TASTm ECTTm Th,c TAN ECT Test Card i-; based on the method ofNovrak acid DIAGNOSTfCS INC Test Card Hucha.1 The TAS system is designed Eneliminate ailay of [he "I vansport: that are encountered Kit 25 ECT Test Cards variables such as and handling 61 Containing with orher cougulacion methods-Principle 1 For in vitro diagnostic use only 'IbLIAS F-C17Te%t Card is a one-siage, two-step test that measures the dotting time of a btcxxl wimple. The p;Ldenesh1mad swn* Ls first dfluted, with pooled normal human plasma. Then. the diluted Humanitarian Device, Avidiorized by Federal Iaw for use -,-imrAeis added to the dcy reagent on Elie prew2 rmc-d Ecr i*,%it In determlrilngth-manticoagulant effectof recombin-in Card. 13YUsing Cearin to activate prothronibin, the coagulation h1rud1n (ir-hiritidin) during cardiopulmonary bypass am-ade (afaivution of facton; V - = Lebypassed and 2 deficiency (CPO) in padents wlio bave heparin-induced in one or rnore of ihese faccorswiU not he reflected in the result. t1wombocytopenia (HM. The effectiveness of this device for Oils use has not been demonstrate& Reagent Federal law restricts dils device for sale and distributlon Comoonents Storage Stabili to, or on the order of, a pliysician or to a clinical FA-4rincalcium 2--SIC(36-46*F) Unopened-24 months laboratory. Use Is restricted or on thL Order Of a to, by, chloride,huffer,, of untilexpiration date physic'---'. stabilizers,and paramagneticiron or, o3tideparticles. 20-251C (6&-77'F) Unopened-2 wcdcb Intended Use The TA.ST14 (Thrombolytic Assessment System) Ecarin Clouing Time WARNING: Exposure of the testcards -1EUnY time. (0 MUgneEiC (EC'I)TcsL Car(.[ is to be used with Elie TAISAfialyZef and Ls ol4ectsor fields(for example, an MRT In.sTrut'nent)may corrupt intended ro determine the anticoagulant effCa of r-hirudin during the encoded informationand preventthe analyzerfrom starting cardiopulmonary bypass in patients who huve hcparin-iriduced thetest. thrombacyLopenia. CAUrION. Any pouches not kept refrigeratedshould be dated The TAS ECT (the TAS Ecr Test Card together with the 'LAS and not be used beyond dli,-)2-week period.Pouches shouldnot Analyzer) i.-;.-;UiEed for professional use- in decentralized areas of be repeatedlywarmed and returnedto the refrigerator.Once the cesEingnear die site of patient care as well its for use in the more pouch isopened, the card Must be used within15 minutes. LraditioniAlclinical laboramry. POTENTLAL ADVERSE EFFECTS OF THE DEVICE ON HEALTH: Monitoring widi Elie TAS EC`r is indicated for persoas who have InaLcktrateinronn-adon on the coagulationstacus of the patient been identiftorl with and/or confirmed as .1 bigh risk for TUTý and poses a significantrisk to the patientduring CP13 sinceboth require high dose anEicoagulatioa With TeCOillhit-atlt hirUdin for -a and under-Ereau-nentcan have fatalconsequences over-treatment, scheduled or emergency CPB procedure. (bleedingin Eliepatient and cloLqin the CPB &-ystem,respectively). Possiblerisks of using the TA-SECE TestCard could include Contraindications underestimationor ovefemimationof the levelof hirudinin the TAS ECT is contraindicated for patient,; on couniadin therapy with pafientCurrently, an antidotefor hirudin is unavailable, and the an INR > 4.5, pntiemi -i(h > 25% heinolysis, PLEje.nt..,:WiEh > 30% clirticui(haa airuilUble are insullicientto establish Elie Probabilities hemottiludon, padenruqwith > 0.5 U/nil Concentration of or incidenceof erroneousmedical judgements and theirclinical unfractionared heparin (LIM, and patients with less ti= 30% outcomes. prothrombin UCLivityor 15 mg/cil fibrinogen cuncentrIlLif.in. POTENTIAL BIOHAZARD: All componcritsiof thisproduct = of Patients on thrombolycic therUpy AXA[ld nor lie nionitored with nonhuman and US SLIch,should not containHBV, HCV, or the TAS FCT. The use ong4 of acid ciimEe liload collection is also HIV. sinceabsence or infectiousagents cannot be coniraindiC'Med with the 'IAS Nevertheless, ECJ'. proven.211 Samples (e.g.,Patient blood) and products(e.g., human blood should and Explanation Slan&-trdand c(,.)nErotpl-asyna) obtained from Summary always he handled vALh due the precautions a care,observing Ecariti, protein prothrombin activator from EcbLqcarinarlis recommended for bioliazardousmaiLrial.1-1 venom (E-C 3.4-99.27), was isolated Kornalik et at. in 1969-1 by Specimen Collection and Preparation Ecarin causwo,%coagulation of citraLed whole blood ((-,XrB) or citrated plasma (CF) by the calcium-hideperidetit aciivaLioa of The TAS ECr TestCard isto be used with cirratedwhole blood prcAhrombin. Latrin hus been characterizcd by Morita eL aL! and collectedand processed iccordingto recognizedstandards for Bloint-jack-1 single.