Reflotron® Cholesterol

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Reflotron® Cholesterol
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&KROHVWHUROLVDVWHURLGZLWKDVHFRQGDU\K\GUR[\OJURXSLQWKH& position. It is synthesized in many tissues, but particularly in the liver and the wall of the intestine. About
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comes from the diet.
Determination of cholesterol is used to screen for an atherogenic risk and in the diagnosis and treatment of diseases with elevated cholesterol levels and disorders of lipid and
lipoprotein metabolism.
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cholesterol esters are cleaved into the corresponding fatty acid and cholesterol, which
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concentration in the sample:
cholesterol
cholesterol esters + H22õõõõõúFKROHVWHURO5&22+
esterase
cholesterol
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H222 + indicator õõõõõú dye + H22
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or mmol/L.
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For in vitro diagnostic use.
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Disposal of all waste material should be in accordance with local guidelines.
Avoid any contact to the application zone of a test strip (e.g., during pipetting of sample).
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blood kept in closed containers should be used within 4 hours if stored at a temperature
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before performing the test to ensure homogeneous distribution of the cellular components.
If coated single-use containers or capillary pipettes are used, please observe the stability data given by the manufacturer.
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samples.
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For optimum performance of the assay, follow the directions given in this document for
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assay instructions.
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zone. Avoid air-bubbles.
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test strip onto the guide, and slide it forward horizontally until it locks into place. Close
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depending on the setting of the instrument.
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+ Check.
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the limits.
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and function and conversion factors read from the magnetic strip on the lower face of
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chende Fettsäure und Cholesterin gespalten, das in Anwesenheit von Sauerstoff zu
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Dabei entsteht ein blauer Farbstoff, der zur Cholesterinkonzentration in der Probe
proportional ist:
CholesterinCholesterinester + H22õõõõõú&KROHVWHULQ5&22+
esterase
Cholesterin&KROHVWHULQ22 õõõõõú Cholestenon + H222
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H222 + Indikator õõõõõú Farbstoff + H22
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in mg/dL oder mmol/L angezeigt.
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7KHIROORZLQJKDGQRLQűXHQFHRQWKHUHVXOWVLQWKHFRQFHQWUDWLRQUDQJHVWHVWHGFULterion: recovery ± 10 % of baseline): physiological concentrations of bilirubin, lipaemic
sera, haematocrit up to 55 %, haemolysis up to 1 %, and 44 further drugs.
High concentrations of the following substances can lower the measured cholesterol
values: aminoantipyrine, ascorbic acid, L-cysteine, gentisic acid, glutathione, methyldopa, noramidopyrine.
For diagnostic purposes, the results should always be assessed in conjunction with the
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In-vitro-Diagnostikum.
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Auftragezone eines Reagenzträgers (z.B. beim Auftragen einer Probe) nicht berühren.
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,IWKHPHDVXUHGFKROHVWHUROYDOXHLVDERYHWKHPHDVXULQJUDQJHIRUWKH5HűRWURQ&KRlesterol assay, the sample may be diluted 1 + 1 with serum or plasma having a known
cholesterol concentration C07KHWUXHFKROHVWHUROYDOXH&FDQEHFDOFXODWHGIURPWKH
measured cholesterol concentration Cdil using the following formula: C = 2 Cdil - C0.
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< 200 mg/dL or < 5.2 mmol/L.
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patient population and if necessary determine its own reference ranges.
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majority of the test results were within the given ranges.
Precision
Repeatability (within-run precision):
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sample material: heparinized blood.
Intermediate precision (between-day precision):
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sera.
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the following correlations:
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References
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Catalogue number
5()
0088
Batch code/Lot number
In vitro diagnostic medical device
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Manufacturer
Use by
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Consult instructions for use
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Die Reagenzträger sind gebrauchsfertig.
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Durchführung der Messung aufschütteln, um die homogene Verteilung der zellulären
Bestandteile zu gewährleisten.
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Haltbarkeitsdaten des Herstellers zu beachten.
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Proben nicht einfrieren.
