I-COVID-19 Antigen Rapid Test Cassette (Colloidal Gold)

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UKUSETSHENZISWA OKUHLOSIWE

I-COVID-19 Antigen Rapid Test Cassette (Colloidal Gold) iyi-lateral flow immunoassay ehloselwe ukuthola ama-antigen e-SARS-CoV-2 ama-nucleocapsid e-swab yamakhala evela kubantu abasolwa ngokuba ne-COVID-19 ngumhlinzeki wabo wezempilo.

Imiphumela ingeyokuhlonza i-SARS-CoV-2 nucleocapsid antigen.I-Antigen ivame ukutholakala ku-swab yamakhala ngesikhathi sesigaba esibucayi sokutheleleka.Imiphumela emihle ibonisa ukuba khona kwama-antigen egciwane, kodwa ukuhlobana komtholampilo nomlando wesiguli kanye nolunye ulwazi lokuxilonga kuyadingeka ukuze kunqunywe isimo sokutheleleka.Imiphumela emihle ayikukhiphi ukutheleleka ngebhaktheriya noma ukutheleleka okuhlangene namanye amagciwane.I-ejenti etholiwe ingase ingabi imbangela eqondile yesifo.

Imiphumela engemihle ayikukhiphi ukutheleleka kwe-SARS-CoV-2 futhi akufanele isetshenziswe njengesisekelo sodwa sokwelashwa noma izinqumo zokuphatha isiguli, okuhlanganisa nezinqumo zokulawula ukutheleleka.Imiphumela engemihle kufanele icatshangelwe esimweni sokuchayeka kwesiguli kwakamuva, umlando kanye nokuba khona kwezimpawu zomtholampilo kanye nezimpawu ezihambisana ne-COVID-19, futhi kuqinisekiswe ngokuhlolwa kwamangqamuzana, uma kudingekile ukuze kuphathwe isiguli.Le khithi ingeyokusetshenziswa ekhaya ngabantu abavamile endaweni okungeyona eyaselabhorethri (njengekhaya lomuntu noma iziza ezithile okungezona ezendabuko ezifana namahhovisi, imicimbi yezemidlalo, izikole njll.).Imiphumela yokuhlolwa yale khithi ingeyenkomba yomtholampilo kuphela.Kunconywa ukwenza ukuhlaziya okuphelele kwesimo ngokusekelwe ekubonakalisweni komtholampilo kweziguli nokunye ukuhlolwa kwelabhorethri.

ISIFINYEZO

I-novel coronaviruses (i-SARS-CoV-2) iyingxenye yohlobo lwe-β.I-COVID-19 yisifo esithathelwanayo sokuphefumula esinamandla.Ngokuvamile abantu bayathinteka.Njengamanje, iziguli ezingenwe yi-coronavirus yenoveli ziwumthombo oyinhloko wokutheleleka;abantu abane-asymptomatic abangenwe yileli gciwane 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.

ISIMISO

I-COVID-19 Antigen Rapid Test Cassette (I-Nasal Swab) iyi-lateral flow immunoassay esekelwe kumgomo wesu lesemishi le-double-antibody.I-SARS-CoV-2 nucleocapsid protein monoclonal antibody ehlanganiswe nama-microparticles anombala isetshenziswa njengomtshina futhi ifuthwe ku-conjugation pad.Ngesikhathi sokuhlolwa, i-antigen ye-SARS-CoV-2 kusifanekiso isebenzisana ne-SARS-CoV-2 antibody ehlanganiswe nama-microparticles anemibala enza i-antigen-antibody ebhalwe ukuthi inkimbinkimbi.Le nkimbinkimbi ifuduka kulwelwesi ngesenzo se-capillary kuze kube umugqa wokuhlola, lapho izothathwa khona i-SARS-CoV-2 efakwe ngaphambili i-nucleocapsid protein monoclonal antibody.Ulayini wokuhlola onemibala (T) uzobonakala efasiteleni lemiphumela uma ama-antigen akwa-SARS-CoV-2 ekhona kusifanekiso.Ukungabikho komugqa T kuphakamisa umphumela ongemuhle.Ulayini wokulawula (C) usetshenziselwa ukulawula inqubo, futhi kufanele uvele njalo uma inqubo yokuhlola yenziwe kahle.

IZIXWAYISO NEZIQINISEKISO

•Okokuzihlolela ukusetshenziswa kokuxilongwa kwe-in vitro kuphela.Le khasethi le-tset elokusetshenziswa kanye nje futhi alikwazi ukuphinda lisetshenziswe noma lisetshenziswe abantu abaningi.

•Ungasebenzisi lo mkhiqizo njengesisekelo sodwa sokuxilonga noma ukukhipha ukutheleleka kwe-SARS-CoV-2 noma ukwazisa isimo sokutheleleka nge-COVID-19.

•Sicela ufunde lonke ulwazi olukuleli pheshana ngaphambi kokwenza ukuhlolwa.

•Ungawusebenzisi lo mkhiqizo ngemva kosuku lokuphelelwa yisikhathi.

