Instruction/ maintenance manual of the product 2000 Siemens
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Siemens Medical Solutions Diagnostics Homocysteine.
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.
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.
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.
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.
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.
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.
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.
IMMULITE 20 00 Homocysteine (PIL2K H O-14, 2007-11-20) 9 Es hat sich herausgestellt, dass Homocystein ein Indikator kardiovaskulärer Erkrankungen ist.
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.
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.
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“.
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.
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.
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.
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.
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.
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 .
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.
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 se.
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.
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.
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.
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.
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).
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.
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.
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.
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.
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).
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