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Siemens 2000 manual

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Table of contents for the manual

  • Page 1

    Siemens Medical Solutions Diagnostics Homocysteine[...]

  • Page 2

    IMMULITE ® 2000 Homocysteine 2 IMMULITE 2000 Ho mocysteine (PIL2 KHO-14, 2007-11- 20) English Inte nded Use: For in vitro diagnostic use with the IMMULITE 2000 Analyzer — for the quantitative determination of L-homocysteine in human plasma or serum. This device can assist in the diagnosis and treatment of patients suspected of having hyperhomocy[...]

  • Page 3

    IMMULITE 2000 Ho mocysteine (PIL2 KHO-14, 2007-11- 20) 3 synthesis of HCY will take place in red blood cells after sampling. Samples should be stored on i ce between the time of sampling an d centrifugation. Note that storage on ice makes the use of serum samples particularly difficult. The use of an ultracentrifuge is recommended to clear lipemic [...]

  • Page 4

    4 IMMULITE 2000 Ho mocysteine (PIL2 KHO-14, 2007-11- 20) Storage: 30 days (after opening) at 2–8°C or 6 months (aliquotted) at –20°C. Barcode labels are provided for use with the diluent. Before use, place an appropriate label on a 16 × 100 mm test tube, so that the barcodes can be read by the on-board reader. L2HOZ: 3 labels L2SUBM: Chemilu[...]

  • Page 5

    IMMULITE 2000 Ho mocysteine (PIL2 KHO-14, 2007-11- 20) 5 The assay is traceable to an internal standard manufactured using qualified materials and measurement procedures. Analytical Sensitivity: 0.5 µmol/L Precision: Samples were repeatedly assayed in quadruplicate over the course of several days, for a total of 20 runs and 80 replicates. (See &qu[...]

  • Page 6

    6 IMMULITE 2000 Ho mocysteine (PIL2 KHO-14, 2007-11- 20) factor for vascular disea se. New Eng J Med 1991;324:1149-55. 5) Deloughe ry TG, Evans A, Sadeghi A,et al. Common muta tion in methylenetetrahydrofola te reductase: Correlation with homocy steine metabolism and late - onset va scul a r dise ase. Ci rc ulat i on 1996;94:3074-78. 6) Bo stom AG,[...]

  • Page 7

    IMMULITE 2000 Ho mocysteine (PIL2 KHO-14, 2007-11- 20) 7 Solution 1 Observed 2 Expected 3 %O/E 4 4 — 20.2 — — A 27.7 25.4 109% B 33.0 31.7 104% C 44.5 44.2 101% Method Comparison 1 Kit A, µmol /L 0 10 20 30 40 IMMULITE 2000 Homocysteine 0 10 20 30 40 (IML 2000) = 1.0 ( Kit A) + 0.0 24 µmol/L r = 0.966 Method Comparison 2 HPLC, µmol/L 0 10 [...]

  • Page 8

    8 IMMULITE 20 00 Homocysteine (PIL2K HO-14, 2007-11-20) Graph 3: Serum Deutsch. Precision : 1 Intra-Assay, 2 Ges amt, 3 Mittelw ert, 4 S (Standardabweichung), 5 CV (Variationskoeffizient). Linearity : 1 Verdünnung, 2 Beobachtet (B), 3 E rwartet (E), 4 % B/E, 5 8 in 8. Recovery : 1 Probe, 2 Beobachtet (B) , 3 Erwart et (E), 4 % B/E. Specificity : 1[...]

  • Page 9

    IMMULITE 20 00 Homocysteine (PIL2K H O-14, 2007-11-20) 9 Es hat sich herausgestellt, dass Homocystein ein Indikator kardiovaskulärer Erkrankungen ist. Eine Metaanalyse 27 epidemiologischer Studien zeigte, dass eine Erhöhung der Homocystein-Konzentration um 5 µmol/l das Risiko für kardiovaskulare Erkrankungen bei Männer 1,6-fach und bei Frauen [...]

  • Page 10

    10 IMMULITE 20 00 Homocysteine (PIL2K H O-14, 2007-11-20) Reagenzien: Bei einer Temperatur von 2–8°C lagern. Gemäß der anwendbaren Vorschriften verwerfen. Die allgemein gültigen Vorsichtsmaßnahmen sind zu beachten und alle Komponenten als potentiell infektiöses Material zu behandeln. In diesem Testbesteck enthaltenen Reagenzien humanen Ursp[...]

