Reflotron® Cholesterol
Transcription
Reflotron® Cholesterol
';2/,)UDX9HVHORYVNL Reflotron® Cholesterol WHVWV English ,QWHQGHGXVH 7HVWIRUWKHTXDQWLWDWLYHGHWHUPLQDWLRQRIFKROHVWHUROLQEORRGVHUXPRUSODVPDZLWK 5HűRWURQV\VWHPV 6XPPDU\ &KROHVWHUROLVDVWHURLGZLWKDVHFRQGDU\K\GUR[\OJURXSLQWKH& position. It is synthesized in many tissues, but particularly in the liver and the wall of the intestine. About WKUHHTXDUWHUVRIWKHERG\ŐVFKROHVWHUROLVV\QWKHVL]HGE\WKHWLVVXHVZKLOHRQHTXDUWHU 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. 7HVWSULQFLSOH $IWHUDSSOLFDWLRQWRWKHWHVWVWULSWKHVDPSOHűRZVLQWRWKHUHDFWLRQ]RQHZKHUHLQWKH FDVHRIEORRGVDPSOHVWKHVHSDUDWLRQRIWKHHU\WKURF\WHVIURPWKHSODVPDRFFXUV7KH cholesterol esters are cleaved into the corresponding fatty acid and cholesterol, which DUHWKHQR[LGL]HGWRFKROHVWHQRQHDQGK\GURJHQSHUR[LGHLQWKHSUHVHQFHRIR[\JHQ ,QDIXUWKHUUHDFWLRQVWHSFDWDO\]HGE\WKHHQ]\PHSHUR[LGDVHWKHK\GURJHQSHUR[LGH R[LGL]HVDUHGR[LQGLFDWRUUHVXOWLQJLQDEOXHG\HZKLFKLVSURSRUWLRQDOWRWKHFKROHVWHURO concentration in the sample: cholesterol cholesterol esters + H22õõõõõúFKROHVWHURO5&22+ esterase cholesterol FKROHVWHURO22 õõõõõú cholestenone + H222 R[LGDVH SHUR[LGDVH H222 + indicator õõõõõú dye + H22 7KHFKROHVWHUROFRQFHQWUDWLRQSURSRUWLRQDOWRWKHG\HIRUPHGLVPHDVXUHGDWD ZDYHOHQJWKRIQPDQGr&DQGLVGLVSOD\HGDIWHUDERXWVHFRQGVLQPJG/ or mmol/L. 5HDJHQWV &RPSRQHQWVSHUWHVW&KROHVWHUROHVWHUDVHPLFURRUJDQLVPVū8FKROHVWHURO R[LGDVH%UHYLUHF(FROLū832'KRUVHUDGLVKū8ŐŐWHWUDPHWK\OEHQ]LGLQHƀJEXIIHU 3UHFDXWLRQVDQGZDUQLQJV For in vitro diagnostic use. ([HUFLVHWKHQRUPDOSUHFDXWLRQVUHTXLUHGIRUKDQGOLQJDOOODERUDWRU\UHDJHQWV 6DIHW\GDWDVKHHWDYDLODEOHIRUSURIHVVLRQDOXVHURQUHTXHVW 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). 5HDJHQWKDQGOLQJ 7HVWVWULSVDUHUHDG\IRUXVH 6WRUDJHDQGVWDELOLW\ 6WRUHDWōr&'RQRWXVHWKHWHVWVWULSDIWHUWKHVSHFLŰHGH[SLU\GDWH 6SHFLPHQFROOHFWLRQDQGSUHSDUDWLRQ &DSLOODU\EORRGZKROHEORRGFROOHFWHGLQVWDQGDUGVDPSOHFROOHFWLRQWXEHVVHUXP KHSDULQL]HGRU('7$EORRGRUKHSDULQL]HGRU('7$SODVPD 8VHIUHVKFDSLOODU\RUYHQRXVEORRGLPPHGLDWHO\DIWHUFROOHFWLRQ('7$RUKHSDULQL]HG blood kept in closed containers should be used within 4 hours if stored at a temperature RIōr&RUZLWKLQKRXUVLIVWRUHGDWDWHPSHUDWXUHRIōr&6KDNHWKHVDPSOH before performing the test to ensure homogeneous distribution of the cellular components. If coated single-use containers or capillary pipettes are used, please observe the stability data given by the manufacturer. ('7$RUKHSDULQL]HGSODVPDNHSWLQFORVHGFRQWDLQHUVVKRXOGEHXVHGZLWKLQKRXUV LIVWRUHGDWDWHPSHUDWXUHRIōr&RUZLWKLQKRXUVLIVWRUHGDWDWHPSHUDWXUHRI ōr&'RQRWIUHH]HWKHVDPSOHV &RPSDUHGWRVHUXPUHVXOWVRIXSWRDUHREWDLQHGZLWK('7$EORRGRUSODVPD samples. 6DPSOHYROXPHƀ/ 0DWHULDOVSURYLGHG FRQWDLQHUZLWKWHVWVWULSV 0DWHULDOVUHTXLUHGEXWQRWSURYLGHG ŗ5HűRWURQLQVWUXPHQW ŗ5HűRWURQSLSHWWH ŗ5HűRWURQSLSHWWHWLSV ŗ5HűRWURQFDSLOODU\WXEHV ŗ5HűRWURQ3UHFLQRUP85HűRWURQ3UHFLSDWK8RU5HűRWURQ&OHDQ&KHFN ŗ*HQHUDOODERUDWRU\HTXLSPHQW $VVD\SURFHGXUH For optimum performance of the assay, follow the directions given in this document for WKHDQDO\]HUFRQFHUQHG5HIHUWRWKHDSSURSULDWHRSHUDWRUŐVPDQXDOIRUDQDO\]HUVSHFLŰF assay instructions. ŗ 5HPRYHDWHVWVWULSIURPWKHFRQWDLQHU7LJKWO\UHFDSWKHFRQWDLQHULPPHGLDWHO\ DIWHUUHPRYLQJDWHVWVWULS ŗ 3HHORIIWKHDOXPLQLXPSURWHFWLYHIRLOWDNLQJFDUHQRWWREHQGWKHWHVWVWULS ŗ $OO5HűRWURQWHVWVUHTXLUHDVDPSOHYROXPHRIƀ/ ŗ $SSO\WKHUHTXLUHGYROXPHRIVDPSOHRQWRWKHcentre of the red application zone XVLQJDSLSHWWHHJ5HűRWURQSLSHWWHōEHLQJFDUHIXOQRWWRWRXFKWKHDSSOLFDWLRQ zone. Avoid air-bubbles. ŗ 2SHQWKHűDSRUVOLGLQJFRYHU:LWKLQVHFRQGVRIDSSO\LQJWKHVDPSOHSODFHWKH test strip onto the guide, and slide it forward horizontally until it locks into place. Close WKHVOLGLQJFRYHURUűDS ŗ 7KHWHVWSDUDPHWHUDEEUHYLDWLRQLVVKRZQRQWKHGLVSOD\LIWKHWHVWVWULSKDVEHHQ FRUUHFWO\LQVHUWHGDQGWKHPDJQHWLFFRGHKDVEHHQUHDG7KHUHVXOWLVGLVSOD\HG depending on the setting of the instrument. &DOLEUDWLRQ 7KHIXQFWLRQFXUYHIRUWKH5HűRWURQ&KROHVWHURODVVD\IRUFRQYHUWLQJUHűHFWDQFHYDOXHV LQWRFRQFHQWUDWLRQVLVGHŰQHGIRUHDFKORWXVLQJWKHFKROHVWHURO&+2'3$3PHWKRG IURP5RFKH'LDJQRVWLFVVWDQGDUGL]HGWR*&067KHSDUDPHWHUVRIWKHFXUYHDUHDXWRmatically transferred to the instrument via the magnetic strip during testing. 4XDOLW\FRQWURO )RUTXDOLW\FRQWUROXVH5HűRWURQ3UHFLQRUP85HűRWURQ3UHFLSDWK8RU5HűRWURQ&OHDQ + Check. 7KHFRQWUROLQWHUYDOVDQGOLPLWVVKRXOGEHDGDSWHGWRHDFKODERUDWRU\ŐVLQGLYLGXDO UHTXLUHPHQWV9DOXHVREWDLQHGVKRXOGIDOOZLWKLQWKHGHŰQHGOLPLWV (DFKODERUDWRU\VKRXOGHVWDEOLVKFRUUHFWLYHPHDVXUHVWREHWDNHQLIYDOXHVIDOORXWVLGH the limits. )ROORZWKHDSSOLFDEOHJRYHUQPHQWUHJXODWLRQVDQGORFDOJXLGHOLQHVIRUTXDOLW\FRQWURO &DOFXODWLRQ 7KHFKROHVWHUROFRQFHQWUDWLRQLVFDOFXODWHGDXWRPDWLFDOO\IURPWKHPHDVXUHPHQWVWDNHQ and function and conversion factors read from the magnetic strip on the lower face of HDFKWHVWVWULS7KHFKROHVWHUROFRQFHQWUDWLRQLVGLVSOD\HGLQPJG/RUPPRO/GHSHQGing on whether the instrument has been set to show conventional or SI units. &RQYHUVLRQIDFWRUPJG/[ PPRO/ chende Fettsäure und Cholesterin gespalten, das in Anwesenheit von Sauerstoff zu &KROHVWHQRQR[LGLHUWZLUGZREHLJOHLFK]HLWLJ:DVVHUVWRIISHUR[LGJHELOGHWZLUG'LHVHV R[LGLHUWXQWHUGHUNDWDO\WLVFKHQ:LUNXQJGHV(Q]\PV3HUR[LGDVHHLQHQ5HGR[LQGLNDWRU Dabei entsteht ein blauer Farbstoff, der zur Cholesterinkonzentration in der Probe proportional ist: CholesterinCholesterinester + H22õõõõõú&KROHVWHULQ5&22+ esterase Cholesterin&KROHVWHULQ22 õõõõõú Cholestenon + H222 R[LGDVH 3HUR[LGDVH H222 + Indikator õõõõõú Farbstoff + H22 'LH&KROHVWHULQNRQ]HQWUDWLRQSURSRUWLRQDO]XPJHELOGHWHQ)DUEVWRIIZLUGEHLHLQHU:HOOHQO¦QJHYRQQPXQGr&JHPHVVHQ'DV(UJHEQLVZLUGQDFKFD6HNXQGHQ in mg/dL oder mmol/L angezeigt. 5HDJHQ]LHQ ,QKDOWVVWRIIHSUR7HVWIHOG&KROHVWHULQHVWHUDVH0LNURRUJDQLVPHQū8&KROHVWHULQR[LGDVH%UHYLUHF(FROLū832'0HHUUHWWLFKū8ŏv7HWUDPHWK\OEHQ]LGLQƀJ3XIIHU /LPLWDWLRQVLQWHUIHUHQFHV2,3 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 SDWLHQWŐVPHGLFDOKLVWRU\FOLQLFDOH[DPLQDWLRQDQGRWKHUŰQGLQJV 9RUVLFKWVPDćQDKPHQXQG:DUQKLQZHLVH In-vitro-Diagnostikum. 'LHEHLP8PJDQJPLW/DERUUHDJHQ]LHQ¾EOLFKHQ9RUVLFKWVPD¡QDKPHQEHDFKWHQ 6LFKHUKHLWVGDWHQEODWWDXI$QIUDJHI¾UEHUXIVP¦¡LJH1XW]HUHUK¦OWOLFK 'LH(QWVRUJXQJDOOHU$EI¦OOHLVWJHP¦¡GHQORNDOHQ5LFKWOLQLHQGXUFK]XI¾KUHQ Auftragezone eines Reagenzträgers (z.B. beim Auftragen einer Probe) nicht berühren. 0HDVXULQJUDQJH ōPJG/RUōPPRO/ ,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. /DJHUXQJXQG+DOWEDUNHLW %HLr&DXIEHZDKUHQ'HU5HDJHQ]WU¦JHUGDUIQLFKW¾EHUGDVDQJHJHEHQH9HUIDOOVdatum hinaus verwendet werden. ([SHFWHGYDOXHV4 < 200 mg/dL or < 5.2 mmol/L. (DFKODERUDWRU\VKRXOGLQYHVWLJDWHWKHWUDQVIHUDELOLW\RIWKHH[SHFWHGYDOXHVWRLWVRZQ patient population and if necessary determine its own reference ranges. 