hs-CRP - Drug testing supplies from CLIA waived,Inc, drug tests
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1. T 1 e Manufacturer Use By M Fecha de caducidad Temperature Limitation Fabricante Verfallsdatum L mite de temperatura Hersteller e Utilizzare entro e Temperaturbereich e Fabbricante e Utiliser avant le eLimiti di temperatura Fabricant Utilizar at Limite de temp rature Fabricante eAnv nd fore Limites de temperatura Tillverkad av Holdbar til e Temperaturbegr nsning Fremstillet af Huspounvia AnEnc Temperaturbegransning e Katackeua Thc e leprLopLou c 6eppokpao aq REP e Authorized Representative in the European Community eRepresentante autorizado en la Uni n Europea Bevollm chtigter in der EG Mandatario autorizzato per la Comunit Europea e Mandataire dans la Communaut europ enne Mandat rio na Comunidade Europeia Auktoriserad representant i Europeiska gemenskapen Repraesentant i det Europ iske F llesskab e EEOUOLO OTN VOG AVTLNP OWTOG yla tnv Eupwnaik Kow tntra b BE Biological Risks eConsult instructions for use Riesgos biol gicos eConsulte las instrucciones de uso Biologische Risiken Gebrauchsanweisung beachten Rischi biologici Consultare le istruzioni per l uso Risques biologiques e Consulter le mode d emploi Riscos biol gicos Consultar as instru es de utiliza o Biologiska risker e Konsultera bruksanvisningen eBiologiske risici eSe brugsanvisningen BioAoyiKoi Kivouvot ezuufgouAeurs re Tic o ny eq xenon2. Cassette Handling Cassettes should sit at room temperature for 10 minutes before opening the pouch Use the cassette as soon as the pouch is opened Sample Requirement e Sample Volume 50 uL of whole blood or 40 uL of serum or plasma Fingerstick whole blood Collect the sample from a fingerstick into a 50 uL Cholestech Capillary Tube See the Fingerstick Procedure below Place the blood into the cassette within 5 minutes after collection e Blood from the fingerstick should flow freely into the capillary tube Too much squeezing of the finger may produce inaccurate results Venous whole blood e Collect blood into a green top tube lithium or sodium heparin anticoagulant or a serum tube without additives NOTE Do not use a tube with any other additives because it may cause inaccurate results e Whole blood should be used within thirty minutes Blood sample may be taken directly from the tube after mixing e Serum samples should be allowed to clot for 30 minutes Serum should be separated from the blood cells immediately and stored refrigerated in a tightly sealed sample tube at 2 8 C 36 46 F until testing is performed e Samples should be at room temperature before testing e Mix all samples by inverting gently 7 8 times before testing Do not use the Cholestech capillary tubes for measuring venous whole blood or serum e Use a Cholestech LDX 50 uL MiniPet Pipette and tips or a micropipetter that is calibrated
3. which is typically less than 10 mg L CRP levels in conditions characterized by chronic inflammation such as rheumatoid arthritis and certain other rheumatic disorders are likewise characterized by significant elevations Conventional CRP assays have therefore been optimized to facilitate measurement of dynamic increases in concentration But this is achieved at the expense of sensitivity to detect low level increases due to more subtle causes of inflammation Low level increases in CRP have been reported in various conditions and disease states that are thought to be associated with inflammation 3 6 The most prominently studied utility has been for cardiovascular disease where CRP has been reported to predict cardiovascular outcomes independently of other conventional markers of risk 4 7 8 Increases in CRP are nonspecific however and should be interpreted in the context of a complete clinical evaluation Elevated values observed in an apparently healthy individual should be repeated in order to help rule out a recent response to undetected infection or tissue injury 8 TEST PRINCIPLE The Cholestech LDX System is a desk top analyzer that utilizes dry chemistry cassettes and reflectance photometry to quantify substances in blood Samples used for testing can be whole blood from a fingerstick collected in a lithium heparin coated capillary tube serum or anticoagulated whole blood collected by venipuncture The sample is applied to a Choles
