Ikhithi yokuhlola ye-SARS-CoV-2 Antigen

SARS-CoV-2 Antigen Assay Kit

(Immunochromatography Method) Product Manual

【PI-RODUCT NAME】Ikhithi yokuhlola ye-SARS-CoV-2 Antigen(Indlela ye-Immunochromatography)

【I-PACKAGING SI-PECIFIIKATIIONS】1 Test/Kit ,25Tests/Kit, 100Tests/Kit

【ABSTRACT】

Ama-coronavirus anoveli awohlobo lwe-β. I-COVID-19 yisifo esithathelwanayo sokuphefumula esiyingozi. 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, kakhulukazi 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.

【EXPECTED USAGE】

Le khithi isetshenziselwa ukuthola ngokufanelekile i-antigen ye-novel coronaviruses (SARS-CoV-2) kuma-swabs omphimbo womuntu wamakhala, ama-oral throat swabs, amathe angemuva oropharyngeal, isikhwehlela namasampula esindle.

Ilungele kuphela ukuxilongwa kwe-in vitro kochwepheshe, hhayi ukusetshenziswa komuntu siqu.

Lo mkhiqizo usetshenziswa kuphela kumalabhorethri emtholampilo noma ekuhlolweni ngokushesha ngabasebenzi bezokwelapha. Awukwazi ukusetshenziselwa ukuhlolwa kwasekhaya.

Ngeke isetshenziswe njengesisekelo sokuxilonga kanye nokukhishwa ngaphandle kwenyumoniya ebangelwa ukutheleleka kwenoveli coronaviruses (SARS-CoV-2). Ayifanele ukuthi ihlolwe ngabantu abaningi.

Umphumela wokuhlolwa une-positive udinga ukuqinisekiswa okwengeziwe, futhi umphumela wokuhlolwa onegayo awukwazi ukukhipha amathuba okutheleleka.

Ikhithi nemiphumela yokuhlolwa ingeyenkomba yomtholampilo kuphela. Kutuswa ukuthi ukubonakaliswa komtholampilo kwesiguli nokunye ukuhlolwa kwaselabhorethri kuhlanganiswe ukuze kuhlaziywe kabanzi isimo.Ikhithi ayikwazi ukuhlukanisa phakathi kwe-SARS-CoV kanye ne-SARS-CoV-2.

【PRINCIPLES OF THE PI-ROCEI-DURE】

Lo mkhiqizo usebenzisa ubuchwepheshe be-colloidal gold immunochromatography, ufafaza igolide eli-colloidal elibhalwe ukuthi SARS-CoV-2 mono-clonal antibody 1 ku-golden pad I-SARS-CoV-2 monoclonal antibody 2 ifakwe kulwelwesi lwe-nitrocellulose njengomugqa wokuhlola (umugqa we-T) kanye nembuzi. I-anti-mouse IgG antibody iboshwe njengomugqa wokulawula ikhwalithi (umugqa C). Uma inani elifanele lesampula elizohlolwa lengezwa embotsheni yesampula yekhadi lokuhlola, isampula izoqhubekela phambili eduze nekhadi lokuhlola ngaphansi kwesenzo se-capillary. Uma isampula liqukethe i-antigen ye-SARS-CoV-2, i-antigen izobopha ngegolide eli-colloidal elibhalwe ukuthi SARS-CoV-2 monoclonal antibody 1, kanti i-immune complex yakha inkimbi ene-SARS-CoV-2 ehlanganisiwe ye-monoclonal antibody 2 endaweni. Umugqa we-T, okhombisa umugqa we-T onsomi-obomvu, okhombisa ukuthi i-antigen yakwa-SARS-CoV-2 ilungile. Uma umugqa wokuhlola T ungabonisi umbala futhi ubonisa umphumela ongemuhle, kusho ukuthi isampula alinayo i-antigen yakwa-SARS-CoV-2. Ikhadi lokuhlola liqukethe nomugqa wokulawula ikhwalithi C, kungakhathaliseki ukuthi ukhona yini umugqa wokuhlola, umugqa wokulawula ikhwalithi onsomi-obomvu kufanele uvele. Uma ulayini wokulawula ikhwalithi C ungaveli, kubonisa ukuthi umphumela wokuhlolwa awuvumelekile, futhi le sampuli idinga ukuhlolwa futhi.

【MAIN COMPOI-NENTS】

1.Ikhadi lokuhlola :Ikhadi lokuhlola linekhadi lepulasitiki kanye nomugqa wokuhlola. Umucu wokuhlola wenziwe ngolwelwesi lwe-nitrocellulose (indawo etholwayo ihlanganiswe ne-SARS-CoV-2 monoclonal antibody 2, indawo yokulawula ikhwalithi igcotshwe nge-antimouse IgG antibody yembuzi), kanye nephedi legolide (elifafazwe ngegolide eli-colloidal elibhalwe SARS-CoV- 2 i-monoclonal antibody 1), iphedi yesampula, iphepha elimuncayo, kanye nebhodi le-PVC.

