des contr les et les limites de confiance doivent tre adapt es aux exigences du laboratoire Les r sultats doivent se situer dans les limites de confiance d finies Chaque laboratoire devra tablir la proc dure a suivre si les r sultats se situent en dehors de ces limites Se conformer a la r glementation gouvernementale et aux directives locales en vigueur relatives au contr le de qualit Calcul des r sultats Les systemes Roche Hitachi cobas c calculent automatiquement la concentration en analyte de chaque chantillon mmol L x 38 66 mg dL mmol L x 0 3866 g L mg dL x 0 0259 mmol L Facteurs de conversion Limites d utilisation interf rences Critere d acceptabilit recouvrement 10 de l
18. se o colesterol HDL for Colesterol 5218 200 800 lt 0 9 mmol L lt 35 mg dL Colesterol gt 78 gt 300 si Triglic ridos gt 23 gt 200 m Recomenda es do Painel de Tratamento de Adultos do NCEP para os seguintes limiares de cutoff de risco para a popula o norte americana N vel de colesterol desej vel lt 5 2 mmol L lt 200 mg dL Colesterol elevado limitrofe borderline 5 2 6 2 mmol L 200 240 mg dL Colesterol elevado gt 6 2 mmol L 2 240 mg dL Cada laborat rio deve verificar a transferibilidade dos valores te ricos para a sua pr pria populac o de pacientes e se necess rio determinar os seus pr prios intervalos de refer ncia Dados especificos sobre o desempenho S o apresentados a seguir dados representativos do desempenho nos analisadores Os resultados podem diferir de laborat rio para laborat rio Precis o A precis o foi determinada utilizando amostras humanas e controlos num protocolo interno Repetibilidade n 21 precis o interm dia 3 al quotas por s rie 1 s rie por dia 21 dias Obtiveram se os seguintes resultados Reprodutibilidade M dia DP CV mmol L mg dL mmol L mg dl Precinorm U 2 29 88 5 0 02 0 8 1 1 Precipath U 4 74 183 0 04 2 0 9 Soro humano 1 2 85 110 0 03 1 1 1 Soro humano 2 7 39 286 0 05 2 0 7 Precis o Media DP CV interm dia mmol L mg dL mmol L mg dL Precinorm U 2 31 89 3 0 04 1 6 1 6 Precipath U 4 85 188 0 08 3 1 6
19. 03039773190V7 CHOL2 Cholesterol Gen 2 cobas e Indicates cobas c systems on which reagents can be used Order information Roche Hitachi cobas c systems Cholesterol Gen 2 cobas c 311 cobas c 501 502 400 tests Cat No 03039773 190 System ID 07 6726 3 h Calibrator f a s 12 x 3 mL Cat No 10759350 190 Code 401 Calibrator f a s 12 x 3 mL for USA Cat No 10759350 360 Code 401 Precinorm U plus 10 x 3 mL Cat No 12149435 122 Code 300 Precinorm U plus 10 x 3 mL for USA Cat No 12149435 160 Code 300 Precipath U plus 10 x 3 mL Cat No 12149443 122 Code 301 Precipath U plus 10 x 3 mL for USA Cat No 12149443 160 Code 301 Precinorm U 20 x 5 mL Cat No 10171743 122 Code 300 Precipath U 20 x 5 mL Cat No 10171778 122 Code 301 Precinorm L 4x 3 mL Cat No 10781827 122 Code 304 Precipath L 4 x 3 mL Cat No 11285874 122 Code 305 Diluent NaCl 9 50 mL Cat No 04489357 190 System ID 07 6869 3 English Cholesterol O2 gt cholest 4 en 3 one H202 System information For cobas c 311 501 analyzers CHO2I ACN 798 ID MS Standardization CHO2A ACN 433 Abell Kendall Standardization For cobas c 502 analyzer CHO2I ACN 8798 ID MS Standardization CHO2A ACN 8433 Abell Kendall Standardization Intended use In vitro test for the quantitative determination of cholesterol in human serum and plasma on Roche Hitachi cobas c systems Summary Cholesterol is a steroid with a secondar
20. 2 uL Diminui o 2 uL 15 uL 135 uL Aumento 4 uL u Calibra o Calibradores S1 H20 S2 C fa s Modo de calibra o Linear Frequ ncia da calibra o Calibra o de 2 pontos ap s a mudan a de lote de reagente e conforme necess rio segundo os procedimentos de controlo da qualidade cobas Rastreabilidade Este m todo foi padronizado de acordo com Abell Kendall 2 e tamb m por dilui o do is topo espectrometria de massa Controlo da Qualidade Para o controlo da qualidade utilize os materiais de controlo indicados na sec o Informa es para encomenda Adicionalmente pode ser utilizado outro material de controlo adequado Os intervalos e limites de controlo dever o ser adaptados s exig ncias espec ficas de cada laborat rio Os valores obtidos devem situar se dentro dos limites definidos Cada laborat rio deve estabelecer as medidas correctivas a tomar no caso de os valores se situarem fora dos limites Cumpra os regulamentos governamentais aplic veis e as directrizes locais de controlo da qualidade C lculo dos resultados Os sistemas Roche Hitachi cobas c calculam automaticamente a concentra o de analito de cada amostra Factores de convers o mmol L x 38 66 mg dL mmol L x 0 3866 g L mg dL x 0 0259 mmol L Limita es interfer ncias Crit rio Recupera o dentro de 10 dos valores iniciais com uma concentra o de colesterol de 5 2 mmol L 200 mg dL Ictericia Nenh
21. A Ref 12149443 160 C digo 301 Precinorm U 20 x 5 mL Ref 10171743 122 C digo 300 Precipath U 20 x 5 mL Ref 10171778 122 C digo 301 Precinorm L 4 x 3 mL Ref 10781827 122 C digo 304 Precipath L 4 x 3 mL Ref 11285874 122 C digo 305 Diluent NaCl 9 50 mL Ref 04489357 190 System ID 07 6869 3 4 CE Portugu s Esteres de colesterol H20 gt colesterol RCOOH Informac es do sistema CHOD Analisadores cobas c 311 501 Colesterol Oo gt colest 4 en 3 ona H202 CHO2I ACN 798 Padroniza o ID MS POD CHO2A ACN 433 Padroniza o Abell Kendall Analisador cobas c 502 CHO2I ACN 8798 Padroniza o ID MS CHO2A ACN 8433 Padroniza o Abell Kendall Utilizac o prevista Teste in vitro para determina o quantitativa de colesterol em soro e plasma humanos utilizando os sistemas Roche Hitachi cobas c Resumo O colesterol um esterdide com um grupo hidroxilico secund rio na posi o C3 E sintetizado em muitos tipos de tecido mas sobretudo no figado e na parede intestinal Cerca de tr s quatros do colesterol formado por s ntese e um quarto tem origem na dieta alimentar As determina es do colesterol s o utilizadas para a despistagem do risco aterog nico e no diagn stico e tratamento de doen as que envolvem n veis elevados de colesterol bem como de perturba es do metabolismo lip dico e lipoproteico A an lise do colesterol foi descrita pela 1 vez por Liebermann em 1885 e mais tarde por Burcha
22. Best Nr 12149443 122 Code 301 Precipath U plus 10 x 3 mL fiir USA Best Nr 12149443 160 Code 301 Precinorm U 20 x 5 mL Best Nr 10171743 122 Code 300 Precipath U 20 x 5 mL Best Nr 10171778 122 Code 301 Precinorm L 4 x 3 mL Best Nr 10781827 122 Code 304 Precipath L 4 x 3 mL Best Nr 11285874 122 Code 305 Diluent NaCl 9 50 mL Best Nr 04489357 190 System ID 07 6869 3 CE Deutsch Cholesterinester H20 gt Cholesterin RCOOH Systeminformation CHOD F r cobas c 311 501 Ger te Cholesterin Oo gt Cholest 4 en 3 on H202 CHO2I ACN 798 ID MS Standardisierung POD CHO2A ACN 433 Standardisierung nach Abell Kendall F r cobas c 502 Ger te CHO2I ACN 8798 ID MS Standardisierung CHO2A ACN 8433 Standardisierung nach Abell Kendall Anwendungszweck In vitro Test zur quantitativen Bestimmung von Cholesterin in Humanserum und plasma mit Roche Hitachi cobas c Systemen Zusammenfassung Cholesterin ist ein Steroid mit einer sekund ren Hydroxylgruppe in C3 Stellung Es wird in vielen Geweben besonders aber in der Leber und der Darmwand synthetisiert Etwa drei Viertel des Cholesterins entstehen durch Neusynthese und ein Viertel durch die Nahrungsaufnahme Die Cholesterinbestimmungen dienen als Screening auf ein atherogenes Risiko und zur Diagnose und Behandlung von Krankheiten mit erh htem Cholesterin sowie f r Lipid und Lipoproteinstoffwechselst rungen Die erste Cholesterinbestimmung beschrieb Lieberm
23. D CV interm diaire mmol L mg dL mmol L mg dL Precinorm U 2 31 89 3 0 04 1 6 1 6 Precipath U 4 85 188 0 08 3 1 6 S rum humain 3 1 97 76 2 0 03 1 2 1 6 S rum humain 4 7 13 276 0 10 4 14 R p tabilit pr cision intra s rie Pr cision interm diaire pr cision totale pr cision inter s ries pr cision inter jours Comparaison de m thodes Les taux de cholest rol obtenus dans des chantillons de s rum et de plasma humains sur un analyseur Roche Hitachi cobas c 501 y ont t compar s avec ceux obtenus avec le m me r actif sur un analyseur Roche Hitachi 917 x n 266 Passing Bablok Regression lin aire y 1 002x 0 045 mmol L y 1 012x 0 015 mmol L T 0 953 r 0 997 Les concentrations des chantillons taient situ es entre 1 53 et 18 5 mmol L 59 1 et 715 mg dL cobas 1 Greiling H Gressner AM ds Lehrbuch der Klinischen Chemie und Pathobiochemie 3 dition Stuttgart New York Schattauer 1995 2 Liebermann C Ber Dtsch chem Ges 1885 18 1803 3 Burchard H Beitrage zur Kenntnis der Cholesterine Dissertation Rostock 1889 Abell L et al Standard Methods in Clinical Chemistry 1958 26 2 Allain CC et al Clin Chem 1974 20 470 Roeschlau P et al Z Klin Chem Klin Biochem 1974 12 226 Trinder P Ann Clin Biochem 1969 6 24 Siedel J Hagele EO Ziegenhorn J et al Clin Chem 1983 29 1075 Wiebe DA Bernert JT Clin Chem 1984 30 352 Cohn JS McNamara JR Schae
24. J Clin Chem Clin Biochem 1996 34 385 386 19 Sonntag O Scholer A Drug interference in clinical chemistry recommendation of drugs and their concentrations to be used in drug interference studies Ann Clin Biochem 2001 38 376 385 20 Study Group European Atherosclerosis Society Strategies for the prevention of coronary heart disease A policy statement of the European Atherosclerosis Society European Heart Journal 1987 8 77 21 Third Report of the National Cholesterol Education Program NCEP Expert Panel on Detection Evaluation and Treatment of High Blood Cholesterol in Adults Adult Treatment Panel III NIH Publication No 01 3670 mai 2001 22 Passing H Bablok W et al A General Regression Procedure for Method Transformation J Clin Chem Clin Biochem 1988 26 783 790 SSP OO o Les modifications importantes par rapport la version pr c dente sont signal es par une barre verticale dans la marge O 2010 Roche Diagnostics CE wi Roche Diagnostics GmbH Sandhofer Strasse 116 D 68305 Mannheim www roche com 2010 04 V 7 Francais 3 3 Syst mes cobas c 03039773190V7 CHOL2 Cholesterol Gen 2 cobas Estuche adecuado para el analizador cobas c respectivo Informaci n de pedido Cholesterol Gen 2 400 tests Calibrator f a s 12 x 3 mL Calibrator f a s 12 x 3 mL para los EE UU Precinorm U plus 10 x 3 mL Precinorm U plus 10 x 3 mL para los EE UU Precipath U plus 10 x 3 mL Precipa