- sruidies.7 by Krimallic and as a chain glycoprotein with a the handlingor blood specimertifor coagulation 77he molewlar wcight of 5.5-60 fU>akons which exerts mecatloproteinase blood should be added to either109 or 129 mmol (3.2% or 3.8%) aLdviry inhibited by EDTA, 911.11-11thionc,cysteinc, and of the dihydratcform of Sodium cilratcin a proportionof nLne(9) mer-captoeEhanol. Common serine proceinasc inhibitors SLICh Is partswhole blood to one (1) p-art-,indcoagulant. The blood diisopropyl-fluorophosphate (DFII), soybean Erypsin inhibkor should be mixed wellwith the anticoagulantiffirnediately upon ovoinucoid and alirorinin do not inaCEiv:1(&ccirin, -(SM, collection. Ecarin (:.4Laly&,sthe hyrtrolytic clea-agc of the " The citiratedwhole blood Sample must be dilutcdone to one 3-223Arg-3-1-ille EesEing.' bond in the human prorhrombin airilecule, wherehY ffirombin (1:1)with pooled normal human plasin-aprior 10 activity is gCnCrUtCoLlwithOUL Lhc release of itay zymogen fragment. Precisepipetting of the sample isimportant. This forin of active prothfoinbin has been cerined meizothromblin " Using -.t100 pl pipette,di.,;pcnsr- 100 jilorthc Citr.LEC-11whole and is inhibited by r-hirudin, PEG-hirudin, and low molecular blood intoa PolypropylenePIUSUC tube. weightsyndietic thrombin inhibitorb such aN :irt;:jLrob-,Ln,but nkA efficiently bv the lieptrin-ATIII complex. tia.,, Ecarin been ased to develop a senýttive :in;jjyrj(j,I rnetliod for die & terMin' aLion of Lliconibij-1InilibilL011 bý' the SARI'(Helena) and FAC-Tr(George plasnia.-wei'e LLýed as r-hifL1(tin.',' aCIOCIII'Otilhindrug King) 'rhc ý11)PhCýiCiOnfor Ljij,,ýtc.,,j i.s to Monitor the the pooled n0ffnalhUnian ptasniafor all the ECT scudie-ý antiCoagulmlt effc-CLinduced in a patienc receiving r-hirudin perfonned :it(--VT)I. Use of .Inyothcr poolrd normA human during (:;1r((i0j)L1lrnomry pla"I-1121112Y p!",e ciffererit result-s. ar anibieric reniperuturus the sagic 100 [Al pipette with a new pil)dEte add 100 " ()pera[e the TAS AnalyZef only jisingol' Eip, pl porited normal hum.in plasma to the plastic tube between IS EO 32'C. leave the unit plugged into Contail-Ling 100 l-il of civared whole blood. Mix the -ý;utmple. " To maintain a fully charged hatiery. its power which Ls in rum plugged into 2n AC outlet. Using a SUMPIC tr'.Lr%Sl`e.rdevice capable of delivering supply, 'OFF" Leave the powerswitch in the posicloti while storing the 30-35 1A, transfer 30-35 111dikltCd whole blood appiroxi-inacelyto the sample tc..ýt well when prompted by die analyzer. "nalyzer, Identification Code and Elie Quality Control Diluted whole blood shOUld he Ee.Sted within 15 rriinute:; of " The Ol-&racof are optional features. Refer to [he Operator Manual if collection to ;ivi)id ex vivo changcs that may affect the clotting Lockout has been enabled. time either of the.,;e features " Ensure dial the sealed pouch containing a test card has reached MaterialsRequired but not Provided room temperature and LhtL the TAS Analyzer is either plugged - TAS Analyzer inco an 21111r0piriateWall Outlet or ha-i a sufficiently charged TASL Operator Manual battery. " Collect and dilute blood in ;1 1:1 ratio with pooled normal Pooled normal hLinian plasnia plasm-a" hunian as de-sefibed in the Specimen Collection and niaterials such as ve-nipunc-e Blood sampling needles, Preparation Section. .syringe-,;, alcohol swuhs, vacurainer tubes containing sodium cilrale QualityControl Sampletransfer devices (pipcucs wich tips or droppers) anpahle Calibration: No user calibration Is necessary with the TAS ECr - ofiJelivering approximately 30 35PI Test Card. Calibration of the TAS Analyzer was performed at e Two levels Of (40-Mily control plasnut avail-ahle from CARDIOVASURAR DUGN091-ICS, Inc. Cardiov.ts-CUlar Procedures. Prior to each CP13 Elie f)iagrI(AliC.S. Quality Control INC-Routine use, on * 100 pl pipette with Lips operator should verify that the date and time displayed cbe analyzer are accurate- Ptese if necessary. (See die TAS Operator * Polypropylene tubes Manual for insmwitions.) This s[ep ensures Eliat the operator Directions for Use w1U be warned of any attempt to use an expired test card. ri-quilibrate test carcLs aL rnOIY1 Eemperature (20 - 25'C) before Tlie microprocessor in the TAS Analyzer automatically monitors for accurate testing. Ifthe TAS removing frorn Elie foil pouch. No further preparation of the the parameters necessary the performance ofthe tes;L it TAS ECT Test Card is necessaiy prior to beginning the IesE_ Analyzer dietects an error during will an error WC982ge (ýee the TAS Analyzer Operator CAUTION: 1he ce-q card miist be used within 15 minutes after display details and an explanation oferror messages.) the pouch is opened. Vouche.,; of cards should not be Marnial for the end of the dke operator should confirm that the repeate dly warmed and returned to the refrigerator. At test, test was performed with the aimaly=r set to die appropriate 2. Kemovc the rest card from iLs foil pouch and hold it so that sample type. The sample type is displayed along with the die full name is righE side up, facing you. result at the end of the 3. Pass the L;ý_q(card firiAy and steadily through Elie c-ard the card is removedtest-Whim from the analyzer at the end of analyzer interprets the encoclcd infontiation Oft diereader-The ECSt reaction each tests the operator should be sum that the endre card and displays prompts for each sto of Elie procedure.