Ikhithi Yokuhlola Esheshayo ye-COVID-19 IgG/IgM

Imininingwane Esheshayo

I-COVID-19 IgG/IgM Rapid Test Kit AMRDT100 (Igazi Eliphelele/Iserum)

Ukupakisha Nokulethwa

Imininingwane

[UKUSEBENZISA OKUHLOSIWE]
I-AMRDT100 IgG/IgM Rapid Test Cassette iyi-lateral flow chromatographic immunoassay yokutholwa kwekhwalithi yamasosha omzimba (i-IgG ne-IgM) kuya ku-Novel coronavirus egazini lomuntu/iSerum/Plasma.
Ihlinzeka ngosizo ekuxilongweni kokutheleleka nge-Novel coronavirus.

[ISIFINYEZO]
Ekuqaleni kukaJanuwari 2020, i-coronavirus yenoveli (i-SARS-CoV-2, eyayaziwa ngokuthi i-2019-nCoV) yahlonzwa njenge-ejenti ethelelanayo ebangela ukuqubuka kwe-viral pneumonia e-Wuhan, eChina, lapho amacala okuqala aqala khona izimpawu zawo ngoDisemba 2019.
Ama-Coronavirus amagciwane e-RNA amboziwe asatshalaliswa kabanzi phakathi kwabantu, ezinye izilwane ezincelisayo, nezinyoni futhi abangela izifo zokuphefumula, i-enteric, i-hepatic, kanye ne-neurologic.Izinhlobo eziyisithupha zama-coronavirus zaziwa ngokubangela izifo zabantu.Amagciwane amane-229E, OC43, NL63, kanye ne-HKU1 avamile futhi ngokuvamile abangela izimpawu zomkhuhlane ezivamile kubantu abangenawo amandla okuzivikela.Ezinye izinhlobo ezimbili ze-acute respiratory syndrome coronavirus (SARS-CoV) kanye ne-Middle East Respiratory Syndrome coronavirus (MERS-CoV) ziyimvelaphi ye-zoonotic futhi ziye zaxhunyaniswa nesifo esibulalayo kwesinye isikhathi.
Ama-Coronaviruses ayi-zoonotic, okusho ukuthi asakazwa phakathi kwezilwane nabantu.Izimpawu ezijwayelekile zokutheleleka zihlanganisa izimpawu zokuphefumula, imfiva, ukukhwehlela, ukuphelelwa umoya kanye nobunzima bokuphefumula.Ezimweni ezimbi kakhulu, ukutheleleka kungabangela inyumoniya, isifo sokuphefumula esinamandla kakhulu, ukwehluleka kwezinso ngisho nokufa.
Izincomo ezijwayelekile zokuvimbela ukusakazeka kwezifo zihlanganisa ukugeza izandla njalo, ukuvala umlomo nekhala lapho ukhwehlela futhi uthimula, ukupheka kahle inyama namaqanda.Gwema ukusondelana nanoma ubani obonisa izimpawu zesifo sokuphefumula njengokukhwehlela nokuthimula.

