LDX_hsCRP_Package_In..
Contents
1. analytic sources of variations in C reactive protein measurement Implications for cardiovascular disease risk assessment Clin Chem 2003 49 1258 71 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 National Committee for Clinical Laboratory Standards Evaluation of precision performance of clinical chemistry devices approved guideline NCCLS document EP5 A 1999 Wayne PA IVD Para uso diagn stico in vitro e n vitro Diagnostikum e Esclusivamente per uso diagnostico in vitro e Pour usage diagnostique in vitro Para utiliza o em diagn stico in vitro e F r diagnostisk anv ndning in vitro Til in vitro diagnostisk brug e Medisinsk utstyr for in vitro diagnostikk In Vitro tan sal tibbi cihaz e Tia in vitro Siayvwotikh xenon e Na in vitro diagnostick pou itie REF eCatalog Number e N mero de cat logo e Katalognummer e Numero di catalogo e Num ro de catalogue e N mero de cat logo e Katalognummer e Katalognummer e Katalognummer e Katalog numaras e ApiOu kata you AN Caution consult accompanying documents Precauci n Consulte los documentos adjuntos e Achtung lesen Sie die beigelegten Dokumente e Attenzione Consultare la documentazione in allegato e Attention Consulter les documents joints Atenc o Consulte as instru2. es de utiliza o OBS Se bruksanvisningen e Forsigtig l s medf lgende dokumenter e Forsiktig se medf lgende dokumentasjon e Dikkat beraberindeki belgelere bakin poooyn ouuBouieuteite Ta ouvodeuTIKd Eyypaga e Pozor Pozri n vod na pou vanie Do not reuse No reutilizar Nicht zur Wiederverwendung Non riutilizzare Ne pas r utiliser Nao reutilizar Ateranv nd ej ikke genbruges Til engangsbruk e Tekrar kullanmay n e Mnv enavaypnoponoeite e Nepou vajte opakovane e Katal gov slo e Do not use if package is damaged or open e No utilizar si el envase est abierto o da ado Nicht verwenden wenn Verpac besch digt ist Ne pas utiliser si l emballage e endommag ou danificada e F r inte anv ndas om f rpackn ppnats a ikke anvendes hvis pakken abnet e Ma ikke brukes hvis innpakningen er skadet eller pen e Paket hasarl veya a lm sa kulla Mn xpnotporoie te eav n ouvokevaoia Exel UTOOTE nui rj yet avoiyte e Nepou va ak je obal po koden alebo otvoren e Non usare se la confezione aperta o danneggiata e N o utilizar se a embalagem se apresentar aberta LOT e Lot Number e N mero de lote e Chargennummer e Codice del lotto e Num ro de lot e N mero de lote e Partinummer e Lotnummer e Partinummer e Parti numaras ApiOu napti a e slo ar e kung ge ffnet oder st ouvert ou i
3. hard non absorbent flat surface IMPORTANT Gloves should be worn whenever working with blood samples IMPORTANT When running fingerstick or venous whole blood the configuration menu must be set for whole blood When running serum or plasma or control calibration verification or proficiency testing materials 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 display b The cassette drawer will open The screen will display 6 Place the sample into the cassette s sample well Use a Cholestech LDX 50 uL Capillary Tube for fingerstick samples Use the Cholestech 40 uL MiniPet Pipette for serum or plasma or control calibration verification or proficiency testing materials IMPORTANT Do not touch the white material at the end of the sample well with the tip of the capillary tube or pipette IMPORTANT Fingerstick samples must be applied within five 5 minutes or the blood will clot 7 Keep the cassette flat after the sample has been applied Immediately place the cassette into the drawer of the Analyzer The black reaction bar must face toward the Analyzer The brown magnetic stripe must be on the right 8 DO NOT PUSH IN THE DRAWER Immediately Press RUN The drawer will close During the test the screen will display 9 Put everything that touched the blood samples or control calibration
4. mg L 0 09 0 21 0 33 0 32 CV 15 0 17 2 11 4 6 6 REFERENCES Pepys MB C reactive protein fifty years on Lancet 1981 1 653 7 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 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 Ridker PM Clinical application of C reactive protein for cardiovascular disease detection and prevention Circulation 2003 107 363 9 Spector TD Hart DJ Nandra D Doyle DV et al Low level increases in serum Creactive protein are present in early osteoarthritis of the knee and predict progressive disease Arthritis Rheum 1997 40 723 7 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 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 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 Ledue TB Rifai N Preanalytic and