  • Page 11

    IMMULITE 20 00 Homocysteine (PIL2K H O-14, 2007-11-20) 11 Ebenfalls benötigt Destilliertes bzw. deionisiertes Wasser; Teströhrchen, Kontrollen. Testdurchführung Für eine optimale Funktion des Gerätes ist unbedingt zu beachten, dass die Wartungen, wie im IMMULITE 2000- Handbuch beschrieben, regelmäßig durchgeführt werden. Hinweise zur Vorber[...]

  • Page 12

    12 IMMULITE 20 00 Homocysteine (PIL2K H O-14, 2007-11-20) 20 Läufen mit 80 Bestimmungen. (Siehe "Precision" Tabelle.) Linearität: Proben wurden in verschiedenen Verdünnungen getestet. (Repräsentative Daten entnehmen Sie bitte der Tabelle „Linearity“.) Wiederf indung: Proben w urden mit drei Lösungen (125, 250 und 500 µmol/l) im [...]

  • Page 13

    IMMULITE 20 00 Homocysteine (PIL2K H O-14, 2007-11-20) 13 Español Homocisteína Utilidad del Test: Para el diagnó stico in vitro usado con el Analizador IMMULITE 2000, para la medición cuantativa de L-homocisteína en suero humano o plasma. Este kit no está pensado para el diagnóstico y tratamiento de los pacientes que tengan hiperhomocistinem[...]

  • Page 14

    14 IMMULITE 20 00 Homocysteine (PIL2K H O-14, 2007-11-20) también puede ser utilizado. Es importante separar el plasma o suero de las células lo antes posible después de la recogida de la muestra, debido a que la síntesis de HCY puede tener lugar en los eritrocitos después de la toma de muestra. Las muestras deberían ser conservadas en hielo [...]

  • Page 15

    IMMULITE 20 00 Homocysteine (PIL2K H O-14, 2007-11-20) 15 (SAH) der ivada sin tét icamen te en un a mat riz de proteina/buffer. Estable a 2–8°C durante 30 días después de abrise, o hasta 6 meses (alicuotados) a –20°C. L2KHO2: 1 juego. Antes de hacer un ajuste, colocar las etiquetas a las alícuotas apropiadas (suministradas con el kit) sob[...]

  • Page 16

    16 IMMULITE 20 00 Homocysteine (PIL2K H O-14, 2007-11-20) Los anticuerpos heterofílicos en el suero humano pueden reaccionar con las inmunoglobulinas de los componentes del ensayo provocando interferencias con los inmunoanálisis in vitro. [Ver Boscato LM, Stuart MC. Heterophilic antibodies: a problem for all immunoassays. Clin Chem 1988:34:27-33.[...]

  • Page 17

    IMMULITE 20 00 Homocysteine (PIL2K H O-14, 2007-11-20) 17 Medias: 12,9 µmol/l (IMMULITE 2000) 12,7 µmol/l (Kit A) Método Comparati vo 2: El ensayo fue también comparado con HPLC método usado en un laboratorio de referencia en Estados Unidos, en 95 muestras de plasma heparinizado (Rango de concentración: aproximadamente de 4 a 44 µmol/l. Ver [...]

  • Page 18

    18 IMMULITE 20 00 Homocysteine (PIL2K H O-14, 2007-11-20) risque qu'une augmentation de 0,5 mmol/l du cholestérol. 7 De plus, les patients atteints de pathologie rénale chronique aggravée par une maladie cardiovasculaire ar thérosclérotique présentent des taux d'Hcy élevés dus à l'incapacité du rein à éliminer l'Hcy [...]

  • Page 19

    IMMULITE 20 00 Homocysteine (PIL2K H O-14, 2007-11-20) 19 l'évacuer avec de grandes quantités d'eau pour éviter une accumulation d'azides métalliques explosifs dans les canalisations. Substrat chimiluminesce nt : éviter la contamination et l'exposition directe au soleil. (Voir notice). Eau : utiliser de l'eau distillé[...]

  • Page 20

    20 IMMULITE 20 00 Homocysteine (PIL2K H O-14, 2007-11-20) concentration (faible ou élevé) d'homocystéine. Valeurs attendues Les taux d'homocystéine peuvent varier avec l'âge, le sexe, le lieu géographique et les facteurs génétiques, aussi il est important pour les laboratoires d'établir leurs propres valeurs de référe[...]