•Ikhasethi lokuhlola kufanele lihlale esikhwameni esivaliwe kuze kube yilapho lisetshenziswa.

•Zonke izifanekiso kufanele zibhekwe njengeziyingozi futhi ziphathwe ngendlela efanayo ne-ejenti ethelelanayo.

•Ukuhlolwa kwezingane kanye nabantu abasha kufanele kusetshenziswe nomuntu omdala.

•Ikhasethi lokuhlola elisetshenzisiwe kufanele lilahlwe ngokuvumelana nemithetho kahulumeni, yesifunda neyendawo.

•Ungakusebenzisi ukuhlolwa ezinganeni ezingaphansi kweminyaka emi-2 ubudala.

•Izingane ezincane kufanele zigezwe ngosizo lomuntu wesibili omdala.

•Geza izandla kahle ngaphambi nangemuva kokubamba.

COMPOSITION

Izinto Ezinikeziwe

•Hlola Amakhasethi: ikhasethi ngalinye eline-desiccant esikhwameni se-foil ngasinye

•Ama-reagents Okukhipha Asesepakishwe:

•Izinsalela zeSwabs: ukusetshenziswa okukodwa kweswabhu eyinyumba yokuqoqwa kwesifanekiso

•Iphakheji Faka

Izinto Ezidingekayo Kodwa Ezinganikezwanga

•Isibali sikhathi

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.

•UNGAMMISI.

I-SPECIMEN

Izibonelo ezitholwe kusenesikhathi ngesikhathi kuqala izimpawu zizoqukatha ama-viral titer aphezulu kakhulu;izifanekiso ezitholwe ngemva kwezinsuku ezinhlanu zezimpawu kungenzeka ziveze imiphumela engemihle uma ziqhathaniswa nokuhlolwa kwe-RT-PCR.Ukungaqoqwa kwesifanekiso esinganele, ukuphathwa kwesampula okungafanele kanye/noma ukuthutha kungase kuveze imiphumela engamanga;ngakho-ke, ukuqeqeshwa ekuqoqweni kwesampula kunconywa kakhulu ngenxa yokubaluleka kwekhwalithi yesifanekiso ukuze kutholwe imiphumela yokuhlolwa enembile.Uhlobo lwesampula olwamukelekayo lokuhlola isampula ye-swab yamakhala eqondile etholwe indlela yokuqoqa i-dual nares.Lungiselela ishubhu yokukhipha ngokuvumelana Nenqubo Yokuhlola futhi usebenzise i-swab oyinyumba enikezwe kukhithi ukuqoqwa kwesifanekiso.

Iqoqo Lesampula Leswab Yamakhala

1.Susa i-swab ephaketheni.

2.Jikisa ikhanda lesiguli emuva cishe ngo-70°.

3.1-2Ngenkathi uphendukisa kahle i-swab, faka i-swab cishe ngo-2.5 cm (1 iyintshi) ekhaleni kuze kube yilapho ukumelana kuhlangatshezwana nayo kuma-turbinate.

4.Zungezisa i-swab izikhathi eziningana odongeni lwamakhala futhi uphinde kwenye ikhala usebenzisa i-swab efanayo.

I-Special Transport and Storage

Ungabuyisi i-swab ekufakweni kwe-swab yasekuqaleni.Izibonelo ezisanda kuqoqwa kufanele zicutshungulwe ngokushesha ngangokunokwenzeka, kodwa kungakapheli ihora elilodwa ngemva kokuqoqwa kwesifanekiso.

INQUBO YOKUHLOLA

Qaphela:Vumela amakhasethi okuhlola, ama-reagents nezifanekiso ukuthi zilingane nezinga lokushisa legumbi (15-30℃ noma 59-86℉) ngaphambi kokuhlolwa.

1.Beka ithubhu yokukhipha endaweni yokusebenza.

2.Hlubula isivalo se-aluminium foil kusukela phezulu kweshubhu yokukhipha eliqukethe ishubhu yokukhipha eliqukethe isigcinalwazi sokukhipha.

3.Ukusampula kubhekisa esigabeni 'Ukuqoqwa Kwesampula'.

4.Faka isifanekiso se-swab yamakhala eshubhuni yokukhipha equkethe into ekhipha isikhunta.Roll swab okungenani izikhathi ezi-5 ngenkathi ucindezela ikhanda phansi kanye nohlangothi lweshubhu yokukhipha.Shiya i-swab yamakhala eshubhuni yokukhipha umzuzu owodwa.

5.Susa i-swab yamakhala ngenkathi ucindezela izinhlangothi zeshubhu ukuze ukhiphe uketshezi ku-swab.Isixazululo esikhishiwe sizosetshenziswa njengesampula yokuhlola.6.Mboza ithubhu yokukhipha ngethiphu ye-dropper ngokuqinile.

7.Khipha ikhasethi lokuhlola esikhwameni esivaliwe.

