HIV 1/2 Human Immunodeficiency Virus Rapid Test Device Package Faka
Isishwankathelo
I-HIV yi-etiologic agent ye-Acquired Immune Deficiency Syndrome (AIDS).I-virion ijikelezwe yimvulophu ye-lipid ephuma kwi-host cell membrane.Zininzi iintsholongwane ze-glycoprotein ezikwimvulophu.Intsholongwane nganye ineekopi ezimbini ze-positive-sense genomic RNAs.I-HIV 1 ibekwe yodwa kwizigulane ezine-AIDS kunye ne-AIDS-ezinzima ezinxulumene ne-AIDS, kunye nabantu abanempilo kunye nomngcipheko ophezulu wokuba noGawulayo. I-2 ifuna impendulo yamajoni omzimba.3 Ukufunyanwa kwezilwa-ntsholongwane ze-HIV kwiserum, kwiplasma okanye kwigazi elipheleleyo yeyona ndlela isebenzayo neqhelekileyo yokufumanisa ukuba umntu ukhe wachanabeka kwi-HIV kunye nokuhlola igazi kunye neemveliso zegazi le-HIV.4 Nangona kukho umahluko phakathi iimpawu zabo zebhayoloji, imisebenzi ye-serological kunye nolandelelwano lwe-genome, i-HIV 1 kunye ne-HIV 2 ibonisa i-antigenic cross-reactivity eqinile.
I-HIV 1/2 Human Immunodeficiency Virus Rapid Test Device (Igazi Elipheleleyo/iSerum/Plasma) luvavanyo olukhawulezayo lokubona ngokomgangatho ubukho be-antibody kwi-HIV 1 kunye/okanye i-HIV 2 egazini, kwiserum okanye kwisampulu yeplasma.Uvavanyo lusebenzisa i-latex conjugate kunye neeprotheyini ezininzi eziphinda ziphinde ziphinde zenzeke kwi-HIV ukuze zikhethe ukukhetha izilwa-buhlungu ze-HIV 1/2 kwigazi elipheleleyo, kwiserum okanye kwiplasma.
Umgaqo
I-HIV 1/2 Human Immunodeficiency Virus Rapid Test Device (Igazi Elipheleleyo/iSerum/Plasma) luvavanyo lomgangatho, inwebu esekwe kwi-immunoassay yokubhaqa izilwa-buhlungu ze-HIV 1/2 kwigazi elipheleleyo, i-serum okanye iplasma.Inwebu iqatywe nge-antigens ye-HIV ephinde yahlanganiswa.Ngexesha lovavanyo, igazi lilonke, i-serum okanye i-plasma specimen idibana namasuntswana e-HIV antigen agqunywe kumcwe wovavanyo.Umxube ke ufudukele phezulu kwinwebu yechromatographically ngecapillary action kwaye isabela nge-recombinant HIV antigen kwi-membrane ekummandla wovavanyo.Ukuba umfuziselo unezilwa-buhlungu eziya ku-HIV 1 kunye/okanye i-HIV 2, umgca onemibala uya kuvela kummandla wovavanyo obonisa iziphumo ezibonisa ukuba unayo.Ukuba umfuziselo awunazo izilwa-buhlungu ze-HIV 1 kunye/okanye ze-HIV 2, umgca ombala awuzukuvela kummandla wovavanyo obonisa iziphumo ezingalunganga.Ukuze usebenze njengolawulo lwenkqubo, umgca onemibala uya kuhlala ubonakala kummandla wolawulo obonisa ukuba umthamo ofanelekileyo we-specimen wongeziwe kwaye i-membrane wicking yenzeke.
Ukugcinwa kunye nokuzinza
Ikiti ingagcinwa kwindawo yokushisa okanye ifakwe efrijini (2-30 ° C).Isixhobo sovavanyo sizinzile ngomhla wokuphelelwa oshicilelweyo kwisingxobo esitywiniweyo.Isixhobo sovavanyo kufuneka sihlale kwisingxobo esivaliweyo de sisetyenziswe.MUSA UKUMKHENZA.Musa ukusebenzisa ngaphaya komhla wokuphelelwa.
Ukulumkela
★ Ukusetyenziswa koxilongo lwe-in vitro kuphela.Musa ukusebenzisa emva komhla wokuphelelwa.
• Ungatyi, ungaseli okanye utshaye kwindawo apho imizekelo okanye iikiti ziphathwa khona.
★ Phatha yonke imizekelo ngokungathi inee-arhente ezosulelayo.Qwalasela izilumkiso ezimiselweyo malunga nobungozi be-microbiological ngexesha lovavanyo kwaye ulandele iinkqubo ezisemgangathweni zokulahla ngokufanelekileyo imizekelo.