4. collect another drop of blood massage the finger again from base to tip NOTE A warm hand and good blood flow from the puncture site are essential in order to collect a good capillary sample Fill the capillary tube in under 10 seconds Using the Cholestech MiniPet Pipettes Use this procedure to apply a venous sample control sample or proficiency testing material to the cassette Use a 50 uL MiniPet Pipette for venous whole blood Use a 40 pL MiniPet Pipette for serum controls samples or proficiency testing material Any pipette that can accurately deliver the correct volume may also be used l Firmly attach the pipette tip to the end of the MiniPet Pipette 2 Tofill the pipette push the plunger down as far as you can Place the pipette tip into the sample and slowly release the plunger Do not allow air to be drawn into the tip 3 Dispense the sample into the cassette sample well by pressing the plunger again Move the pipette tip out of the sample well before releasing the plunger 4 Remove the pipette tip and throw it away in a biohazardous waste container NOTE 1 Keep the cassette horizontal at all times after applying the sample 2 If the plunger is released before the pipette tip is out of the sample well it will remove the sample just dispensed QUALITY CONTROL Quality Control should be run routinely to confirm that your Cholestech LDX System is giving accurate results We recommend the following Quality Control
5. procedures for the Cholestech LDX System Choice of Materials A high and a low control is preferred Cholestech branded controls work well with the Cholestech LDX System If you use other controls you will need to establish ranges for the Cholestech LDX System Handling e Follow the instructions that are included with your controls e Check the expiration date before use Do not use expired controls e Use a 40 yL pipette e Run the Cholestech LDX System in Serum mode see Setting the Configuration Menu in the Cholestech LDX System User Manual e See Running a Test above for the procedure NOTE If you will be running fingerstick or whole blood samples after you have tested Quality Control materials be sure to change the sample type in the configuration menu to whole blood mode prior to running the fingerstick or whole blood samples External Quality Control External controls must also be used to demonstrate that the reagents and assay procedure perform properly Level 1 and Level 2 Controls containing CRP are available from Cholestech Controls must be tested e with each new shipment of cassettes even if cassettes are from the same lot previously received with each lot of cassettes received as required by your laboratory s standard Quality Control procedures each day that patient samples are tested if your local or state regulations require more frequent testing of Quality Control material Good
6. to deliver 50 uL to place whole blood into the cassette e Use a Cholestech LDX 40 uL MiniPet Pipette and tips or a micropipetter that is calibrated to deliver 40 uL to place serum or plasma into the cassette e Serum or plasma samples may be stored for at least 7 days at 2 8 C 9 Serum or plasma samples should be stored frozen if they are to be kept for longer PRECAUTION All blood samples containers capillary tubes and materials that have come in contact with whole blood serum or plasma should be handled as if capable of transmitting infectious disease and discarded into a biohazardous waste container after use Calibration No calibration is performed by the user Test information is encoded on the brown magnetic stripe of the cassette The magnetic stripe is read by the Cholestech LDX Analyzer each time a cassette is run An Optics Check should be run on the Cholestech LDX Analyzer each day before patient samples are tested See the Cholestech LDX User Manual for instructions TEST PROCEDURE Materials Provided hs CRP Cassette Ue Materials Required Cholestech LDX Analyzer and power supply Alcohol swabs and gauze for cleaning puncture site Lancets for capillary blood collection Cholestech LDX 50 uL Capillary Tubes with lithium heparin anticoagulant only Cholestech LDX Capillary Plungers Latex Gloves Biohazard waste containers Quality Control material Cholestech MiniPet Pipette and tips or micropipetter that wil
7. 997 40 723 7 6 Schmidt R Schmidt H Curb JD Masaki K et al Early inflammation and dementia a 25 year follow up of the Honolulu Asia Aging Study Ann Neurol 2002 52 168 74 7 Danesh J Whincup P Walker M Lennon L et al Low grade inflammation and coronary heart disease prospective study and updated meta analyses BMJ 2000 321 199 204 8 Pearson TA Mensah GA Alexander RW Anderson JL et al Markers of inflammation and cardiovascular disease application to clinical and public health practice a statement for healthcare professionals from the Centers for Disease Control and Prevention and the American Heart Association Circulation 2003 107 499 511 9 Ledue TB Rifai N Preanalytic and analytic sources of variations in C reactive protein measurement Implications for cardiovascular disease risk assessment Clin Chem 2003 49 1258 71 10 Rifai N Ridker PM Population distributions of C reactive protein in apparently healthy men and women in the United States implication for clinical interpretation Clin Chem 2003 49 666 9 11 National Committee for Clinical Laboratory Standards Evaluation of precision performance of clinical chemistry devices approved guideline NCCLS document EP5 A 1999 Wayne PA CLIA warvedcom For more information please contact CLIAwaived Inc at TEL 858 481 5031 roLL FREE 888 882 7739 E MAIL info cliawaived com wes www cliawaived com Distributed by CLIAwaived Inc San Diego CA
