I-SARS-CoV-2 Antigen Assay Kit (Indlela ye-Immunochromatography)

SARS-CoV-2 Antigen Assay Kit

(Immunochromatography Method) Product Manual

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

【PI-ACKAGING SPECIFIIKATIIONS】1 Isivivinyo/Ikhithi

【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) kumasampula amathe omuntu ku-vitro. 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.

【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.

(2) Incwadi.

Qaphela: Izingxenye kumaqoqo ahlukene wamakhithi azikwazi ukusetshenziswa ngokushintshana.

【STI-ORAGE AND EXPIRATION】

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 REQUIREMENTS】

1. Isebenza kuma-swabs omphimbo womuntu wamakhala, ama-swabs omphimbo womlomo, isampula yamathe.

2. Iqoqo lesampula:

( 1) Ukuqoqwa kwamathe(YXN-SARS-AT-01): Yenza inhlanzeko yezandla ngensipho namanzi /ukuhlikihla ngesandla okusekelwe otshwaleni. Vula isitsha. Yenza umsindo we-Kruuua' emphinjeni ukuze usule amathe emphinjeni, 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.Isampula yamathe(YXN-SARS-AT-01):

( 1) Ngemva kokuba ikhasethi lokuhlola selibuyele ezingeni lokushisa legumbi, vula isikhwama se-aluminium foil bese ukhipha ikhasethi lokuhlola bese ulibeka livundlile kudeskithophu.

(2) Khipha isihloko sekhasethi lokuhlola, cwilisa induku yekhasethi lokuhlola ematheni, noma ubeke induku yekhasethi yokuhlola ngaphansi kolimi imizuzu emi-2.

(3) Gcina ikhasethi lokuhlola liqondile futhi uvumele uketshezi lwamathe luye phezulu luze lufike noma ludlule ulayini C, bese ubuyisela isivalo bese ubeka phansi ikhasethi lokuhlola phezu kwedeski.

(4) Funda imiphumela ebonisiwe phakathi nemizuzu eyi-15-30, futhi imiphumela efundwa ngemva kwemizuzu engama-30 ayivumelekile.

【[INTERPREI-TATION OF TEST RESULTS】

【LIMITATION OF THOLAION METHOD】

1. Ukuqinisekiswa komtholampilo

Ukuze kuhlolwe ukusebenza kokuxilonga, lolu cwaningo lusebenzise izifanekiso ezine-COVID-19 ezivela kubantu abayi-150 kanye nezabantu abangenayo i-COVID-19 ezivela kubantu abangama-350. Lezi zibonelo zahlolwa futhi zaqinisekiswa indlela ye-RT-PCR. Imiphumela imi kanje:

a) Ukuzwela :92.67% (139/ 150), 95%CI (87.26% , 96.28%).

b) Ukucaciswa:98.29% ( 344/350), 95%CI( 96.31%, 99.37%) .

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. Kusetshenziswe amaqoqo ahlukene ama-reagents ukuhlola isampula efanayo izikhathi eziyi-10 ngokulandelana, kanye no

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, kungakhathaliseki ukuthi igciwane liyathelelana. Ngakho-ke, imiphumela yokuhlolwa yalo mkhiqizo kanye nemiphumela yesiko legciwane lesampula efanayo ingase ingahlotshaniswa.

3. Ikhadi lokuhlola kanye nesixazululo sokukhipha isampula salo mkhiqizo kudinga ukubuyiselwa ekamelweni lokushisa ngaphambi kokusetshenziswa. Izinga lokushisa elingafanele lingabangela umphumela wokuhlolwa ongavamile.

4. Phakathi nenqubo yokuhlola, imiphumela yokuhlolwa ingase ingafani nemiphumela yomtholampilo ngenxa yesampula enganele yokuqoqwa kwama-swabs oyinyumba noma ukuqoqwa okungafanele nokusebenza kokukhipha isifanekiso.

5. Ngesikhathi sokusebenzisa lo mkhiqizo, udinga ukulandela ngokuqinile izinyathelo zokusebenza zebhukwana. Izinyathelo zokusebenza ezingafanele nezimo zemvelo zingadala imiphumela yokuhlolwa engavamile.

6. I-swab kufanele ijikelezwe cishe izikhathi ezingu-10 odongeni lwangaphakathi lweshubhu lokuhlola eliqukethe isisombululo sokukhishwa kwesampula. Ukuzungezisa okumbalwa kakhulu noma okuningi kakhulu kungabangela imiphumela yokuhlolwa engavamile.

7. Umphumela omuhle walo mkhiqizo awukwazi ukukhipha amathuba okuthi amanye amagciwane abe positive.

8. Umphumela wokuhlolwa onegethivu uma lo mkhiqizo awukwazi ukusho ukuthi kungenzeka amanye amagciwane abe positive.

9. Imiphumela yokuhlolwa engemihle iyanconywa ukuthi iqinisekiswe ngama-reagents okuthola i-nucleic acid ukuze kugwenywe ingozi yokuhlolwa okugejiwe.

10. Kungase kube nomehluko emiphumeleni yokuhlolwa phakathi kwamasampula omtholampilo aqandisiwe kanye namasampula omtholampilo aqoqwe asanda kuqoqwa.

11. Isifanekiso kufanele sihlolwe ngokushesha ngemva kokuqoqwa ukuze kugwenywe imiphumela yokuhlolwa engavamile ngemva kokushiywa isikhathi eside kakhulu.

12. Ngesikhathi sokusebenzisa lo mkhiqizo, inani elifanele lesampula liyadingeka, inani elincane kakhulu noma eliningi kakhulu lesampula lingabangela imiphumela yokuhlolwa engavamile. Kunconywa ukusebenzisa i-pipette enevolumu yesampula enembe kakhulu ukuze kuhlolwe isampula yokwengeza.

【PRECAUTIONS】

1. Sicela ulinganise isampula ye-diluent nekhadi lokuhlola nezinga lokushisa legumbi (ngaphezu kwama-30min) ngaphambi kokuhlolwa.

2. Ukuhlolwa kufanele kwenziwe ngokuhambisana ngokuqinile nemiyalelo.

3. Umphumela kufanele uhunyushwe phakathi kwemizuzu eyi-15-30, futhi umphumela ofundwe ngemva kwemizuzu engama-30 awuvumelekile.