5. 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 to blood to the fingertip 4 Clean the site with an alcohol swab Dry thoroughly with a gauze pad hefore pricking the finger 5 Firmly prick the selected site with a lancet 6 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 8 Hold the capillary tube horizontally or at a slightly descending angle by the end with the plunger Touch it 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 ecessary to collect another drop of blood wipe the finger with gauze then massage again from base to tip until a large drop of blood forms 9 Fill the capillary tube within 10 seconds 10 Wipe off any excess blood from the finger and have the patient apply pressure to the puncture until the bleeding stops Using the Cholestech MiniPet Pipette Use 50 uL for venous whole blood U
6. LDX hs CRP High Sensitivity C Reactive Protein Test Cassette 12 807 ivo C Cholestech LDX and the Inverness Medical logo are registered trademarks of the Inverness Medical group of companies MiniPet is a trademark of TriContinent Scientific Inc 2010 Inverness Medical All rights reserved 22960 Rev A Protected by patents US 5744096 7220595 and 7238519 European Union EP1369473 Australia 735107 Canada 2280902 France 1546722 Germany 1546722 Hong Kong 1061043 and 1076864 Japan 3727952 New Zealand 337473 EC REP Taiwan 200404096 United Kingdom 1546722 other Authorized Representative rights granted and pending MDSS GmbH Schiffgraben 41 30175 Hannover m minverness medical Germany Biosite Incorporated 9975 Summers Ridge Road San Diego CA 92121 U S A Tel 1 877 441 7440 Fax 1 321 441 7400 www cholestech com Refer to the CD in the Cholestech LDX Analyzer package for instructions in English The instructions are also available from your local distributor Le CD contenu dans l emballage de l analyseur Cholestech LDX inclut les directives d utilisation en francais Le mode d emploi est galement disponible aupr s du distributeur local Anweisungen auf Deutsch befinden sich auf der CD in der Verpackung des Cholestech LDX Analyseger ts Die Anleitung ist auch von Ihrem Handler erh ltlich Fare riferimento al CD nella confezione dell analizzatore Cholestech LDX per istruzion
7. a serum tube without additives IMPORTANT Do not use a tube with any other additives because it may cause inaccurate results Use a pipette and tip to place blood into the cassette e Whole blood should be used within 30 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 for testing e Mix all samples by inverting gently 7 8 times before testing TEST PROCEDURE 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 Analyzer each day that patient samples are tested See the Cholestech LDX User Manual for instructions IMPORTANT A warm hand and good blood flow from the puncture site are essential in order to collect a good capillary sample WARNING Squeezing the finger excessively may cause inaccurate test results ences Procedure The patient should sit quietly for five minutes before the blood sample is collected 2 Puta capillary plunger into the end of a Cholestech LDX 50 uL Capillary Tube with the green mark Set aside 3 Choose a spot that is on
8. apen e Biologiske risici e Se brugsanvisningen e Repr sentant i den Europ iske Union e Biologisk risiko e Se bruksanvisningen e Autorisert representant i Det europeiske felleskap e Biyolojik riskler e Kullanma talimat na ba vurun e Avrupa Toplulugu ndaki yetkili temsilci e EEOUOIO OTN VO AVTITP OWTO yia TNV Eupwraikr Koiv tnta e Autorizovan z stupca v Eur pskej nii e Biodoyikoi Kiv uvol e Biologick rizik e LuuBoureuteite tic o ny ec xprjonc e Pre tajte si n vod na pou vanie Professional Use Only e Professional use only ePara uso profesional solamente e Nur zum Gebrauch durch Fachleute vorgesehen Solo per uso professionale e R serv un usage professionnel e Apenas para utiliza o por profissionais e Endast f r professionell anv ndning e Kun beregnet til faglig brug e Bare til profesjonell bruk e Sadece mesleki kullan m e ia enayye patik xprjor u vov e Len na odborn pou itie w e Room Temperature expiration d room temperature plus 30 days e Fecha de caducidad a temperatura ambiente a los 30 d as de pon producto a dicha temperatura e Verfallsdatum bei Raumtemperatur Anfangsdatum der Lagerung be Raumtemperatur plus 30 Tage e Data di scadenza a temperatura ambiente 30 giorni dopo la data di scade temperatura ambiente Date de p remption temp rature ambiante date temp rature ambiante plus 30 jo