[ISIMISO]
I-AMRDT100IgG/IgM Rapid Test Cassette iyi-qualitative membrane strip based immunoassay ukuze kutholwe amasosha omzimba (i-IgG ne-IgM) ku-Novel coronavirus ku-Whole Blood/Serum/Plasma yomuntu.Ikhasethi lokuhlola liqukethe: 1) i-burgundy colored conjugate pad equkethe i-Novel coronavirus recombinant envelope antigens ehlanganiswe negolide le-Colloid (Novel coronavirus conjugates), 2) i-nitrocellulose membrane strip equkethe imigqa yokuhlola emibili (imigqa ye-IgG ne-IgM) kanye nolayini wokulawula ( C line).Ulayini we-IgM uhlanganiswe kuqala ne-Mouse anti-Human IgM antibody, ulayini we-IgG uhlanganiswe ne-Mouse anti-Human IgG antibody.Uma ivolumu eyanele yesampula yokuhlola ikhishelwa emthonjeni wesampula wekhasethi lokuhlola, isifanekiso sihamba ngesenzo se-capillary kulo lonke ikhasethi.I-IgM anti-Novel coronavirus, uma ikhona kusampula, izobophezela ku-conjugates ye-Novel coronavirus.I-immunocomplex ibe isithathwa yi-reagent embozwe ngaphambili ebhendini ye-IgM, yakhe umugqa we-IgM onombala obomvana, okhombisa umphumela wokuhlola we-Novel coronavirus IgM.I-IgG anti-Novel coronavirus uma ikhona kusampula izobophezela kuma-conjugates e-Novel coronavirus.I-immunocomplex ibe isithathwa yi-reagent ehlanganiswe kulayini we-IgG, yakha umugqa we-IgG onemibala ebomvana, ekhombisa umphumela wokuhlola we-Novel coronavirus IgG.Ukungabikho kwanoma yimiphi imigqa ye-T (IgG ne-IgM) kuphakamisa umphumela ongemuhle.Ukuze usebenze njengesilawuli senqubo, ulayini onemibala uzohlala uvela endaweni yomugqa wokulawula obonisa ukuthi umthamo ofanele wesifanekiso sengeziwe futhi i-membrane wicking yenzekile.

[IZEXWAYISO NEZIQINISEKISO]
Kwabasebenzi bezempilo kanye nezingcweti endaweni yezindawo zokunakekelwa.
Ungasebenzisi ngemva kosuku lokuphelelwa yisikhathi.
Sicela ufunde lonke ulwazi olukuleli pheshana ngaphambi kokwenza ukuhlolwa.
Ikhasethi lokuhlola kufanele lihlale esikhwameni esivaliwe kuze kube yilapho lisetshenziswa.
Zonke izifanekiso kufanele zibhekwe njengeziyingozi futhi ziphathwe ngendlela efanayo ne-ejenti ethelelanayo.
Ikhasethi lokuhlola elisetshenzisiwe kufanele lilahlwe ngokuvumelana nemithetho kahulumeni, yesifunda neyendawo.

[UKWAKHIWA]
Ukuhlolwa kuqukethe umucu we-membrane ohlanganiswe ne-Mouse anti-Human IgM antibody kanye ne-Mouse anti-Human IgG antibody kulayini wokuhlola, kanye nephedi likadayi eliqukethe igolide elicwebezelayo elihlanganiswe ne-Novel coronavirus recombinant antigen.
Inani lokuhlolwa laphrintwa kulebula.
Izinto Ezinikeziwe
Hlola ikhasethiPhakheji Faka
Ibhafa
Izinto Ezidingekayo Kodwa Azinikezwa
Isiqukathi seqoqo lesifanekisoIsiqukathi

[ISITOREJI NOKUZInza]
Gcina njengoba kupakishwe esikhwameni esivaliwe ezingeni lokushisa (4-30℃ noma 40-86℉).Ikhithi izinzile phakathi nedethi yokuphelelwa yisikhathi ephrintwe kulebula.
Uma usuvule isikhwama, ukuhlola kufanele kusetshenziswe phakathi nehora elilodwa.Ukuchayeka isikhathi eside endaweni eshisayo neswakeme kuzodala ukuwohloka komkhiqizo.
I-LOT kanye nosuku lokuphelelwa yisikhathi kwaphrintwa kulebula.

