I-SARS-CoV-2 Antigen Rapid Test Cassette

UKUSETSHENZISWA OKUHLOSIWE

II-SARS-CoV-2 Antigen Rapid Test Cassettei-chromatographic immunoassay esheshayo yokutholwa kwekhwalithi ye-antigen ye-SARS-CoV-2 kumaswabs e-Oropharyngeal yabantu.Ukuhlonza kusekelwe kumasosha omzimba we-monoclonal aqondene ne-Nucleocapsid (N) Protein ye-SARS-CoV-2.Kuhloselwe ukusiza ekuxilongweni okuhlukile okusheshaI-COVID 19ukutheleleka.

Imininingwane Yephakheji

25 test/pack, 50 test/pack, 100 test/pack

ISINGENISO

Ama-coronavirus anoveli ayingxenye ye-β.I-COVID 19Abantu bavame ukungenwa kalula yizifo. Okwamanje, iziguli ezitheleleke nge-coronavirus yenoveli ziwumthombo omkhulu wokutheleleka; abantu abanama-asymptomatic bangaba umthombo othelelanayo.Ngokusekelwe ophenyweni lwamanje lwe-epidemiological, isikhathi sokufukamela yizinsuku ezi-1 kuya kweziyi-14, izikhathi eziningi izinsuku ezi-3 kuya kweziyi-7. Izimpawu eziyinhloko zihlanganisa umkhuhlane, ukukhathala nokukhwehlela okomile. Ukuminyana emakhaleni, ikhala eligijimayo, umphimbo obuhlungu, i-myalgia kanye nesifo sohudo kutholakala ezimweni ezimbalwa.

REAGENTS

Ikhasethi lokuhlola liqukethe izinhlayiya ze-anti-SARS-CoV-2 Nucleocapsid protein kanye ne-anti-SARS-CoV-2 Nucleocapsid protein embozwe kulwelwesi.

IZINYATHELO ZOKUZIVIKELA

Sicela ufunde yonke imininingwane ekule phakheji ngaphambi kokwenza ukuhlolwa.

1.Ngokusetshenziswa kochwepheshe be-in vitro diagnostic kuphela. Ungasebenzisi ngemva kosuku lokuphelelwa yisikhathi.

2.Isivivinyo kufanele sihlale esikhwameni esivaliwe kuze kube yilapho sesilungele ukusetshenziswa.

3.Zonke izifanekiso kufanele zithathwe njengeziyingozi futhi ziphathwe ngendlela efanayo ne-ejenti yokutheleleka.

4.Ukuhlolwa okusetshenzisiwe kufanele kulahlwe ngokwemithetho yendawo.

5.Gwema ukusebenzisa amasampula anegazi.

6.Gqoka amagilavu lapho unikeza amasampula, gwema ukuthinta ulwelwesi lwe-reagent kanye nesampula kahle.

ISITOREJI NOKUZInza

Isikhathi sokuqinisekisa siyizinyanga eziyi-18 uma lo mkhiqizo ugcinwe endaweni ye

2-30℃. Ukuhlolwa kuzinzile ngosuku lokuphelelwa yisikhathi oluphrintwe esikhwameni esivaliwe. Ukuhlolwa kufanele kuhlale esikhwameni esivaliwe kuze kusetshenziswe..UNGAQISHI.Ungasebenzisi ngale kosuku lokuphelelwa yisikhathi.

UKUQOQWA KANYE NOKULUNGISWA KOMHLABA

1.Iqoqo lokuphuma komphimbo: Faka i-swab oyinyumba emphinjeni ngokuphelele isuka emlonyeni, igxile obondeni lomphimbo kanye nendawo ebovu yamathonsi olwanga, sula amathoni wepharyngeal amabili kanye nodonga lwangemuva lwepharyngeal ngokumaphakathi.

phoqa, gwema ukuthinta ulimi futhi ukhiphe i-swab.

2.Lungisa isampula ngokushesha ngesixazululo sokukhipha isampula esinikezwe kukhithi ngemuva kokuthi isampula isiqoqwe. 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 ℃.

3. 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.

IZINTO ZEKHITHI

Izinto ziyahlinzeka

Izinto ezidingekayo kodwa azihlinzeki

Imininingwane25

ukuhlolwa/iphakethe50

tests/pack100

izivivinyo/ipaketheIsampula Extraction Reagent25 test/pack50 test/pack100 test/packIsampula isizinda

tube≥25 tests/pack≥50 tests/pack≥100 test/packInstructionReference

packageBheka ku-

packageBheka ku-

iphasela

IZINDLELA ZOKUSEBENZISA

Vumela ukuhlola, isifanekiso, isigcinalwazi sokukhipha ukuze silingane nezinga lokushisa legumbi(15-30℃) ngaphambi kokuhlolwa.

1. Khipha ikhasethi lokuhlola esikhwameni se-foil esivaliwe futhi ulisebenzise phakathi nemizuzu engu-15. Imiphumela emihle kakhulu izotholakala uma ukuhlolwa kwenziwa ngokushesha ngemva kokuvula isikhwama se-foil.