8. LDX hs CRP High Sensitivity C Reactive Protein Test Cassette REF 12 807 For professional in vitro diagnostic use C lj CHOLESTECH 5 3347 Investment Blvd Hayward CA 94545 U S A Cholestech LDX is a registered trademark of Pede Tel 1 800 733 0404 Cholestech Corporation MiniPet is a trademark of TriContinent Scientific Inc Fax 1 510 732 7227 2005 Cholestech Corporation 402 12786 REV B www cholestech com One or more of the following patents may apply U S Patents Ec REP REP Authorized Representative 4 477 575 4 816 224 and 5 110 724 EC ip Ltd Runnymede Malthouse Egham TW20 9BD United Kingdom Refer to the CD in the analyzer package for instructions in English The instructions are available from your local distributor Le CD contenu dans l emballage de l analyseur inclut les directives d utilisation en francais Le mode d emploi est disponible aupr s du distributeur local Anweisungen auf Deutsch befinden sich auf der CD in der Verpackung des Analyseger ts Die Anleitung ist von Ihrem Handler erhaltlich Fare riferimento al CD nella confezione dell analizzatore per istruzioni in italiano Le istruzioni sono disponibili presso il distributore di zona Consulte el CD incluido en el envase del analizador para obtener instrucciones en espa iol Tambi n puede pedir las instrucciones a su distribuidor local Consulte o CD no pacote do analisador para instru es em Portugu s As instru es
9. Laboratory Practice principles suggest that external controls must be run whenever the laboratory director has any question about test system integrity or operator technique e g when reagents may have been stored or handled in a way that can degrade their performance or when operators have not performed a particular test in recent weeks If the controls do not perform as expected repeat the test or contact Cholestech Technical Service prior to testing patient samples The Quality Control results should be within range before testing patient samples Refer to the Cholestech LDX User Manual if they are not Please call Cholestech Technical Service at 1 800 733 0404 or 510 732 7200 if you have any questions about quality control RESULTS hs CRP test results will show on the screen when the test is complete LIMITATIONS The measuring range for hs CRP using whole blood or fingersticks is 0 30 10 00 mg L Results outside this range will appear as 0 30 or gt 10 00 The measuring range for hs CRP using serum or plasma is 0 30 8 00 mg L Results outside this range will appear as 0 30 or gt 8 00 Increases in CRP are nonspecific and should be interpreted in the context of a complete clinical evaluation hs CRP values gt 8 00 mg L observed in an apparently healthy individual should be repeated in order to help rule out a recent response to undetected infection or tissue injury 8 The substances listed below were tested for interference wi
10. est o dispon veis junto do seu distribuidor local Der henvises til den vedlagte CD i analysatorpakken for instruktioner p dansk Instruktionerne f s hos den lokale forhandler Se CD n i analysatorf rpackningen betr ffande instruktioner pa svenska Instruktionerna finns att fa hos din lokala terf rs ljare Avatp te oto CD otn cuokeuao a rou avaAuTH yra odnyies ora EAAnvuk OL odnyies eivat aO otpeg AMO rov TOTILKO ravop a OAG INTENDED USE Cholestech LDX high sensitivity C Reactive Protein hs CRP is an in vitro diagnostic test for the quantitative determination of C reactive protein in whole blood or serum Measurement of CRP is useful as an aid in the detection and evaluation of infection tissue injury inflammatory disorders and associated diseases INTRODUCTION CRP is an acute phase reactant that responds as a sensitive though nonspecific marker of systemic inflammation The pentameric globular protein is synthesized by the liver in response to stimuli from circulating inflammatory cytokines CRP has traditionally been used as a systemic marker of infection and tissue injury An expanding body of research now indicates that CRP likely plays a direct active inflammatory role in blood vessels leading to the development of atherosclerosis 2 Within 24 48 hours of an infectious or noninfectious stimulus CRP levels may rise up to 3 000 fold over the circulating levels seen in apparently healthy individuals