★ Nxiba iimpahla ezikhuselayo ezifana neebhatyi zaselabhoratri, iiglavu ezilahlwayo kunye nokukhusela amehlo xa kuvavanywa imizekelo.
★ Ukufuma kunye nobushushu bunokuchaphazela kakubi iziphumo.
Ukuqokelelwa koMfanekiso kunye noLungiselelo
★ I-HIV 1/2 Human Immunodeficiency Virus Rapid Test Device (Igazi Elipheleleyo/iSerum/Plasma) inokwenziwa kusetyenziswa igazi elipheleleyo (ukusuka kwi-venipuncture okanye intonga yeminwe), i-serum, okanye iplasma.
★ Ukuqokelela iFingerstick Whole Blood samples:
Hlamba isandla somguli ngesepha kunye namanzi ashushu okanye ucoce nge-alcohol swab.Vumela ukuba zome.
Gcoba ulusu nge-lancet enyumba.Sula uphawu lokuqala lwegazi.
Hlikihla ngobunono isandla ukusuka esihlahleni ukuya entendeni ukuya emnweni ukwenza ithontsi legazi elingqukuva kwindawo yokuhlatywa.
Yongeza umfanekiso we-Fingersitck Whole Blood kwisixhobo sovavanyo ngokusebenzisa ityhubhu ye-capillary okanye ithontsi elijingayo.
★ Yahlula i-serum okanye iplasma egazini ngokukhawuleza ukuthintela ukopha.Sebenzisa kuphela imizekelo ecacileyo, engekho hemolyzed.
★ Uvavanyo kufuneka lwenziwe ngokukhawuleza emva kokuqokelelwa kwesampuli.Musa ukushiya imizekelo kwiqondo lobushushu begumbi ixesha elide.Iisampuli ze-Serum kunye ne-plasma zingagcinwa kwi-2-8 ° C ukuya kwii-3 iintsuku.Ukugcina ixesha elide, imizekelo kufuneka igcinwe ngaphantsi kwe-20°C.Igazi elipheleleyo eliqokelelwe nge-venipuncture kufuneka ligcinwe kwi-2-8 ° C ukuba uvavanyo luza kuqhutywa phakathi kweentsuku ezi-2 zokuqokelela.Musa ukukhenkcisa iisampuli zegazi elipheleleyo.Igazi elipheleleyo eliqokelelwe ngomnwe kufuneka lihlolwe ngoko nangoko.
★ Zisa iisampulu kwiqondo lobushushu begumbi phambi kovavanyo.Iisampulu ezikhenkcezisiweyo kufuneka zinyibilike ngokupheleleyo kwaye zixutywe kakuhle phambi kovavanyo.Iisampuli akufuneki zifakwe emkhenkceni kwaye zinyibilike ngokuphindaphindiweyo.
★ Ukuba iisampulu ziza kuthunyelwa, kufuneka zipakishwe ngokuhambelana nemimiselo ye-federal equka ukuthuthwa kwee-etiologic agents.
Izinto eziphathekayo
Izixhobo ezibonelelweyo
| Izixhobo zovavanyo | Iidropha zomzekelo ezilahlwayo |
| Isithinteli | Faka iphakheji |
Izinto Eziyimfuneko Kodwa Ezingabonelelwanga
| Izikhongozeli zokuqokelela imizekelo | ILancets (yeminwe yegazi kuphela) |
| I-Centrifuge (yeplasma kuphela) | Isibali-xesha |
| Iityhubhu ze-heparinized capillary ezilahlwayo kunye nebhalbhu yokukhupha (kwigazi elipheleleyo leminwe kuphela) | |
Imikhomba-ndlela yokusetyenziswa
Vumela isixhobo sovavanyo, umfuziselo, isithinteli, kunye/okanye nolawulo ukuba lulingane neqondo lobushushu begumbi (15-30°C) phambi kovavanyo.
1.Susa isixhobo sovavanyo kwisingxobo sefoil kwaye usisebenzise ngokukhawuleza.Iziphumo ezingcono kakhulu ziya kufumaneka ukuba uvavanyo lwenziwe kwiyure enye.
2.Beka isixhobo sovavanyo kwindawo ecocekileyo kunye nenqanaba.
Bamba i-dropper ngokuthe nkqo kwaye udlulisele ama-2 amathontsi e-specimen (malunga ne-80 L) kwi-specimen well (S) yesixhobo sokuvavanya, uze udibanise i-1 drop of buffer (malunga ne-40 L) kwaye uqalise isibali-xesha.
