I-Novel Coronavirus COVID-19 IgG/IgM Diagnostic Rapid

Imininingwane Esheshayo

I-COVID-19 Anti-2020-nCoV ICoronavirus entsha
ikhithi yokuhlola i-coronavirus ye-COVID-19 ikhithi yokuhlola okusheshayo ye-IgM/IgG yokuhlola i-TUV
I-Novel Coronavirus COVID-19 IgG/IgM Diagnostic Rapid

Ukupakisha Nokulethwa

Imininingwane

I-AMRPA68
Ikhithi Yokuhlola Esheshayo Ye-COVID-19 IgM/IgG
(I-Immunochromatography)
PRODUCT NAME
Ikhithi Yokuhlola Esheshayo Ye-COVID-19 IgM/IgG
(I-Immunochromatography)
UKUSETSHENZISWA OKUHLOSIWE
I-reagent isetshenziselwa ukuthola i-Corona Virus-19 IgM/IgG Antibody ngaphakathi
i-serum/plasma/igazi lonke ngokwekhwalithi.
ISIMISO SOKUHLOLA
Le khithi isekelwe kumgomo welebula yegolide yokuhlolwa kwe-immunochromatographic futhi isebenzisa indlela yokuthwebula ukuthola i-COVID-19 IgM/IgG kusampula.

ISIMISO SOKUHLOLA

I-COVID-19 IgM
Uma isampula iqukethe i-COVID-19 IgM antibody, yakha inkimbinkimbi ene-antigen yelebula legolide (i-COVID-19 recombinant antigen).Inkimbinkimbi iya phambili ngaphansi kwesenzo se-chromatography futhi ihlangana ne-antibody emboziwe (Igundane elilwa nomuntu IgM monoclonal antibody) kumugqa we-T ukuze kwakheke umbala oyinkimbinkimbi futhi uthuthukise (umugqa T), okuwumphumela omuhle.Uma isampula lingenayo i-antibody ye-COVID-19 IgM, ayikho inkimbinkimbi engakhiwa kulayini we-T, futhi alikho ibhande elibomvu elivelayo, okuwumphumela ongemuhle.
Noma ngabe i-antibody ye-COVID-19 IgM iqukethwe kusampula, i-antibody yokulawula ikhwalithi yelebula yegolide (i-rabbit IgG antibody) izobopha ne-antibody ehlanganisiwe (i-anti-rabbit IgG antibody) kulayini C ukuze yakhe inkimbinkimbi futhi ithuthuke. umbala (umugqa C).

I-COVID-19 IgG
Uma isampula iqukethe i-COVID-19 IgG antibody, yakha inkimbinkimbi ene-antigen yelebula legolide (i-COVID-19 recombinant antigen).Inkimbinkimbi iqhubekela phambili ngaphansi kwesenzo se-chromatography futhi ihlangana ne-antibody emboziwe (Igundane elilwa ne-IgG monoclonal antibody) kumugqa we-T ukuze kwakheke umbala oyinkimbinkimbi futhi uthuthukise (umugqa T), okuwumphumela omuhle.Uma isampula ingenayo i-antibody ye-COVID-19 IgG, ayikho inkimbinkimbi engakhiwa kulayini we-T, futhi alikho ibhande elibomvu elivelayo, okuwumphumela ongemuhle.
 

Noma ngabe i-antibody ye-COVID-19 IgG iqukethwe kusampula, i-antibody yokulawula ikhwalithi yelebula yegolide (i-rabbit IgM antibody) izobophezela ne-antibody ehlanganisiwe (i-anti-rabbit IgG antibody) kulayini C ukuze yakhe inkimbinkimbi futhi ithuthuke. umbala (umugqa C).

IZINTO EZIYINHLOKO
I-COVID-19 IgM: I-T-line ehlanganiswe ne-anti-human IgM monoclonal antibody, i-golden label pad solid phase COVID-19 recombinant antigen, i-rabbit IgG antibody, i-C-line ehlanganiswe ne-anti-rabbit ye-IgG yembuzi.

I-COVID-19 IgG: I-T-line ehlanganiswe ne-anti-human IgG monoclonal antibody, i-golden label pad solid phase COVID-19 recombinant antigen, i-rabbit IgM antibody, i-C-line ehlanganiswe ne-anti-rabbit IgM antibody.Ukuhlanjululwa kwesampula: okwakhiwe ngesisombululo sebhafa se-phosphate esingu-20 mM (PBS)

ISITOREJI NOKUPHELA ISIKHATHI
Gcina njengoba kupakishwe esikhwameni esivaliwe ku-4-30℃, gwema ukushisa nokushisa kwelanga, indawo eyomile, esebenza izinyanga eziyi-12.UNGAQISHI.Ezinye izinyathelo zokuvikela kufanele zithathwe ehlobo elishisayo nasebusika obubandayo ukuze kugwenywe izinga lokushisa eliphezulu noma ukuncibilika kweqhwa.Ungawavuli amaphakheji angaphakathi aze alungele, kufanele asetshenziswe ehoreni elilodwa uma evuliwe (Umswakama≤60%, Temp: 20℃-30℃).Sicela usebenzise ngokushesha lapho umswakama ~60%.