25. Philadelphia PA WB Saunders Company 1995 130 131 Use of Anticoagulants in Diagnostic Laboratory Investigations WHO publication WHO DIL LAB 99 1 Rev 2 Jan 2002 Siekmann L H skes KP Breuer H 1976 Determination of cholesterol in serum using mass fragmentography a reference method in clinical chemistry Z Anal Chem 279 145 146 Glick MR Ryder KW Jackson SA Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation Clin Chem 1986 32 470 475 Breuer J Report on the Symposium Drug effects in Clinical Chemistry Methods Eur J Clin Chem Clin Biochem 1996 34 385 386 Sonntag O Scholer A Drug interference in clinical chemistry recommendation of drugs and their concentrations to be used in drug interference studies Ann Clin Biochem 2001 38 376 385 Study Group European Atherosclerosis Society Strategies for the prevention of coronary heart disease A policy statement of the European Atherosclerosis Society European Heart Journal 1987 8 77 Third Report of the National Cholesterol Education Program NCEP Expert Panel on Detection Evaluation and Treatment of High Blood Cholesterol in Adults Adult Treatment Panel III NIH Publication No 01 3670 May 2001 Passing H Bablok W et al A General Regression Procedure for Method Transformation J Clin Chem Clin Biochem 1988 26 783 790 Signifikante Erg nzungen oder nderungen sind durch eine Markierung am Rand gekennzeichnet 2010 Roche Diagnostic
26. Sorohumano3 1 97 76 2 0 03 1 2 1 6 Soro humano 4 7 13 276 0 10 4 14 Repetibilidade precis o intra ensaio Precis o interm dia precis o total precis o inter ensaio precis o entre dias Compara o dos m todos Os valores de colesterol das amostras de soro e plasma humanos obtidos num analisador Roche Hitachi cobas c 501 y foram comparados com os obtidos com o mesmo reagente num analisador Roche Hitachi 917 x Tamanho da amostra n 266 Passing Bablok Regress o linear y 1 002x 0 045 mmol L y 1 012x 0 015 mmol L T 0 953 r 0 997 As concentrac es das amostras variaram entre 1 53 18 5 mmol L 59 1 715 mg dL cobas 1 Greiling H Gressner AM eds Lehrbuch der Klinischen Chemie und Pathobiochemie 3 ed Stuttgart New York Schattauer 1995 2 Liebermann C Ber Dtsch chem Ges 1885 18 1803 3 Burchard H Beitr ge zur Kenntnis der Cholesterine Dissertation Rostock 1889 Abell L et al Standard Methods in Clinical Chemistry 1958 26 2 Allain CC et al Clin Chem 1974 20 470 Roeschlau P et al Z Klin Chem Klin Biochem 1974 12 226 Trinder P Ann Clin Biochem 1969 6 24 Siedel J H gele EO Ziegenhorn J et al Clin Chem 1983 29 1075 Wiebe DA Bernert JT Clin Chem 1984 30 352 Cohn JS McNamara JR Schaefer EJ Lipoprotein Cholesterol Concentrations in the Plasma of Human Subjects as Measured in the Fed and Fasted States Clin Chem 1988 34 2456 2459 11 Pisani T Gebski CP Leary E
27. T et al Accurate Direct Determination of Low density Lipoprotein Cholesterol Using an Immunoseparation Reagent and Enzymatic Cholesterol Assay Arch Pathol Lab Med 1995 119 1127 12 Recommendations for Improving Cholesterol Measurement A Report from the Laboratory Standardization Panel of the National Cholesterol Education Program NIH Publication No 90 2964 February 1990 13 Nader R Dufour DR Cooper GR Preanalytical Variation in Lipid Lipoprotein and Apolipoprotein Testing In Rifai N Warnick GR and Dominiczak MH editors Handbook of Lipoprotein Testing 2nd ed Washington AACC press p 176 14 Tietz NW ed Clinical Guide to Laboratory Tests 31 ed Philadelphia PA WB Saunders Company 1995 130 131 15 Use of Anticoagulants in Diagnostic Laboratory Investigations WHO publication WHO DIL LAB 99 1 Rev 2 Jan 2002 16 Siekmann L H skes KP Breuer H 1976 Determination of cholesterol in serum using mass fragmentography a reference method in clinical chemistry Z Anal Chem 279 145 146 17 Glick MR Ryder KW Jackson SA Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation Clin Chem 1986 32 470 475 18 Breuer J Report on the Symposium Drug Effects in Clinical Chemistry Methods Eur J Clin Chem Clin Biochem 1996 34 385 386 19 Sonntag O Scholer A Drug interference in clinical chemistry recommendation of drugs and their concentrations to be used in drug interference studies Ann Clin
28. a valeur initiale a une concentration en cholest rol de 5 2 mmol L 200 mg dL Ict re pas d interf rence significative jusqu un indice de 16 pour la bilirubine conjugu e et de 14 pour la bilirubine non conjugu e concentration approximative en bilirubine conjugu e 274 umol L ou 16 mg dL et en bilirubine non conjugu e 239 pmol L ou 14 mg dL H molyse pas d interf rence significative jusqu a un indice H de 700 concentration approximative d h moglobine 435 umol L ou 700 mg dL Lip mie Intralipid pas d interf rence significative jusqu un indice L de 2000 Il n y a pas de concordance satisfaisante entre la turbidit et la concentration en triglyc rides M dicaments aucune interf rence n a t trouv e aux concentrations th rapeutiques sur un panel de m dicaments fr quemment administr s 18 19 Dans de tr s rares cas la gammapathie en particulier de type IgM macroglobulin mie de Waldenstr m peut conduire a des r sultats erron s Pour le diagnostic les r sultats doivent toujours tre confront s aux donn es de lPanamn se du patient au tableau clinique et aux r sultats d autres examens ACTION N CESSAIRE Programmation de lavages sp ciaux sur les analyseurs Roche Hitachi cobas c certaines combinaisons de tests n cessitent la programmation d tapes de lavage sp ciales La derni re version de la liste de pr vention des contaminations Carry over evasion list figure dan
29. ack Etikett Im Ger t in Gebrauch und gek hlt 4 Wochen Diluent NaCl 9 Haltbarkeit bei 2 8 C Siehe Verfallsdatum auf dem cobas c pack Etikett Im Ger t in Gebrauch und gek hlt 12 Wochen Probenentnahme und Vorbereitung Zur Probenentnahme und vorbereitung nur geeignete R hrchen oder Sammelgef e verwenden Nur die unten aufgef hrten Proben wurden getestet und k nnen verwendet werden Serum Plasma Li Heparin und K2 EDTA Plasma Kein Citrat Oxalat oder Fluorid verwenden 3 N chternproben und postprandiale Proben k nnen eingesetzt werden Die aufgef hrten Probenarten wurden mit einer Auswahl an handels blichen Probenentnahmer hrchen die zu diesem Zeitpunkt erh ltlich waren getestet d h nicht alle erh ltlichen R hrchen aller Hersteller wurden getestet Probenentnahmesysteme von verschiedenen Herstellern 2010 04 V 7 Deutsch 1 3 cobas c Systeme CHOL2 Cholesterol Gen 2 k nnen unterschiedliche Materialien enthalten die die Testergebnisse im Einzelfall beeinflussen k nnen Bei der Verwendung von Prim rr hrchen Probenentnahmesysteme sind die Anweisungen des Herstellers zu beachten Proben die Pr zipitate enthalten m ssen vor dem Test zentrifugiert werden Haltbarkeit 1415 7 Tage bei 15 25 C 7 Tage bei 2 8 C 3 Monate bei 15 25 C Gelieferte Materialien Siehe Reagenzien gebrauchsfertige L sungen Zus tzlich ben tigte Materialien Siehe Abschnitt Beste
30. ample Diluent NaC 2 uL 2 uL 15 uL 135 uL 4 uL St H20 S2 C f a s Linear 2 point calibration after reagent lot change and as required following quality control procedures Traceability This method has been standardized according to Abell Kendall 2 and also by isotope dilution mass spectrometry 16 Quality Control For quality control use control materials as listed in the Order information section Other suitable control material can be used in addition The control intervals and limits should be adapted to each laboratory s individual requirements Values obtained should fall within the defined limits Each laboratory should establish corrective measures to be taken if values fall outside the limits Follow the applicable government regulations and local guidelines for quality control cobas Roche Hitachi cobas c systems automatically calculate the analyte concentration of each sample Conversion factors mmol L x 38 66 mg dL mmol L x 0 3866 g L mg dL x 0 0259 mmol L Limitations interference Criterion Recovery within 10 of initial values at a cholesterol concentration of 5 2 mmol L 200 mg dL Icterus No significant interference up to an index of 16 for conjugated bilirubin and 14 for unconjugated bilirubin approximate conjugated bilirubin concentration 274 umol L 16 mg dL and approximate unconjugated bilirubin concentration 239 pmol L 14 mg dL Hemolysis No si
31. ance data on the analyzers are given below Results obtained in individual laboratories may differ Precision Precision was determined using human samples and controls in an internal protocol Repeatability n 21 intermediate precision 3 aliquots per run 1 run per day 21 days The following results were obtained Repeatability Mean SD CV mmol L mg dL mmol L mg dL Precinorm U 2 29 88 5 0 02 0 8 14 Precipath U 4 74 183 0 04 2 0 9 Human serum 1 2 85 110 0 03 1 11 Human serum 2 7 39 286 0 05 2 0 7 Intermediate Mean SD CV precision mmol L mg dL mmol L mg dL Precinorm U 2 31 89 3 0 04 1 6 1 6 Precipath U 4 85 188 0 08 3 1 6 Human serum 3 1 97 76 2 0 03 1 2 1 6 Human serum 4 7 13 276 0 10 4 1 4 repeatability within run precision intermediate precision total precision between run precision between day precision Method comparison Cholesterol values for human serum and plasma samples obtained on a Roche Hitachi cobas c 501 analyzer y were compared with those determined using the same reagent on a Roche Hitachi 917 analyzer x Sample size n 266 Passing Bablok Linear regression y 1 002x 0 045 mmol L y 1 012x 0 015 mmol L T 0 953 r 0 997 The sample concentrations were between 1 53 and 18 5 mmol L 59 1 and 715 mg dL References 1 Greiling H Gressner AM eds Lehrbuch der Klinischen Chemie und Pathobiochemie 3 ed Stuttgart New York Schattaue