2. Isixazululo sokukhipha isampula: Isixazululo sebhafa esiqukethe i-phosphate ehambisana nezicaciso zekhithi (pH6.5-8.0).

3. Ishubhu yokukhipha isampula.

4. I-swab eyinyumba, hlikihla, isitsha.

5. Imanuwali.

Qaphela: Izingxenye kumaqoqo ahlukene wamakhithi azikwazi ukusetshenziswa ngokushintshana.

【SI-TORAGE KANYE EXPII-RATION】

Isikhathi sokuqinisekisa siyizinyanga eziyi-18 uma lo mkhiqizo ugcinwe endaweni engu-2℃-30℃.

Umkhiqizo kufanele usetshenziswe phakathi nemizuzu engu-15 uma isikhwama se-foil sesivuliwe.Vala isivalo ngokushesha ngemva kokukhipha isisombululo sokukhipha isampula. Idethi yokukhiqiza kanye nosuku lokuphelelwa yisikhathi kuphawulwe kulebula.

【SAMPLE I-REQUIREMENTS】

1. Isebenza kuma-swabs omphimbo womuntu wamakhala, ama-swabs omphimbo womlomo, amathe e-oropharyngeal angemuva, amasampula esikhwehlela kanye nendle.

2. Iqoqo lesampula:

( 1)Iqoqo lokuphuma kwamakhala: Lapho uqoqa ukuphumela emakhaleni, faka i-swab eyinyumba endaweni lapho uketshezi kuningi khona emgodini wamakhala, phendula ngobumnene bese uphushela i-swab emgodini kuze kube yilapho i-turbinate ivaleka, bese uzungezisa i-swab kathathu. izikhathi ngokumelene nodonga lomgodi wamakhala

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bese ekhipha i-swab.

(2)Iqoqo lokuphuma komphimbo: Faka i-swab oyinyumba emphinjeni ngokuphelele isuka emlonyeni, igxile odongeni lomphimbo kanye nendawo ebomvu yenkalakahla, sula amathoni epharyngeal ahlangene ngamabili kanye nodonga lwangemuva lwepharyngeal ngamandla amaphakathi, gwema ukuthinta ulimi. bese ekhipha i-swab.

(3) Amathe angemuva kwe-oropharyngeal: Yenza inhlanzeko yesandla ngensipho namanzi /ukuhlikihla ngesandla okusekelwe otshwaleni. Vula isitsha. Yenza umsindo we-Kruuua' emphinjeni ukuze usule amathe emphinjeni ejulile , bese ukhafulela amathe (cishe ama-2 ml) esitsheni. Gwema noma yikuphi ukungcoliswa kwamathe endaweni engaphandle yesitsha. Isikhathi esifanelekile sokuqoqwa kwesifanekiso: Ngemuva kokuvuka nangaphambi kokuxubha amazinyo, ukudla noma ukuphuza.

3. Cubungula isampula ngokushesha ngesixazululo sokukhipha isampula esihlinzekwe kukhithi ngemva kokuqoqwa kwesampula. Uma ingeke ikwazi ukucutshungulwa ngokushesha, isampula kufanele igcinwe epayipini lepulasitiki elomile, inzalo nelivalwe ngokuqinile. Ingagcinwa ku-2 ℃ -8 ℃ amahora angu-8, futhi ingagcinwa isikhathi eside ku -70 ℃.

4. Amasampula angcoliswe kakhulu yizinsalela zokudla okuphuzwayo awakwazi ukusetshenziselwa ukuhlolwa kwalo mkhiqizo. Amasampuli aqoqwe kuma-swabs ane-viscous kakhulu noma ama-agglomerated awanconywa ukuthi ahlolwe lo mkhiqizo. Uma ama-swabs engcolile ngenani elikhulu legazi, awanconywa ukuba ahlolwe. Akunconywa ukusebenzisa amasampuli acutshungulwa ngesixazululo sokukhipha isampula esinganikezwanga kule kit ukuze kuhlolwe lo mkhiqizo.

【TESTING METHOD】

Sicela ufunde incwadi yeziqondiso ngokucophelela ngaphambi kokuhlolwa. Sicela ubuyisele wonke ama-reagents ekamelweni lokushisa ngaphambi kokuhlolwa. Ukuhlolwa kufanele kwenziwe ekamelweni lokushisa.