11. f the sample well with the tip of the capillary tube or pipette NOTE Fingerstick samples must be applied within five 5 minutes after collection or the blood may clot 7 Keep the cassette flat after the sample has been applied Place the cassette into the drawer of the Analyzer immediately The black bar must face the Analyzer The magnetic stripe must be on the right 8 Immediately Press RUN The drawer will close During the test the display screen will read 9 Discard everything that contacted the blood sample or Quality Control material into a biohazardous waste container 10 When the test is complete the Analyzer will beep The display screen will read 11 When the results are outside the measuring range the screen will read Fingerstick or Whole Blood Serum 12 Ifthere is a problem with the test an error message will appear on the screen See the Troubleshooting section of the Cholestech LDX User Manual for additional information Please call Cholestech Technical Service at 1 800 733 0404 or 1 510 732 7200 if you have any questions about the Cholestech LDX System 13 When the drawer opens remove the cassette Discard into a biohazardous waste container Leave the Cholestech LDX Analyzer drawer empty when not in use 14 Record the hs CRP results 15 To run another cassette press RUN The screen will read 16 Repeat the test procedure 17 Otherwise after 4 minutes of inactivity a beep wi
12. ick 78 1 08 0 00 0 98 0 17 8 75 REFERENCES 1 Pepys MB C reactive protein fifty years on Lancet 1981 1 653 7 2 Szmitko PE Wang CH Weisel RD de Almeida JR et al New markers of inflammation and endothelial cell activation Part Circulation 2003 108 1917 23 3 Wasunna A Whitelaw A Gallimore R Hawkins PN Pepys MB C reactive protein and bacterial infection in preterm infants Eur J Pediatr 1990 149 424 7 4 Ridker PM Clinical application of C reactive protein for cardiovascular disease detection and prevention Circulation 2003 107 363 9 5 Spector TD Hart DJ Nandra D Doyle DV et al Low level increases in serum C For In Vitro Diagnostic Use Para uso diagn stico in vitro e n vitro Diagnostikum eEsclusivamente per uso diagnostico in vitro Pour usage diagnostique in vitro Para utiliza o em diagn stico in vitro eF r diagnostisk anv ndning in vitro Til in vitro diagnostisk brug ia in vitro S ayVWOTLKN xporjon REF eCatalog Number e N mero de cat logo e Katalognummer de uso e Numero di catalogo Achtung G e Num ro de catalogue e Attenzione eNumero de cat logo e Attention Katalognummer Katalognummer e AplLOL G KATAAOYOU utiliza o OBS Se br 1poooyf AN e Attention See instructions for use e Atenci n Consulte las instrucciones ebrauchsanweisung beachten Vedere le istruzioni per l uso Voir le mode d emploi Atenc o Consulte as instru es de u
13. ksanvisningen Bemark Se brugsanvisningen BA ne odnyiec xoronc D Do not reuse o reutilizar icht zur Wiederverwendung on riutilizzare e pas r utiliser N o reutilizar Ateranvand ej ikke genbruges 1a in vitro SuayvwotuKh xenon Do not use if package is damaged or open No utilizar si el envase est abierto o da ado Nicht verwenden wenn Verpackung ge ffnet oder besch digt ist Non usare se la confezione aperta o danneggiata eNe pas utiliser si l emballage est ouvert ou endommag N o utilizar se a embalagem se apresentar aberta ou danificada eFar inte anv ndas om f rpackningen skadats ler ppnats eMa ikke anvendes hvis pakken er beskadi get eller abnet eMn xpnouiorotre re dv n ouckeuao a XEL UNOOTE CQnpt fj XEL avorxtet 15 LOT e ot Number eN mero de lote eChargennummer Codice del lotto eNum ro de lot e N mero de lote ePartinummer e otnummer e ApLOL G napr oaq hs CRP Commercial Commercial Control Material Control Material Frozen Level 1 Level 2 Serum Pool X mg L 1 20 2 94 6 51 Within run CV 12 1 11 7 8 7 Total CV 96 14 3 11 5 11 4 Whole Blood Within Run Precision Level 1 Level 2 Level 3 Level 4 X mg L 0 60 1 22 2 89 4 85 SD mg L 0 09 0 21 0 33 0 32 CV 15 0 17 2 11 4 6 6 reactive protein are present in early osteoarthritis of the knee and predict progressive disease Arthritis Rheum 1
14. l deliver 5O uL for use with whole blood venipuncture samples and 40 uL for use with serum plasma and Quality Control material e Vacuum collection tubes needles tube holders and sample tubes ifthe sample is to be collected by venipuncture inning a Test Remove the cassette pouch from the refrigerator 4 Let the cassette pouch sit at room temperature for a minimum of 10 minutes 3 Remove the cassette from its pouch Hold the cassette by the short sides only Do not touch the black bar or the magnetic stripe Place the cassette on a clean hard flat surface NOTE Gloves should be worn whenever working with blood samples that are potentially biohazardous NOTE When running a fingerstick or venous whole blood the configuration menu must be set for whole blood When running serum or plasma quality control or proficiency testing material the configuration menu must be set for serum See Setting the Configuration Menu in the Cholestech LDX System User Manual 4 Press RUN In a few seconds the screen will read b The cassette drawer will open The screen will read 6 Place the sample into the cassette s sample well Use a Cholestech LDX 50 uL Capillary Tube for fingerstick samples Use the Cholestech 5OuL MiniPet Pipette for venous whole blood use the Cholestech 40uL MiniPet Pipette for serum plasma Quality Control material and proficiency testing material NOTE Do not touch the white material at the end o