[UMBONO]
Ukuhlolwa kungasetshenziswa ukuhlola Igazi Eliphelele/iSerum/Plasma.
Ukuqoqa igazi eliphelele, i-serum noma izibonelo ze-plasma ngokulandela izinqubo zaselabhorethri zomtholampilo ezivamile.
Hlukanisa i-serum noma i-plasma egazini ngokushesha ngangokunokwenzeka ukuze ugweme i-hemolysis.Sebenzisa kuphela izibonelo ezicacile ezingenayo i-hemolyzed.
Gcina izifanekiso ku-2-8℃ (36-46℉) uma zingahloliwe ngokushesha.Gcina ama-specimens ku-2-8℃ kufika ezinsukwini ezingu-7.Izibonelo kufanele ziqandiswe ku-
-20℃ (-4℉) ukuze ugcine isikhathi eside.Ungawaqandi amasampula egazi eliphelele.
Gwema imijikelezo eminingi yokuqandisa.Ngaphambi kokuhlola, letha izibonelo eziqandisiwe ekamelweni lokushisa kancane futhi uhlanganise kahle.Izibonelo eziqukethe i-particle ebonakalayo kufanele zicaciswe nge-centrifugation ngaphambi kokuhlolwa.
Ungasebenzisi amasampula abonisa i-gross lipemia, i-gross hemolysis noma i-turbidity ukuze ugweme ukuphazamiseka ekuchazeni umphumela.

[INKQUBO YOKUHLOLA]
Vumela idivayisi yokuhlola nezifanekiso ukuthi zilingane nezinga lokushisa (15-30℃noma 59-86℉) ngaphambi kokuhlolwa.
1.Khipha ikhasethi lokuhlola esikhwameni esivaliwe.
2.Bamba i-dropper ngokuqondile bese udlulisela iconsi elingu-1 lesifanekiso kumthombo wesibonelo(I-S) sedivayisi yokuhlola, bese wengeza amathonsi angu-2 ebhafa (cishe u-70μl) bese uqala isibali sikhathi.Bheka umfanekiso ongezansi.
3.Linda ukuthi kuvele imigqa enemibala.Humusha imiphumela yokuhlolwa emizuzwini eyi-15.Ungafundi imiphumela ngemuva kwemizuzu engama-20.

[UKUTOLIZWA KWEMIPHUMELA]
Okuhle: Ulayini wokulawula kanye okungenani nomugqa owodwa wokuhlola uvela kulwelwesi.Ukubonakala komugqa wokuhlola we-IgG kukhombisa ukuba khona kwamasosha omzimba e-Novel coronavirus akhethekile e-IgG.Ukuvela komugqa wokuhlola we-IgM kukhombisa ukuba khona kwamasosha omzimba e-Novel coronavirus akhethekile e-IgM.Futhi uma ulayini we-IgG ne-IgM uvela, kukhombisa ukuthi ubukhona bamasosha omzimba we-Novel coronavirus aqondene ne-IgG ne-IgM.
Okubi: Umugqa owodwa onombala uvela endaweni yokulawula(C).Awukho umugqa onombala obonakalayo ovela endaweni yomugqa wokuhlola.
Akuvumelekile: Ulayini wokulawula uyehluleka ukuvela.Ivolumu yesampula enganele noma izindlela zenqubo ezingalungile yizona zizathu okungenzeka kakhulu zokwehluleka komugqa wokulawula.Buyekeza inqubo bese uphinda ukuhlola ngekhasethi elisha lokuhlola.Uma inkinga iqhubeka, yeka ukusebenzisa ikhithi yokuhlola ngokushesha futhi uxhumane nomsabalalisi wangakini.

[IKHWALITHI YOKULAWULA]
Ukulawulwa kwenqubo kufakiwe ekuhlolweni.Ulayini onombala ovela endaweni yokulawula (C) uthathwa njengokulawula kwenqubo yangaphakathi.Iqinisekisa ivolumu eyanele yesifanekiso, i-membrane wicking eyanele kanye nezindlela ezilungile zenqubo.
Amazinga okulawula awanikezwanga nale khithi.Kodwa-ke, kuyanconywa ukuthi izilawuli ezinhle nezingezinhle zihlolwe njengomkhuba omuhle waselabhorethri ukuze kuqinisekiswe inqubo yokuhlola kanye nokuqinisekisa ukusebenza kahle kokuhlolwa.