6SHFLğFSHUIRUPDQFHGDWD 7KHGDWDIRUWKH5HűRWURQ&KROHVWHURODVVD\ZHUHGHWHUPLQHGLQHYDOXDWLRQVWXGLHV7KH majority of the test results were within the given ranges. Precision Repeatability (within-run precision): &9FRHIŰFLHQWRIYDULDWLRQLQWKHQRUPDOUDQJHLQWKHSDWKRORJLFDOUDQJH sample material: heparinized blood. Intermediate precision (between-day precision): &9LQWKHQRUPDOUDQJHLQWKHSDWKRORJLFDOUDQJHVDPSOHPDWHULDOFRQWURO sera. 0HWKRGFRPSDULVRQ $FRPSDULVRQRIWKH5HűRWURQ&KROHVWHURODVVD\\ZLWKWKH&+2'3$3PHWKRG[JDYH the following correlations: \ [ōQ U VDPSOHPDWHULDOKHSDULQL]HGEORRG References %UDXQ+3HWDO&OLQ&KHP 3ULFH3&.ROOHU38-&OLQ&KHP&OLQ%LRFKHP .ROOHU38HWDO/DEPHG LOT (XURSHDQ$WKHURVFOHURVLV6RFLHW\1XWU0HWDE&DUGLRYDVF'LVF /DVWXSGDWH 6\PEROWDEOH Catalogue number 5() 0088 Batch code/Lot number In vitro diagnostic medical device IVD LOT Manufacturer Use by LOT +30oC 7HPSHUDWXUHOLPLWDWLRQ6WRUHDW +2oC Consult instructions for use LOT 0088 7KLVSURGXFWIXOŰOOVWKHUHTXLUHPHQWVRIWKH(XURSHDQ 0088 'LUHFWLYH(&IRULQYLWURGLDJQRVWLFPHGLFDOGHYLFHV 6LJQLŰFDQWDGGLWLRQVRUFKDQJHVDUHLQGLFDWHGE\DFKDQJHEDULQWKHPDUJLQ IVD0088 IVD 7HVWV Deutsch IVD +30oC $QZHQGXQJV]ZHFN +30oC 7HVW]XUTXDQWLWDWLYHQ%HVWLPPXQJYRQ&KROHVWHULQLQ%OXW6HUXPRGHU3ODVPDPLW +2oC +2oC 5HűRWURQ6\VWHPHQ 5HDJHQ]KDQGKDEXQJ Die Reagenzträger sind gebrauchsfertig. 3UREHQHQWQDKPHXQG9RUEHUHLWXQJ .DSLOODUEOXWPLW6WDQGDUG3UREHQHQWQDKPHU¸KUFKHQHQWQRPPHQHV9ROOEOXW6HUXP +HSDULQRGHU('7$%OXW+HSDULQRGHU('7$3ODVPD )ULVFKHV.DSLOODURGHU9HQHQEOXWVRIRUWQDFKGHU(QWQDKPHHLQVHW]HQ('7$RGHU +HSDULQEOXWEHL$XIEHZDKUXQJLPJHVFKORVVHQHQ*HI¦¡EHLr&LQQHUKDOEYRQ 6WXQGHQEHL/DJHUXQJEHLr&LQQHUKDOEYRQ6WXQGHQYHUZHQGHQ3UREHYRU Durchführung der Messung aufschütteln, um die homogene Verteilung der zellulären Bestandteile zu gewährleisten. %HL9HUZHQGXQJYRQEHVFKLFKWHWHQ(LQPDOJHI¦¡HQRGHU.DSLOODUSLSHWWHQVLQGGLH Haltbarkeitsdaten des Herstellers zu beachten. ('7$RGHU+HSDULQSODVPDEHL$XIEHZDKUXQJLPJHVFKORVVHQHQ*HI¦¡EHLr& LQQHUKDOEYRQ6WXQGHQEHL/DJHUXQJEHLr&LQQHUKDOEYRQ6WXQGHQYHUZHQGHQ Proben nicht einfrieren. ,P9HUJOHLFK]X6HUXPVLQGGLH(UJHEQLVVHYRQ('7$%OXWRGHU3ODVPDSUREHQXP 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 /LHJWGHUJHPHVVHQH&KROHVWHULQZHUWREHUKDOEGHV0HVVEHUHLFKVYRQ5HűRWURQ 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. 6SH]LğVFKH/HLVWXQJVGDWHQGHV7HVWV 'LH'DWHQI¾UGHQ5HűRWURQ&KROHVWHURO7HVWZXUGHQLQ(USUREXQJVXQWHUVXFKXQJHQ HUPLWWHOW'LH0HKUKHLWGHU7HVWHUJHEQLVVHODJLQQHUKDOEGHUDQJHJHEHQHQ%HUHLFKH Präzision Wiederholpräzision (Präzision in der Serie): 9.9DULDWLRQVNRHIŰ]LHQWLP1RUPDOEHUHLFKLPSDWKRORJLVFKHQ%HUHLFK Probenmaterial: Heparinblut. Zwischenpräzision (Tag/Tag-Präzision): 9.LP1RUPDOEHUHLFKLPSDWKRORJLVFKHQ%HUHLFK3UREHQPDWHULDO Kontrollseren. 0HWKRGHQYHUJOHLFK (LQ9HUJOHLFKGHV5HűRWURQ&KROHVWHURO7HVWV\PLWGHU&+2'3$30HWKRGH[HUJDE folgende Korrelationen: \ [ōQ U 3UREHQPDWHULDO+HSDULQEOXW /LWHUDWXU %UDXQ+3HWDO&OLQ&KHP 3ULFH3&.ROOHU38-&OLQ&KHP&OLQ%LRFKHP .ROOHU38HWDO/DEPHG (XURSHDQ$WKHURVFOHURVLV6RFLHW\1XWU0HWDE&DUGLRYDVF'LVF LOT /HW]WH$NWXDOLVLHUXQJ 6\PEROWDEHOOH Bestellnummer 5() 3UREHQYROXPHQƀ/ Chargenbezeichnung 0088 *HOLHIHUWH0DWHULDOLHQ 5¸KUHPLW5HDJHQ]WU¦JHUQ =XVÃW]OLFKEHQùWLJWH0DWHULDOLHQ ŗ5HűRWURQ*HU¦W ŗ5HűRWURQ3LSHWWH ŗ5HűRWURQ3LSHWWHQVSLW]HQ ŗ5HűRWURQ.DSLOODUU¸KUFKHQ ŗ5HűRWURQ3UHFLQRUP85HűRWURQ3UHFLSDWK8RGHU5HűRWURQ&OHDQ&KHFN ŗ$OOJHPHLQ¾EOLFKH/DERUDXVU¾VWXQJ In-Vitro-Diagnostikum IVD LOT Hersteller Verwendbar bis LOT +30oC 7HPSHUDWXUEHJUHQ]XQJ$XIEHZDKUXQJEHL +2oC LOT 7HVWGXUFKIđKUXQJ 8PHLQHHLQZDQGIUHLH)XQNWLRQGHV7HVWVVLFKHU]XVWHOOHQVLQGGLH$QZHLVXQJHQLQ GLHVHP'RNXPHQWI¾UGDVMHZHLOLJH*HU¦W]XEHIROJHQ*HU¦WHVSH]LŰVFKH7HVWDQZHLVXQJHQVLQGLPHQWVSUHFKHQGHQ%HGLHQXQJVKDQGEXFK]XŰQGHQ ŗ (LQHQ5HDJHQ]WU¦JHUDXVGHU5¸KUHHQWQHKPHQ5ùKUHQDFK(QWQDKPHHLQHV 