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UDengue IgG/IgM Rapid Test Package Insert

UDengue IgG/IgM Rapid Test Package Insert

Amagciwane odenga, umndeni wama-serotypes amane ahlukene wamagciwane (Den 1,2,3,4), angamagciwane e-RNA angagxilile, amboziwe, anengqondo eqondile.
Ukuhlola kuyasebenziseka kalula, ngaphandle kwemishini yaselabhorethri enzima, futhi kudinga ukuqeqeshwa okuncane kwabasebenzi.


Imininingwane Yomkhiqizo

Omaka bomkhiqizo

Isimiso

I-Dengue IgG/IgM Rapid Test Device (Igazi Eliphelele/iSerum/Plasma) iyi-immunoassay esekelwe kulwelwesi esezingeni ukuze kutholwe amasosha omzimba oDengue egazini lonke, i-serum, noma i-plasma.Lokhu kuhlola kuqukethe izingxenye ezimbili, ingxenye ye-IgG kanye nengxenye ye-IgM.Esifundeni sokuhlola, i-IgM elwa nobuntu ne-IgG ihlanganiswe.

Ngesikhathi sokuhlolwa, isifanekiso sibhekana nezinhlayiya ze-Dengue antigen-coated emgqeni wokuhlola.Ingxube ibe isithuthela phezulu kulwelwesi lwe-chromatographical ngesenzo se-capillary futhi isabela ne-IgM emelene nomuntu noma i-IgG endaweni yomugqa wokuhlola.Uma isifanekiso siqukethe amasosha omzimba e-IgM noma e-IgG kuDengue, kuzovela umugqa onemibala endaweni yomugqa wokuhlola.

Ngakho-ke, uma isifanekiso siqukethe amasosha omzimba kaDengue IgM, umugqa onemibala uzovela esifundeni somugqa wokuhlola 1. Uma isifanekiso siqukethe amasosha omzimba kaDengue IgG, umugqa onombala uzovela esifundeni somugqa wokuhlola 2. Uma isifanekiso singenawo amasosha omzimba oDengue, cha. umugqa onombala uzovela kunoma yisiphi isifunda somugqa wokuhlola, okubonisa umphumela ongemuhle.Ukuze usebenze njengokulawula kwenqubo, umugqa onemibala uzohlala uvela endaweni yokulawula, okubonisa ukuthi umthamo ofanele we-specimen ungeziwe futhi i-membrane wicking yenzekile.

Inqubo

INQUBO YOKUHLOLA
Letha isifanekiso nezingxenye zokuhlola ekamelweni lokushisa Xuba isifanekiso kahle ngaphambi kokuhlolwa uma sesincibilikile.Beka idivayisi yokuhlola endaweni ehlanzekile, eyisicaba.

Isampula legazi eliphelele:
Gcwalisa i-dropper ngesifanekiso bese wengeza i-dropper engu-1 yesampula emthonjeni wesampula.Ivolumu icishe ibe ngu-10µL.Ukuqinisekisa ukuthi awekho amabhamuza omoya.Bese wengeza amaconsi angu-2 (cishe ama-80 µL) e-Diluent Yesampuli ngokushesha emthonjeni wesampula.

Okwesampula ye-Plasma/Serum:
Gcwalisa i-dropper nge-specimen ukuze ungadluli umugqa wesifanekiso.Umthamo wesampula ungama-5µL.

Nikeza sonke isifanekiso phakathi nendawo yesampula kahle wenze isiqiniseko sokuthi awekho amabhamuza omoya.Bese wengeza amaconsi angu-2 (cishe ama-80 µL) e-Sample Diluent ngokushesha emthonjeni wesampula.

Qaphela: Zilolonge izikhathi ezimbalwa ngaphambi kokuhlola uma ungayazi i-mini dropper.Ukuze uthole ukunemba okungcono, dlulisela isibonelo sephayiphi elikwazi ukudiliva5µLofvolume.

Setha isibali sikhathi.Funda umphumela ngemizuzu eyi-15.Ungafundi umphumela ngemva kwemizuzu engu-30. Ukuze ugweme ukudideka, lahla ithuluzi lokuhlola ngemva komphumela wokuhumusha.

2.I-Dengue NS1 Rapid Test Package Insert

I-Dengue NS1 Rapid Test Device iyi-lateral flow chromatographic immunoassay yokutholwa kwekhwalithi ye-antigen ye-dengue virus (Dengue Ag) egazini lomuntu lonke, i-serum noma i-plasma.Kuhloswe ukuthi kusetshenziswe njengokuhlola ukuhlola futhi njengosizo ekuhlonzweni kokutheleleka ngamagciwane oDengue.Noma isiphi isifanekiso esisebenzayo esineDengue NS1 Rapid Test Device kufanele siqinisekiswe ngenye indlela(izindlela) zokuhlola kanye nokutholakele emitholampilo.

