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HemosIL™ PT-Fibrinogen HS PLUS - 0008469810 …

84698-05 R13 12/2004 HemosIL™ Instrumentation Laboratory Company - Lexington, MA 02421-3125 (USA) Instrumentation Laboratory SpA - V.le Monza 338 - …




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Text of HemosIL™ PT-Fibrinogen HS PLUS - 0008469810 …

84698-05 R13 12/2004HemosIL Instrumentation Laboratory Company - Lexington, MA 02421-3125 (USA)Instrumentation Laboratory SpA - Monza 338 - 20128 Milano (Italy)PT-Fibrinogen HS PLUS - 0008469810ENGLISH - Insert revision 12/2004ACL Futura/ACL AdvanceMean (PT seconds)CV % (Within run)CV % (Total)Normal Abnormal Abnormal FamilyMean (Fibrinogen mg/dL) CV % (Within run)CV % (Total)Normal Fibrinogen Futura/ACL AdvanceMean (Fibrinogen mg/dL) CV % (Within run)CV % (Total)Normal Fibrinogen :AssaysystemslopeinterceptrReference methodPTACL on ACLPTACL Futura/ACL HS PLUS on ACLFibACL (PT based) on ACLFibACL Futura/ACL (PT HS PLUS based) on ACLThese precision and correlation results were obtained using specific lots ofreagents and Linearity:SystemACL Futura/ACL Advance80 - 700 mg/dLACL Family75 - 1000 mg/dLDue to many variables which may affect results, each laboratory should establishits own Linearity certificationVariable PT results may occur when samples are tested with thromboplastins ofvarious sources and/or using different techniques (manual, semi/fullyautomated).7,8 The ICSH (International Committee for Standardization inHaematology) and the ICTH (International Committee on Thrombosis andHaemostasis) have proposed the ISI (International Sensitivity Index) as astandardization to calculate INR (International Normalized Ratio) and givecomparable PT results for OAT batch of PT-FIB HS PLUS is calibrated against a House Standard with anISI certified against the correspondent international reference standard(CRM 149S) according to the WHO values in the insert sheet are measured using IL Coagulation in INR are automatically given when the ISI value is entered in the ILCoagulation INR is calculated as follows:INR = (Patient s PT/Mean of PT normal range)ISIThe ISI values of this lot are reported in the last section of this insert rangeFor OAT indications11 and duration of treatment make reference to useA very high sensitivity calcium thromboplastin for simultaneous determinations ofProthrombin Time (PT) and Fibrinogen (Fib), for evaluation of the extrinsiccoagulation pathway and monitoring Oral Anticoagulant Therapy in humancitrated plasma on the IL Coagulation PT-FIB HS PLUS is a lyophilized rabbit brain extract with an optimalconcentration of calcium ions. This product is manufactured with high sensitivityto Factor II, V, VII and X, comparable to International Reference Preparations,making it particularly suitable for monitoring PT-Fibrinogen HS PLUS kit consists of:T Thromboplastin (Cat. No. 0008469820): 5 x mL vials of rabbit brainthromboplastin with stabilizers, polybrene and Buffer (Cat. No. 0008469822): 5 x mL vials of buffer with CaCl2 AND WARNINGS:Avoid contact with skin and eyes (S 24/25). Do not empty into drains (S 29).Wear suitable protective clothing (S 36).The Buffer contains sodium azide that may form explosive azides in metalplumbing. Use proper disposal the ISI value from the insert and establish the Mean of the PT NormalRange with each new product is For in vitro Diagnostic the contents of each vial of thromboplastin by pouring the entirecontents of one vial of buffer into the reagent vial. Replace the stopper and swirlgently. DO NOT try to pipette the exact volume required for reconstitution ofThromboplastin reagent. Make sure of the complete reconstitution of theproduct. Keep the reagent at 15-25 C for 30 minutes (ACL Family) and overnightat 2-8 C (ACL Futura /ACL Advance) and invert to mix before use. Do not storage and stabilityUnopened reagent is stable until the expiration date shown on the vial, whenstored at 2-8 after reconstitution: 5 days at 2-8 C in the original vial, 12 hours at 15 Con the IL Coagulation Systems under continuous stirring. For optimal stabilityremove reagent from the system and store it at 2-8 C in the original proceduresRefer to the appropriate IL instrument s Operator s Manual and/or ApplicationManual for the complete assay procedure collection and preparationNine parts of freshly drawn venous blood are collected into one part trisodiumcitrate. Refer to NCCLS Document H21-A4 for further instructions on specimencollection, handling and reagents and control plasmasThe following are not supplied with the kit and must be purchased and Pacific RimEuropeCat. plasma00200000000008467300Normal Control00200031200020003110Low Abnormal Control00200032200020003210High Abnormal Control00200033200020003310Low Fibrinogen Control00200042000020004200Sample diluent00097568000009756800Factor diluent00097576000009757600Cleaning solution00098317000009831700Quality controlNormal and Abnormal controls are recommended for a complete quality ,4 Normal Control, Low Abnormal Control, High Abnormal Control andLow Fibrinogen Control are designed for this program. Each laboratory shouldestablish its own mean and standard deviation and should establish a