9. e 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 SUMMARY AND EXPLANATION 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 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 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 inflammat
10. ed for the Cholestech LDX Analyzer to convert the reflectance reading 6 R to hs CRP concentration in mg L REAGENTS AND MATERIALS Materials Provided Cholestech LDX hs CRP Cassettes Each cassette contains CRP antibody gold conjugate Titered CRP Antibody Titered Nonreactive Ingredients buffers and stabilizers Materials Required But Not Provided Cholestech LDX Analyzer and power supply e Alcohol swabs and gauze for cleaning puncture site Lancets for capillary blood collection e Cholestech LDX 50 uL Capillary Tubes with green mark with lithium heparin anticoagulant only Cholestech LDX Capillary Plungers Gloves Biohazard waste containers Quality control material Cholestech MiniPet pipettes and tips or micropipetter that will deliver 50 uL for use with whole blood venipuncture samples and 40 uL for use with serum or plasma and control calibration verification or proficiency testing materials e Vacuum collection tubes needles tube holders and sample tubes if the sample is to be collected by venipuncture PRECAUTIONS For professional in vitro diagnostic use only All blood samples containers capillary tubes and materials that have come in contact with blood should be handled as if capable of transmitting infectious disease and discarded into a biohazardous waste container after use STORAGE AND HANDLING Cassette Storage and Stability Cassettes must be stored in the sealed foil pouches Place cassettes in the refri
11. gerator after receipt Cassettes may be used until the date printed on the pouch when stored in a refrigerator 36 46 F 2 8 C The cassettes may be stored for up to 30 days at room temperature 48 86 F 9 30 C The new expiration date is the date the cassettes are placed at room temperature plus 30 days Write the new expiration date on the side of the cassette box in the space provided IMPORTANT Once the 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 e Do not use a cassette that has been stored at room temperature for more than 30 days e Do not reuse cassettes 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 SPECIMEN COLLECTION AND HANDLING Sample Type Fingerstick or venous whole blood serum or plasma Sample Requirement e Sample Volume 50 uL of whole blood or 40 uL or serum or plasma Fingerstick whole blood Collect the sample from a fingerstick into a Cholestech LDX 50 uL 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 Too much squeezing of the finger may produce inaccurate results Venous blood e Collect blood into a green top tube sodium or lithium heparin anticoagulant or
12. i in italiano Le istruzioni sono disponibili presso il distributore di zona Consulte el CD incluido en el envase del analizador Cholestech LDX para obtener instrucciones en espa iol Tambi n puede pedir las instrucciones a su distribuidor local Consulte o CD no pacote do Analisador LDX Cholestech para instru es em Portugu s As instru es tamb m est o dispon veis junto do seu distribuidor local Der henvises til den vedlagte CD i Cholestech LDX analysatorpakken for instruktioner p dansk Instruktionerne fas ogsa hos lokale forhandler Se CD n i Cholestech LDX analysatorf rpackningen betr ffande instruktioner pa svenska Instruktionerna finns ocks att fa hos din lokala terf rs ljare Hvis du vil ha flere instruksjoner kan du se CDen som fglger med i Cholestech LCX analysatorpakken Instruksjonene fas ogs hos din n rmeste forhandler Turkce Talimatlar i in Cholestech LDX Analiz r paketindeki CD ye ba vurun Bu talimatlar yerel distrib t r n zden de alabilirsiniz Avarp amp re oTo CD otn ouokeuaocia rou Avaduth Cholestech LDX yia odnyies ota EAAnvika Or o ny gg Eival 61a0 cipeg ATTO TOV TOTTIKO ravop a cag Pokyny v anglictine z skate z disku CD ktor sa nach dza v bal ku analyz tora Pokyny m ete z ska od miestneho distrib tora INTENDED USE Cholestech LDX high sensitivity C reactive protein hs CRP is an in vitro diagnostic test for the quantitative determination of C reactiv
13. ion 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 8 Increases in CRP are nonspecific however and should be interpreted in the context of a complete clinical evaluation Apparently healthy individuals with an elevated hs CRP value should have the test repeated to rule out a recent response to undetected infection or tissue injury PRINCIPLES OF THE PROCEDURE 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 Cholestech 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 requir