5HDJHQ]WUÃJHUVVRIRUWZLHGHUIHVWYHUVFKOLHćHQ ŗ 6FKXW]IROLHYRP5HDJHQ]WU¦JHUHQWIHUQHQKLHUEHL'XUFKELHJHQGHV5HDJHQ]WU¦JHUV vermeiden. ŗ %HLDOOHQ5HűRWURQ7HVWVLVWHLQ3UREHQYROXPHQYRQƀ/HUIRUGHUOLFK ŗ %HQ¸WLJWHV3UREHQYROXPHQPLWHLQHU3LSHWWH]%5HűRWURQ3LSHWWHDXIQHKPHQXQG ]HQWUDODXIGHQURWHQ7HLOGHU$XIWUDJH]RQHDSSOL]LHUHQRKQHGLHVHPLWGHU3LSHWWHQspitze zu berühren. Luftblasen vermeiden. ŗ .ODSSHE]Z6FKLHEHU¸IIQHQ5HDJHQ]WU¦JHULQQHUKDOEYRQ6HNXQGHQQDFKGHP Auftragen der Probe in die Führungsschiene stecken und waagrecht bis zum spürbaUHQ(LQUDVWHQHLQVFKLHEHQ 6FKLHEHUE]Z.ODSSHVFKOLH¡HQ ŗ ,P'LVSOD\HUVFKHLQWGLH$EN¾U]XQJGHV7HVWSDUDPHWHUVZHQQGHU5HDJHQ]WU¦JHU korrekt eingelegt und der Magnetcode eingelesen wurde. 'DV(UJHEQLVZLUGMHQDFK(LQVWHOOXQJGHV*HU¦WHVDQJH]HLJW .DOLEUDWLRQ 'LH)HVWOHJXQJGHU)XQNWLRQVNXUYHYRQ5HűRWURQ&KROHVWHURO]XU8PUHFKQXQJYRQ 5HűH[LRQVZHUWHQLQ.RQ]HQWUDWLRQHQHUIROJWFKDUJHQVSH]LŰVFKXQWHU9HUZHQGXQJGHU JHJHQ*&06VWDQGDUGLVLHUWHQ&KROHVWHULQ&+2'3$30HWKRGHYRQ5RFKH'LDJQRVWLFV Die Daten werden über das Magnetband automatisch an das Gerät übermittelt. 4XDOLWÃWVNRQWUROOH =XU4XDOLW¦WVNRQWUROOH5HűRWURQ3UHFLQRUP85HűRWURQ3UHFLSDWK8RGHU5HűRWURQ&OHDQ + Check verwenden. 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IVD0088 IVD IVD Italiano WHVW +30oC +30oC +2oC +2oC )LQDOLW¿GłXVR 7HVWSHUODGHWHUPLQD]LRQHTXDQWLWDWLYDGHOFROHVWHURORLQFDPSLRQLGLVDQJXHVLHURR +30oC SODVPDLPSLHJDQGRVLVWHPL5HűRWURQ +2oC 6RPPDULR ,OFROHVWHURORªXQRVWHURLGHFRQXQJUXSSRLGURVVLOLFRVHFRQGDULRQHOODSRVL]LRQH& Viene sintetizzato in molti tessuti, particolarmente nel fegato e nella parete intestinale. &LUFDWUHTXDUWLGHOFROHVWHURORSUHVHQWHQHOOŐRUJDQLVPRKDQQRRULJLQHGDLWHVVXWLXQ TXDUWRGDJOLDOLPHQWL/DGHWHUPLQD]LRQHGHOFROHVWHURORYLHQHLPSLHJDWDFRPHVFUHHQLQJ SHULQGLYLGXDUHLOULVFKLRDWHURJHQLFRQRQFK«SHUODGLDJQRVLHGLOWUDWWDPHQWRGLSDWRORgie associate ad ipercolesterolemia e di disturbi del metabolismo lipidico e lipoproteico. 3ULQFLSLRGHOWHVW Il campione applicato sulla striscia reattiva penetra nella zona di reazione, dove, in caso di campioni di sangue, ha luogo la separazione degli eritrociti dal plasma. Gli esteri del colesterolo vengono dissociati in acido grasso e colesterolo corrispondenti, successivamente ossidati a colestenone e perossido di idrogeno in presenza di ossigeno. In un’ulteriore fase della reazione catalizzata dell’enzima perossidasi, il perossido di idrogeno RVVLGDXQLQGLFDWRUHUHGR[VYLOXSSDQGRLQWDOPRGRXQFRORUDQWHEOXSURSRU]LRQDOHDOOD concentrazione di colesterolo nel campione: colesterolo esteri del colesterolo + H22õõõõõúFROHVWHUROR5&22+ esterasi colesterolo FROHVWHUROR22 õõõõõú colestenone + H222 ossidasi &RQVHUYD]LRQHHVWDELOLW¿ &RQVHUYDUHDōr&1RQXVDUHODVWULVFLDUHDWWLYDROWUHODGDWDGLVFDGHQ]DLQGLFDWD 3UHOLHYRHSUHSDUD]LRQHGHLFDPSLRQL 6DQJXHFDSLOODUHVDQJXHLQWHURSUHOHYDWRLQDSSRVLWHSURYHWWHVWDQGDUGVLHURVDQJXH HSDULQDWRRFRQ('7$RSSXUHSODVPDHSDULQDWRRFRQ('7$ Impiegare il sangue capillare o venoso fresco immediatamente dopo il prelievo. Il VDQJXHHSDULQDWRRFRQ('7$PDQWHQXWRLQFRQWHQLWRULFKLXVLGHYHHVVHUHXWLOL]]DWR HQWURRUHVHFRQVHUYDWRDōr&RSSXUHHQWURRUHVHFRQVHUYDWRDōr& Prima di eseguire il test, agitare il campione per assicurare una distribuzione omogenea dei componenti cellulari. Per l’impiego di provette usa e getta o pipette capillari rivestite, osservare le indicazioni UHODWLYHDOODVWDELOLW¢ULSRUWDWHGDOULVSHWWLYRSURGXWWRUH ,OSODVPDHSDULQDWRRFRQ('7$PDQWHQXWRLQFRQWHQLWRULFKLXVLGHYHHVVHUHXWLOL]]DWR HQWURRUHVHFRQVHUYDWRDōr&RSSXUHHQWURRUHVHFRQVHUYDWRDōr&1RQ congelare i campioni. 