  • Page 21

    IMMULITE 20 00 Homocysteine (PIL2K H O-14, 2007-11-20) 21 précision du dosage si la concentration ne dépasse pas 200 mg/l. Hémolyse: La présence d'hémogl obine ne présente aucun effet sur les résultats ni sur la précision du dosage si la concentration ne dépasse pas 512 mg/dl. Lipémie : La présence de trigl ycérides jusqu'à u[...]

  • Page 22

    22 IMMULITE 20 00 Homocysteine (PIL2K H O-14, 2007-11-20) Attenzione: campioni di pazienti che assumono farmaci contenenti adenosil-metionina possono presentare livelli falsamente elevati di omocisteina. Risultati su campioni ottenuti da pazienti che assumono metotrexato, carbamazepina, fenitoina, ossido di nitro, ed anti-convulsivi, o 6-triacetato[...]

  • Page 23

    IMMULITE 20 00 Homocysteine (PIL2K H O-14, 2007-11-20) 23 La centrifugazione dei campioni del siero prima che la coagulazione sia completa può produrre fibrina. Per evitare risultati errati dovuti alla presenza di fibrina, assicurarsi che il processo di coagulazione sia completo prima di centrifugare i campioni. Alcuni campioni, in modo particolar[...]

  • Page 24

    24 IMMULITE 20 00 Homocysteine (PIL2K H O-14, 2007-11-20) a 2–8°C oppure 6 mesi (in aliquote) a –20°C. Vengono Fornite Le provette da utilizzarsi con il diluente. Prima dell'utilizzo, collocare un'etichetta appropriata su una provetta 16 × 100 mm cosicchè i codici a barre possano essere letti dal lettore interno L2HOZ: 3 etichette[...]

  • Page 25

    IMMULITE 20 00 Homocysteine (PIL2K H O-14, 2007-11-20) 25 Prestazioni del Dosaggio Vedi tavole e grafici per dati rappresentativi . I risultati sono indicati in µmol/L. (Se non diversamente notato, tutti i risultati sono stati generati da campioni di plasma eparinizzato). Range di calibrazi one: 2 – 50 µmol/L Il dosaggio è standardizzato verso[...]

  • Page 26

    26 IMMULITE 20 00 Homocysteine (PIL2K H O-14, 2007-11-20) Valore medio: 8,7 µmol/L (IMMULITE 2000) 9,6 µmol/L (Kit B) Assistenza Tecnica All'estero: Si prega di contattare il proprio Distributore Siemens Medical Solutions Diagnostics Nazionale. Il Sistema Qualità della Siemen s Medical Solutions Diagnostics è ce rtificato ISO 13485:2003. P[...]

  • Page 27

    IMMULITE 20 00 Homocysteine (PIL2K H O-14, 2007-11-20) 27 Ciclos de incubação: 2 × 30 minutos. 2 posições de teste por ensaio: 1 cuvete de pretratamento da amostra. 1 vaso de imunoreacção. Ciclo 1: Libertação da homocisteina ligada e conversão em SAH. Ciclo 2: Imunoreacção. Colheita É acoselhavel usar plasma heparanizado ou com EDTA, m[...]

  • Page 28

    28 IMMULITE 20 00 Homocysteine (PIL2K H O-14, 2007-11-20) validade a 2–8°C. L2KHO2: 1 embalagem. Antes de utilizar, retire a etiqueta de protecção da tampa deslizante; levante a tampa, remova o remanescente da etiqueta com o cuidado de não danificar o código de barras. Remova o selo de alumínio do topo da embalagem, encaixe a tampa deslizan[...]

  • Page 29

    IMMULITE 20 00 Homocysteine (PIL2K H O-14, 2007-11-20) 29 deve estabelecer os seus próprios valores. Limitações Doentes tratados com medicamentos envolvendo S-adenosil-metionina podem apresentar niveis fálsamente elevados de homocisteina. Embora a análise de componentes semelhantes da carbomazepina, fenitoína, 6-azauridina e antropeterina, in[...]

  • Page 30

    30 IMMULITE 20 00 Homocysteine (PIL2K H O-14, 2007-11-20) efeito do tempo e temperatura de conservação para heparina, EDTA e soro (Ver gráficos 1-3). Método de Comparação 1: O ensaio foi comparado com um imunoensaio enzimático disponivel comercialmente (Kit A) em 168 amostras de plasma (Gama de concentração: apróximadamente 4 a 43 µmol/L[...]