Izinyathelo Zokuhlola:

1. Ukukhishwa kwesampula:

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(2)Isampula Yesihlalo: Engeza ngokuma mpo isixazululo sokukhipha isampula esingu-200ul (cishe amathonsi angu-6) eshubhuni yokukhipha isampula, sebenzisa intonga yesampula ukuze ucoshe cishe u-30mg wamasampuli esitulo esisha (Okulingana nosayizi wekhanda likamentshisi). Faka i-sampling rod ku-Sample Extraction Tube bese unyakazisa uhlanganise ngokuphelele kuze kuhlakazeke sonke indle.

(3) Isampula ye-Swabs: Ngeza mpo ngesixazululo sokukhipha isampula esingu-500ul (cishe amaconsi angu-15) kushubhu yokukhipha isampula. Faka i-swab eqoqiwe esixazululweni kushubhu yokukhipha isampula, bese uyizungezisa eduze kodonga lwangaphakathi lweshubhu yokuhlola izikhathi ezingaba ngu-10 ukuze wenze isampuli incibilike esixazululweni ngangokunokwenzeka. Khama ikhanda le-swab odongeni lwangaphakathi lweshubhu yokukhipha ukuze ugcine uketshezi eshubhuni ngangokunokwenzeka, khipha futhi ulahle i-swab. Vala isivalo.

2. Izinqubo zokutholwa:

( 1) Ngemva kokuba ikhadi lokuhlola libuyele ekamelweni lokushisa, vula isikhwama se-aluminium foil bese ukhipha ikhadi lokuhlola bese ulibeka livundlile kudeskithophu.

(2) Engeza u-65ul (cishe amaconsi angu-2) wesampula esikhishwe noma ungeze ngokuqondile u-65ul (cishe amaconsi angu-2) wesixazululo sesampula segciwane elicutshunguliwe emgodini wesampula wekhadi lokuhlola.

(3) Funda umphumela obonisiwe phakathi nemizuzu eyi-15-30, futhi imiphumela efundwa ngemva kwemizuzu engama-30 ayivumelekile.

【INTERPRETATION OF TEST RESULTS】

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【LIMII-TATION OF THOLAION METHOD】

1. Ukuqinisekiswa komtholampilo

Ukuze kuhlolwe ukusebenza kokuxilonga, lolu cwaningo lusebenzise izifanekiso ezine-COVID-19 ezivela kubantu abangama-252 kanye nezabantu abangenayo i-COVID-19 ezivela kubantu abangama-686. Lezi zibonelo zahlolwa futhi zaqinisekiswa indlela ye-RT-PCR. Imiphumela imi kanje:

a) Ukuzwela: 95.24%(240/252), 95%CI(91.83%, 97.52%)

b) Ukucaciswa: 99. 13%(680/686), 95%CI(98. 11%, 99.68%)

2. Umkhawulo wokuthola ubuncane:

Uma okuqukethwe kwegciwane kungaphezu kuka-400TCID50/ml, izinga lokutholwa okuhle likhulu kuno-95%. Uma okuqukethwe kwegciwane kungaphansi kuka-200TCID50/ml, izinga lokutholwa okuhle lingaphansi kuka-95%, ngakho umkhawulo omncane wokutholwa kwalo mkhiqizo ngu-400TCID50/ml.

3. Ukunemba:

Amaqoqo amathathu alandelanayo ama-reagents ahlolwe ukunemba. Amaqoqo ahlukene ama-reagents asetshenziselwa ukuhlola isampula elibi elifanayo izikhathi ezingu-10 ngokulandelana, futhi imiphumela yonke ibe mibi. Amaqoqo ahlukene ama-reagents asetshenziselwa ukuhlola isampula efanayo izikhathi ezingu-10 ngokulandelana, futhi imiphumela yonke ibe mihle.

4. Umphumela we-HOOK:

Uma okuqukethwe kwegciwane kusampula ezohlolwa kufinyelela ku-4.0*105TCID50/ml, umphumela wokuhlola usalokhu ungabonisi umphumela we-HOOK.

5. Ukusabela okuphambene

Ukuphambana kwekhithi kuye kwahlolwa. Imiphumela ayizange ibonise ukusebenza kabusha okuphambene nesifanekiso esilandelayo.

6. Izinto eziphazamisayo

Imiphumela yokuhlolwa ayiphazanyiswa into ekugxilweni okulandelayo:

【LIMII-TATION OF THOLAION METHOD】

1. Lo mkhiqizo uhlinzekwa kuphela kumalabhorethri emtholampilo noma kubasebenzi bezokwelapha ukuze uhlolwe ngokushesha, futhi awukwazi ukusetshenziselwa ukuhlolwa kwasekhaya.

2. Lo mkhiqizo ufaneleka kuphela ukutholwa komgodi wamakhala womuntu noma amasampula okuphuma komphimbo. Ithola okuqukethwe kwegciwane kusampula yesampula,

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