32. ann 1885 und nachfolgend Burchard 1889 Cholesterin bildet nach dem Liebermann Burchard Prinzip mit Essigs ure Essigs ureanhydrid und konzentrierter Schwefels ure blaugr n gef rbte Verbindungen aus polymeren unges ttigten Kohlenwasserstoffen Die Methode nach Abell und Kendall ist spezifisch f r Cholesterin aber technisch umst ndlich und verwendet ebenfalls tzende Reagenzien 1974 beschrieben Roeschlau und Allain die erste vollenzymatische Methode Diese Methode beruht auf der Bestimmung von A4 Cholestenon nach enzymatischer Spaltung der Cholesterinester mit Cholesterinesterase und Umwandlung des Cholesterins durch Cholesterinoxidase sowie der anschlie enden Messung des gebildeten Wasserstoffperoxids ber eine Trinderreaktion Die Optimierung der Esterspaltung gt 99 5 erm glicht die Standardisierung durch prim re und sekund re Standards und einen direkten Vergleich zu den CDC und NIST Referenzverfahren 23 45 6 7 8 9 Die postprandialen Werte k nnen etwas niedriger als die Ergebnisse in N chternseren liegen 1011 12 Der Cholesterintest von Roche erreicht die Zielvorgabe des National Institutes of Health NIH von 1992 von h chstens 3 sowohl f r Pr zision als auch Abweichung 2 Der Test wird wahlweise gegen Abell Kendall und Isotopenverd nnung Massenspektrometrie standardisiert Die hier dargestellten Leistungsanforderungen und daten sind unabh ngig von der Standardisierung Testprinzip Enzymatischer Farbtest D
33. cholest rol est rase suivie de la transformation en pr sence de cholest rol oxydase du cholest rol en A4 cholest none l eau oxyg n e form e au cours de cette derni re r action est mesur e l aide d une r action de Trinder Loptimisation de l hydrolyse des esters gt 99 5 permet une standardisation l aide de standards primaires et secondaires et une comparaison directe avec les m thodes de r f rence du CDC Center for Disease Control et du NIST National Institute of Standards and Technology 23456789 Les valeurs post prandiales sont l g rement inf rieures aux valeurs jeun 10 11 12 La m thode de dosage du cholest rol de Roche r pond aux objectifs de performance de 1992 du NIH National Institute of Health pr cision et erreur syst matique inf rieures ou gales 3 Le test est standardis selon Abell Kendall et par rapport la dilution isotopique spectrom trie de masse Les d clarations et les performances analytiques indiqu es dans la pr sente notice d utilisation sont ind pendantes de la standardisation Principe M thode colorim trique enzymatique Sous l action de la cholest rol est rase les esters du cholest rol sont scind s en cholest rol libre et en acides gras Dans une r action ult rieure catalys e par la cholest rol oxydase le cholest rol est transform en pr sence d oxyg ne en A4 cholest none avec formation d eau oxyg n e En pr sence de
34. da laboratorio en particular pueden diferir de estos valores Precision La precisi n ha sido determinada mediante muestras humanas y controles seg n un protocolo interno Repetibilidad n 21 precisi n intermedia 3 al cuotas por serie 1 serie por d a 21 dias Se han obtenido los siguientes resultados Repetibilidad VM DE CV mmol L mg dL mmol L mg dL Precinorm U 2 29 88 5 0 02 0 8 1 1 Precipath U 4 74 183 0 04 2 0 9 Suero humano 1 2 85 110 0 03 1 1 1 Suero humano 2 7 39 286 0 05 2 0 7 Precisi n VM DE CV intermedia mmol L mg dL mmol L mg dL Precinorm U 2 31 89 3 0 04 1 6 1 6 Precipath U 4 85 188 0 08 3 1 6 Suero humano 3 1 97 76 2 0 08 1 2 16 Suero humano 4 713 276 0 10 4 14 repetibilidad precisi n intraserie precisi n intermedia precisi n total precisi n interserie precisi n dia a dia Comparaci n de m todos Se han comparado los valores de colesterol en muestras de suero y plasma humanos obtenidos en un analizador Roche Hitachi cobas c 501 y con los obtenidos con el mismo reactivo en un analizador Roche Hitachi 917 x Cant de muestras n 266 Passing Bablok Regresi n lineal y 1 002x 0 045 mmol L y 1 012x 0 015 mmol L T 0 953 r 0 997 La concentraci n de las muestras se situ entre 1 53 y 18 5 mmol L 59 1 715 mg dL cobas Referencias bibliogr ficas 1 2 3 SO 00 OO d o 11 12 13 14
35. dias a 15 25 C 7 dias a 2 8 C 3 meses a 15 25 C Materiais fornecidos Consulte a secg o Reagentes solug es de trabalho Materiais necessarios mas nao fornecidos Consulte a secg o Informac es para encomenda Equipamento normal de laborat rio Ensaio Para assegurar a correcta execu o do ensaio importante cumprir as instruc es fornecidas neste documento para o analisador utilizado Consulte o manual do operador apropriado para obter informag es mais especificas sobre o ensaio feito no analisador A realiza o de aplica es n o validadas pela Roche n o garantida e deve ser definida pelo utilizador Aplica o para soro e plasma Analisador cobas c 311 Defini o do teste Tipo de teste 1 Point Tempo da reac o 10 57 Pontos de ensaio Comprimento de onda 700 505 nm sub principal Sentido da reac o Aumento Unidades mmol L mg dL g L Pipetagem de reagente Diluente H20 Ri 47 uL 93 uL Volumes das amostras Amostra Dilui o da amostra Amostra Diluente NaCl Normal 2 uL E Diminui o 2 uL 15 uL 135 uL Aumento 4 uL a Analisadores cobas c 501 502 Defini o do teste Tipo de teste 1 Point Tempo da reac o 10 70 Pontos de ensaio Comprimento de onda 700 505 nm sub principal Sentido da reacc o Aumento Unidades mmol L mg dL g L Pipetagem de reagente Diluente H20 Ri 47 uL 93 uL Volumes das amostras Amostra Dilui o da amostra Amostra Diluente NaCl Normal
36. dini Normale attrezzatura da laboratorio Esecuzione Per una performance ottimale del test attenersi alle indicazioni riportate nel presente documento per l analizzatore in questione Per le istruzioni specifiche dell analizzatore relative all esecuzione del test consultare il manuale d uso dello strumento Roche non risponde delle performance delle applicazioni che non sono state validate dalla stessa Roche tali performance devono quindi essere definite dall utilizzatore Applicazione per il siero ed il plasma Definizione del test per l analizzatore cobas c 311 Tipo di misura 1 Punto finale Tempo di reazione punti di misura 10 57 Lunghezze d onda sec princ 700 505 nm Andamento della reazione Crescente Unit di misura mmol L mg dL g L Diluente H20 93 pL Campione Diluizione del campione Campione Diluente NaCl Volumi dei reagenti RI 47 uL Volumi dei campioni Normale 2 uL Ridotto Diluito 2 uL 15 uL 135 uL Concentrato 4 uL Definizione del test per gli analizzatori cobas c 501 502 Tipo di misura 1 Punto finale Tempo di reazione punti di misura 10 70 Lunghezze d onda sec princ 700 505 nm Andamento della reazione Crescente Unit di misura mmol L mg dL g L Diluente H20 93 uL Campione Diluizione del campione Campione Diluente NaCl Volumi dei reagenti Ri 47 uL Volumi dei campioni Normale 2 uL u Ridotto Diluito 2 uL 15 uL 135 uL Concentrato 4 uL
37. fer EJ Lipoprotein Cholesterol Concentrations in the Plasma of Human Subjects as Measured in the Fed and Fasted States Clin Chem 1988 34 2456 2459 11 Pisani T Gebski CP Leary ET et al Accurate Direct Determination of Low density Lipoprotein Cholesterol Using an Immunoseparation Reagent and Enzymatic Cholesterol Assay Arch Pathol Lab Med 1995 119 1127 12 Recommendations for Improving Cholesterol Measurement A Report from the Laboratory Standardization Panel of the National Cholesterol Education Program NIH Publication No 90 2964 f vrier 1990 13 Nader R Dufour DR Cooper GR Preanalytical Variation in Lipid Lipoprotein and Apolipoprotein Testing Dans Rifai N Warnick GR and Dominiczak MH diteurs Handbook of Lipoprotein Testing 2e dition Washington AACC press p 176 14 Tietz NW diteur Clinical Guide to Laboratory Tests 3 dition Philadelphie PA WB Saunders Company 1995 130 131 15 Use of Anticoagulants in Diagnostic Laboratory Investigations WHO publication WHO DIL LAB 99 1 Rev 2 Janvier 2002 16 Siekmann L H skes KP Breuer H 1976 Determination of cholesterol in serum using mass fragmentography a reference method in clinical chemistry Z Anal Chem 279 145 146 17 Glick MR Ryder KW Jackson SA Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation Clin Chem 1986 32 470 475 18 Breuer J Report on the Symposium Drug effects in Clinical Chemistry Methods Eur
38. gnificant interference up to an H index of 700 approximate hemoglobin concentration 435 umol L 700 mg dL Lipemia Intralipid No significant interference up to an L index of 2000 There is poor correlation between the L index corresponds to turbidity and triglycerides concentration Drugs No interference was found at therapeutic concentrations using common drug panels 8 19 In very rare cases gammopathy in particular type IgM Waldenstr m s macroglobulinemia may cause unreliable results For diagnostic purposes the results should always be assessed in conjunction with the patients medical history clinical examination and other findings ACTION REQUIRED Special Wash Programming The use of special wash steps is mandatory when certain test combinations are run together on Roche Hitachi cobas c systems The latest version of the Carry over evasion list can be found with the NaOHD SMS Multiclean SCCS or the NaOQHD SMS SmpCin1 2 SCCS Method Sheets For further instructions refer to the operator manual cobas c 502 analyzer All special wash programming necessary for avoiding carry over is available via the cobas link manual input is not required Where required special wash carry over evasion programming must be implemented prior to reporting results with this test Limits and ranges Measuring range 0 1 20 7 mmol L 3 86 800 mg dL Determine samples having higher concentrations via the rerun function Dilution of samples