3.Lindela i(imi)layini enemibala.Isiphumo kufuneka sifundwe ngemizuzu eyi-10.Sukutolika iziphumo emva kwemizuzu engama-20.
Ukutolikwa kweziPhumo
IZIPHUMO EZINYO: 
| * Ibhendi enemibala ibonakala kwingingqi yebhanti yolawulo (C) kwaye enye ibhendi enemibala ibonakala kwindawo ye-T band. |
| IZIPHUMO EZINGAMBI:
| Ibhendi enye enemibala ibonakala kwingingqi yebhanti yolawulo (C).Akukho bhendi ivela kummandla webhendi yovavanyo (T). |
| IZIPHUMO EZINGAVUMI:
| Ibhendi yolawulo ayibonakali.Iziphumo zalo naluphi na uvavanyo olungakhange luvelise ibhendi yolawulo ngexesha lokufunda elichaziweyo mazichithwe.Nceda ujonge inkqubo kwaye uphinde ngovavanyo olutsha.Ukuba ingxaki iyaqhubeka, yeka ukusebenzisa ikhithi ngoko nangoko kwaye uqhagamshelane nomsasazi wakho wendawo. |
Phawula
Ubunzulu bombala kumgca wovavanyo (T) buya kwahluka ngokuxhomekeke kuxinzelelo lwezilwa-buhlungu ze-HIV ezikhoyo kumzekelo.Ke ngoko, nawuphi na umthunzi wombala kwindawo yovavanyo (T) kufuneka ithathwe njengelungileyo.
Ulawulo lwemeko
Ulawulo lwenkqubo lwangaphakathi lubandakanyiwe kuvavanyo.Umgca wombala ovela kummandla wolawulo (C) lulawulo olulungileyo lwangaphakathi.Iqinisekisa umthamo owaneleyo wesampuli kunye nobuchule benkqubo obuchanekileyo.
Imigangatho yolawulo ayibonelelwanga nale khithi;nangona kunjalo, kucetyiswa ukuba ulawulo oluqinisekileyo nolungalunganga luvavanywe njengenkqubo efanelekileyo yaselabhoratri yokuqinisekisa inkqubo yovavanyo kunye nokuqinisekisa ukusebenza kovavanyo olufanelekileyo.
Ukulinganiselwa
1.I-HIV 1/2 Human Immunodeficiency Virus Rapid Test Device (Igazi Elipheleleyo/iSerum/Plasma) yeyokusetyenziswa kuphela kwi-in vitro diagnostic.Olu vavanyo kufuneka lusetyenziselwe ukukhangela izilwa-buhlungu ze-HIV kwigazi elipheleleyo, kwiserum okanye kwiplasma.Ixabiso lomyinge okanye izinga lokunyuka koxinzelelo lwe-HIV inokumiselwa ngolu vavanyo lomgangatho.
2. Olu vavanyo luya kubonisa kuphela ubukho be-antibodies kwi-HIV kumzekelo kwaye akufanelekanga ukuba lusetyenziswe njengeyona ndlela yodwa yokuxilongwa kosulelo lwe-HIV 1 kunye/okanye ne-HIV 2.
3.Ukuqinisekisa, uhlalutyo olongezelelweyo lwemizekelo kufuneka lwenziwe, njenge-ELISA kunye / okanye uhlalutyo lwe-Western Blot.
4.Njengazo zonke iimvavanyo zokuxilonga, zonke iziphumo kufuneka zitolikwe kunye nolunye ulwazi lwekliniki olukhoyo kugqirha.
5.Ukuba iziphumo zovavanyo zibi kwaye iimpawu zeklinikhi ziqhubeka, iimvavanyo ezongezelelweyo zokulandela usebenzisa ezinye iindlela zeklinikhi ziyacetyiswa.Isiphumo esibi nangaliphi na ixesha asikuthinteli ukuba nokwenzeka kosulelo lwe-HIV 1 kunye/okanye ne-HIV 2.
Imilinganiselo elindelekileyo
I-HIV 1/2 Human Immunodeficiency Virus Rapid Test Device (Igazi Elipheleleyo/iSerum/Plasma) iye yathelekiswa novavanyo oluphambili lwe-HIV EIA yorhwebo.Unxulumano phakathi kwezi nkqubo zimbini yi-99.8%.