qualitycontrol program to monitor laboratory testing. Controls should be analyzed atleast once every 8 hour shift in accordance with good laboratory practice. Referto the instrument s Operator s Manual for additional information. Refer toWestgard et al for identification and resolution of out-of-control results may be reported in the following units:PT: seconds, % activity, Ratio, INRFibrinogen: mg/dL, g/LRefer to the instrument s Operator s Manual for additional substancesPT results may be affected by many commonly administered drugs and furtherstudies should be made to determine the source of unexpected abnormal assay results (PT-based method) may be affected by degradationproducts (fibrin or fibrinogen) in the plasma interference on the IL Coagulation Systems up U/mL100 mg/dL700 mg/dL15 U/mL100 mg/dL700 mg/dL15 mg/dLExpected valuesA normal range study was performed using PT-Fibrinogen HS PLUS (units)PTACL - (seconds)PTACL Futura /ACL - (seconds)FibrinogenACL Family36169 - 515 (mg/dL)FibrinogenACL Futura/ACL Advance36140 - 533 (mg/dL)These results were obtained using a specific lot of reagent. Due to manyvariables which may affect clotting times, each laboratory should establish itsown reference characteristicsPrecision:Within run and total (run to run and day to day) precision were assessed overmultiple runs using both normal and abnormal FamilyMean (PT seconds)CV % (Within run)CV % (Total)Normal Abnormal Abnormal R13 12/2004Instrumentation Laboratory Company - Lexington, MA 02421-3125 (USA)Instrumentation Laboratory SpA - Monza 338 - 20128 Milano (Italy)HemosIL Symbols used / Verwendete Symbole / S mbolos utilizados / Symboles utilis s / Simboli impiegati / S mbolos utilizados / Anvendte symboler / Anv nda Symboler /Biological risksBiologisches RisikoRiesgo biol gicoRisque biologiqueRischio biologicoRisco biol gicoMilj oplysningerBiologiska riskerConsult instructions foruseBeilage beachtenConsultar la met dicaLire le mode d emploiVedere istruzioni per l usoConsultar as instru esde utiliza oSe vejledning foranvendelseTa del av instruktionenf re anv ndningBatch codeChargen-BezeichnungIdentificaci nn mero de loteD signation du lotNumero del lottoN mero de loteBatch byVerwendbar bisCaducidadUtilisable jusqu Da utilizzare primadelData l mite deutiliza oAnvendelseAnv ndningTemperaturelimitationFestgelegteTe mperaturTemperatura deAlmacenamientoTemp ratures limitesde conservationLimiti di temperaturaL mite detemperaturaTemperaturbegr nsningerTemperatur gr nsControlKontrollenControlContr leControlloControloKontrolKontrollIn vitro diagnosticmedical deviceIn-vitro DiagnostikumDe uso diagn stico invitroDispositif m dical dediagnostic in vitroPer uso diagnostico invitroDispositivo m dicopara utiliza o emdiagn stico in vitro in vitro diagnostiskudstyrIn vitro diagnostiskmedicinsk produktIn vitroManufacturerHergestellt vonFabricado porFabricantProdotto daFabricado porProducentTillverkareAuthorised representativeBevollm chtigterRepresentante autorizadoMandataireRappresentanzaautori zzataRepresentante autorizadoLeverand rAuktoriserad representantValue / Wert / Valor / Valeur / Valore / Valor / V rdi / V rde /VALUE1. Miale JB, and Kent JW. Standardization for the therapeutic range for oralanticoagulants based on standard reference plasmas, 1972; 57: National Committee for Clinical Laboratory Standards. Collection, Transport,and Processing of Blood Specimens for Testing Plasma-Based CoagulationAssays, Fourth Edition, NCCLS Document H21-A4; Vol. 23 No. National Committee for Clinical Laboratory Standards. One StageProthrombin Time (PT) Test and Activated Partial Thromboplastin Time(APTT) Test; Approved Guideline, NCCLS Document H47-A; Vol. 16 Zucker S, Cathey MH, and West B. Preparation of Quality Control Specimenfor Coagulation, 1970; 53: / Literatur / Bibliograf a / Bibliographie / Bibliografia /Bibliografia / Litteratur / Litteraturf rteckning /5. Westgard JO, and Barry PL. Cost-Effective Quality Control; Managing theQuality and Productivity of Analytical Process, AACC Press Rossi E, Mondonico P, Lombardi A, Preda L. Method for the determination offunctional (clottable) fibrinogen by the new family of ACL Res. 1988; 52: Van Rijn JLML, Schmidt NA, and Rutten WPF. Correction of Instrument-andReagent-Based Differences in Determination of the International NormalizedRatio (INR) for Monitoring Anticoagulant Therapy,Clinical Chemistry. 1989; 35 (5): Ray MJ, and Smith IR. The Dependence of the International Sensitivity Indexon the Coagulometer used to Perform the Prothrombin Time,Thromb. Haemost. 1990; 63 (3): ICSH/ICTH Recommendations for Reporting Prothrombin Time in OralAnticoagulant Control, Thromb. Haemost. 1985; 53 (1): Guidelines for thromboplastin and plasma used to control oral anticoagulanttherapy. In: WHO Expert Committee on Biological Standardization. 48thReport, WHO Technical Report Series 889; p. 64-93, Geneva, WHO, Hirsh J, Dalen JE, Deykin D, Poller L. Oral anticoagulants: mechanism ofaction, clinical effectiveness and optimal therapeutic 1992;102(4): and ACL Futura are registered trademarks of Instrumentation Laboratory. 1998 Instrumentation Laboratory. Issued December in

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