39. gt Die Ergebnisse des einzelnen Labors k nnen davon abweichen Pr zision Die Pr zision wurde mit Humanproben und Kontrollen gem einem internen Protokoll bestimmt Wiederholpr zision n 21 Zwischenpr zision 3 Aliquote pro Durchlauf 1 Durchlauf pro Tag 21 Tage Folgende Ergebnisse wurden erzielt Wiederholpr zision MW SD VK mmol L mg dL mmol L mg dL Precinorm U 2 29 88 5 0 02 0 8 1 1 Precipath U 4 74 183 0 04 2 0 9 Humanserum 1 2 85 110 0 03 1 1 1 Humanserum 2 7 39 286 0 05 2 0 7 Zwischenpr zision MW SD VK mmol L mg dL mmol L mg dL Precinorm U 2 31 89 3 0 04 1 6 1 6 Precipath U 4 85 188 0 08 3 1 6 Humanserum 3 1 97 76 2 0 03 1 2 1 6 Humanserum 4 713 276 0 10 4 1 4 Wiederholpr zision Pr zision in der Serie Zwischenprazision Gesamt Pr zision Lauf Lauf Pr zision Tag Tag Pr zision Methodenvergleich Die auf einem Roche Hitachi cobas c 501 Ger t y ermittelten Cholesterinwerte f r Humanserum und plasmaproben wurden mit den Werten verglichen die mit dem gleichen Reagenz auf einem Roche Hitachi 917 Ger t x bestimmt wurden Probenanzahl n 266 Passing Bablok Lineare Regression y 1 002x 0 045 mmol L y 1 012x 0 015 mmol L T 0 953 r 0 997 Die Probenkonzentrationen lagen zwischen 1 53 und 18 5 mmol L 59 1 und 715 mg dL cobas Literatur 1 2 3 9 00 o o o 11 12 13 14 15 16 17 18 19
40. holesterol assay meets the 1992 National Institutes of Health NIH goal of less than or equal to 3 for both precision and bias 2 The assay is optionally standardized against Abell Kendall and isotope dilution mass spectrometry The performance claims and data presented here are independent of the standardization Test principle Enzymatic colorimetric method Cholesterol esters are cleaved by the action of cholesterol esterase to yield free cholesterol and fatty acids Cholesterol oxidase then catalyzes the oxidation of cholesterol to cholest 4 en 3 one and hydrogen peroxide In the presence of peroxidase the hydrogen peroxide formed effects the oxidative coupling of phenol and 4 aminophenazone to form a red quinone imine dye POD 2 H202 4 AAP phenol gt quinone imine dye 4 H20 The color intensity of the dye formed is directly proportional to the cholesterol concentration It is determined by measuring the increase in absorbance Reagents working solutions R1 PIPES buffer 225 mmol L pH 6 8 Mg 10 mmol L sodium cholate 0 6 mmol L 4 aminophenazone gt 0 45 mmol L phenol gt 12 6 mmol L fatty alcohol polyglycol ether 3 cholesterol esterase Pseudomonas spec gt 25 ukat L gt 1 5 U mL cholesterol oxidase E coli gt 7 5 ukat L gt 0 45 U mL peroxidase horseradish gt 12 5 ukat L gt 0 75 U mL stabilizers preservative Precautions and warnings For in vitro diagnostic use Exerc
41. ia particularmente del tipo IgM macroglobulinemia de Waldenstroem Con fines diagn sticos los resultados obtenidos con el test siempre deben evaluarse junto al historial del paciente los ex menes cl nicos y los resultados de otros an lisis ACCI N REQUERIDA Programa especial de lavado Los pasos de lavado especial se aplican cuando ciertos tests se utilizan de forma combinada en los sistemas Roche Hitachi cobas c La versi n m s actual de la lista de contaminaciones por arrastre se encuentra en la met dica NaOHD SMS Multiclean SCCS o la met dica NaOHD SMS SmpCln1 2 SCCS Para mayor informaci n consulte el manual del operador Analizador cobas c 502 Todos los pasos de lavado necesarios para evitar la contaminaci n por arrastre est n disponibles a trav s del enlace cobas de modo que no se requiere la entrada manual de los datos En caso de que sea necesario implemente el lavado especial destinado a evitar la contaminaci n por arrastre antes de comunicar los resultados del test L mites e intervalos Intervalo de medici n 0 1 20 7 mmol L 3 86 800 mg dL Determinar las muestras con concentraciones superiores a trav s de la funci n de repetici n del ciclo La diluci n de las muestras por la funci n de repetici n del ciclo es de 1 10 Los resultados de las muestras diluidas por la funci n de repetici n del ciclo se multiplican autom ticamente por el factor 10 sistemas cobas c 213 2010 04 V 7 Espafiol
42. ie Cholesterinester werden unter Einwirkung der Cholesterinesterase in freies Cholesterin und Fetts uren gespalten Die Cholesterinoxidase katalysiert die Oxidation von Cholesterin zu Cholest 4 en 3 on und Wasserstoffperoxid Das entstandene Wasserstoffperoxid bildet mit 4 Aminophenazon und Phenol unter katalytischer Wirkung der Peroxidase einen roten Chinoniminfarbstoff 2 H202 4 AAP Phenol Chinoniminfarbstoff 4 H20 Die Farbintensitat des gebildeten Farbstoffes ist direkt proportional zur Cholesterinkonzentration Sie wird durch Messung der Extinktionszunahme bestimmt Reagenzien gebrauchsfertige Losungen R1 PIPES Puffer 225 mmol L pH 6 8 Mg 10 mmol L Natriumcholat 0 6 mmol L 4 Aminophenazon gt 0 45 mmol L Phenol gt 12 6 mmol L Fettalkoholpolyglykolether 3 Cholesterinesterase Pseudomonas spec gt 25 ukat L gt 1 5 U mL Cholesterinoxidase E coli gt 7 5 ukat L 2 0 45 U mL Peroxidase Meerrettich gt 12 5 ukat L 2 0 75 U mL Stabilisatoren Konservierungsmittel VorsichtsmaBnahmen und Warnhinweise In vitro Diagnostikum Die beim Umgang mit Laborreagenzien blichen Vorsichtsma nahmen beachten Sicherheitsdatenblatt auf Anfrage f r berufsm ige Benutzer erh ltlich Die Entsorgung aller Abf lle ist gem den lokalen Richtlinien durchzuf hren Reagenz Handhabung Gebrauchsfertig Lagerung und Haltbarkeit CHOL2 Haltbarkeit bei 2 8 C Siehe Verfallsdatum auf dem cobas c p
43. iety Strategies for the prevention of coronary heart disease A policy statement of the European Atherosclerosis Society European Heart Journal 1987 8 77 21 Third Report of the National Cholesterol Education Program NCEP Expert Panel on Detection Evaluation and Treatment of High Blood Cholesterol in Adults Adult Treatment Panel III NIH Publication No 01 3670 maggio 2001 22 Passing H Bablok W et al A General Regression Procedure for Method Transformation J Clin Chem Clin Biochem 1988 26 783 790 Se DO d o Le aggiunte o modifiche significative sono indicate mediante una linea verticale posizionata al margine 2010 Roche Diagnostics sl Roche Diagnostics GmbH Sandhofer Strasse 116 D 68305 Mannheim www roche com 2010 03 V 7 Italiano 3 3 Sistemi cobas c 03039773190V7 CHOL2 Cholesterol Gen 2 cobas e Indica em que sistemas cobas c podem ser utilizados os reagentes Informac es para encomenda Sistemas Roche Hitachi cobas c Cholesterol Gen 2 cobas c 311 cobas c 501 502 400 testes Ref 03039773 190 System ID 07 6726 3 y Calibrator f a s 12 x 3 mL Ref 10759350 190 C digo 401 Calibrator f a s 12 x 3 mL para os EUA Ref 10759350 360 C digo 401 Precinorm U plus 10 x 3 mL Ref 12149435 122 C digo 300 Precinorm U plus 10 x 3 mL para os EUA Ref 12149435 160 C digo 300 Precipath U plus 10 x 3 mL Ref 12149443 122 C digo 301 Precipath U plus 10 x 3 mL para os EU
44. ise the normal precautions required for handling all laboratory reagents Safety data sheet available for professional user on request Disposal of all waste material should be in accordance with local guidelines Reagent handling Ready for use Storage and stability CHOL2 Shelf life at 2 8 C See expiration date on cobas c pack label On board in use and refrigerated on the analyzer 4 weeks Diluent NaCl 9 Shelf life at 2 8 C See expiration date on cobas c pack label On board in use and refrigerated on the analyzer 12 weeks Specimen collection and preparation For specimen collection and preparation only use suitable tubes or collection containers Only the specimens listed below were tested and found acceptable Serum Plasma Li heparin and K gt EDTA plasma Do not use citrate oxalate or fluoride Fasting and nonfasting samples can be used The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing i e not all available tubes of all manufacturers were tested Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases When processing samples in primary tubes sample collection systems follow the instructions of the tube manufacturer Centrifuge samples containing precipitates before performing the assay CE Stability 1415 7 days at 15 25 C Choleste
45. itare possibili carry over sono disponibili tramite cobas link senza che sia necessario effettuare inserimenti manuali necessario implementare la procedura di extralavaggio qualora richiesta prima di riportare i risultati di questo test Limiti ed intervalli Intervallo di misura 0 1 20 7 mmol L 3 86 800 mg dL Determinare i campioni con concentrazioni pi alte mediante la funzione rerun La diluizione dei campioni mediante la funzione rerun avviene nel rapporto 1 10 risultati ottenuti con i campioni diluiti mediante la funzione rerun vengono automaticamente moltiplicati per il fattore 10 Sistemi cobas c 2 3 2010 03 V 7 Italiano 03039773190V7 CHOL2 Cholesterol Gen 2 Limiti inferiori di misura Limite di sensibilita inferiore del test 0 1 mmol L 3 86 mg dL Il limite di sensibilit inferiore rappresenta la minima concentrazione misurabile dell analita che pu essere distinta dallo zero Viene calcolato come il valore che si trova 3 deviazioni standard al di sopra dello standard pi basso standard 1 3 DS ripetibilit n 21 Valori di riferimento Interpretazione clinica secondo le raccomandazioni della European Atherosclerosis Society 20 mmol L mg dL Disturbi nel metabolismo lipidico Colesterolo lt 5 2 lt 200 Trigliceridi 23 lt 200 9 S se il colesterolo HDL Colesterolo 52 78 200 300 09 mmol L lt 35 mg dL Colesterolo gt 7 8 gt 300 si Trigliceridi gt 2 3 gt 200 Racc
