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I-Cytomegalovirus Isinyathelo esisodwa CMV IgG/IgM Rapid Test Package Insert

I-Cytomegalovirus Isinyathelo esisodwa CMV IgG/IgM Rapid Test Package Insert

I-One Step CMV IgG/IgM Rapid Test Device ukuhlolwa kokugeleza kwekhwalithi okusheshayo okuklanyelwe ukutholwa kobuningi bamasosha omzimba e-IgG ne-IgM ku-Cytomegalovirus (CMV) egazini lomuntu Lonke, i-serum noma amasampula e-plasma.


Imininingwane Yomkhiqizo

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Isimiso

Kuyi-chromatographic immunoassay esheshayo yokutholwa kwekhwalithi yamasosha omzimba (IgG ne-IgM) kuya ku-CMV egazini Eliphelele, iSerum noma iPlasma.Ukuhlolwa ngakunye kuqukethe: 1) i-burgundy colored conjugate pad equkethe i-CMV recombinant envelope antigens ehlanganiswe ne-Colloid gold (CMV conjugates) kanye ne-rabbit IgG-gold conjugates,2) i-nitrocellulose membrane strip equkethe amabhendi amabili okuhlola (amabhendi we-T1 kanye ne-T2) kanye ibhendi yokulawula (ibhendi C).Ibhendi ye-T1 ihlanganiswe ngaphambili ne-anti-CMV ukuze kutholwe i-IgM anti-CMV, ibhendi ye-T2 imbozwe ngamasosha omzimba ukuze kutholwe i-IgG anti-CMV, futhi i-C band imbozwe ngaphambili nge-anti-rabbit IgG yembuzi.Uma ivolumu eyanele yesampula yokuhlola ikhishelwa emthonjeni wesampula wekhasethi lokuhlola, isifanekiso sihamba ngesenzo se-capillary kulo lonke ikhasethi.I-IgG anti-CMV, uma ikhona kusifanekiso, izobophezela kuma-conjugate e-CMV.I-immunocomplex bese ibanjwa i-reagent embozwe ngaphambili ebhendini ye-T2, yakhe ibhande le-T2 elinemibala e-burgundy, ekhombisa umphumela wokuhlolwa omuhle we-CMV IgG futhi iphakamisa ukutheleleka kwakamuva noma okuphindayo.I-IgM anti-CMV uma ikhona kusifanekiso izobophezela kuma-conjugate e-CMV.I-immunocomplex bese ibanjwa yi-reagent ehlanganiswe ebhendini ye-T1, yakhe ibhande le-T1 elinemibala e-burgundy, ekhombisa umphumela wokuhlolwa omuhle we-CMV IgM futhi iphakamisa ukutheleleka okusha.Ukungabikho kwanoma yimaphi amabhendi e-T (T1 kanye ne-T2) kuphakamisa umphumela ongemuhle.Ukuhlola kuqukethe isilawuli sangaphakathi (i-C band) okufanele sibonise ibhande elinemibala e-burgundy ye-immunocomplex ye-goat anti rabbit IgG/rabbit IgG‐gold conjugate kungakhathaliseki ukuthuthuka kombala kunoma yimaphi amabhendi e-T.Uma kungenjalo, umphumela wokuhlola awuvumelekile futhi isifanekiso kufanele sihlolwe kabusha ngenye idivayisi.

Inqubo

1. Letha isikhwama ekamelweni lokushisa ngaphambi kokusivula.Susa idivayisi yokuhlola esikhwameni esivaliwe futhi uyisebenzise ngokushesha.

2. Beka idivayisi yokuhlola endaweni ehlanzekile neleveli.

3. Bamba i-dropper ngokuqondile bese udlulisela iconsi elingu-1 le-Plasma/serum specimen (cishe u-10μl) noma amaconsi angu-2 esampula yegazi eliphelele (cishe u-20μl) kusifanekiso somthombo(S) wedivayisi yokuhlola, bese wengeza amaconsi angu-2 ebhafa (cishe 80μl) bese uqala isibali sikhathi.Bheka umfanekiso ngezansi.

4. Linda kuze kuvele i(ama)layini anombala.Funda imiphumela ngemizuzu eyi-15.Ungahumushi umphumela ngemuva kwemizuzu engama-20.

Amanothi:
Ukusebenzisa inani elanele lesifanekiso kubalulekile ukuze uthole umphumela wokuhlola ovumelekile.Uma ukufuduka (ukumanziswa kolwelwesi) kungabonwa efasiteleni lokuhlola ngemva komzuzu owodwa, engeza ithonsi elilodwa lebhafa kusifanekiso kahle.

Ukunemba:
Imiphumela yabonisa>99% ukunemba kukonke kwe-hCG One Step Pregnancy Combo Test Device uma iqhathaniswa nolunye ukuhlolwa kwe-hCG yolwelwesi lomchamo.

Imiphumela

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I-IgM POSITIVE: * Umugqa onombala endaweni yomugqa wokulawula (C) uyavela futhi umugqa onombala uvela esifundeni somugqa wokuhlola 1 (T1).Umphumela ukhombisa ukuba khona kwamasosha omzimba athile e-CMV e-IgM.

I-IgG POSITIVE: * Umugqa onombala endaweni yomugqa wokulawula (C) uyavela futhi umugqa onombala uvela esifundeni somugqa wokuhlola 2 (T2).Umphumela ukhombisa ukuba khona kwamasosha omzimba athile e-CMV e-IgG.

I-IgG KANYE NE-IgM OKUHLE: * Umugqa onemibala endaweni yomugqa wokulawula (C) uyavela futhi imigqa emibili enemibala kufanele ivele ezifundeni zomugqa wokuhlola 1 no-2 (T1 kanye ne-T2).Ukuqina kombala wemigqa akudingeki ukuthi kuhambisane.Umphumela ukhombisa ukuthi kukhona kokubili amasosha omzimba e-CMV e-IgG kanye ne-IgM.

*QAPHELA: Ukushuba kombala kusifunda somugqa wokuhlola (T1 kanye/noma i-T2) kuzohluka kuye ngokuhlangana kwamasosha omzimba e-CMV kusifanekiso.Ngakho-ke, noma imuphi umthunzi wombala esifundeni/iziyingi zomugqa wokuhlola (T1 kanye/noma i-T2) kufanele kubhekwe njengokuhle.

UMPHUMELA EMIBI:
Umugqa onemibala endaweni yomugqa wokulawula (C) uyavela.Awukho umugqa ovela ezifundeni zomugqa wokuhlola 1 noma 2 (T1 noma T2).

UMPHUMELA ONGAvumelekile:

Ulayini wokulawula uyehluleka ukuvela.Ivolumu yesampula enganele noma izindlela zenqubo ezingalungile yizona zizathu okungenzeka kakhulu zokwehluleka komugqa wokulawula.Buyekeza inqubo bese uphinda ukuhlola ngedivayisi entsha yokuhlola.Uma inkinga iqhubeka, yeka ukusebenzisa ikhithi yokuhlola ngokushesha futhi uxhumane nomsabalalisi wangakini.

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