6HVLLPSLHJDQRFDPSLRQLGLVDQJXHFRQ('7$RGLSODVPDFRQ('7$LULVXOWDWLVRQR LQIHULRULGLŰQRDOULVSHWWRDTXHOOLRWWHQXWLFRQLOVLHUR 0DWHULDOLDGLVSRVL]LRQH FRQWHQLWRUHGDVWULVFHUHDWWLYH 0DWHULDOLQHFHVVDULPDQRQIRUQLWL ŗ6WUXPHQWR5HűRWURQ ŗ3LSHWWD5HűRWURQ ŗ3XQWDOLGLSLSHWWDJJLR5HűRWURQ ŗ7XELFDSLOODUL5HűRWURQ ŗ5HűRWURQ3UHFLQRUP85HűRWURQ3UHFLSDWK8R5HűRWURQ&OHDQ&KHFN ŗ1RUPDOHDWWUH]]DWXUDGDODERUDWRULR (VHFX]LRQH Per una performance ottimale del test, attenersi alle indicazioni riportate nel presente GRFXPHQWRSHUOŐDQDOL]]DWRUHLQTXHVWLRQH3HUOHLVWUX]LRQLVSHFLŰFKHGHOOŐDQDOL]]DWRUH relative all’esecuzione del test, consultare il manuale d’uso dello strumento. ŗ 3UHOHYDUHXQDVWULVFLDUHDWWLYDGDOFRQWHQLWRUH5LFKLXGHUHLOFRQWHQLWRUHHUPHWLFD PHQWHVXELWRGRSRDYHUWROWRXQDVWULVFLDUHDWWLYD ŗ 7RJOLHUHODODPLQDGLSURWH]LRQHLQDOOXPLQLRHYLWDQGRGLSLHJDUHODVWULVFLDUHDWWLYD ŗ 9ROXPHGHOFDPSLRQHQHFHVVDULRSHUWXWWLLWHVW5HűRWURQƀ/ ŗ $SSOLFDUHLOYROXPHGHOFDPSLRQHQHFHVVDULRDOcentro della zona reattiva rossa con XQDSLSHWWDDGHVSLSHWWD5HűRWURQDVVLFXUDQGRVLGLQRQWRFFDUHWDOH]RQD(YLWDUH la formazione di bolle d’aria. ŗ $SULUHORVSRUWHOORGHOORVWUXPHQWR(QWURVHFRQGLGDOOŐDSSOLFD]LRQHGHOFDPSLRQH LQVHULUHODVWULVFLDRUL]]RQWDOPHQWHOXQJRODJXLGDŰQRDOVHUUDJJLRFRPSOHWR5LFKLXdere lo sportello. ŗ 6XOGLVSOD\DSSDUHOŐDFURQLPRGHOSDUDPHWURWHVWVSHFLŰFRFKHFRQIHUPDLOFRUUHWWR inserimento della striscia reattiva e l’avvenuta lettura del codice magnetico. Il risultato viene visualizzato a seconda delle impostazioni programmate nello strumento. &DOLEUD]LRQH /DFXUYDGLIXQ]LRQHGHOWHVW5HűRWURQ&KROHVWHUROSHUFRQYHUWLUHLYDORULGLULűHVVLRQH LQFRQFHQWUD]LRQLªGHŰQLWDSHURJQLORWWRXWLOL]]DQGRLOPHWRGRSHULOFROHVWHUROR&+2' PAP) di Roche Diagnostics standardizzato contro la GC/MS. I parametri della curva vengono trasmessi automaticamente allo strumento attraverso la striscia magnetica durante l’esecuzione del test. &RQWUROORGLTXDOLW¿ 3HULOFRQWUROORGLTXDOLW¢LPSLHJDUH5HűRWURQ3UHFLQRUP85HűRWURQ3UHFLSDWK8R 5HűRWURQ&OHDQ&KHFN Gli intervalli e limiti del controllo dovranno essere conformi alle esigenze individuali di RJQLODERUDWRULR,YDORULRWWHQXWLGHYRQRULHQWUDUHQHLOLPLWLGHŰQLWL 2JQLODERUDWRULRGHYHGHŰQLUHGHOOHPLVXUHFRUUHWWLYHGDDWWXDUHQHOFDVRFKHDOFXQL valori siano al di fuori dei limiti. 3HULOFRQWUROORGLTXDOLW¢DWWHQHUVLDOOHQRUPDWLYHYLJHQWLHDOOHOLQHHJXLGDORFDOL &DOFROR La concentrazione di colesterolo viene calcolata automaticamente in base alle misura]LRQLHVHJXLWHQRQFK«DOOHIXQ]LRQLHDLIDWWRULGLFRQYHUVLRQHOHWWLQHOORVWUXPHQWRGDOOD VWULVFLDPDJQHWLFDFKHVLWURYDVXOODVXSHUŰFLHGLFRQWDWWRGLFLDVFXQDVWULVFLDUHDWWLYD$ seconda delle impostazioni programmate nello strumento, la concentrazione di colesteURORYLHQHYLVXDOL]]DWDLQXQLW¢FRQYHQ]LRQDOLPJG/RXQLW¢6,PPRO/ )DWWRUHGLFRQYHUVLRQHPJG/[ PPRO/ /LPLWLGHOPHWRGRŋLQWHUIHUHQ]H2,3 Non sono state osservate interferenze sui risultati del test da parte delle seguenti sostanze nelle concentrazioni controllate (valutazione: recupero ±10 % del basale): FRQFHQWUD]LRQLŰVLRORJLFKHGLELOLUXELQDVLHULOLSHPLFLYDORULGLHPDWRFULWRVLQRDO 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. $LŰQLGLDJQRVWLFLLULVXOWDWLGHYRQRVHPSUHHVVHUHYDOXWDWLFRQJLXQWDPHQWHFRQODVWRULD clinica del paziente, con gli esami clinici e con altre evidenze cliniche. La concentrazione di colesterolo (proporzionale al colorante formatosi) viene misurata DGXQDOXQJKH]]DGŐRQGDGLQPHDGXQDWHPSHUDWXUDGLr&GRSRFD secondi il display visualizza il risultato in mg/dL oppure mmol/L. 5HDJHQWL &RPSRQHQWLSHUWHVWFROHVWHURORHVWHUDVLPLFURUJDQLVPLū8FROHVWHURORRVVLdasi (Brevi ric. E. coliū832'UDIDQRū8ŐŐWHWUDPHWLOEHQ]LGLQD ƀJWDPSRQH 9DORULGLULIHULPHQWR4 <200 mg/dL oppure <5,2 mmol/L. 2JQLODERUDWRULRGHYHFRQWUROODUHOŐDSSOLFDELOLW¢GHLYDORULGLULIHULPHQWRDOODSURSULDSRSRlazione di pazienti e, se necessario, determinare intervalli di riferimento propri. 