Ikhasethi Lokuhlola Elisheshayo le-COVID-19 IgG/IgM

Okokusetshenziswa kochwepheshe kanye ne-in vitro diagnostic kuphela.

UKUSETSHENZISWA OKUHLOSIWE

IIkhasethi Lokuhlola Elisheshayo le-COVID-19 IgG/IgMi-lateral flow immunoassay eyenzelwe ukutholwa kwekhwalithi yamasosha omzimba e-IgG ne-IgM egciwaneni le-SARS-CoV-2 egazini lonke, i-serum noma isampula ye-plasma evela kubantu okusolwa ukuthi bane-COVID -19 ngumhlinzeki wabo wezempilo.

I-CO VID-19 IgG/IgM Rapid Test iwusizo ekuxilongweni kweziguli ezinezinsolo zokutheleleka nge-SARS -CoV-2 ngokuhambisana nokwethulwa komtholampilo kanye nemiphumela yolunye ukuhlolwa kwaselabhorethri. Kuphakanyiswa ukuthi kusetshenziswe njengenkomba yokuhlola eyengeziwe yamacala asolwayo ane-negative nucleic acid test of novel coronavirus noma asetshenziswe kanye nokuhlolwa kwe-nucleic acid ezimweni ezisolisayo. Imiphumela yokuhlolwa kwe-antibody akufanele isetshenziswe njengesisekelo sodwa sokuxilonga noma ukukhipha ukutheleleka kwe-SARS -CoV-2 noma ukwazisa isimo sokutheleleka.

Imiphumela engemihle ayikukhiphi ukutheleleka kwe-SARS -CoV-2, ikakhulukazi kulabo abaye bathintana nabantu abaziwayo abanaleli gciwane noma ezindaweni ezivame kakhulu ukutheleleka okusebenzayo . Ukuhlolwa kokulandelela ngokuxilonga amangqamuzana kufanele kubhekwe ukuze kukhishwe ukutheleleka kulaba bantu.

Imiphumela emihle ingase ibe ngenxa yokutheleleka kwangaphambilini noma kwamanje nge-coronavirus okungeyona i-SARS-CoV-2 .

Ukuhlolwa kuhloswe ukuthi kusetshenziswe ezindaweni zokunakekelwa kwempilo noma abasebenzi bezempilo endaweni yokunakekelwa, hhayi ukusetshenziswa kwasekhaya. Ukuhlolwa akufanele kusetshenziselwe ukuhlola igazi elinikelwe.

ISIFINYEZO

Ama-coronavirus anoveli ayingxenye yohlobo lwe-p.I-COVID 19yisifo esithathelwanayo sokuphefumula esinamandla. Ngokuvamile abantu bayathinteka. Njengamanje, iziguli ezingenwe yi-coronavirus yenoveli ziwumthombo oyinhloko wokutheleleka; abantu abajovwe nge-asymptomatic bangaba umthombo othathelwanayo. Ngokusekelwe ophenyweni lwamanje lwe-epidemiological, isikhathi sokufukamela siyizinsuku ezi-1 kuya kweziyi-14, izikhathi eziningi izinsuku ezi-3 kuya kweziyi-7. Izimpawu eziyinhloko zihlanganisa umkhuhlane, ukukhathala nokukhwehlela okomile. Ukucinana kwamakhala, ikhala eligijimayo, umphimbo obuhlungu, i-myalgia kanye nesifo sohudo kutholakala ezimweni ezimbalwa.

Lapho igciwane le-SARS-CoV2 lingena entweni ephilayo, i-RNA, izakhi zofuzo zegciwane, iwuphawu lokuqala olungatholwa. Iphrofayili ye-viral load ye-SARS-CoV-2 ifana naleyo yomkhuhlane, ekhuphuka cishe ngesikhathi sokuqala kwezimpawu, bese iqala ukwehla. Ngokuthuthukiswa kwenkambo yesifo ngemva kokutheleleka, isimiso somzimba sokuzivikela ezifweni sizokhiqiza amasosha omzimba, phakathi kwawo i-IgM iyi-antibody yokuqala ekhiqizwa umzimba ngemva kokutheleleka, okubonisa isigaba esibi sokutheleleka. Amasosha omzimba e-IgG ku-SARS-CoV2 abonakala kamuva ngemva kokutheleleka. Imiphumela emihle yakho kokubili i-IgG ne-IgM ingase yenzeke ngemva kokutheleleka futhi ingaba inkomba yokutheleleka okukhulu noma kwakamuva. I-IgG ibonisa isigaba sokululama sokutheleleka noma umlando wokutheleleka okwedlule.

