Isinyathelo esisodwa se-SARS-CoV2(COVID-19)IgG/IgM Test
Ukusetshenziswa Okuhlosiwe
I-One Step SARS-CoV2(COVID-19)IgG/IgM Test iyi-chromatographic immunoassay esheshayo yokutholwa kwekhwalithi yamasosha omzimba (i-IgG ne-IgM) ukuya kugciwane le-COVID-19 ku-Whole Blood / Serum / Plasma ukusiza ekuxilongweni kwe-COVID. -19 ukutheleleka ngegciwane.
Isifinyezo
Amagciwane e-Corona angamagciwane e-RNA amboziwe asatshalaliswa kabanzi phakathi kwabantu, ezinye izilwane ezincelisayo, nezinyoni futhi abangela izifo zokuphefumula, i-enteric, i-hepatic kanye ne-neurologic.Izinhlobo eziyisikhombisa zegciwane le-corona zaziwa ngokubangela izifo zabantu.Amagciwane amane-229E.OC43.I-NL63 ne-HKu1- zivamile futhi ngokuvamile zibangela izimpawu zomkhuhlane ezivamile kubantu abangenawo amandla omzimba.4 Ezinye izinhlobo ezintathu ze-acute acute respiratory syndrome (SARS-Cov), Middle East Respiratory Syndrome coronavirus (MERS-Cov) kanye ne-Novel Coronavirus (COVID-2019) 19)- ziyi-zoonotic ngemvelaphi futhi ziye zaxhunyaniswa nokugula okubulalayo kwesinye isikhathi.Amasosha omzimba e-IgG kanye ne-lgM ku-2019 Novel Coronavirus angatholwa emavikini ama-2-3 ngemuva kokuchayeka.I-lgG ihlala ine-positive, kodwa izinga le-antibody liyehla esikhathini esengeziwe.
Isimiso
I-One Step SARS-CoV2(COVID-19)IgG/IgM (Whole Blood/Serum/Plasma) iyisivivinyo se-lateral flow immunochromatographic.Ukuhlola kusebenzisa i-anti-human lgM antibody (umugqa wokuhlola we-IgM), i-lgG ephikisana nomuntu (umugqa wokuhlola i-lgG kanye ne-igG yembuzi emelene nonogwaja (umugqa wokulawula C) enganyakazi emgqeni we-nitrocellulose. Ama-antigen e-COVID-19 ahlanganiswe negolide eli-colloid (COVID-19 conjugatesabbit LgG-gold conjugates. Uma isifanekiso esilandelwa yi-assay buffer singezwa emthonjeni wesampula, amasosha omzimba e-IgM &/noma e-lgG uma ekhona, azobophezela ekwenzeni ama-conjugate e-COVID-19 Ama-antigen antibodies. Le nkimbinkimbi ifuduka ngolwelwesi lwe-nitrocellulose ngesenzo se-capillary Lapho inkimbinkimbi ihlangana nomugqa we-anti-human IgM &/noma i-anit-human lgG) inkimbinkimbi ivaleleke yenze ibhande elinombala o-burgundy. umphumela wokuhlolwa osebenzayo Ukungabikho kwebhendi enemibala endaweni yokuhlola kubonisa umphumela wokuhlola ongasasebenzi.
Ukuhlola kuqukethe isilawuli sangaphakathi(i-C band) okufanele sibonise ibhande elinombala o-burgundy we-immunocomplex goat anti rabbit IgG/rabbit lgG-gold conjugate kungakhathaliseki ukuthuthuka kombala kunoma yimaphi amabhendi okuhlola.Uma kungenjalo, umphumela wokuhlola awuvumelekile futhi isifanekiso kufanele sihlolwe kabusha ngenye idivayisi.
Isitoreji Nokuzinza
- Gcina njengoba kuhlanganiswe esikhwameni esivaliwe ekamelweni lokushisa noma esiqandisini (4-30℃ noma 40-86℉).Idivayisi yokuhlola izinzile ngedethi yokuphelelwa yisikhathi ephrintwe esikhwameni esivaliwe.
