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Capture-R® Ready-Screen® (Pooled Cells) Rx ONLY al Bee 346-14 Somme caer Intended Use: Captures Roady Scser® (Pooled Cele) i intended for use in Be detection of unexpected IgG anibodes lo eo tod calls by menu, savored or sulomated sole phase ed boo col achoronce meted, ‘Summary ofthe Test: Unerpeced anibodes aw found in the sora of 03 10 3% of donor and patent epuaons "Many anodes ate of clnical inpatanco sine they may ease ecreased red bod col survival as the result of hemolie tansasen reacions, analy dees of the newbom of aucune Rema enemi. In vito andy etecon (scoring) es ae employed to reveal presence of ese anodes in patent an donor sea. Solacd red Dood oa, such as hae rovdes as Caplire-R Ready Scen, are incbaled wi test sera or pla under cordon thet wil ate anibody detection‘ Captue-R Ready-Scsen (Poled Cols) ot rcarmendes fr proantusin lest done in eu of «major cossmach to delet unexpecedsnboles patenls samples. Principle ofthe Test: Capture-R Ready Screon sa odd sold phase anbody detdion sss based on the procedures of lope land et a® Membranes of ed Bld als have been aud io and dried on he sures of ystrne micrwels. The membrane anégens fae used lo cepure rod ood cal-spec anbodes rom patent or door sera ot Plasmas. Flowing a bet meubaton pot, unbound resid! Inmunogabans are nse rom he wes and replaced wih suspension of anyG-xaed ict fed ‘ood cals. Conus ngs the inatr red oa carat wih anodes bons 'o the reagent ad lod col menbyanes. Inthe case ofa poste es themiron of the inde red blood cls to he boom f te wes knpoded as arg kG complenes are formed on the surtace of Be srencbiied reagent bye. As @ consequence of antbdy riding the calor rd cas eherto a seeing cls ot a sacnd inmobizd layer. in the absonoe of delectable anigon-anodyieractone (negalve tet, the indealor ed blood cts wi pl be enpeded dng tno miraton andi peel the bot othe well as bg agghiated red el ors. Reagents: 1. Capture-R Ready Screen (Pooled Cel) canssing of x 8 sips camying the bound and ded fed blood call montanes prepared om a polo wo group O eons. Twelve 1 8 ships ae package win suppor fame and encosed i ouch io wich a desiccant and moss ical have been aes. Each sips ready o be used as sipped. Sips can bo used sng orn mules, ‘Sb the sips al 130 (under rettgeraton ol rom tenporatie) whan nt se. Ihe humidor encosed win a poch shows the presence of alte (by he humityindeter turing fom ble op he sips shone be wed ‘Unused sts, desixan and mse indir shuld be carey resealed win the fo pouch to provet exposure fo mous tt can destroy th red aod oa ‘martares. Sips wihin eseled pouches sou tol ba sod the handy Indio shows th presence of mie. Sips emaved fom pouches should be sod win eight hours 2, Mastr List: provided wih each lo of Caple-R Ready Seen inate the code ‘and antigenic composon ofeach Sonor whose red ood als ae used to prepare heed reagent nonlaer. ‘Aunet Reagents to Capture Test Wels: 4. Capture LISS: 2 ow ini stengh scion conning gyn, bores pale ye and he peserabe sodium ade (0.1%). Soe a M10. [Solid Phase System for the Detection of Unexpected IgG Antibo s to Red Cell en IMMUCOR. 2. Capture Ready Indicator Red Calls: 2 suspension ord blod oes coat wth ‘sine monoderal ani-punan IG mole, The ragont i suspended in 2 bufered presevatve soliton to which chioranphencol (0.25 mgmt), neon sale (11 mginL) and gentamycin sult (005 mginl) have been added as presenaives. Sore al 10C. 3. Capture Postve Control Serum (Weak): cons anodes ore Hood cal Sodium az (0.1) sad as a preservative” Str at 1-10. .CaptureR Negative Contol Serum: canans no antbodles lo red blood cls. Sodium az (0.1%) adied as a presenatie. Sloat 1106, NOTE: The indaty components (Capte-R Reaty-Scen walls, Cope Ready Indator Re Cals, Cope LISS and Captue-R Conot Seca) used to peor apres Ready Seen assays can be used irechangesly wit oer component ls, povided he conpaneis ae wit hk dang gerade. NOTE: Master Lt re lo specte Precautions: 1. Fern vito dognosic use. 2 D paraeaeranist cine i ae ‘Sum azide mayrsc wit ad ana copper purbing fom expose compounds. 1 ‘Seared i the sk, hash wi large vou of water prevent ze bull 3 Moshe Rent cen maps ms bought 1299 Cekre es 4. Capre-R Ready Indeator Red Cals must be suspended belo use by get lnvering each vl several times. his naa fo Cape Ready Indicator Rod Cole to agregle sity ctsng {10 C slrage. Capture Ready Indias Red Cals shuld ot be sed ite res bhood cls daen om red to brown, Here eros oi te cals fal io peso propery n postive and negsbe con ests. Slghthemeys may acu wit 90 ‘5, Turily of Capi USS and Capture Contl Reagents may be an ingcaton of cb containaton, Reagens hat are coniamingled shoud note used 6, Do nose reagent beyont he expraton dates. Leong vas should no be use. The fama re exgition dt i expressed as CCYY-MN.DO(year-monh-). ‘8, Handle and depose of eagont si potent intocous. CAUTION: ALL BLOOD PRODUCTS SHOULD BE TREATED AS POTENTIALLY INFECTIOUS. "SOURCE MATERIAL FROM WHICH THIS PRODUCT WAS DERIVED WAS FOUND NEGATIVE WHEN TESTED IN ACCORDANCE WITH ‘CURRENT FDA REQUIRED TESTS. NO KNOWN TEST METHODS CAN OFFER ASSURANCE THAT PRODUCTS DERIVED FROM HUMAN SLOOD WAL NOT TRANSMIT INFECTIOUS AGENTS. THE PACKAGING OF THIS PRODUCT (DROPPER BULBS) CONTANS DRY NATURAL RUBBER. ‘Specimen Collection and Preparation: Plasma or serum: Orewa toad specimen wing an sceoptble plot tech Fresh serum or plasma EDTA, ACD, CPD, CPOA-T,CPZD) maybe used ins 0. ‘Al sing shou be paromed ss Soon as pose flowing callocton lo miniiz tho hence of fbepostne or fae-ogathe reactions due 10 improser slrage ‘aminaton of he space, Specimens fat canna be ised win 26 hous shoul ‘be soed at 1-10 Ca aon as posse. Aleravely specimens can be separated fom ‘ed boot cls and sored foam Woatyreatie anibodes may deleorae and boca undotocal in specimens sled at eam trgeratve fr savrl day Delo teeing orn spacimens sed ‘or pologod pots at 1-10.C. Donal use spacmens Key: Underline = Addition or significant change; & = Deletion of ext

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