3UHFDX]LRQLHDYYHUWHQ]H Per uso diagnostico in vitro. 2VVHUYDUHOHSUHFDX]LRQLQRUPDOPHQWHDGRWWDWHQHOODPDQLSROD]LRQHGHLUHDJHQWLGL laboratorio. Scheda dati di sicurezza disponibile su richiesta per gli utilizzatori professionali. /RVPDOWLPHQWRGLWXWWLLULŰXWLGHYHDYYHQLUHVHFRQGROHGLUHWWLYHORFDOL (YLWDUHVHPSUHLOFRQWDWWRFRQOD]RQDGLUHD]LRQHGHOODVWULVFLDUHDWWLYDDGHVGXUDQWHLO pipettamento del campione). 'DWLVSHFLğFLVXOODSHUIRUPDQFHGHOWHVW ,GDWLUHODWLYLDOWHVW5HűRWURQ&KROHVWHUROVRQRVWDWLGHWHUPLQDWLLQDQDOLVLGLYDOXWD]LRQH /DPDJJLRUDQ]DGHLYDORULPLVXUDWLªULVXOWDWDDOOŐLQWHUQRGHJOLLQWHUYDOOLVSHFLŰFDWL 8WLOL]]RGHLUHDWWLYL Le strisce reattive sono pronte all’uso. /HWWHUDWXUD %UDXQ+3HWDO&OLQ&KHP 3ULFH3&.ROOHU38-&OLQ&KHP&OLQ%LRFKHPō .ROOHU38HWDO/DEPHGō (XURSHDQ$WKHURVFOHURVLV6RFLHW\1XWU0HWDE&DUGLRYDVF'LVF LOT 8OWLPRDJJLRUQDPHQWR 7DEHOODGHLVLPEROL Precisione Ripetibilità (precisione nella serie): &9FRHIŰFLHQWHGLYDULD]LRQHQHOOŐLQWHUYDOORQRUPDOHQHOOŐLQWHUYDOOR SDWRORJLFRFDPSLRQLVDQJXHHSDULQDWR Precisione intermedia (precisione intergiornaliera): &9QHOOŐLQWHUYDOORQRUPDOHQHOOŐLQWHUYDOORSDWRORJLFRFDPSLRQLVLHULGL controllo. Numero di catalogo 5() Codice del lotto 0088 9ROXPHGHOFDPSLRQHƀ/ ,QWHUYDOORGLPLVXUD ōPJG/RSSXUHōPPRO/ Nel caso in cui il valore di colesterolo misurato risulti al di sopra dell’intervallo di misura VSHFLŰFRGHOWHVW5HűRWURQ&KROHVWHUROLOFDPSLRQHSX´HVVHUHGLOXLWRFRQVLHUR 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 &RQIURQWRWUDPHWRGL ,OFRQIURQWRGHOWHVW5HűRWURQ&KROHVWHURO\FRQLOPHWRGRSHULO&+2'3$3[KD prodotto le seguenti correlazioni: \ [ōQ U FDPSLRQLVDQJXHHSDULQDWR Dispositivo medico-diagnostico in vitro IVD LOT Fabbricante Utilizzare entro LOT +30oC Limiti di temperatura (Conservare a) +2oC LOT Consultare le istruzioni per l’uso 0088 4XHVWRSURGRWWRªFRQIRUPHDLUHTXLVLWLGHOOD'LUHWWLYD(XURSHD &(UHODWLYDDLGLVSRVLWLYLPHGLFRGLDJQRVWLFLLQYLWUR 0088 /HDJJLXQWHRPRGLŰFKHVLJQLŰFDWLYHVRQRLQGLFDWHPHGLDQWHXQDOLQHDYHUWLFDOH posizionata al margine. IVD IVD 0088 IVD +30oC Nederlands +30oC WHVWHQ +2oC +2oC 7RHSDVVLQJ +30oC 7HVWYRRUGHNZDQWLWDWLHYHEHSDOLQJYDQFKROHVWHUROLQEORHGVHUXPRISODVPDPHW 5HűRWURQV\VWHPHQ +2oC 6DPHQYDWWLQJ &KROHVWHUROLVHHQVWHUR±GHPHWHHQVHFXQGDLUHK\GUR[\OJURHSLQGH&SRVLWLH +HWZRUGWLQHHQJURRWDDQWDOZHHIVHOVLQKHWEó]RQGHULQGHOHYHUHQGHGDUPZDQG JHV\QWKHWLVHHUG2QJHYHHUGULHNZDUWYDQGHFKROHVWHUROLQKHWOLFKDDPZRUGWGRRUGH ZHHIVHOVJHV\QWKHWLVHHUGWHUZóOHHQNZDUWDINRPVWLJLVYDQRSQDPHXLWKHWYRHGVHO'H bepaling van cholesterol wordt gebruikt voor het screenen op een atherogeen risico en voor de diagnose en de behandeling van aandoeningen met verhoogde cholesterolspieJHOVHQYDQVWRRUQLVVHQYDQGHOLSLGHHQOLSRSURWH±QHVWRIZLVVHOLQJ 7HVWSULQFLSH 1DRSEUHQJHQRSGHWHVWVWULSYORHLWKHWPRQVWHUQDDUKHWWHVWYHOG+LHUEóZRUGHQLQ het geval van bloed als monster de erytrocyten eerst van het plasma gescheiden. 