INQUBO YOKUHLOLA
Isinyathelo 1: Letha isifanekiso nezingxenye zokuhlola ekamelweni lokushisa uma kuqandisiwe noma kuqandisiwe.Hlanganisa kahle isifanekiso ngaphambi kokuhlolwa uma usuncibilikile.

Isinyathelo sesi-2: Uma usulungele ukuhlola, vula isikhwama ku-notch bese ukhipha idivayisi.Beka idivayisi yokuhlola endaweni ehlanzekile, eyisicaba.

Isinyathelo sesi-3: Qiniseka ukuthi ulebula idivayisi ngenombolo ye-ID yesifanekiso.

Isinyathelo sesi-4: Ngamasampula egazi eliphelele:
Gcwalisa i-dropper nge-specimen bese wengeza amaconsi angu-2 (cishe u-80µL) wesampula kanye namaconsi angu-2 ebhafa emthonjeni wesampula, uqiniseke ukuthi awekho amabhamuza omoya.

Ngamasampula e-Plasma/Serum:

Gcwalisa i-dropper yepulasitiki ngesifanekiso.Ubambe i-dropper ngokuqondile, khipha ukwehla okungu-1 (cishe u-40µL) kwesampula kanye namaconsi angu-2 ebhafa emthonjeni wesampula, wenze isiqiniseko sokuthi awekho amabhamuza omoya.

Isinyathelo sesi-5: Setha isibali sikhathi.

Isinyathelo sesi-6: Funda umphumela ngemizuzu eyi-15.

Ungafundi imiphumela ngemuva kwemizuzu engama-30.Ukuze ugweme ukudideka, lahla idivayisi yokuhlola ngemva kokuhumusha umphumela.

3.Dengue IgG/IgM/NS1 Combo Rapid Test Package Insert

I-Dengue IgG/IgM/NS1 I-Combo Rapid Test Device iyi-lateral flow chromatographic immunoassay yokutholwa kwekhwalithi ye-dengue IgG/IgM kanye ne-virus antigen (Dengue Ag) egazini lomuntu lonke, i-serum noma i-plasma.Kuhloswe ukuthi kusetshenziswe njengokuhlola ukuhlola futhi njengosizo ekuhlonzweni kokutheleleka ngamagciwane oDengue.Noma yisiphi isifanekiso esisebenzayo esinoDengue IgG/IgM/NS1 Combo Rapid Test Device kufanele siqinisekiswe ngenye indlela(s) yokuhlola kanye nokutholwe komtholampilo.

INQUBO YOKUHLOLA
Isinyathelo 1: Letha isifanekiso nezingxenye zokuhlola ekamelweni lokushisa uma kuqandisiwe noma kuqandisiwe.Hlanganisa kahle isifanekiso ngaphambi kokuhlolwa uma usuncibilikile.

Isinyathelo sesi-2: Uma usulungele ukuhlola, vula isikhwama ku-notch bese ukhipha idivayisi.Beka idivayisi yokuhlola endaweni ehlanzekile, eyisicaba.

Isinyathelo sesi-3: Qiniseka ukuthi ulebula idivayisi ngenombolo ye-ID yesifanekiso.

Isinyathelo sesi-4: Ngamasampula egazi eliphelele:
Gcwalisa i-dropper nge-specimen bese wengeza iconsi elingu-1 (cishe u-10µL) wesampula kanye namaconsi angu-2 e-buffer kusampula ye-IgG/IgM kahle kanye namaconsi angu-4 esampula kanye namaconsi angu-2 ebhafa kusampula ye-NS1 kahle, uqiniseke ukuthi awukho umoya. amagwebu.

Ngamasampula e-Plasma/Serum:
Gcwalisa i-dropper yepulasitiki ngesifanekiso.Ubambe i-dropper uqonde, khipha u-5 µL wesampula kanye namaconsi angu-2 ebhafa kusampula ye-IgG/IgM kahle kanye namaconsi angu-4 esampula namaconsi angu-1 ebhafa kusampula ye-NS1 kahle, wenze isiqiniseko sokuthi awekho amabhamuza omoya.

Isinyathelo sesi-5: Setha isibali sikhathi.

Isinyathelo sesi-6: Imiphumela ingafundwa emizuzwini eyi-15.Imiphumela emihle ingabonakala emfushane njengeminithi elingu-1.

Ungafundi imiphumela ngemuva kwemizuzu engama-30.Ukuze ugweme ukudideka, lahla idivayisi yokuhlola ngemva kokuhumusha umphumela

Ukuhunyushwa Komphumela Wokuhlola

savsva2
vsava

Udenga IgG/IgM

savasvb

I-IgG Positive

svanrw213

I-IgM Positive

12 asv

Umphumela we-IgG kanye ne-IgM Positive NEGATIVE

abdb

Umphumela Ongavumelekile

vsavasv

Udenga IgG/IgM/NS1


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