- Ukuhlolwa kufanele kuhlale esikhwameni esivaliwe kuze kusetshenziswe.
Izisetshenziswa Ezikhethekile Ezengeziwe
Izinto Ezinikeziwe:
| .Imishini yokuhlola | .Ama-droppers wesampula alahlwayo |
| .Ibhafa | .Faka iphakheji |
Izinto Ezidingekayo Kodwa Azinikezwa:
| .I-Centrifuge | .Isikhathi |
| .Iphedi Lotshwala | .Iziqukathi zokuqoqa isampula |
Izinyathelo zokuzivikela
☆ Okokusetshenziswa kochwepheshe be-in vitro diagnostic kuphela.Ungasebenzisi ngemuva kosuku lokuphelelwa yisikhathi.
☆ Ungadli, uphuze noma ungabhemi endaweni lapho kusingathwa khona ama-specimens namakhithi.
☆ Phatha zonke izibonelo njengokungathi ziqukethe izinto ezithathelwanayo.
☆ Bheka izinyathelo ezimisiwe zokuvikela izingozi ze-microbiological kuzo zonke izinqubo futhi ulandele izinqubo ezijwayelekile zokulahlwa okufanele kwezibonelo.
☆ Gqoka izingubo ezivikelayo njengamajazi aselabhorethri, amagilavu alahlwayo kanye nokuvikela amehlo lapho izibonelo zihlolwa.
☆ Landela imihlahlandlela ejwayelekile ye-bio-safety yokuphatha nokulahlwa kwezinto ezingaba yizifo ezithathelanayo.
☆ Umswakama kanye nezinga lokushisa kungaba nomthelela omubi emiphumeleni.
Ukuqoqwa nokulungiselelwa kwesifanekiso
1. Ukuhlolwa kwe-SARS-CoV2(COVID-19)IgG/IgM kungenziwa ku-Whole Blood/Serum/Plasma.
2. Ukuqoqa igazi eliphelele, i-serum noma i-plasma specimens ngokulandela izinqubo zaselabhorethri zomtholampilo ezivamile.
3. Ukuhlolwa kufanele kwenziwe ngokushesha ngemva kokuqoqwa kwesifanekiso.Ungashiyi ama-specimens ekamelweni lokushisa isikhathi eside.Ukugcina isikhathi eside, ama-specimens kufanele agcinwe ngaphansi -20 ℃.Igazi eliphelele kufanele ligcinwe ku-2-8℃ uma ukuhlolwa kuzokwenziwa phakathi kwezinsuku ezi-2 zokuqoqwa.Ungawaqandi amasampula egazi eliphelele.
4. Letha izibonelo ekamelweni lokushisa ngaphambi kokuhlolwa.Izifanekiso eziqandisiwe kufanele zincibilikiswe ngokuphelele futhi zixutshwe kahle ngaphambi kokuhlolwa.Izibonelo akufanele zifrizwe futhi zincibilikiswe ngokuphindaphindiwe.
Inqubo Yokuhlola
1. Vumela ukuhlola, isifanekiso, ibhafa kanye/noma izilawuli ukuthi zifinyelele izinga lokushisa legumbi elingu-15-30℃ (59-86℉) ngaphambi kokuhlolwa.
2. Letha isikhwama ekamelweni lokushisa ngaphambi kokusivula.Susa idivayisi yokuhlola esikhwameni esivaliwe futhi uyisebenzise ngokushesha.
3. Beka idivayisi yokuhlola endaweni ehlanzekile neleveli.
4. Bamba idropha ngokuqondile bese udlulisela iconsi elingu-1 lesifanekiso (cishe u-10μl) esibonelweni somthombo(S) wedivayisi yokuhlola, bese wengeza amathonsi angu-2 ebhafa (cishe u-70μl) bese uqala isibali sikhathi.Bheka umfanekiso ngezansi.
5. 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.