Iimpawu zokuSebenza
Uvakalelo
I-HIV 1/2 Human Immunodeficiency Virus Rapid Test Device (Igazi Elipheleleyo/iSerum/Plasma) iye yavavanywa yi-anti-HIV 1 low titer performance panel, anti-HIV 2 performance panel kunye ne-anti-HIV 1 seroconversion panel (Boston Biomedica, Inc. .).Kwaye iye yathelekiswa novavanyo oluphambili lwe-EIA yorhwebo kwisampulu zeklinikhi.Iziphumo zibonisa ukuba i-HIV 1/2 Human Immunodeficiency Virus Rapid Test Device (Igazi Elipheleleyo/iSerum/Plasma) inovelwano kakhulu kwi-HIV 1 kunye/okanye kwi-HIV 2 antibodies.
Ukuchaza ngokuthe ngqo
Ubume bovavanyo buthelekiseka novavanyo oluphambili lwe-HIV EIA yorhwebo.I-HIV 1/2 Human Immunodeficiency Virus Rapid Test Device (Igazi Elipheleleyo/iSerum/Plasma) igxininise kakhulu kwi-anti-HIV 1 kunye/okanye i-HIV 2 xa kuthelekiswa novavanyo oluphambili lwe-HIV EIA yorhwebo.
| Indlela | I-EIA | Zizonke iziphumo | ||
| HIV 1/2 Isixhobo sokuVavanya ngokukhawuleza | Iziphumo | Okuhle | Ibi | |
| Okuhle | 554 | 4 | 558 | |
| Ibi | 0 | 1159 | 1159 | |
| Zizonke iziphumo | 554 | 1163 | 1717 | |
I-Sensitivity Relative: 99.9% (99.3% -100.0%)*IiNgcaciso eziNxulumeneyo: 99.6% (99.1% -99.9%)*
Ukuchaneka okuNxulumeneyo: 99.8% (99.4% -99.9%)*
Ukuchaneka
I-Intra Assay
Ukuchaneka okungaphakathi kuchongiwe ngokusetyenziswa kwee-replicates ze-15 zemizekelo emithathu: i-negative, i-positive ephantsi kunye ne-high positive.Amanani angalunganga, aphantsi anika ithemba kunye namaxabiso aphezulu aphezulu achongwe ngokuchanekileyo ama-99.5% exesha.
Inter-Assay
Ukuchaneka okuphakathi kokuqhutywa kuye kwamiselwa ziimvavanyo ezili-15 ezizimeleyo kwimizekelo emithathu efanayo: i-negative, i-positive ephantsi kunye ne-positive ephezulu.Izixhobo ezithathu ezahlukeneyo ze-HIV 1/2 Human Immunodeficiency Virus Rapid Test Device (Igazi Elipheleleyo/iSerum/Plasma) ziye zavavanywa kusetyenziswa imizekelo ebonisa ukuba awunayo, awunayo kwaye uneempawu eziphezulu.Imizekelo yayichongwe ngokuchanekileyo ngama-99.5% exesha.
Uluhlu lweencwadi
1.Chang, SY, Bowman, BH, Weiss, JB, Garcia, RE kunye noMhlophe, TJ.Imvelaphi ye-HIV-1 yodwa i-HTLV-IIIB.Indalo (1993) 3;363:466-9
2.Arya, SK, Beaver, B, Jagodzinski, L, Ensoli, B, Kanki, PJ, Albert, J, Fenyo, EM, Biberfeld, G, Zagury, JF kunye noLaure, F. Abantu abatsha kunye ne-simian retroviruses ezinxulumene ne-HIV babe nejini ye-transactivator (tat) esebenzayo.Indalo (1987) 328:548-550
3.Caetano JA Imiba ye-Immunologic yosulelo lwe-HIV.Acta Med Port (1991) 4 Suppl 1:52S-58S
4.Janssen, RS, Satten, GA, Stramer, SL, Rawal, BD, O'Brien, TR, Weiblen, BJ, Hecht, FM, Jack, N, Cleghorn, FR, Kahn, JO, Chesney, MA kunye neBusch MP .Isicwangciso esitsha sovavanyo lokubona usulelo lwe-HIV-1 kwangoko ukuze lusetyenziswe kuqikelelo lwezehlo kunye neenjongo zeklinikhi kunye nothintelo.JAMA (1998) 280(1):42-48
5.Travers, K, Mboup, S, Marlink, R, Gueye-Nidaye, A, Siby, T, Thior, I, Traore, I, Dieng-Sarr, A, Sankale, JL kunye ne-Mullins, C. Ukukhuselwa kwendalo kwi-HIV -1 usulelo olunikezelwa yi-HIV-2.Inzululwazi (1995) 268:1612-1615
6.Greenberg, AE, Wiktor, SZ, DeCock, KM, Smith, P, Jaffe HW kunye neDondero, TJ, Jr. HIV-2 kunye nokukhuselwa kwendalo kwi-HIV-1.Inzululwazi (1996) 272:1959-1960