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niedriger.
+ 10 % vom Ausgangswert): physiologische Konzentrationen von Bilirubin, lipämische
Seren, Hämatokritwerte bis 55 %, Hämolyse bis 1 % sowie 44 weitere geprüfte
Arzneiwirkstoffe.
Folgende Substanzen können in höheren Konzentrationen zu erniedrigten Cholesterinwerten führen: Aminoantipyrin, Ascorbinsäure, L-Cystein, Gentisinsäure, Glutathion,
Methyldopa, Noramidopyrin.
Für diagnostische Zwecke sind die Messergebnisse stets im Zusammenhang mit der
Anamnese, der klinischen Untersuchung und anderen Untersuchungsergebnissen zu
werten.
Messbereich
100-500 mg/dL bzw. 2,59-12,9 mmol/L
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Cholesterol, so kann die Probe mit einem Serum oder Plasma mit einer bekannten Cholesterinkonzentration C0 im Verhältnis 1 + 1 verdünnt werden. Der wahre Cholesterinwert C kann aus der gemessenen Cholesterinkonzentration Cverd. nach folgender Formel
berechnet werden: C = 2 Cverd. - C0.
Referenzwerte4
< 200 mg/dL bzw. < 5,2 mmol/L
Jedes Labor sollte die Übertragbarkeit der Referenzwerte für die eigenen Patientengruppen überprüfen und gegebenenfalls selbst ermitteln.
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Präzision
Wiederholpräzision (Präzision in der Serie):
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Probenmaterial: Heparinblut.
Zwischenpräzision (Tag/Tag-Präzision):
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Kontrollseren.
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folgende Korrelationen:
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Bestellnummer
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Chargenbezeichnung
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In-Vitro-Diagnostikum
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sostanze nelle concentrazioni controllate (valutazione: recupero ±10 % del basale):
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emolisi sino all’1 % e altri 44 farmaci.
Le seguenti sostanze, se presenti in alte concentrazioni, possono provocare valori
diminuiti di colesterolo: amminoantipirina, acido ascorbico, L-cisteina, acido gentisico,
glutatione, metildopa, noramidopirina.
$LŰQLGLDJQRVWLFLLULVXOWDWLGHYRQRVHPSUHHVVHUHYDOXWDWLFRQJLXQWDPHQWHFRQODVWRULD
clinica del paziente, con gli esami clinici e con altre evidenze cliniche.
La concentrazione di colesterolo (proporzionale al colorante formatosi) viene misurata
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secondi il display visualizza il risultato in mg/dL oppure mmol/L.
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<200 mg/dL oppure <5,2 mmol/L.
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Per uso diagnostico in vitro.
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laboratorio.
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pipettamento del campione).
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Le strisce reattive sono pronte all’uso.
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controllo.
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0088
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Nel caso in cui il valore di colesterolo misurato risulti al di sopra dell’intervallo di misura
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o plasma di nota concentrazione di colesterolo (C0,OYDORUHUHDOHGLFROHVWHUROR&SX´
essere calcolato in base alla concentrazione di colesterolo misurata (Cdil) secondo la
seguente formula: C = 2 Cdilō&0.
perossidasi
H222 + indicatore õõõõõú colorante + H22
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prodotto le seguenti correlazioni:
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Dispositivo medico-diagnostico in vitro
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+2oC
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posizionata al margine.
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bepaling van cholesterol wordt gebruikt voor het screenen op een atherogeen risico en
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het geval van bloed als monster de erytrocyten eerst van het plasma gescheiden.
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gevormd, waarvan de hoeveelheid evenredig is met de cholesterolconcentratie in het
monster:
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esterase
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De cholesterolconcentratie (evenredig met de gevormde hoeveelheid kleurstof) wordt
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150 seconden in mg/dL of mmol/L op de display weergegeven.
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9RRU]RUJVPDDWUHJHOHQHQZDDUVFKXZLQJHQ
Voor in vitro diagnostisch gebruik.