Ukuhunyushwa Kwemiphumela
Okuhle:Ulayini wokulawula futhi okungenani umugqa owodwa wokuhlola uvela kulwelwesi.Ukubonakala komugqa wokuhlola we-T2 kukhombisa ukuba khona kwamasosha omzimba athile e-COVID-19 e-IgG.Ukubukeka komugqa wokuhlola we-T1 kukhombisa ukuba khona kwamasosha omzimba akhethekile e-COVID-19 e-IgM.Futhi uma ulayini we-T1 no-T2 uvela, kukhombisa ukuthi ubukhona bamasosha omzimba athile e-COVID-19 e-IgG ne-IgM.Uma ukuncipha kokugxilisa amasosha omzimba, umugqa wemiphumela uba buthaka.
Okubi:Umugqa owodwa onombala uvela endaweni yokulawula(C).Awukho umugqa onombala ovela endaweni yomugqa wokuhlola.
Okungavumelekile:Ulayini wokulawula uyehluleka ukuvela.Ivolumu yesampula enganele noma izindlela zenqubo ezingalungile yizona zizathu okungenzeka kakhulu zokwehluleka komugqa wokulawula.Buyekeza inqubo bese uphinda ukuhlola ngedivayisi yokuhlola entsha.Uma inkinga iqhubeka, yeka ukusebenzisa ikhithi yokuhlola ngokushesha futhi uxhumane nomsabalalisi wangakini.
Ukulinganiselwa
1.Ukuhlolwa kwe-SARS-CoV2(COVID-19)IgG/IgM okokusetshenziswa kokuxilongwa kwe-in vitro kuphela.Ukuhlolwa kufanele kusetshenziselwe ukutholwa kwamasosha omzimba e-COVID-19 kumasampula e-Whole Blood/Serum/Plasma kuphela.Akulona inani lobuningi noma izinga lokukhuphuka kokungu-2. Amasosha omzimba e-COVID-19 anganqunywa yilolu hlolo lwekhwalithi.
3. Njengazo zonke izivivinyo zokuxilonga, yonke imiphumela kufanele ihunyushwe kanye nolunye ulwazi lomtholampilo olutholakala kudokotela.
4. Uma umphumela wokuhlolwa ungemuhle futhi izimpawu zomtholampilo ziqhubeka, ukuhlolwa okwengeziwe kusetshenziswa ezinye izindlela zomtholampilo kuyanconywa.Umphumela ongemuhle awuvimbeli noma nini ithuba lokutheleleka ngegciwane le-COVID-19.
Ulwazi Lombukiso
Isitifiketi Sokuhlonishwa
Iphrofayela Yenkampani
Thina, i-Hangzhou Testsea Biotechnology Co., Ltd yinkampani ekhula ngokushesha yobuchwephesha be-biotechnology ekhethekile ekucwaningeni, ekuthuthukiseni, ekukhiqizeni nasekusabalaliseni amakhithi okuhlola e-in-vitro diagnostic(IVD) athuthukile namathuluzi ezokwelapha.
Indawo yethu yi-GMP, ISO9001, kanye ne-ISO13458 futhi sinemvume ye-CE FDA.Manje sesibheke ngabomvu ukubambisana nezinye izinkampani zaphesheya kwezilwandle ukuze sithuthukiselane.
Sikhiqiza ukuhlolwa kwenzalo, ukuhlolwa kwezifo ezithathelwanayo, ukuhlola ukusetshenziswa kabi kwezidakamizwa, ukuhlola umaka wenhliziyo, ukuhlolwa komaka isimila, ukuhlolwa kokudla nokuphepha kanye nokuhlolwa kwezifo zezilwane, ngaphezu kwalokho, uhlobo lwethu lwe-TESTSEALABS lwaziwa kakhulu ezimakethe zasekhaya neziphesheya kwezilwandle.Izinga eliphezulu nezintengo ezivumayo zisenza sikwazi ukuthatha amasheya asekhaya angaphezu kuka-50%.
Inqubo Yomkhiqizo
1.Lungiselela
2.Ikhava
3.Ulwelwesi oluphambanayo
4.Sika umucu
5.Umhlangano
6.Pakisha izikhwama
7.Vala izikhwama
8.Pakisha ibhokisi
9.Encasement
