Sze: 137x218 mm ce FalciVax™ RAPID TEST FOR MALARIA PuiPr INTENDED USE Fala sa rapid, qualia, wo se suntv immunoassay ung woe toed fre deacon of Patipaum ‘pectic histidine rch pron? (Pt HRP-2) and Pox spec pLOF. The test can also be used for speci detection and ereniaionatPyvarmaariaand Placipaum mairainareas wh ighraesol med iochns. Thetetsintndeaforpessonal use at clicaland pom carstesin suspeced cases iralsainfecton. SUMMARY Four specs othe Plasmodium parasites re resonsble formal ifeionsinhumen vi Pflepanim, Prva, Pavale and Palio. Of hese P flaps ad vivaxareconsderoathe "Bq Two duo idence ocrera eli ard ug ressianoe asso win Pflpsru malian high acct andrlapseassocated wit Piva. Aste couse ‘fesimerts dependent onthe species, dferntalonaetneen Pfaparim and Pivaris of nos erpatanc obtet patent managomentand seedy recovery In Falla, tha dalacton syst or Patou malaria based on he detection of Palparum specie hist ri Protar2(PCHRP-2), which swale sole retin that reas or praised eros of hfacted dials hedolocton systamle Paar maar sbaredonpresence of PuivarpaciepLOM, PRINCIPLE FaeiVax™uitzes be principle of again of nkosi! aneara with epee angen in inmun-chemalagaphy formatlong wih use ane golspars as agglstnaion ovealng ago. Ash txt campl ows veughthe nombrane assembly oe davis aration ofthe cleaneg bute, fhe colored coil god corugats che AqguSnating Sra fot HRP-2 andthe Agutnang SraforP vivax speci PLOM comsleeshe HRP-2/pLOH he sed samole Ths complex ‘owes futher onthe membrane te est ropan wheres mabized by he Agung Sere for Pan hia space LD andor Aggtatng Sera for -2 este onthe memaeleedr aman fix supiecalredbandis which Eanes posv testes, Abang wll appear under athe tron nfaleparum posite sales, wl band vl sepear urdor Prin vivaxalara post samples Appearance of tard under Pas wel as Pv in teas eie suggests 2 rio acon ‘Aesanee of ored baalin the tesreion nates anepatve testes The uresctedcorugats and unboundcorplexit ry, nove luther onthe mebrane ard ae suosequely ercbiizadby Agltraing Sorafr Rat gobuln cated on he ‘arane at he caro region fog 2 prk puri ans. The cntel ban fomaton i based on te Rabo gobi ‘Aaghtinalng Serer Rabi gob sytem. ices complet indpendanf ha anata deletion esto, iatates formation of consson corr band sigalindependet of he anaye concerate, Ths can band serves alata the lestperomance REAGENTS AND MATERIALS SUPPLIED Faeax” contin ‘A. India pauses, each catalog 1 Merérane assemby pre-Sspensed wih Agglnatng Sera for HRP-2~ enlidal ols conugate ‘Aagltnaing Soa fr var Spee 9LDH - calla god cng abl slobln colada gol cones, ‘Aagutnaing Sora for HRP-2, Aggaratng Sea fr Pan Naira spac LDH and Aggungtng Sra for Rabi globulins respecveregors. 2. Doseean pouch, 4. ETE DisposablePlasic Sample Apaltr 8, CBT Clarngbuterina eoper date ©. Packageinses 1. “Ach swabe—70% pray aloha E, “Bloolarents-Sturle Wile rovidedenyanrequest Producteodes Es]| sosovooot sosorooro | eoaoron2s | sosorooso | sosavor00 Pouchseakedtests Wo a 2 0 100 Cleringbuferboties | Cixizem | oixadnt | OixtGm | texan | exami "Alcohol ewabe oF iw a o 100 Bloodloneats oF 1 25 0 100 Instructions fous or vi ol w oFSze: 137x218 mm ‘OPTIONAL MATERIAL REQUIRED Calbrtedmicopipte capab of alvin Spl samplaccrstey STORAGE AND STABILITY The sealed pouches inte eli ne components mayb sored between 