15. ll sound and the display screen will read If the RUN button is not pushed within 15 seconds the drawer will close and the display screen will be blank Fingerstick Procedure 1 The patient should sit quietly for five minutes before the blood sample is collected 2 Puta capillary plunger into the end of a Cholestech capillary tube with the green mark Set aside 3 Choose a spot that is on the side of one of the center fingers of either hand The fingers and hands should be warm to the touch To warm the hand you can a Wash the patient s hand with warm water or b Apply a warm not hot compress to the hand for several minutes or c Gently massage the finger from the base to the tip several times to bring the blood to the fingertip Clean the site with an alcohol swab Dry thoroughly before pricking the finger Firmly prick the selected site with a lancet Squeeze the finger gently to obtain a large drop of blood Wipe away this first drop of blood as it may contain tissue fluid 7 Squeeze the finger gently again while holding it downward until a second large drop of blood forms Do not milk the finger The puncture should provide a free flowing drop of blood D Oi gs 8 Hold the capillary tube horizontally by the end with the plunger Touch the end of the tube to the drop of blood without touching the skin The tube will fill by capillary action to the black mark Do not collect air bubbles If it is necessary to
16. tech LDX hs CRP cassette The cassette is then placed into the Cholestech LDX Analyzer where a unique system on the cassette separates the plasma from the blood cells Plasma is then incubated with a colloidal gold anti CRP conjugate A lateral flow system transfers the gold conjugate through an anti CRP antibody capture zone Gold conjugate containing CRP is captured by the antibody while the rest of the gold conjugate is washed away The signal in the capture zone is measured by the Cholestech LDX Analyzer A brown magnetic stripe on each cassette contains the calibration information required for the Cholestech LDX Analyzer to convert the reflectance reading R to hs CRP concentration in mg L hs CRP Each hs CRP Cassette contains CRP antibody gold conjugate Titered CRP Antibody Titered Nonreactive Ingredients buffers and stabilizers For in vitro diagnostic use only Cassette Storage and Stability Cassettes must be stored in the sealed foil pouches Cassettes may be used until the date printed on the pouch when stored in a refrigerator 36 46 F 2 8 C Or the cassettes may be stored for up to 30 days at room temperature less than 86 F 30 C Once cassettes have been stored at room temperature they should not be returned to the refrigerator Do not use a cassette beyond the printed expiration date Do not use a cassette that has been stored at room temperature for more than 30 days Do not reuse cassettes
17. th the hs CRP test Less than 10 interference was seen with the addition of the levels shown Substance Concentration mg dL hs CRP Interferents mg dL mmol L Ascorbic Acid 3 0 17 Bilirubin unconjugated 20 0 34 Creatinine 30 2 65 Ditaurobilirubin 20 0 24 Glucose 1200 66 61 Hemoglobin 120 0 02 Lactate 100 11 10 Potassium 39 10 00 Triglycerides 3000 33 88 Urea 500 83 25 Uric Acid 20 1 19 g dL g L Protein total 9 0 90 Protein albumin 3 0 30 Protein gamma globulin 4 5 45 Hematocrits from 30 to 55 do not affect results EXPECTED VALUES hs CRP values range between 0 28 and 8 55 mg L in healthy men and between 0 19 and 9 14 mg L in healthy women who are not taking hormone replacement therapy 10 hs CRP values 8 00 mg L observed in an apparently healthy individual should be repeated in order to help rule out a recent response to undetected infection or tissue injury Precision A study was conducted according to NCCLS protocol EP5 A Evaluation of Precision Performance of Clinical Chemistry Devices Approved Guideline 1999 11 ACCURACY METHOD COMPARISON hs CRP measured using the Cholestech LDX cassette was compared to a nephelometric reference method Results X 2 Commercial Method serum Y Cholestech LDX Analyzer Sample No of y Correlation Range Type LDX Pairs Slope Intercept Coefficient of Values Serum 12 1 02 0 21 0 98 0 17 7 18 Venous Whole Blood 78 1 06 0 07 0 98 0 17 8 75 Fingerst
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