14. ngen skadats eller er beskadiget eller nmay n Use By Fecha de caducidad e Verfallsdatum e Utilizzare entro e Date de p remption e Utilizar at e Anv nd f re e Holdbar til e Bruk innen e Son kullanma tarihi Huepopnvia A Eng e Pou i do 1 Temperature Limitation L mite de temperatura e Temperaturbereich Limiti di temperatura Limite de temp rature e Limites de temperatura Temperaturbegr nsning Temperaturbegrensning e Sicaklik s n rlamas e Obmedzenie teploty e Temperaturbegr nsning leptopiou c Beppokpaocia ud e Manufacturer e Fabricante e Hersteller e Fabbricante e Fabricant e Fabricante Tillverkad av e Fremstillet af e Produsent Uretici Karaokevaotr c Vjrobca Authorized Representative in the European m Lii S izado en la Uni n e Biological Risks e Consult instructions for use naa d Europaischen Tan e Riesgos biol gicos Consulte las instrucciones de uso e Mandatario autorizzato per la Comunit Europea Biologische Risiken Gebrauchsanweisung beachten Repr sentant autoris dans la Communaut Rischi biologici e Consultare le istruzioni per l uso europ enne e Risques biologiques e Consulter le mode d emploi e Mandat rio na Comunidade Europeia e Riscos biol gicos e Consultar as instru es de utiliza o e Auktoriserad representant i Europeiska e Biologiska risker e Konsultera bruksanvisningen gemensk
15. or the Cholestech LDX System Choice of Materials Liquid Level 1 and Level 2 controls that work well with the Cholestech LDX System are available If you use other controls you will need to establish ranges for the Cholestech LDX System Handling Follow the instructions that come with your controls e Check the expiration date before use Do not use if expired e See Running a Test for the procedure External Quality Control External control material should be used to demonstrate that the reagents and the assay procedure perform properly Good Laboratory Practice principles suggest that controls should be run whenever the laboratory director has any question about test system integrity reagent storage conditions or the reliability of any test result If the controls do not perform as expected repeat the test or contact Technical Service before testing patient samples Controls should be tested e With each new lot of cassettes e With every new shipment of cassettes even if the lot has been received previously e When reagents may have been stored or handled in a way that can degrade their performance e As otherwise required by your laboratory s standard quality control procedures e As otherwise required by federal state and local guidelines Record the results in a Quality Control Log The quality control results should be in range before testing patient samples See the Cholestech LDX System User Manual if they a
16. re not Please call Technical Service at 1 877 441 7440 or 1 321 441 7200 to report any problems or if you have any questions about quality control RESULTS hs CRP test results will be displayed on the screen when the test is complete LIMITATIONS e The measuring range for hs CRP using whole blood or fingersticks is 0 30 10 0 mg L Results outside this range will appear as 0 30 or gt 10 0 e 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 28 00 e ncreases in CRP are nonspecific and should be interpreted in the context of a complete clinical evaluation Apparently healthy individuals with an elevated hs CRP value should have the test repeated to rule out a recent response to undetected infection or tissue injury Patient samples may contain heterophilic antibodies that could react in immunoassays to give a falsely elevated or depressed result Results of this test ACCURACY METHOD COMPARISON hs CRP measured using the Cholestech LDX cassette was compared to a commercial nephelometric method Results X Commercial Method serum Y Cholestech LDX Analyzer No of Correlation Range Sample Type Pairs Slope y intercept Coefficient of Values Venous Whole Blood 72 1 02 0 21 0 98 0 17 7 18 Serum 78 1 06 0 07 0 98 0 17 8 75 Fingerstick 78 1 08 0 00 0 98 0 17 8 75 should always be interpreted in conjunction with the patient s medical histo