ISIDINGO SESAMBULO
1. I-reagent ingasetshenziselwa i-serum, i-plasma kanye namasampula egazi lonke.
2. I-serum / plasma / isampula yegazi lonke kufanele iqoqwe esitsheni esihlanzekile nesomile.I-EDTA, i-sodium citrate, i-heparin ingasetshenziswa njengama-anticoagulants kumasampula e-plasma / lonke igazi.Thola ngokushesha ngemva kokuqoqa igazi.
3.Amasampula e-Serum kanye ne-plasma angase agcinwe ku-2-8℃ izinsuku ezingu-3 ngaphambi kokuhlolwa.Uma ukuhlola kubambezeleke ngaphezu kwezinsuku ezi-3, isampula kufanele iqandiswe (-20℃ noma ukubanda).Phinda ube yiqhwa futhi uncibilike izikhathi ezingaphezu kwezingu-3.Amasampula egazi aphelele ane-anticoagulant angagcinwa ku-2-8℃ izinsuku ezi-3, futhi akufanele aqandiswe;amasampula egazi eliphelele ngaphandle kwe-anticoagulant kufanele asetshenziswe ngokushesha (uma isampula ine-agglutination, ingatholwa nge-serum).

IZINDLELA ZOKUHLOLA
Imiyalo kufanele ifundwe ngokuphelele ngaphambi kokuhlolwa.Vumela izilawuli zedivayisi yokuhlola ukuthi zilingane nezinga lokushisa legumbi imizuzu engama-30 (20℃-30℃) ngaphambi kokuhlolwa.Ungawavuli amaphakheji angaphakathi aze alungele, kufanele asetshenziswe ehoreni elilodwa uma evuliwe (Umswakama≤60%, Temp: 20℃-30℃).Sicela usebenzise ngokushesha lapho umswakama ~60%.
OkweSerum/Plasma
1. Khipha idivayisi yokuhlola esikhwameni esivaliwe, uyibeke endaweni ehlanzekile neleveli isampula ligcwale.
2. Engeza iconsi elilodwa (1) eligcwele le-serum noma i-plasma (10μl) ngokuqondile emthonjeni wesampula we-IgM ne-IgG ngokuhlukana.
3. Engeza amaconsi amabili (2) (80-100μl) esampula sebhafa kumthombo wesampula we-IgM ne-IgG ngokuhlukana.
4. Bheka imiphumela yokuhlolwa ngokushesha phakathi kwemizuzu eyi-15 ~ 20, umphumela awuvumelekile emaminithini angama-20.

I-COVID-19 IgG
Ukuhlaziywa kwezinga lokuzenzakalela kwe-COVID-19 IgG Ab yokuhlolwa okusheshayo kanye ne-nucleic acid reagent kumasampula e-serum:
Izinga lokuqondana okuhle=46 / (46+4) × 100% = 92%,
Izinga lokuqondana okubi =291 / (9+291) × 100% = 97%,
Isamba sezinga lokuzenzakalela=(46+291) / (46+4+9+291) × 100% = 96.3%.

I-COVID-19 IgM
Ukuhlaziywa kwezinga lokuzenzakalela kwe-COVID-19 IgM Ab yokuhlolwa okusheshayo kanye ne-nucleic acid
Amasampula e-reagent ku-serum:
Izinga lokuqondana okuhle=41 / (41+9) × 100% = 82%,
Izinga lokuqondana okubi =282 / (18+282) × 100% = 94%,
Isamba sezinga lokuzenzakalela=(41+282) / (41+9+18+282) × 100% = 92.3%

UKUNAKWA
1. Okokusetshenziswa kokuxilongwa kwe-IN VITRO kuphela.
2. Ama-reagents kufanele asetshenziswe ngokushesha ngangokunokwenzeka ngemva kokuvulwa.Lesi sikhungo asikwazi ukuphinda sisetshenziswe ukuze silahlwe.
3. Umshini wokuhlola kufanele uhlale usezikhwameni ezivaliwe kuze kusetshenziswe.Uma kwenzeka inkinga yokuvala uphawu, ungahloli.Ungasebenzisi ngemva kosuku lokuphelelwa yisikhathi.
4.Zonke izifanekiso nama-reagents kufanele kubhekwe njengeziyingozi futhi ziphathwe ngendlela efanayo ne-ejenti ethelelanayo ngemva kokusetshenziswa.