46. labeling and will be free from defects in material and workmanship until the expiration date printed on the label THIS LIMITED WARRANTY IS IN LIEU OF ANY OTHER WARRANTY EXPRESS OR IMPLIED INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR PARTICULAR PURPOSE IN NO EVENT SHALL ROCHE DIAGNOSTICS BE LIABLE FOR INCIDENTAL INDIRECT SPECIAL OR CONSEQUENTIAL DAMAGES COBAS COBAS C PRECINORM and PRECIPATH are trademarks of Roche Other brand or product names are trademarks of their respective holders Significant additions or changes are indicated by a change bar in the margin 2010 Roche Diagnostics CE wi Roche Diagnostics GmbH Sandhofer Strasse 116 D 68305 Mannheim www roche com Distribution in USA by Roche Diagnostics Indianapolis IN US Customer Technical Support 1 800 428 2336 2010 03 V 7 English 3 3 cobas c systems 03039773190V7 CHOL2 Cholesterol Gen 2 cobas Die Reagenzien k nnen auf diesen cobas c Systemen verwendet werden Bestellinformation Roche Hitachi cobas c Systeme Cholesterol Gen 2 cobas c 311 cobas c 501 502 400 Tests Best Nr 03039773 190 System ID 07 6726 3 Calibrator f a s 12 x 3 mL Best Nr 10759350 190 Code 401 Calibrator f a s 12 x 3 mL f r USA Best Nr 10759350 360 Code 401 Precinorm U plus 10 x 3 mL Best Nr 12149435 122 Code 300 Precinorm U plus 10 x 3 mL f r USA Best Nr 12149435 160 Code 300 Precipath U plus 10 x 3 mL
47. lizado Armazenamento e estabilidade CHOL2 Validade a 2 8 C Consulte o prazo de validade da embalagem que cont m os reagentes cobas c pack Refrigerado no analisador 4 semanas Diluent NaCl 9 Validade a 2 8 C Consulte o prazo de validade da embalagem que cont m os reagentes cobas c pack Refrigerado no analisador 12 semanas Colheita e prepara o das amostras Para colheita e preparac o das amostras utilize apenas tubos ou cuvetes de amostra apropriados Apenas as amostras indicadas em seguida foram testadas e consideradas aceit veis Soro Plasma Tratado com heparina Li e EDTA Ko N o utilizar citrato oxalato ou fluoreto 1 Podem ser utilizadas amostras colhidas com e sem jejum Os tipos de amostras indicados foram testados usando tubos de colheita de amostras seleccionados e comercialmente dispon veis data do teste i e nem todos os tubos dos diferentes fabricantes dispon veis no mercado foram testados Os sistemas de colheita de amostras de diferentes fabricantes podem por sua vez conter materiais diferentes que em alguns casos podem afectar os resultados dos testes Se 2010 03 V 7 Portugu s 1 3 sistemas cobas c CHOL2 Cholesterol Gen 2 processar amostras em tubos prim rios sistemas de colheita de amostras consulte as instruc es do fabricante dos tubos As amostras que cont m precipitado t m de ser centrifugadas antes da realizac o do ensaio Estabilidade 1415 7
48. llinformation Allgemein bliche Laborausr stung Testdurchf hrung Um eine einwandfreie Funktion des Tests sicherzustellen sind die ger tespezifischen Anweisungen zu befolgen Ger tespezifische Testanweisungen sind im entsprechenden Bedienungshandbuch zu finden F r Arbeitsanleitungen die nicht von Roche validiert wurden wird keine Gew hr bernommen Sie m ssen vom Anwender definiert werden Applikation f r Serum und Plasma cobas c 311 Testdefinition Messart 1 Punkt Reaktionszeit Messpunkte 10 57 Wellenl nge Neben Haupt 700 505 nm Reaktionsrichtung Steigend Einheiten mmol L mg dL g L Reagenzpipettierung Diluens H20 RI 47 uL 93 pL Probenvolumen Probe Probenverd nnung Probe Diluens NaCl Normal 2 uL n Reduziert 2 uL 15 uL 135 uL Erh ht 4 uL cobas c 501 502 Testdefinition Messart 1 Punkt Reaktionszeit Messpunkte 10 70 Wellenl nge Neben Haupt 700 505 nm Reaktionsrichtung Steigend Einheiten mmol L mg dL g L Reagenzpipettierung Diluens H20 RI 47 uL 93 uL Probenvolumen Probe Probenverd nnung Probe Diluens NaCl Normal 2 uL u Reduziert 2 uL 15 uL 135 uL Erh ht 4 uL Kalibration Kalibratoren St H20 S2 C fa s Kalibrationsart Linear Kalibrationsh ufigkeit Zweipunktkalibration nach Reagenzchargenwechsel und wenn Qualit tskontrollverfahren dies erfordern R ckf hrbarkeit Diese Methode wurde nach Abell Kendall 2 sowie mit Isotopenverd nnung Massenspektrometrie standardisiert
49. olesterolo H20 gt colesterolo RCOOH CHOD Colesterolo O2 gt colest 4 en 3 one H202 POD 2 H202 4 AAP fenolo colorante chinoneiminico 4 H20 Lintensita di colore del colorante formatosi amp direttamente proporzionale alla concentrazione di colesterolo Viene determinata misurando l aumento dell assorbanza Reattivi soluzioni pronte all uso R1 Tampone PIPES 225 mmol L pH 6 8 Mg 10 mmol L sodio colato 0 6 mmol L 4 aminofenazone 20 45 mmol L fenolo 212 6 mmol L poliglicoletere di alcol grasso 3 colesterolo esterasi Pseudomonas spec 225 ukat L 21 5 U mL colesterolo ossidasi E coli 27 5 ukat L 20 45 U mL perossidasi rafano 212 5 pkat L 20 75 U mL stabilizzatori conservante Precauzioni e avvertenze Per uso diagnostico in vitro Osservare le precauzioni normalmente adottate nella manipolazione dei reagenti di laboratorio Scheda dati di sicurezza disponibile su richiesta per gli utilizzatori professionali Lo smaltimento di tutti i rifiuti deve avvenire secondo le direttive locali Utilizzo dei reattivi Pronti all uso Conservazione e stabilita CHOL2 Stabilit a 2 8 C Vedere la data di scadenza indicata sull etichetta del contenitore portareagenti cobas c pack In uso e refrigerato a bordo dello strumento 4 settimane Diluent NaCl 9 Stabilit a 2 8 C Vedere la data di scadenza indicata sull etichetta del contenitore portareagenti cobas c pack In
50. omandazioni dell Adult Treatment Panel Panel trattamento adulti del NCEP per le seguenti soglie del cutoff di rischio relative alla popolazione degli Stati Uniti 21 Livello di colesterolo desiderabile lt 5 2 mmol L lt 200 mg dL Colesterolo alto al limite 5 2 6 2 mmol L 200 240 mg dL Colesterolo alto 26 2 mmol L 2240 mg dL Ogni laboratorio deve controllare l applicabilit dei valori di riferimento alla propria popolazione di pazienti e se necessario determinare intervalli di riferimento propri Dati specifici sulla performance del test Qui di seguito sono riportati i dati rappresentativi delle prestazioni sugli analizzatori risultati dei singoli laboratori possono differire da questi Precisione La precisione stata determinata usando campioni umani e controlli eseguiti in base ad un protocollo interno Ripetibilit n 21 precisione intermedia 3 aliquote per serie 1 serie al giorno 21 giorni Sono stati ottenuti i seguenti risultati Ripetibilit Media DS CV mmol L mg dL mmol L mg dL Precinorm U 2 29 88 5 0 02 0 8 1 1 Precipath U 4 74 183 0 04 2 0 9 Siero umano 1 2 85 110 0 03 1 1 1 Siero umano 2 7 39 286 0 05 2 0 7 Precisione Media DS CV intermedia mmol L mg dL mmol L mg dl Precinorm U 2 31 89 3 0 04 1 6 1 6 Precipath U 4 85 188 0 08 3 1 6 Siero umano 3 1 97 76 2 0 03 1 2 1 6 Siero umano 4 7 13 276 0 10 4 1 4 Ripetibilita precisione nella serie
51. omo para diagnosticar y tratar enfermedades con niveles elevados de colesterol o trastornos de los metabolismos lipidico y lipoproteico La determinaci n del colesterol fue descrita por vez primera por Liebermann en 1885 y luego por Burchard en 1889 Segun el principio de Liebermann Burchard el colesterol forma un compuesto verde azulado a partir de carbohidratos polimeros insaturados en un medio en el que estan presentes el cido ac tico el anh drido ac tico y el cido sulf rico concentrado En el m todo de Abell y Kendall que es m s espec fico pero m s complejo desde un punto de vista t cnico se emplean tambi n reactivos c usticos En 1974 Roeschlau y Allain describieron el primer m todo completamente enzim tico Este m todo se basa en la determinaci n de la A4 colestenona tras el desdoblamiento enzim tico del ster de colesterol por la colesterol esterasa despu s de la transformaci n del colesterol por la colesterol oxidasa as como la medici n subsiguiente del per xido de hidr geno formado a trav s de una reacci n de Trinder La optimizaci n del desdoblamiento de los steres gt 99 5 permite la estandarizaci n por est ndares primarios y secundarios y una comparaci n directa con los m todos de referencia de CDC y NIST 1 2 3 4 5 67 89 Las muestras recogidas tras la ingesti n de alimentos pueden dar resultados ligeramente inferiores a las obtenidas en ayunas 10 11 12 El test de colesterol de Roche cumple con
52. peroxydase l eau oxyg n e form e r agit avec le ph nol et l amino 4 ph nazone pour former un d riv color rouge quinone imine CE Esters du cholest rol HO gt cholest rol RCOOH CHOD Cholest rol O2 gt cholest 4 en 3 one H202 2 H20 amino 4 ph nazone POD ph nol gt colorant quinone imine 4 H20 Lintensit du d riv color form est directement proportionnelle au taux de cholest rol Elle est d termin e en mesurant l augmentation de l absorbance R actifs composition et concentrations R1 Tampon PIPES 225 mmol L pH 6 8 Mg 10 mmol L cholate de sodium 0 6 mmol L amino 4 ph nazone gt 0 45 mmol L ph nol gt 12 6 mmol L mono ther d alcool gras de poly thyl ne glycol 3 cholest rol est rase de Pseudomonas gt 25 pkat L gt 1 5 U mL cholest rol oxydase d E coll gt 7 5 ukat L gt 0 45 U mL peroxydase de raifort gt 12 5 pkat L gt 0 75 U mL stabilisateurs conservateur Pr cautions d emploi et mises en garde Pour diagnostic in vitro Observer les pr cautions habituelles de manipulation en laboratoire Fiche de s curit disponible sur demande pour les professionnels L limination de tous les d chets doit tre effectu e conform ment aux dispositions l gales Pr paration des r actifs Les r actifs sont pr ts l emploi Conservation et stabilit CHOL2 Conservation entre 2 et 8 C voir date