Kodwa-ke, kokubili i-IgM ne-IgG inesikhathi sewindi ukusuka ekuthelelekeni kwegciwane kuya ekukhiqizweni kwamasosha omzimba, i-IgM icishe ivele ngemva kokuqala kwesifo izinsuku ezimbalwa, ngakho ukutholakala kwayo kuvame ukusala ngemuva kokutholwa kwe-nucleic acid futhi ayizweli kakhulu kunokutholwa kwe-nucleic acid. Ezimeni lapho ukuhlolwa kokukhulisa i-nucleic acid kungenayo futhi kukhona isixhumanisi esiqinile se-epidemiological ekuthelelekeni kwe-COVID-19, amasampula e-serum abhanqiwe (esigabeni se-acute ne-convalescent) angasekela ukuxilongwa.

ISIMISO

Ikhasethi Lokuhlola Elisheshayo le-COVID-19 IgG/IgM(I-WB/S/P) iyi-qualitative membrane strip esekelwe ku-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 coiyugate pad equkethe i-Novel coronavirus recombinant envelope antigens coi^ehlanganiswe negolide le-Colloid (Novel coronavirus c两ugates), i-2) i-nitrocellulose membrane strip equkethe imigqa emibili yokuhlola (imigqa ye-IgG ne-IgM) kanye nomugqa wokulawula (umugqa we-C). Ulayini we-IgM umbozwe ngaphambili nge-Mouse anti-Human IgM antibody, ulayini we-IgG umbozwe i-Mouse anti-Human IgG antibody, lapho ivolumu eyanele yesampula encane ikhishwa emthonjeni wesampula wekhasethi lokuhlola. Isifanekiso sihamba ngesenzo se-capillary kukhasethi. I-IgM anti-Novel coronavirus, uma ikhona kusampula, izobophezela kuma-Novel coronavirus coiyugates. 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 ekhona kusifanekiso izobophezela kuma-conjugates e-Novel coronavirus. I-immunocomplex ibe isithathwa yi-reagent embozwe kulayini we-lhe IgG, yenza umugqa we-IgG onemibala ebomvana, okubonisa umphumela wokuhlolwa we-Novel coronavirus IgG. Ukungabikho kwanoma yimiphi imigqa engu-T (IgG ne-IgM) kuphakamisa ukuthi a

umphumela omubi. Ukuze usebenze njengesilawuli senqubo, ulayini onemibala uzohlala uvela endaweni yomugqa wokulawula obonisa ukuthi umthamo ofanele wesifanekiso sengeziwe futhi i-membrane wicking yenzekile.

IZIXWAYISO NEZIQINISEKISO

• Ukusetshenziswa kwe-in vitro diagnostic kuphela.
• Ukuze uthole ochwepheshe bezempilo kanye nezingcweti iphuzu lezindawo zokunakekela.

•Ungasebenzisi ngemva kosuku lokuphelelwa yisikhathi.

• Sicela ufunde lonke ulwazi kuleli 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.

COMPOSITION

Ukuhlolwa kuqukethe umucu we-membrane ohlanganiswe ne-Mouse anti-Human IgM antibody kanye ne-Mouse anti-Human IgG antibody

umugqa wokuhlola, kanye nephedi likadayi eliqukethe igolide eliqinile elihlanganiswe ne-Novel corona virus recombinant antigen. Inani lokuhlolwa laphrintwa kulebula.

Izinto Ezinikeziwe

• Ikhasethi lokuhlola • Faka iphakheji
• Isigcinalwazi • I-dropper
• I-Lancet

Izinto Ezidingekayo Kodwa Azinikezwa

•Isitsha sokuqoqwa kwesampula • Isikhathi

ISITOREJI NOKUZInza

•Londoloza Njengoba Kupakishwe esikhwameni esivaliwe ezingeni lokushisa(4-30″Cor 40-86°F). Ikhithi izinzile phakathi nedethi yokuphelelwa yisikhathi ephrintwe kulebula.

•Uma usuvule isikhwama, isikhwama esincane kufanele sisetshenziswe phakathi nehora elilodwa. Ukuchayeka isikhathi eside endaweni eshisayo neswakeme kuzodala ukuwohloka komkhiqizo.

•I-LOT nosuku lokuphelelwa yisikhathi kwaphrintwa ekulebulani kwe-SPECIMEN

•Ukuhlolwa kungasetshenziswa ukuhlola izibonelo zegazi/iSerum/Plasma lonke.