1°Co 40°C he duration ofthe sha fe 3s Indicator pouch caren, DONOT FREEZE Ate trstopenngolhe cleaingbuer tote, canbe slredbetween °C {od0"Crorteromaning ureionot is shales NoTES Resdthsinstuctonscartuly before petomingthtest Forinvitodiagosiuse ony NOT FOR MEDICINAL USE. Forprofessonalus. Thstotnotinondedforuseinsreanieg of esymptomazepopustn, Donctusebeyond expry dat Donotinerixcomponets offre, “Tevie athe same applicator aro sigl use ony. Contact wth the cones of esecant pouch colanng, rang ote substances, cbatclorde (CASE 7646.79) shoud bekeptloaminmam Ihsan sweloning may case am, Handle specinonsas otal efocsus. Fol standard isa quieras for hanging andsposaf potently nectvemateral Clearing bute contais Sedum Ao(. 1%), aol sincntat with reaganl Azide may roacwahleadandcoperinhe pPubieg anor hgh explosive metal oxes, Push inlarge volumes of ater prevertaziebullup nthe plumbing. "Tneslonlewab ndblodlaretarforsingleuse ony SPECIMEN COLLECTION AND PREPARATION Freshbled fom ger ick! punctur shold bo wsed as lost spoinen Howov, tosh ar coaguated wal bload ay aso be used asa fest sample. EDTA or CPOA or Heparn or Oxalate or Trsodum Cita canbe Used as sutabe arScoapulars Tha spacer shouldbe colectsdina dean gassor pas caine. fimmedaltesingsratpossbiethen the spose maybe sored at 2°C 18° or upo 72heus Belo lestng, Cited ocomaminatedlacd sanpes shoul nt bevsediarperaming eles TESTING PROCEDURE ANDINTERPRETATION OF RESULTS 1 BingteFalefVax™ ktcomponenisio room enperatr bee tesig. 2. Open the pouch and rete he device, sample apalcatr and descent pouch. Check he clr of the desiccant. Stouldbe bie, ithas tured olotoss or pink, stad dove anduse anther deve. Once opened, the device Imustboused immediately. 3, Label testdvig wth pat sient 4, Tttontecapot the cearngbutorbrtle provided waht tinh clocks drctonto piece th buf botte nozzle 5. Evan than cosquted toed sarplby gene sing Dipth samp eplcscinotha sap Erssng hat, an applcaer tof boosie retove, bthe boos eo colecad nthe samp pot NT vers appro 5 of ‘hewholebloodspecen}, oR Incas pger pret bloods being used, ouch he sample appli tothe ood onthe ge prick Esutingthat an pps eed ities sired bathe specimen nthe sampla pos (Care shoud be an tht he blood aslo hasrocotadand the banfrtolesanplopols nada oR ‘Atamatvay, Su of the ant coagulated ongr pk speci ay bo delivered nha sample por’ usingamico NOTE Esuretattha bond tom the sagle appl has been corgllal akan ups ne sample pat 6 Immodaioy dispense two drops cf dearing bts ber por byhodngthebuter bt ver call, 7. Readtaresutsathe endef 20 minutes salons [10 @ | _NeGATivEsormalaria: Oniyonepink-urplebandappesrsinthe contol window C: FS eq] _POSMIVE or Pvvarmalar: nation oh contol tan, a pk pple band also appess FE | uncerthereginmarted PY thes widow = POSITIVE for Paleparum malaria naddn to the conta band, a poke bard ao TATE 8 | sopearsunserderegonnarced Printetas wndow rs POSITIVE for Pfaeperum and vivax mala: in aon ae canton, Wop puple GEES | tandsapearunar erogonsared Pr and PV intelestrdonSze: 137x218 mm == Sq] _INVALIORESULT Thetet shouldbe conserdinvaidnobands apparent doe Thus FT12 S| shoul ato be consis invid ony test ands (andor Papper end no con ane TEEE|oe | sper. Ropect he ost ith anew device ensisng Bal he lst procedure has boon flowed CLES | scrvatey, PERFORMANCE CHARACTERISTICS In an mhause study, panel of 200 samples whose rosuts were carer contmed wih microscopy were tasted wih FaelVax™ Therestsb'ened seas alows Sanps “oa No.of sales testes Fae Sensi) Spectety Pate Negabve o Plaarom postive 2 a Q Par soiive 25 F a 70 Walara nate 18 o 8 : 100 LUMTATIONS OF THE TEST 4. Aswihalapnosclets,eresutsrustaaysbe coveted wih lca ndings. 