'HFKROHVWHUROHVWHUVZRUGHQLQGHEóEHKRUHQGHYHW]XUHQHQFKROHVWHUROJHVSOLWVW FKROHVWHUROZRUGWYHUYROJHQVLQDDQZH]LJKHLGYDQ]XXUVWRIJHR[LGHHUGWRWFKROHVWHQRQ HQZDWHUVWRISHUR[LGH ,QHHQYROJHQGHGRRUKHWHQ]\PSHUR[LGDVHJHNDWDO\VHHUGHUHDFWLHR[LGHHUWKHW JHYRUPGHZDWHUVWRISHUR[LGHHHQUHGR[LQGLFDWRUZDDUEóHHQEODXZHNOHXUVWRIZRUGW gevormd, waarvan de hoeveelheid evenredig is met de cholesterolconcentratie in het monster: cholesterolcholesterolesters + H22õõõõõúFKROHVWHURO5&22+ esterase cholesterolFKROHVWHURO22 õõõõõú cholestenon + H222 R[LGDVH SHUR[LGDVH H222 + indicator õõõõõú kleurstof + H22 De cholesterolconcentratie (evenredig met de gevormde hoeveelheid kleurstof) wordt JHPHWHQEóHHQJRűHQJWHYDQQPHQHHQWHPSHUDWXXUYDQr&HQZRUGWQDFLUFD 150 seconden in mg/dL of mmol/L op de display weergegeven. 5HDJHQWLD %HVWDQGGHOHQYDQGHWHVW&KROHVWHUROHVWHUDVHPLFURRUJDQLVPHQū8FKROHVWHUROR[LGDVH%UHYLUHF(FROLū832'PLHULNVZRUWHOū8ŐŐWHWUDPHWK\OEHQ]LGLQHƀJEXIIHU 9RRU]RUJVPDDWUHJHOHQHQZDDUVFKXZLQJHQ Voor in vitro diagnostisch gebruik. 7UHIGHYRRU]RUJVPDDWUHJHOHQGLHJHEUXLNHOóN]óQYRRUKHWZHUNHQPHWODERUDWRULXPreagentia. (HQYHLOLJKHLGVLQIRUPDWLHEODGLVYRRUSURIHVVLRQHOHJHEUXLNHUVRSDDQYUDDJYHUNUóJEDDU 'HYHUZóGHULQJYDQDOOHDIYDOPDWHULDOHQGLHQWLQRYHUHHQVWHPPLQJWH]óQPHWGHORNDOH voorschriften. 9HUPóGLHGHUFRQWDFWPHWGHRSEUHQJ]RQHYDQHHQWHVWVWULSEYWóGHQVKHWSLSHWWHUHQ van het monster). %HKDQGHOLQJYDQGHUHDJHQWLD 'HWHVWVWULSV]óQJHUHHGYRRUJHEUXLN 2SVODJHQKRXGEDDUKHLG %óHHQWHPSHUDWXXUWXVVHQHQr&EHZDUHQ*HEUXLNGHWHVWVWULSVQLHWQDGH aangegeven vervaldatum. 0RQVWHUDIQDPHHQPRQVWHUYRRUEHZHUNLQJ &DSLOODLUEORHGYROEORHGDIJHQRPHQPHWVWDQGDDUGEORHGDIQDPHEXL]HQVHUXPJHKHSDULQLVHHUGRI('7$EORHGRIKHSDULQHRI('7$SODVPD 9HUVFDSLOODLURIYHQHXVYROEORHGPRHWGLUHFWQDGHDIQDPHZRUGHQJHEUXLNW('7$RU JHKHSDULQLVHHUGEORHGEHZDDUGLQHHQDIJHVORWHQEORHGEXLVEóHHQWHPSHUDWXXUYDQ ōr&PRHWELQQHQXUHQZRUGHQJHEUXLNWLQGLHQEHZDDUGEóHHQWHPSHUDWXXUYDQ ōr&ELQQHQXUHQ+HWPRQVWHUYµµUGHXLWYRHULQJYDQGHPHWLQJVFKXGGHQRPHHQ 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. ('7$RUJHKHSDULQLVHHUGSODVPDEHZDDUGLQHHQDIJHVORWHQEORHGEXLVEóHHQWHPSHUDWXXUYDQōr&PRHWELQQHQXUHQZRUGHQJHEUXLNWLQGLHQEHZDDUGEóHHQ WHPSHUDWXXUYDQōr&ELQQHQXUHQ0RQVWHUVQLHWLQYULH]HQ 9HUJHOHNHQPHWVHUXPPRQVWHUVZRUGHQPHWPRQVWHUV('7$EORHGRI('7$SODVPD UHVXOWDWHQYHUNUHJHQGLHPD[LPDDOODJHUOLJJHQ 0RQVWHUYROXPHƀ/ /LWHUDWXXUYHUZġ]LQJHQ %UDXQ+3HWDO&OLQ&KHP 3ULFH3&.ROOHU38-&OLQ&KHP&OLQ%LRFKHP .ROOHU38HWDO/DEPHG (XURSHDQ$WKHURVFOHURVLV6RFLHW\1XWU0HWDE&DUGLRYDVF'LVF LOT 'DWXPYDQXLWJLIWH 7DEHOPHWV\PEROHQ %HQRGLJGHPDWHULDOHQGRFKQLHWEġGHOHYHULQJLQEHJUHSHQ ŗ5HűRWURQDQDO\VHDSSDUDDW ŗ5HűRWURQSLSHW ŗ5HűRWURQSLSHWWLSV ŗ5HűRWURQFDSLOODLUHEXLVMHV ŗ5HűRWURQ3UHFLQRUP85HűRWURQ3UHFLSDWK8RI5HűRWURQ&OHDQ&KHFN ŗ$OJHPHHQJHEUXLNHOóNHODERUDWRULXPDSSDUDWXXUHQEHQRGLJGKHGHQ 8LWYRHULQJYDQGHWHVW Volg voor een optimale uitvoering van de bepaling de in dit document voor het betrefIHQGHDQDO\VHDSSDUDDWJHJHYHQDDQZó]LQJHQ]RUJYXOGLJRS5DDGSOHHJGHEHWUHIIHQGH KDQGOHLGLQJYRRUVSHFLDDOYRRUKHWDQDO\VHDSSDUDDWEHGRHOGHDDQZó]LQJHQYRRUKHW uitvoeren van de bepaling. ŗ 1HHPHHQWHVWVWULSXLWGHűDFRQ6OXLWGHĠDFRQQDKHWXLWQHPHQYDQHHQWHVWVWULS RQPLGGHOOġNZHHUJRHGDIPHWGHGRS ŗ 9HUZóGHUGHDOXPLQLXPEHVFKHUPIROLHYDQGHWHVWVWULS]RQGHUGHWHVWVWULSWHEXLJHQ ŗ 9RRUDOOH5HűRWURQWHVWHQLVHHQPRQVWHUYROXPHYDQƀ/EHQRGLJG ŗ %UHQJGHEHQRGLJGHKRHYHHOKHLGPRQVWHUPHWHHQSLSHWEYGH5HűRWURQSLSHW zonder de opbrengzone te raken op in het PLGGHQYDQGHURGHRSEUHQJ]RQH9HUPóG de vorming van luchtbellen. ŗ 2SHQGHNOHSRIKHWDIGHNVFKXLIMH3ODDWVGHWHVWVWULSELQQHQVHFRQGHQQDKHW opbrengen van het monster op de geleider en schuif deze horizontaal naar voren tot GH]HRS]óQSODDWVYHUJUHQGHOGZRUGW6OXLWGHNOHSUHVSKHWDIGHNVFKXLIMH ŗ $OVGHWHVWVWULSFRUUHFWLVJHSODDWVWHQGHPDJQHWLVFKHFRGHLVDIJHOH]HQZRUGWGH