17. ry clinical presentation and other findings 1 The substances listed below were tested for interference with the hs CRP test Less 2 than 10 interference was seen at the levels shown 3 Substance Concentration mg dL mmol L 4 Ascorbic Acid 3 0 17 Bilirubin 20 0 34 5 Creatinine 30 2 65 Ditaurobilirubin 20 0 24 Glucose 1200 66 61 6 Hemoglobin 120 0 02 Lactate 100 11 10 7 Potassium 39 10 00 Triglycerides 3000 33 88 Urea 500 83 25 8 Uric Acid 20 1 19 g dL g L Protein total 9 0 90 Protein albumin 3 0 30 9 Protein gamma globulin 4 5 45 Hematocrits between 30 to 55 do not affect results 10 EXPECTED VALUES u 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 1 Apparently healthy individuals with an elevated hs CRP value should have the test repeated to rule out a recent response to undetected infection or tissue injury PERFORMANCE CHARACTERISTICS Precision A study was conducted according to NCCLS protocol EP5 A Evaluation of Precision Performance of Clinical Chemistry Devices Approved Guideline 1999 1 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 96 12 196 11 7 8 796 Total CV 96 14 396 11 596 11 496 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
18. se 40 uL for serum or plasma or control calibration verification or proficiency testing materials Use this procedure to apply a venous blood sample or control calibration verification or proficiency testing materials to the cassette Any pipette that can deliver the correct volume may be used l Firmly attach the pipette tip to the end of the appropriate MiniPet Pipette Use a new tip for each sample 2 Tofill the pipette push the plunger down as far as you can Place the pipette tip midway into the sample and slowly release the plunger Confirm that no air bubbles are in the pipette tip 3 Place the pipette tip into the cassette sample well Dispense the sample into the cassette sample well by pressing the plunger down Move the pipette tip out of the sample well before releasing the plunger again 4 Remove the pipette tip and throw it away in a biohazard waste container IMPORTANT If the plunger is released before the pipette tip is out of the sample well it will remove the sample just dispensed IMPORTANT Keep the cassette horizontal at all times after applying the sample Running a Test If the cassettes have been refrigerated allow them to come to room temperature at least 10 minutes before opening 2 2 Make sure the Analyzer is plugged in and has warmed up 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
19. urs e Prazo de validade temperatura ambiente 30 dias ap s a data de coloca o temperatura ambientes Utgangsdatum vid rumstemperatur datum f r placering i rumstemperatur e Udlgbsdato ved stuetemperatur stuetemperatur plus 30 dage Utlopsdato ved romtemperatur romtemperatur dato pluss 30 dager Oda Sicakliginda son kullanim tarihi oda s cakl na yerle tirildi i tarih arti Hyepounvia An ns oe Beppokpaoia wpatiou nuepounv a oe Beppokpaoia wpatiou ouv 30 np pe e D tum exspir cie pri izbovej teplote d tum uskladnenia pri izbovej teplote plus 30 dn eContains sufficient for lt n gt tests eCantidad suficiente para lt n gt pruebas e Enth lt eine ausreichende Menge f r lt n gt Tests e Sufficiente per lt n gt test eContient du mat riel en quantit suffisante pour lt n gt tests e Conte do suficiente para n testes e Inneh ller tillr cklig m ngd for lt n gt tester e Indeholder nok til lt n gt test e Innholdet er nok til lt n gt tester e lt n gt test i in yeterli miktar i erir e lepiey pevo enapk yia lt n gt ate date at erse el nza a E ETAOEIC plus 30 daga Obsahuje material posta uj ci na dato ved lt n gt testov 30 gun
20. verification or proficiency testing materials into a biohazardous waste container 10 When the test is complete the Analyzer will beep and the screen will display 11 When the results are outside the measuring range the screen will display Fingerstick or Whole Blood Serum 12 Ifthere is a problem with the test a message will appear on the screen See the Troubleshooting section of the Cholestech LDX User Manual if this happens Please call Technical Service at 1 877 441 7440 or 1 321 441 7200 to report any problems or if you have questions about the operation of the Cholestech LDX System 13 When the drawer opens remove the cassette and put it in a biohazardous waste container Leave the Analyzer drawer empty when not in use 14 Record the hs CRP results on the appropriate form 15 To run another cassette press RUN The screen will display IMPORTANT If you do not want to run another test and the drawer is open press STOP to close the drawer 16 Repeat step 3 and steps 6 through 14 17 Otherwise after four minutes a beep will sound and the screen will display 18 If necessary press the DATA button to view the results from the last cassette used IMPORTANT Pressing the RUN button will erase the previous result QUALITY CONTROL External quality control material should be run routinely to show that your system is giving accurate results We recommend the following quality control procedures f
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