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'HYHUZóGHULQJYDQDOOHDIYDOPDWHULDOHQGLHQWLQRYHUHHQVWHPPLQJWH]óQPHWGHORNDOH
voorschriften.
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van het monster).
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aangegeven vervaldatum.
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homogene verdeling van de cellulaire bestanddelen te waarborgen.
Indien gecoate buizen voor eenmalig gebruik of capillaire pipetten worden gebruikt,
dient zorgvuldig op de door de fabrikant verstrekte gegevens m.b.t. tot de stabiliteit te
worden gelet.
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Volg voor een optimale uitvoering van de bepaling de in dit document voor het betrefIHQGHDQDO\VHDSSDUDDWJHJHYHQDDQZó]LQJHQ]RUJYXOGLJRS5DDGSOHHJGHEHWUHIIHQGH
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uitvoeren van de bepaling.
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zonder de opbrengzone te raken op in het PLGGHQYDQGHURGHRSEUHQJ]RQH9HUPóG
de vorming van luchtbellen.
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opbrengen van het monster op de geleider en schuif deze horizontaal naar voren tot
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afkorting van de parameter op de display weergegeven. Het resultaat wordt afhankeOóNYDQGHLQVWHOOLQJYDQKHWDSSDUDDWRSGHGLVSOD\ZHHUJHJHYHQ
Lot nummer
0088
Medisch hulpmiddel voor in-vitro diagnostiek
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betreffende medische hulpmiddelen voor in-vitrodiagnostiek
0088
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de marge.
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&+2'3$3EHSDOLQJYDQ5RFKH'LDJQRVWLFVGLHJHVWDQGDDUGLVHHUGLVWRY*&06'H
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Clean + Check gebruiken.
De intervallen en de grenswaarden van de controles dienen te worden aangepast aan de
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De verkregen waarden dienen binnen de vastgestelde grenswaarden te liggen.
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genomen, als de waarden buiten het grenswaardenbereik liggen.
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De cholesterolconcentratie wordt met behulp van de functie- en omrekeningsfactoren,
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Van fysiologische concentraties bilirubine, lipemische sera, hematocrietwaarden tot
55 %, hemolyse tot 1 % en 44 onderzochte geneesmiddelen kon in de onderzochte concentratiebereiken geen invloed op de bepaling worden vastgesteld (criterium: recovery:
uitgangswaarde ± 10 %).
Hoge concentraties van de volgende stoffen kunnen de gemeten cholesterolwaarden
YHUODJHQDPLQRDQWLS\ULQHDVFRUELQH]XXU/F\VWH±QHJHQWLVLQH]XXUJOXWDWKLRQPHWK\Odopa, noramidopyrine.
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anamnese, het klinisch onderzoek en andere bevindingen te worden beoordeeld.
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Cholesterol-test ligt, mag het monster 1+1 worden verdund met serum of plasma,
waarvan de cholesterolconcentratie C0EHNHQGLV'HZHUNHOóNHFKROHVWHUROZDDUGH&
kan met behulp van de onderstaande formule uit de gemeten cholesterolconcentratie
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< 200 mg/dL of < 5,2 mmol/L.
Ieder laboratorium dient te controleren of de aangegeven referentiegebieden ook voor
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meerderheid van de meetresultaten lag binnen de aangegeven bereiken.
Precisie
Herhaalbaarheid (precisie in de serie):
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monstermateriaal: gehepariniseerd bloed.
Intermediaire precisie (precisie van dag tot dag):
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controlesera.
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9HUJHOóNLQJYDQGH5HűRWURQ&KROHVWHUROWHVW\PHWGH&+2'3$3EHSDOLQJ[UHVXOteerde in de volgende correlaties:
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0088
5()/27521 and 35(&,1250 are trademarks of Roche.
IVD
© 2010, Roche Diagnostics
Diagnostics GmbH
" Roche
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www.diavant.com
www.roche.com
+30oC
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pi_05904218001_01_INT_420x297_IFU.indd 2
Catalogus nummer
5()
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R1 (black)
30.07.2010 09:57:32