[IMIKHAWULO]
I-AMRDT100 IgG/IgM Rapid Test Cassette inomkhawulo ukuze inikeze ukutholwa kwekhwalithi.Ukuqina komugqa wokuhlola akuhambisani ngempela nokugcwala kwe-antibody egazini.
Imiphumela etholwe kulokhu kuhlolwa ihloselwe ukuba usizo ekuxilongeni kuphela.Udokotela ngamunye kufanele ahumushe imiphumela ngokuhambisana nomlando wesiguli, okutholwe ngokomzimba, nezinye izinqubo zokuxilonga.
Umphumela wokuhlolwa ongemuhle ukhombisa ukuthi amasosha omzimba e-Novel coronavirus awekho noma akumazinga angabonakali lapho kuhlolwa.

[IZIMALI ZOKUSEBENZA]
Ukunemba
Ukuqhathanisa ohlangothini ngalunye kwenziwa kusetshenziswa i-Novel coronavirus IgG/IgM Rapid Test kanye ne-PCR ehamba phambili kwezohwebo.Kwahlolwa izibonelo zemitholampilo eziyi-120 ezivela endaweni yeProfessional Point of Care.Imiphumela elandelayo ihlelwe kusukela kulezi zifundo zomtholampilo:
Ukuqhathaniswa kwezibalo kwenziwe phakathi kwemiphumela eveza ukuzwela okungama-90.00%, ukucaciswa okungu-97.78% nokunemba okungama-95.83%.
I-Cross-Reactivity kanye nokuphazamiseka
1.Ezinye izinto ezivamile eziyimbangela yezifo ezithathelwanayo zahlolwa ukuze kusebenze kabusha okuphambanayo ngokuhlolwa.Ezinye izibonelo ezinhle zezinye izifo ezithathelwanayo ezivamile zafakwa ku-Novel coronavirus izibonelo ezinhle nezingezinhle futhi zahlolwa ngokwehlukana.Akukho ukusebenza kabusha okuphambanayo okubonwe ngezifanekiso ezivela ezigulini ezine-HIV, i-HAV, i-HBsAg, i-HCV, i-HTLV, i-CMV, i-FLUA, i-FLUB, i-RSV ne-TP.
2.Izinto ezingase zibe namandla e-endogenous endogenous okuhlanganisa izingxenye ezivamile zeserum, njenge-lipids, i-hemoglobin, i-bilirubin, zifakwe ekugxiliseni okuphezulu ku-Novel coronavirus izibonelo ezinhle nezingezinhle futhi zahlolwa, ngokuhlukana.Akukho ukwenza kabusha okuphambene noma ukuphazamiseka okubonwe kudivayisi.
3.Abanye abahlaziyi bebhayoloji abajwayelekile bahlotshaniswa ne-Novel coronavirus ezibonelweni ezinhle nezingezinhle futhi zahlolwa ngokwehlukana.Akukho ukuphazamiseka okuphawulekayo okubonwe emazingeni asohlwini lwethebula elingezansi.

Ukukhiqiza kabusha
Izifundo zokuphindaphinda zenzelwe Ukuhlolwa Okusheshayo kwe-Novel coronavirus IgG/IgM ezindaweni zokucwaninga zehhovisi likadokotela ezintathu (POL).Kusetshenziswe izibonelo zeserum yomtholampilo ezingamashumi ayisithupha (60), ezingu-20 ezingezinhle, ezingu-20 emngceleni omuhle kanye nezingu-20 ezinhle, zisetshenziswe kulolu cwaningo.Isifanekiso ngasinye saqhutshwa ngokuphindwe kathathu izinsuku ezintathu ku-POL ngayinye.Izivumelwano ze-intra-assay bezingu-100%.Isivumelwano se-inter-site sasingu-100%.

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