8.Hlehlisa ishubhu lokukhipha isifanekiso, ubambe ishubhu liqondile, dlulisa amaconsi ama-3 (cishe u-100 μL) kancane uye esibonelweni somthombo (S) wekhasethi lokuhlola, bese uqala isibali sikhathi.

9.Linda ukuthi kuvele imigqa enemibala.Humusha imiphumela yokuhlolwa ngemizuzu eyi-15.Ungafundi imiphumela ngemuva kwemizuzu engama-20.

[IZIMALI ZOKUSEBENZA]

Ukusebenza Komtholampilo

Ukuze ulinganisele ukusebenza kahle komtholampilo phakathi kwe-COVID-19 Antigen Rapid Test Cassette kanye ne-PCR comparotor, kwaqoqwa ama-nasal swab angu-628 ezigulini ezazisolakala ukuthi zine-COVID-19. Idatha efinyeziwe ye-COVID-19 Antigen Rapid Test Cassette (Nasal Swab) njengoba ngezansi. .

I-antigen ye-COVID-19		I-RT-PCR		Ingqikithi
I-antigen ye-COVID-19		Okuhle	Okubi	Ingqikithi
I-HEO®	Okuhle	172	0	172
I-HEO®	Okubi	3	453	456
Ingqikithi		175	453	628

I-PPA =98.28% (172/175), (95%CI: 95.08%~99.64%) NPA =100% (453/453), (95%CI: 99.34%~100%)

I-PPA - Isivumelwano Sephesenti Elihle (Ukuzwela) I-NPA - Isivumelwano Sephesenti Elingalungile (Ukucaciswa)

Umkhawulo Wokuthola (Ukuzwela Kokuhlaziya)

Ucwaningo lusebenzise igciwane elikhulisiwe le-SARS-CoV-2 (Isolate USA-WA1/2020 NR- 52287), elingacushiwe ukushisa futhi lifakwe kwisifanekiso se-nasal swab.Umkhawulo Wokutholwa (LoD) ngu-1.0 ×10²I-TCID₅₀/mL.

I-Cross Reactivity (Ukucaciswa Kokuhlaziya)

Ukusebenza kabusha kwesiphambano kwahlolwa ngokuhlola ama-microorganisms angama-32 commensal kanye ne-pathogenic okungenzeka akhona emgodini wekhala.

Akukho ukusabela okuphambanayo okubonwe nge-recombinant MERS-CoV NP amaprotheni lapho ihlolwa ekuhlanganiseni kwe-50 pg/mL.

Akukho ukusabela okuphambene okubonwe nalawa magciwane alandelayo lapho ehlolwa ku-1.0×106 PFU/mL: Umkhuhlane A (H1N1), Umkhuhlane A (H1N1pdm09), Umkhuhlane A (H3N2), Umkhuhlane B (Yamagata), Umkhuhlane B ( Victoria), i-Adenovirus (uhlobo 1, 2, 3, 5, 7, 55), i-metapneumovirus yabantu,

Parainfluenza virus (uhlobo 1, 2, 3, 4), Respiratory syncytial virus, Enterovirus, Rhinovirus, Human coronavirus 229E, Human coronavirus OC43, Human coronavirus NL63, Human coronavirus HKU1.

Akukho ukusabela okuphambene okubonwe namagciwane alandelayo lapho ehlolwa ekugxilweni kwe-1.0×107 CFU/mL: Mycoplasma pneumoniae, Chlamydia pneumoniae, Legionella pneumophila, Haemophilus influenzae, Streptococcus pyogenes (iqembu A), Streptococcus pneumoniae, Candida albicane, Candida pneumoniae, I-Staphylococcus aureus.

Ukugxambukela

Izinto ezilandelayo ezingase zibe nokuphazamiseka zahlolwa nge-COVID-19 Antigen Rapid Test Cassette (Nasal Swab) ekugxiliseni okubhalwe ngezansi futhi kwatholakala ukuthi akuthinti ukusebenza kokuhlolwa.

Ukugxiliswa Kwezidakamizwa

I-Mucin 2%

I-Benzocaine 5 mg/mL Isifutho samakhala saline saline 15%

I-Oxymetazoline 15%

I-Tobramycin 5 μg/mL I-Oseltamivir phosphate 10 mg/mL

I-Arbidol 5 mg/mL

I-Fluticasone propionate 5%

I-Triamcinolone 10 mg/mL

Igazi eliphelele 4%

I-Menthol 10 mg/mL

I-Phenylephrine 15%

I-Mupirocin 10 mg/mL

I-Zanamivir 5 mg/mL

I-Ribavirin 5 mg/mL

I-Dexamethasone 5 mg/mL

I-Histamine 10 mg/mL i-dihydrochloride

I-High-dose Hook Effect

I-COVID-19 Antigen Rapid Test Cassette (Colloidal Gold) ihlolwe yafika ku-1.0×10⁵I-TCID50/mL ye-SARS-CoV-2 engacushiwe futhi awukho umphumela we-hook wedosi ephezulu obonwe.

Inkomba Yophawu