2. Tha sus of test aro be earprcad win he opisarioegia, cial and therapsutc cont, When @ sooms ata tho pavastlgialocniqusofuterence shoud be andor microscope exaniatan fhe Bick ear ‘andinbaoafins). [Anymadcatontsthe stove procdireandoruteofateeagents ilinvldsto he tstpocedu, Ietarenoe duo lo prosenoe of hterephi aniboses i pals sample can 0 to eroneovs ana detec in revanoasay, has ben repre invarau sis. FaleVax” uses HETEROPHILIC BLOCKING REAGENT (HER) 0 anogave et rest oes retrieouthe positon Povo and P mlage 6, Incat ofnfecon wn P vvarusull he v Bande can be employe for mann succes of arial herapy. Howovor shea veaont uation andIedicaton ved atotta Gearanco cf parases, hts shoudberopealod ar Sb daysofstarofveainen 7. the eacton ofthe test reais positive wth the sar intansty ater §-10 days, post eaten. the possi of resistant stan ofnaara asta becorsrd, 8 InP faliparum malaria ioc, Pt HAP-2 inte beabsent ©, Sine Pt HP-2 pert orunto fog ven after sues rey, pois eras oes ating a falas ‘harapeuerespoes. he reactonoltatetrenans postive weh he same tansy tor S0dysposteatment ho posshityofaressansaino'maliahas tobe conscered 10. Tho Py Bad can bo used fr meng succes of ant mail heap. in caso of stand lone Pivaxinocon. For maniog ssses of ar ala heapy in case of stan loa P atparum necton or mbes econ, employing @ Pan specie LDH based stam i retoneande (avlable es Parabank) afar 50 days cf inaton of he harohwapeuteagent 11, Donolintrpethe tes resus byond30 minutes, sdingametogoy stage Hancein ‘Caro he Pt band may WARRANTY This products signed ts porfom as sorb waranty ofuse andsaloran ota pupo¥, ‘abel and package inset The manufacturer disclaims any impiod BIBLIOGRAPHY 11 Howard RJ, etal, 1986: Sereton Malar HisneohPrean (PX. HRP) fom Plasmealu alopanuminectes Enyrosyas.J Clio. 103, 1280-1277 2, Para, NE etal, 1981 ntfeaton of Plasmodium facparumHistitineRich Plein 2inthe Pasma of Hua wih Miata. in Wirt, 28, 1629-1834 3. Redrguaz Oa Vale Mtl, 188. Detecton of Anigens and Artbees inthe Urn of Hunans wih Plasmodium facade. Clin Merb, 2, 1236-1242 4 Par, RC. ela (199) inerane cape iagnostc assays for malaria uluing Plasmodium Lactate Dehyogonase (GLDH}Am J Trp, Mea Hyg (0) 108-18, 5, Hunle-Cooke A. a al, (798) Comgarson of a Parasie Lactate Dehyrogenase-based inmunschromstagraphe Potigen Deacon assay [OptNAL th Nicroscopy forte DetacionofNalana Parasites» Huaneod Samples Am rep Med 602). 173476. 8, Guntane IM, etal, (896) Matra agnosis y dpsick assay in a Hondan Populton with coanéamie Plasmodium falcioarum and Plasmedium ivax Ar Trop Med. Hy, 5316) 853871Size 2137x218 mm 7, Palmer, ©. J (1888 Evaluation of Opal et for a6 diagnos of Plasmodium vx and Plasmodium. Cnt 351) 208206, 1, MoosyA, eta, 2000) Perarmanos ofthe OpsMAL” mara eigen cape dips fo maria dagnoss and tester renitriog Bish Jourralof Hematology, 108,15. 9, Dataontie: Zephyr Bimodal. 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