53. publication WHO DIL LAB 99 1 Rev 2 Jan 2002 So NO On ze 00 os cobas 16 Siekmann L H skes KP Breuer H 1976 Determination of cholesterol in serum using mass fragmentography a reference method in clinical chemistry Z Anal Chem 279 145 146 17 Glick MR Ryder KW Jackson SA Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation Clin Chem 1986 32 470 475 18 Breuer J Report on the Symposium Drug effects in Clinical Chemistry Methods Eur J Clin Chem Clin Biochem 1996 34 385 386 19 Sonntag O Scholer A Drug interference in clinical chemistry recommendation of drugs and their concentrations to be used in drug interference studies Ann Clin Biochem 2001 38 376 385 20 Study Group European Atherosclerosis Society Strategies for the prevention of coronary heart disease A policy statement of the European Atherosclerosis Society European Heart Journal 1987 8 77 21 Third Report of the National Cholesterol Education Program NCEP Expert Panel on Detection Evaluation and Treatment of High Blood Cholesterol in Adults Adult Treatment Panel III NIH Publication No 01 3670 May 2001 22 Passing H Bablok W et al A General Regression Procedure for Method Transformation J Clin Chem Clin Biochem 1988 26 783 790 FOR US CUSTOMERS ONLY LIMITED WARRANTY Roche Diagnostics warrants that this product will meet the specifications stated in the labeling when used in accordance with such
54. r 1995 2 Liebermann C Ber Dtsch chem Ges 1885 18 1803 Burchard H Beitr ge zur Kenntnis der Cholesterine Dissertation Rostock 1889 Abell L et al Standard Methods in Clinical Chemistry 1958 26 2 Allain CC et al Clin Chem 1974 20 470 Roeschlau P et al Z Klin Chem Klin Biochem 1974 12 226 Trinder P Ann Clin Biochem 1969 6 24 Siedel J Hagele EO Ziegenhorn J et al Clin Chem 1983 29 1075 Wiebe DA Bernert JT Clin Chem 1984 30 352 Cohn JS McNamara JR Schaefer EJ Lipoprotein Cholesterol Concentrations in the Plasma of Human Subjects as Measured in the Fed and Fasted States Clin Chem 1988 34 2456 2459 11 Pisani T Gebski CP Leary ET et al Accurate Direct Determination of Low density Lipoprotein Cholesterol Using an Immunoseparation Reagent and Enzymatic Cholesterol Assay Arch Pathol Lab Med 1995 119 1127 12 Recommendations for Improving Cholesterol Measurement A Report from the Laboratory Standardization Panel of the National Cholesterol Education Program NIH Publication No 90 2964 February 1990 13 Nader R Dufour DR Cooper GR Preanalytical Variation in Lipid Lipoprotein and Apolipoprotein Testing In Rifai N Warnick GR and Dominiczak MH editors Handbook of Lipoprotein Testing 2nd ed Washington AACC press p 176 14 Tietz NW ed Clinical Guide to Laboratory Tests 3 ed Philadelphia PA WB Saunders Company 1995 130 131 15 Use of Anticoagulants in Diagnostic Laboratory Investigations WHO
55. rd em 1889 Na reac o Liebermann Burchard o colesterol forma um corante azul esverdeado a partir de hidratos de carbono polim ricos n o saturados num meio de cido ac tico anididro ac tico cido sulf rico concentrado O m todo de Abell e Kendall espec fico do colesterol mas tecnicamente complexo e exige o uso de reagentes corrosivos Em 1974 Roeschlau e Allain descreveram o primeiro m todo totalmente enzim tico Este m todo baseia se na determina o da A4 colestenona ap s clivagem enzim tica do ster de colesterol pela colesterol esterase a convers o do colesterol pela colesterol oxidase e a subsequente determina o do per xido de hidrog nio formado utilizando a reac o de Trinder A optimiza o da clivagem do ster gt 99 5 permite a padroniza o utilizando padr es prim rios e secund rios e uma compara o directa com os m todos de refer ncia do CDC e do NIST 1 2 34 5 67 8 9 Os resultados obtidos com amostras que n o foram colhidas em jejum podem ser ligeiramente mais baixos do que os resultados obtidos em amostras que foram colhidas em jejum 10 11 12 O doseamento do colesterol da Roche cumpre o requisito de 1992 do National Institutes of Health NIH com precis o e desvio inferior ou igual a 3 2 O ensaio tamb m pode ser padronizado contra Abell Kendall e dilui o de is topos espectrometria de massas As afirma es e os dados relativos ao desempenho aqui apresentados s o independente
56. rol esters H20 gt cholesterol RCOOH 7 days at 2 8 C CHOD 3 months at 15 25 C 2010 03 V 7 English 1 3 cobas c systems CHOL2 Cholesterol Gen 2 Materials provided See Reagents working solutions section for reagents Materials required but not provided See Order information section General laboratory equipment Assay For optimum performance of the assay follow the directions given in this document for the analyzer concerned Refer to the appropriate operator s manual for analyzer specific assay instructions The performance of applications not validated by Roche is not warranted and must be defined by the user Application for serum and plasma cobas c 311 test definition Assay type Reaction time Assay points Wavelength sub main Reaction direction Units Reagent pipetting R1 Sample volumes Normal Decreased Increased 1 Point 10 57 700 505 nm Increase mmol L mg dL g L Diluent H20 47 uL 93 uL Sample Sample dilution Sample Diluent NaCl 2 uL 2 uL 15 uL 135 uL 4 uL cobas c 501 502 test definition Assay type Reaction time Assay points Wavelength sub main Reaction direction Units Reagent pipetting R1 Sample volumes Normal Decreased Increased Calibration Calibrators Calibration mode Calibration frequency 1 Point 10 70 700 505 nm Increase mmol L mg dL g L Diluent H20 47 uL 93 pL Sample Sample dilution S
57. s CE sl Roche Diagnostics GmbH Sandhofer Strasse 116 D 68305 Mannheim www roche com 2010 04 V 7 Deutsch 3 3 cobas c Systeme 03039773190V7 CHOL2 Cholesterol Gen 2 cobas R actifs utilisables sur les syst mes cobas c suivants R f rences de commande Cholesterol Gen 2 400 tests Calibrator f a s 12 x 3 mL Calibrator f a s 12 x 3 mL pour les USA Precinorm U plus 10 x 3 mL Precinorm U plus 10 x 3 mL pour les USA Precipath U plus 10 x 3 mL Precipath U plus 10 x 3 mL pour les USA Precinorm U 20 x 5 mL Precipath U 20 x 5 mL Precinorm L 4 x 3 mL Precipath L 4 x 3 mL Diluent NaCl 9 50 mL R f 03039773 190 R f 10759350 190 R f 10759350 360 R f 12149435 122 R f 12149435 160 R f 12149443 122 R f 12149443 160 R f 10171743 122 R f 10171778 122 R f 10781827 122 R f 11285874 122 R f 04489357 190 Systemes Roche Hitachi cobas c cobas c 311 cobas c 501 502 System ID 07 6726 3 y i Code 401 Code 401 Code 300 Code 300 Code 301 Code 301 Code 300 Code 301 Code 304 Code 305 System ID 07 6869 3 Francais Informations techniques Pour les analyseurs cobas c 311 501 CHO2I ACN 798 Standardisation DI SM CHO2A ACN 433 Standardisation Abell Kendall Pour Panalyseur cobas c 502 CHO2I ACN 8798 Standardisation DI SM CHO2A ACN 8433 Standardisation Abell Kendall Domaine d utilisation Test in vitro pour la d
58. s da padroniza o Princ pio do teste M todo colorim trico enzim tico Os steres de colesterol s o clivados atrav s da ac o da colesterol esterase e produzem colesterol livre e cidos gordos A colesterol oxidase catalisa a oxida o do colesterol para colest 4 en 3 ona e per xido de hidrog nio Em presen a da peroxidase o per xido de hidrog nio formado afecta o acoplamento oxidativo do fenol e da 4 aminoantipirina formando um corante vermelho de quinona imina 2 H20 4 AAP fenol gt corante quinona imina 4 H20 A intensidade da cor do corante formado directamente proporcional concentra o de colesterol E determinada medindo o aumento da absorv ncia Reagentes solu es de trabalho R1 Tamp o PIPES 225 mmol L pH 6 8 Mg 10 mmol L colato de s dio 0 6 mmol L 4 aminofenazona gt 0 45 mmol L fenol gt 12 6 mmol L lcool gordo de poliglicol ter 3 colesterol esterase Pseudomonas spec gt 25 ukat L gt 1 5 U mL colesterol oxidase E coli gt 7 5 ukat L gt 0 45 U mL peroxidase r bano gt 12 5 ukat L gt 0 75 U mL estabilizantes conservante Avisos e precau es Para utiliza o em diagn stico in vitro Respeite as precau es normais de manuseamento de reagentes laboratoriais Ficha de seguran a fornecida a pedido para uso profissional Elimine todos os res duos de acordo com os regulamentos locais Prepara o dos reagentes Pronto a ser uti
59. s informa es consulte o manual do operador Analisador cobas c 502 As instru es especiais de lavagem necess rias para evitar a carry over contamina o est o dispon veis via cobas link N o necess rio introduzir dados manualmente Onde requerido a programa o de lavagem especial carry over arrastamento deve ser implementada antes de reportar os resultados deste teste Limites e intervalos Intervalo de medi o 0 1 20 7 mmol L 3 86 800 mg dL Determine as amostras com concentra es superiores atrav s da fun o de rean lise A amostras s o diluidas de 1 10 atrav s da fun o de rean lise Os resultados obtidos em amostras dilu das atrav s da fun o de rean lise s o multiplicados automaticamente pelo factor 10 Limites inferiores de medi o Limite inferior de detec o do teste 0 1 mmol L 3 86 mg dL O limite de detec o inferior representa o n vel de analito mais baixo mensur vel pass vel de ser distinguido de zero E calculado como o valor situado tr s desvios padr o DP acima do padr o mais baixo padr o 1 3 DP reprodutibilidade n 21 sistemas cobas c 213 2010 03 V 7 Portugu s 03039773190V7 CHOL2 Cholesterol Gen 2 Valores de refer ncia Interpreta o cl nica feita de acordo com as recomenda es da Sociedade Europeia de Aterosclerose 20 mmol L mg dL Altera es do metabolismo Colesterol lt 52 lt 200 pesos Triglic ridos lt 23 lt 200 a Sim