afkorting van de parameter op de display weergegeven. Het resultaat wordt afhankeOóNYDQGHLQVWHOOLQJYDQKHWDSSDUDDWRSGHGLVSOD\ZHHUJHJHYHQ Lot nummer 0088 Medisch hulpmiddel voor in-vitro diagnostiek IVD LOT Fabrikant Houdbaar tot LOT +30oC 7HPSHUDWXXUOLPLHW%HZDUHQELM +2oC LOT Raadpleeg de gebruiksaanwijzing 0088 'LWSURGXFWYROGRHWDDQGHHLVHQYDQGH(XURSHVH5LFKWOLMQ(* betreffende medische hulpmiddelen voor in-vitrodiagnostiek 0088 6LJQLŰFDQWHDDQYXOOLQJHQRIZLM]LJLQJHQZRUGHQDDQJHJHYHQGRRUHHQZLM]LJLQJVEDONLQ de marge. IVD0088 IVD IVD +30oC +30oC +2oC +2oC +30oC +2oC .DOLEUDWLH 'HIXQFWLHFXUYHYDQGH5HűRWURQ&KROHVWHUROWHVWYRRUGHRP]HWWLQJYDQUHűHFWLHwaarden in concentraties wordt voor iedere charge bepaald m.b.v. de cholesterol &+2'3$3EHSDOLQJYDQ5RFKH'LDJQRVWLFVGLHJHVWDQGDDUGLVHHUGLVWRY*&06'H SDUDPHWHUVYDQGHFXUYHZRUGHQWóGHQVGHXLWYRHULQJYDQGHWHVWGPYGHPDJQHWLsche strip automatisch aan het analyseapparaat overgedragen. .ZDOLWHLWVFRQWUROH 9RRUNZDOLWHLWVFRQWUROHNXQWX5HűRWURQ3UHFLQRUP85HűRWURQ3UHFLSDWK8RI5HűRWURQ Clean + Check gebruiken. De intervallen en de grenswaarden van de controles dienen te worden aangepast aan de YRRUVFKULIWHQHQULFKWOóQHQGLHKHWODERUDWRULXPKDQWHHUW De verkregen waarden dienen binnen de vastgestelde grenswaarden te liggen. Ieder laboratorium dient vast te leggen, welke correctiemaatregelen moeten worden genomen, als de waarden buiten het grenswaardenbereik liggen. 9ROJGHJHOGHQGHYRRUVFKULIWHQYDQGHRYHUKHLGHQORNDOHULFKWOóQHQPEWNZDOLWHLWVcontrole zorgvuldig op. %HUHNHQLQJ De cholesterolconcentratie wordt met behulp van de functie- en omrekeningsfactoren, GLHYDQGHPDJQHWLVFKHVWULSDDQGHRQGHU]óGHYDQLHGHUHWHVWVWULSZRUGHQDIJHOH]HQ DXWRPDWLVFKXLWGHXLWJHYRHUGHPHWLQJHQEHUHNHQG$IKDQNHOóNYDQGHJHNR]HQLQVWHOling van het apparaat op conventionele- of SI-eenheden wordt de cholesterolconcentratie weergegeven in mg/dL of mmol/L. 2PUHNHQLQJVIDFWRUPJG/[ PPRO/ %HSHUNLQJHQVWRULQJHQ2,3 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. 9RRUKHWVWHOOHQYDQHHQGLDJQRVHGLHQHQGHUHVXOWDWHQDOWóGLQFRPELQDWLHPHWGH anamnese, het klinisch onderzoek en andere bevindingen te worden beoordeeld. 0HHWEHUHLN ōPJG/RIōPPRO/ ,QGLHQGHJHPHWHQFKROHVWHUROZDDUGHERYHQKHWPHHWEHUHLNYDQGH5HűRWURQ 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 Cverd worden berekend: C = 2 Cverd - C0. LOT 5HIHUHQWLHJHELHGHQ4 < 200 mg/dL of < 5,2 mmol/L. Ieder laboratorium dient te controleren of de aangegeven referentiegebieden ook voor KDDUHLJHQSDWLQWHQSRSXODWLHJHOGLJ]óQHQLQGLHQQRRG]DNHOóNHLJHQUHIHUHQWLHJHELHden te bepalen. 6SHFLğFDWLHVYDQGHWHVW 'HJHJHYHQVYDQGH5HűRWURQ&KROHVWHUROWHVWZHUGHQYHUNUHJHQLQHYDOXDWLHVWXGLHV'H meerderheid van de meetresultaten lag binnen de aangegeven bereiken. Precisie Herhaalbaarheid (precisie in de serie): 9&YDULDWLHFRIŰFLQWLQKHWQRUPDOHEHUHLNLQKHWSDWKRORJLVFKHEHUHLN monstermateriaal: gehepariniseerd bloed. Intermediaire precisie (precisie van dag tot dag): 9&LQKHWQRUPDOHEHUHLNLQKHWSDWKRORJLVFKHEHUHLNPRQVWHUPDWHULDDO controlesera. 0HWKRGHQYHUJHOġNLQJ 9HUJHOóNLQJYDQGH5HűRWURQ&KROHVWHUROWHVW\PHWGH&+2'3$3EHSDOLQJ[UHVXOteerde in de volgende correlaties: \ [ōQ U PRQVWHUPDWHULDDOJHKHSDULQLVHHUGEORHG 0088 5()/27521 and 35(&,1250 are trademarks of Roche. IVD © 2010, Roche Diagnostics Diagnostics GmbH " Roche 6DQGKRIHU6WUDVVH '0DQQKHLP*HUPDQ\ www.diavant.com www.roche.com +30oC +2oC pi_05904218001_01_INT_420x297_IFU.indd 2 Catalogus nummer 5() *HOHYHUGHPDWHULDOHQ űDFRQPHWWHVWVWULSV R1 (black) 30.07.2010 09:57:32