•Ukuqoqa igazi eliphelele, i-serum noma i-plasma specimens 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 °C (36-46T) uma zingahloliwe ngokushesha. Gcina izibonelo ku-2-8 °C kuze kufike ezinsukwini ezingu-7. Izibonelo kufanele ziqandiswe ku -20 °C (-4°F) ukuze zigcinwe isikhathi eside. Ungawaqandi amasampula egazi eliphelele,

•Gwema imijikelezo eminingi yokuqandisa, ngaphambi kokuhlola, letha amasampula afriziwe ekamelweni lokushisa kancane futhi uhlanganise kahle.

Izibonelo eziqukethe i-particle ebonakalayo kufanele zicaciswe nge-centrifugation ngaphambi kokuhlolwa.

•Ungasebenzisi amasampula abonisa i-gross lipemia gross hemolysis noma i-turbidity ukuze ugweme ukuphazamiseka ekuchazeni umphumela.

INQUBO YOKUHLOLA

Vumela idivayisi yokuhlola nezifanekiso ukuthi zilingane nezinga lokushisa (15-30 C noma 59-86 T ) ngaphambi kokuhlolwa.

1. Susa i-Cassette yokuhlola esikhwameni esivaliwe.
2. Bamba i-dropper ngokuqondile bese udlulisela iconsi elingu-1 (cishe u-10 ul) lwesampula endaweni engenhla yesifanekiso somthombo(S) uqinisekisa ukuthi awekho amabhamuza omoya. Ukuze uthole ukunemba okungcono, dlulisa isifanekiso nge-pipette ekwazi ukuletha u-10 ul wevolumu. Bheka umfanekiso ongezansi.
3. Bese, engeza amaconsi ama-2(acishe abe ngu-70 ul) wesigcinalwazi ngokushesha emthonjeni wesifanekiso(S).
4. Qala isibali sikhathi.
5. ukuze kuvele imigqa enemibala. Humusha imiphumela yokuhlolwa ngemizuzu eyi-15. Ungafundi imiphumela ngemuva kwemizuzu engama-20.

Indawo Yesampula

(Isithombe ngesethenjwa kuphela, sicela ubhekisele entweni ebalulekile.)

UKUTOLIZWA KWEMIPHUMELA

amasosha omzimba. 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 esifundeni somugqa wokuhlola.

Okungavumelekile:Ulayini wokulawula uyehluleka ukuvela. Ivolumu yesampula enganele noma amasu enqubo angalungile yizona zizathu okungenzeka kakhulu ukuthi u-fbr ulawule ukwehluleka komugqa. 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-COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P) inomkhawulo ukuze inikeze ikhwalithi

ukutholwa. 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 onegethivu ubonisa ukuthi amasosha omzimba e-Novel coronavirus kungenzeka awekho noma akumazinga angabonakali lapho kuhlolwa.

IZIMPAWU ZOKUSEBENZA

Ukunemba

Idatha efingqiwe ye-CO VID-19 IgG/IgM Rapid Test njengoba ingezansi

Mayelana nokuhlolwa kwe-IgG, sibale izinga elihle leziguli ezingama-82 ngesikhathi sokululama.

I-COVID-19 IgG:

Imiphumela iveza ukuzwela okungu-97.56%

Mayelana nokuhlolwa kwe-IgM, umphumela wokuqhathanisa ne-RT-PCR.

I-COVID-19 IgM:

Ukuqhathaniswa kwezibalo kwenziwe phakathi kwemiphumela eveza ukuzwela okungu-88.61 %, ukucaciswa okungu-97.67% nokunemba okungu-93.33%.

I-Cross-Reactivity kanye nokuphazamiseka

1 .Ezinye izinto ezivamile eziyimbangela yezifo ezithathelwanayo ziye zahlolwa ukuze kusebenze kabusha ngokuphambana nokuhlola. Ezinye izibonelo ezinhle zezinye izifo ezithathelwanayo ezivamile zafakwa ku-Novel coronavirus ezibonelweni ezinhle nezingezinhle futhi ezihlolwe ngokwehlukana. Akukho ukuphinda kusebenze okuphambanayo okubonwe ngezifanekiso zeziguli ezine-HIV,HA^ HBsAg, HCV TP, HTIA^ CMV FLUA, FLUB, RSy MP, CP, HPIVs.

2.Izinto ezingase zibe namandla e-endogenous endogenous okuhlanganisa izingxenye ezijwayelekile zeserum, njenge-lipids, i-hemoglobin, i-bilirubin, zifakwe ekugxilweni 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 zazingu-100%. Isivumelwano se-inter-site sasingu-100%.