60. s les fiches de m thodes NaOHD SMS Multiclean SCCS ou NaOHD SMS SmpCin1 2 SCCS Pour de plus amples instructions se r f rer au manuel de l utilisateur Analyseur cobas c 502 toutes les programmations de lavages sp ciaux pour la pr vention des contaminations se font via cobas link Aucune entr e manuelle n est n cessaire Le cas ch ant la programmation des lavages sp ciaux de pr vention des contaminations doit tre impl ment e avant d effectuer le rapport de ce test Limites et intervalles Domaine de mesure 0 1 20 7 mmol L 3 86 800 mg dL Les chantillons dont les concentrations sont plus lev es sont d termin s via la fonction R analyse Le rapport de dilution des chantillons avec la fonction R analyse est 1 10 Les r sultats des chantillons dilu s pour la r analyse sont automatiquement multipli s par le facteur 10 Limites inf rieures de mesure Limite inf rieure de d tection du test 0 1 mmol L 3 86 mg dL La limite inf rieure de d tection correspond au plus faible taux d analyte mesurable pouvant tre distingu de z ro Elle est obtenue par le calcul et correspond a la valeur situ e 3 carts type au dessus du taux le plus faible de la gamme de standards standard 1 3SD r p tabilit n 21 Syst mes cobas c 2 3 2010 04 V 7 Fran ais 03039773190V7 CHOL2 Cholesterol Gen 2 Valeurs de r f rence Interpretation clinique d apr s les recommandations de la Soci t
61. sa Pseudomonas spec gt 25 ukat L gt 1 5 U mL colesterol oxidasa E coli gt 7 5 pkat L gt 0 45 U mL peroxidasa r bano picante gt 12 5 ykat L gt 0 75 U mL estabilizadores conservante Medidas de precauci n y advertencias Para el uso diagn stico in vitro Observar las medidas de precauci n usuales para la manipulaci n de reactivos Ficha de datos de seguridad a la disposici n del usuario profesional que la solicite Eliminar los residuos seg n las normas locales vigentes Preparaci n de los reactivos El contenido est listo para el uso Conservaci n y estabilidad CHOL2 Sin abrir a 2 8 C ver la fecha de caducidad indicada en la etiqueta del cobas c pack En uso y refrigerado en el analizador 4 semanas Diluyente NaCl al 9 Sin abrir a 2 8 C ver la fecha de caducidad indicada en la etiqueta del cobas c pack En uso y refrigerado en el analizador 12 semanas Obtenci n y preparaci n de las muestras Emplear nicamente tubos o recipientes adecuados para recoger y preparar las muestras S lo se han analizado y encontrado aptas las muestras aqu mencionadas Suero Plasma tratado con heparina de litio y EDTA bipot sico No emplear plasma con citrato oxalato o fluoruro 13 Se puede emplear muestras recogidas en ayunas o despu s de comer Los diferentes tipos de muestra fueron analizados en tubos de recogida de muestras seleccionados comercialmente disponibles en aquel
62. sterol Using an Immunoseparation Reagent and Enzymatic Cholesterol Assay Arch Pathol Lab Med 1995 119 1127 12 Recommendations for Improving Cholesterol Measurement A Report from the Laboratory Standardization Panel of the National Cholesterol Education Program NIH Publication No 90 2964 febbraio 1990 13 Nader R Dufour DR Cooper GR Preanalytical Variation in Lipid Lipoprotein and Apolipoprotein Testing In Rifai N Warnick GR e Dominiczak MH editori Handbook of Lipoprotein Testing 28 ed Washington AACC press p 176 14 Tietz NW ed Clinical Guide to Laboratory Tests 32 ed Philadelphia PA WB Saunders Company 1995 130 131 15 Use of Anticoagulants in Diagnostic Laboratory Investigations WHO publication WHO DIL LAB 99 1 Rev 2 Gen 2002 16 Siekmann L H skes KP Breuer H 1976 Determination of cholesterol in serum using mass fragmentography a reference method in clinical chemistry Z Anal Chem 279 145 146 17 Glick MR Ryder KW Jackson SA Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation Clin Chem 1986 32 470 475 18 Breuer J Report on the Symposium Drug effects in Clinical Chemistry Methods Eur J Clin Chem Clin Biochem 1996 34 385 386 19 Sonntag O Scholer A Drug interference in clinical chemistry recommendation of drugs and their concentrations to be used in drug interference studies Ann Clin Biochem 2001 38 376 385 20 Study Group European Atherosclerosis Soc
63. stics CE sil Roche Diagnostics GmbH Sandhofer Strasse 116 D 68305 Mannheim www roche com 2010 04 V 7 Espa ol 3 3 sistemas cobas c 03039773190V7 CHOL2 Cholesterol Gen 2 cobas e Indica i sistemi cobas c su cui i reattivi possono essere usati Informazioni per ordini Sistemi Roche Hitachi cobas c Cholesterol Gen 2 cobas c 311 cobas c 501 502 400 test Art n 03039773 190 N d ident 07 6726 3 s i Calibrator f a s 12 x 3 mL Art n 10759350 190 Codice 401 Calibrator f a s 12 x 3 mL per gli USA Art n 10759350 360 Codice 401 Precinorm U plus 10 x 3 mL Art n 12149435 122 Codice 300 Precinorm U plus 10 x 3 mL per gli USA Art n 12149435 160 Codice 300 Precipath U plus 10 x 3 mL Art n 12149443 122 Codice 301 Precipath U plus 10 x 3 mL per gli USA Art n 12149443 160 Codice 301 Precinorm U 20 x 5 mL Art n 10171743 122 Codice 300 Precipath U 20 x 5 mL Art n 10171778 122 Codice 301 Precinorm L 4 x 3 mL Art n 10781827 122 Codice 304 Precipath L 4 x 3 mL Art n 11285874 122 Codice 305 Diluent NaCl 9 50 mL Art n 04489357 190 N d ident 07 6869 3 Italiano Principio del test Informazioni relative al sistema Per gli analizzatori cobas c 311 501 CHO2I ACN 798 standardizzazione contro l ID MS CHO2A ACN 433 standardizzazione contro Abell Kendall Per l analizzatore cobas c 502 CHO2I ACN 8798 standardizzazione contro l ID MS CHO2A ACN 8433
64. t doivent tre centrifug s avant l analyse Stabilit 1415 7 jours entre 15 et 25 C 7 jours entre 2 et 8 C 3 mois entre 15 et 25 C Mat riel fourni Voir paragraphe R actifs composition et concentrations Mat riel auxiliaire n cessaire Voir section R f rences de commande Equipement habituel de laboratoire R alisation du test Pour garantir le bon fonctionnement du test se conformer aux instructions relatives l analyseur utilis indiqu es dans la pr sente notice Pour les instructions sp cifiques de l analyseur se r f rer au manuel d utilisation appropri En cas d utilisation de tests non valid s par Roche les performances analytiques ne sont pas garanties et doivent tre d finies par l utilisateur Application pour le s rum et le plasma cobas c 311 D finition du test Mode de mesure 1 Point Temps dosage points de mesure 10 57 Longueur d ondes sec princ 700 505 nm Sens de la r action Croissant Unit s mmol L mg dL g L Pipetage des r actifs Diluant H20 RI 47 uL 93 pL Volumes chantillon Echantillon Dilution chantillon Echantillon Diluant NaCl Normal 2 uL E Diminu 2 uL 15 uL 135 pL Augment 4 uL cobas c 501 502 D finition du test Mode de mesure 1 Point Temps dosage points de mesure 10 70 Longueur d ondes sec princ 700 505 nm Sens de la r action Croissant Unit s mmol L mg dL g L Diluant H20 93 uL Pipetage des
65. termination quantitative du cholest rol dans le s rum et le plasma humains sur les systemes Roche Hitachi cobas c Caract ristiques Le cholest rol est un st roide poss dant un groupe hydroxyle secondaire en position C3 Il est synth tis dans de nombreux tissus en particulier dans le foie et la paroi intestinale Environ les trois quarts du cholest rol sont synth tis s dans l organisme un quart est apport par l alimentation Les dosages de cholest rol sont utilis s pour le d pistage d un risque d ath roscl rose ainsi que pour le diagnostic et le traitement de maladies avec taux de cholest rol lev et de troubles du m tabolisme des lipides et des lipoprot ines La premiere m thode de dosage du cholest rol a t d crite par Liebermann en 1885 et par la suite par Burchard en 1889 Dans la r action de Liebermann Burchard le cholest rol donne en pr sence d acide ac tique d anhydride ac tique et d acide sulfurique concentr des d riv s color s bleu vert constitu s d hydrocarbures insatur s polym ris s La m thode d Abell et Kendall est sp cifique du cholest rol mais techniquement complexe et n cessite l utilisation de r actifs corrosifs En 1974 Roeschlau et Allain ont d crit la premi re m thode enti rement enzymatique de dosage du cholest rol La m thode d crite ci dessous repose sur le dosage de la A4 cholestenone form e par l hydrolyse enzymatique des esters du cholest rol par la
66. th U plus 10 x 3 mL para los EE UU Precinorm U 20 x 5 mL Precipath U 20 x 5 mL Precinorm L 4 x 3 mL Precipath L 4 x 3 mL Diluent NaCl 9 50 mL Ref 03039773 190 Ref 10759350 190 Ref 10759350 360 Ref 12149435 122 Ref 12149435 160 Ref 12149443 122 Ref 12149443 160 Ref 10171743 122 Ref 10171778 122 Ref 10781827 122 Ref 11285874 122 Ref 04489357 190 sistemas Roche Hitachi cobas c cobas c 311 cobas c 501 502 ID 07 6726 3 C digo 401 C digo 401 C digo 300 C digo 300 C digo 301 C digo 301 C digo 300 C digo 301 C digo 304 C digo 305 ID 07 6869 3 Espanol Informaci n del sistema Analizadores cobas c 311 501 CHO2I ACN 798 Estandarizaci n DI EM CHO2A ACN 433 Estandarizaci n segun Abell Kendall Analizador cobas c 502 CHO2I ACN 8798 Estandarizaci n DI EM CHO2A ACN 8433 Estandarizaci n seg n Abell Kendall Uso previsto Prueba in vitro para la determinaci n cuantitativa del colesterol en suero y plasma humanos en los sistemas Roche Hitachi cobas c Caracteristicas El colesterol es un esteroide con un grupo hidroxilo secundario en la posici n C3 Se sintetiza en tejidos de varios tipos pero especialmente en el higado y en la pared intestinal Aprox tres cuartos del colesterol se forman por sintesis mientras que el cuarto restante proviene de la alimentaci n La determinaci n del colesterol se emplea para cribar el riesgo ater geno asi c
67. tspricht der Tr bung und der Triglyceridkonzentration Medikamente In therapeutischen Konzentrationen wurde bei blichen Medikamenten Panels keine St rung gefunden 8 9 In sehr seltenen F llen kann eine Gammopathie insbesondere vom Typ IgM Waldenstr m Makroglobulin mie zu unzuverl ssigen Ergebnissen f hren F r diagnostische Zwecke sind die Ergebnisse stets im Zusammenhang mit der Patientenvorgeschichte der klinischen Untersuchung und anderen Untersuchungsergebnissen zu werten WICHTIGER HINWEIS Spezielle Waschprogrammierung Spezielle Waschschritte sind zwingend erforderlich wenn auf Roche Hitachi cobas c Systemen bestimmte Testkombinationen zusammen durchgef hrt werden Die neueste Version der Carry over evasion list ist auch in den NaOHD SMS Multiclean SCCS oder NaOHD SMS SmpCln1 2 SCCS Methodenbl ttern enthalten Weitere Anweisungen siehe Bedienerhandbuch cobas c 502 Ger t Die zur Vermeidung von Verschleppungen notwendigen speziellen Waschprogrammierungen sind ber den cobas link erh ltlich Eine manuelle Eingabe ist nicht erforderlich Gegebenenfalls muss ein spezielles Waschprogramm zur Vermeidung von Verschleppungen vor Ausgabe der Ergebnisse dieses Tests definiert werden Grenzen und Bereiche Messbereich 0 1 20 7 mmol L 3 86 800 mg dL Proben mit h heren Konzentrationen ber die Rerun Funktion bestimmen Bei der Rerun Funktion werden diese Proben 1 10 verd nnt Die Ergebnisse von Proben die d
68. uide to Laboratory Tests 31 ed Philadelphia PA WB Saunders Company 1995 130 131 Use of Anticoagulants in Diagnostic Laboratory Investigations WHO publication WHO DIL LAB 99 1 Rev 2 Jan 2002 Siekmann L H skes KP Breuer H 1976 Determination of cholesterol in serum using mass fragmentography a reference method in clinical chemistry Z Anal Chem 279 145 146 Glick MR Ryder KW Jackson SA Graphical Comparisons of Interferences in Clinical Chemistry Instrumentation Clin Chem 1986 32 470 475 Breuer J Report on the Symposium Drug effects in Clinical Chemistry Methods Eur J Clin Chem Clin Biochem 1996 34 385 386 Sonntag O Scholer A Drug interference in clinical chemistry recommendation of drugs and their concentrations to be used in drug interference studies Ann Clin Biochem 2001 38 376 385 Study Group European Atherosclerosis Society Strategies for the prevention of coronary heart disease A policy statement of the European Atherosclerosis Society European Heart Journal 1987 8 77 Third Report of the National Cholesterol Education Program NCEP Expert Panel on Detection Evaluation and Treatment of High Blood Cholesterol in Adults Adult Treatment Panel III NIH Publication No 01 3670 May 2001 Passing H Bablok W et al A General Regression Procedure for Method Transformation J Clin Chem Clin Biochem 1988 26 783 790 La barra del margen indica cambios o suplementos significativos 2010 Roche Diagno
69. uma interfer ncia significativa at a um indice de 16 para bilirrubina conjugada e de 14 para bilirrubina n o conjugada concentra o aproximada de bilirrubina conjugada 274 umol L ou 16 mg dL concentra o aproximada de bilirrubina n o conjugada 239 mol L ou 14 mg dL Hem lise Nenhuma interfer ncia significativa at um ndice H de 700 concentra o aproximada de hemoglobina 435 umol L 700 mg dL Lipemia Intralipid Nenhuma interfer ncia significativa at um ndice L de 2000 Existe uma correlac o fraca entre o ndice L corresponde a turbidez e a concentrac o de triglic ridos F rmacos N o se encontrou qualquer interfer ncia com concentrac es terap uticas utilizando pain is de f rmacos comuns 18 19 Em casos muito raros a gamapatia em particular a de tipo IgM macroglobulinemia de Waldenstroem pode produzir resultados pouco fi veis Quando o objectivo o diagn stico os resultados devem ser sempre interpretados em conjunto com a hist ria cl nica do paciente o exame cl nico e outros resultados AC O NECESS RIA Programa o de lavagem especial E obrigat ria a utiliza o de ciclos de lavagem suplementares sempre que determinadas combina es de testes sejam executadas em conjunto nos sistemas Roche Hitachi cobas c Consulte a vers o mais recente da lista de carry over arrastamento que se encontra na Folha de M todos NaOHD SMS Multiclean SCCS ou NaOHD SMS SmpCin1 2 SCCS Para mai
70. urch die Rerun Funktion verd nnt wurden werden automatisch mit dem Faktor 10 multipliziert Untere Messgrenzen Untere Nachweisgrenze des Tests 0 1 mmol L 3 86 mg dL Die untere Nachweisgrenze entspricht der niedrigsten messbaren Analytkonzentration die von Null unterschieden werden kann Sie ist berechnet als die Konzentration die drei Standardabweichungen oberhalb des niedrigsten Standards liegt Standard 1 3 SD Wiederholprazision n 21 cobas c Systeme 2 3 2010 04 V 7 Deutsch 03039773190V7 CHOL2 Cholesterol Gen 2 Referenzwerte Klinische Interpretation nach den Empfehlungen der Europ ischen Atherosklerose Gesellschaft 20 mmol L mg dL Lipidstoffwechselst rung Cholesterin lt 5 2 lt 200 Nein Triglyceride lt 23 lt 200 5 HDL Cholesteri Cholesterin 5278 200300 23 mmoll mL Cholesterin gt 7 8 gt 300 y Triglyceride gt 2 3 gt 200 i Empfehlungen des NCEP Adult Treatment Panel f r folgende Risiko Cutoff Bereiche f r die US amerikanische Bev lkerung Idealbereich von Cholesterin lt 5 2 mmol L lt 200 mg dL Grenzwertig hohes Cholesterin 5 2 6 2 mmol L 200 240 mg dL Hohes Cholesterin gt 6 2 mmol L gt 240 mg dL Jedes Labor sollte die bertragbarkeit der Referenzbereiche f r die eigenen Patientengruppen berpr fen und gegebenenfalls selbst ermitteln Spezifische Leistungsdaten des Tests Nachstehend werden repr sentative Leistungsdaten der Analysenger te aufgezei
71. uso e refrigerato a bordo dello strumento 12 settimane 2010 03 V 7 Italiano 1 3 Sistemi cobas c CHOL2 Cholesterol Gen 2 Prelievo e preparazione dei campioni Per il prelievo e la preparazione dei campioni impiegare solo provette o contenitori di raccolta adatti Solo i tipi di campione elencati di seguito sono stati testati e risultano accettabili Siero Plasma plasma con litio eparina e K gt EDTA Non impiegare citrato ossalato o fluoruro 3 Si possono utilizzare campioni prelevati da soggetti a digiuno e non a digiuno tipi di campione elencati sono stati testati impiegando una selezione di provette per il prelievo di campioni disponibili in commercio al momento dell analisi non sono quindi state testate tutte le provette disponibili di tutte le case produttrici Alcuni sistemi per il prelievo di campioni di vari produttori possono contenere diversi materiali e in alcuni casi possono interferire sui risultati del test Quando si trattano i campioni in provette primarie sistemi per il prelievo di campioni seguire le istruzioni del produttore delle provette campioni contenenti precipitati devono essere centrifugati prima dell esecuzione del test Stabilit 1415 7 giorni a 15 25 C 7 giorni a 2 8 C 3 mesi a 15 25 C Materiali a disposizione Per i reattivi vedere la sezione Reattivi soluzioni pronte all uso Materiali necessari ma non forniti Vedere la sezione Informazioni per or
72. via the rerun function is a 1 10 dilution Results from samples diluted by the rerun function are automatically multiplied by a factor of 10 Lower limits of measurement Lower detection limit of the test 0 1 mmol L 3 86 mg dL The lower detection limit represents the lowest measurable analyte level that can be distinguished from zero It is calculated as the value lying three standard deviations above that of the lowest standard standard 1 3 SD repeatability n 21 Expected values Clinical interpretation according to the recommendations of the European Atherosclerosis Society 20 mmol L mg dL Lipid metabolic disorder Cholesterol lt 52 lt 200 N Triglycerides lt 2 3 lt 200 g Yes if HDL cholesterol Cholesterol 5 2 7 8 200 300 lt 0 9 mmol L lt 35 mg dL Cholesterol gt 78 gt 300 vi Triglycerides gt 23 gt 200 gt Recommendations of the NCEP Adult Treatment Panel for the following risk cutoff thresholds for the US American population Desirable cholesterol level lt 5 2 mmol L lt 200 mg dL Borderline high cholesterol 5 2 6 2 mmol L 200 240 mg dL High cholesterol gt 6 2 mmol L 2 240 mg dL cobas c systems 2 3 2010 03 V 7 English 03039773190V7 CHOL2 Cholesterol Gen 2 Each laboratory should investigate the transferability of the expected values to its own patient population and if necessary determine its own reference ranges Specific performance data Representative perform
73. y hydroxyl group in the C3 position It is synthesized in many types of tissue but particularly in the liver and intestinal wall Approximately three quarters of cholesterol is newly synthesized and a quarter originates from dietary intake Cholesterol assays are used for screening for atherosclerotic risk and in the diagnosis and treatment of disorders involving elevated cholesterol levels as well as lipid and lipoprotein metabolic disorders Cholesterol analysis was first reported by Liebermann in 1885 followed by Burchard in 1889 In the Liebermann Burchard reaction cholesterol forms a blue green dye from polymeric unsaturated carbohydrates in an acetic acid acetic anhydride concentrated sulfuric acid medium The Abell and Kendall method is specific for cholesterol but is technically complex and requires the use of corrosive reagents In 1974 Roeschlau and Allain described the first fully enzymatic method This method is based on the determination of A4 cholestenone after enzymatic cleavage of the cholesterol ester by cholesterol esterase conversion of cholesterol by cholesterol oxidase and subsequent measurement by the Trinder reaction of the hydrogen peroxide formed Optimization of ester cleavage gt 99 5 allows standardization using primary and secondary standards and a direct comparison with the CDC and NIST reference methods 2 3 45 6 7 8 9 Nonfasting sample results may be slightly lower than fasting results 10 11 12 The Roche c

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