2.Beka i-Extraction Tube esiteshini sokusebenza.Bamba ibhodlela le-reagent yokukhipha ulibhekise phansi ngokuqondile.Cindezela ibhodlela bese uvumela zonke isixazululo (Approx,250μL) zehlele eshubhuni yokukhipha ngokukhululekile ngaphandle kokuthinta unqenqema lweshubhu ku-Extraction Tube.

3.Beka isifanekiso se-swab ku-Extraction Tube.Zungezisa i-swab cishe imizuzwana eyi-10 ngenkathi ucindezela ikhanda phakathi kweshubhu ukuze ukhulule i-antigen ku-swab.

4.Khipha i-swab ngenkathi ucindezela ikhanda le-swab ngaphakathi kwe-Extraction Tube njengoba ulisusa ukuze ukhiphe uketshezi oluningi ngangokunokwenzeka wenze i-swab.

5.Faka ithiphu le-dropper phezu kweshubhu yokukhipha.Beka ikhasethi lokuhlola endaweni ehlanzekile nesezingeni.

6.Yengeza amaconsi angu-2 esixazululo(cishe,65μL) emthonjeni wesampula bese uqala isibali sikhathi.Funda umphumela obonisiwe phakathi nemizuzu engu-20-30, futhi imiphumela efundwa ngemva kwemizuzu engu-30 ayivumelekile.

UKUTOLIZWA KWEMIPHUMELA

Umugqa owodwa onombala uvela endaweni yomugqa wokulawula (C). Awukho umugqa ovela endaweni yokuhlola (T). Umphumela ongemuhle ubonisa ukuthi i-antigen yakwa-SARS-CoV-2 ayikho esibonelweni, noma ikhona ngaphansi kwezinga elitholakalayo lokuhlola.

OKUHLEUMPHUMELA:

Kuvela imigqa emibili.umugqa owodwa onombala kufanele ube endaweni yokulawula (C) kanti omunye ulayini onombala obonakalayo kufanele ube endaweni yokuhlola (T).Umphumela omuhle ubonisa ukuthi i-SARS-CoV-2 itholwe esibonelweni.

UMPHUMELA ONGAvumelekile:

Ulayini wokulawula uyehluleka ukuvela.Ivolumu yesampula enganele noma izindlela zenqubo ezingalungile cishe ziyizizathu zokwehluleka kolayini wokulawula. Buyekeza inqubo bese uphinda ukuhlolwa ngokuhlolwa okusha. Uma inkinga iqhubeka, yeka ukusebenzisa ikhithi yokuhlola ngokushesha futhi uxhumane nomsabalalisi wangakini.

QAPHELA:

Ukuqina kombala endaweni yomugqa wokuhlola (T) kuzohluka kuye ngokugxila kwe-SARS-CoV-2 Antigen ekhona kusifanekiso. Ngakho-ke, noma imuphi umthunzi wombala endaweni yomugqa wokuhlola(T) kufanele ubhekwe njengomuhle.

IKHWALITHI YOKULAWULA

• Ukulawulwa kwenqubo kufakiwe ekuhlolweni. Ulayini onombala ovela endaweni yokulawula(C) uthathwa njengokulawula kwenqubo yangaphakathi.Uqinisekisa i-wicking eyanele yolwelwesi.
• Amazinga okulawula awanikeziwe ngale khithi; nokho-ke, kuyatuswa ukuthi izilawuli ezinhle nezingezinhle zihlolwe njengomkhuba omuhle waselabhorethri ukuze kuqinisekiswe inqubo yokuhlola kanye nokuqinisekisa ukusebenza kahle kokuhlolwa.

IMIKHAWULOOF THE TEST

1. Ikhasethi le-SARS-CoV-2 Antigen Rapid Test Cassette elokusetshenziswa kochwepheshe be-in vitro ukuhlola kuphela. Ukuhlolwa kufanele kusetshenziselwe ukutholwa kwe-SARS-CoV-2 Antigen ku-Oropharyngeal Swab. Akukho velu yobuningi noma izinga lokukhuphuka kokugxilisa ingqondo kwe-SARS-CoV-2 okunganqunywa yilolu hlolo lwekhwalithi.
2. Ukunemba kokuhlolwa kuncike kukhwalithi yesampula ye-swab.Ama-negative angamanga angase aphumele ekuqoqweni kwesampula okungalungile.
3. Ikhasethi le-SARS-CoV-2 Antigen Rapid Test Cassette lizokhombisa kuphela ukuba khona kwe-SARS-CoV-2 esibonelweni sazo zombili izinhlobo ze-SARS-CoV-2 ezisebenzayo nezingenamandla.
4. Njengazo zonke izivivinyo zokuxilonga, yonke imiphumela kufanele ihunyushwe kanye nolunye ulwazi lomtholampilo olutholakala kudokotela.
5. Umphumela ongemuhle otholwe kule khithi kufanele uqinisekiswe yi-PCR.Umphumela ongemuhle ungatholwa uma ukugxila kwe-SARS-CoV-2 ekhona ku-swab kunganele noma kungaphansi kwezinga elitholakalayo lokuhlola.
6. Igazi eliningi noma amafinyila kusifanekiso se-swab kungase kuphazamise ukusebenza futhi kungase kuveze umphumela ongelona iqiniso.
7. Umphumela omuhle we-SARS-CoV-2 awukuvimbeli ukutheleleka okuyisisekelo okuhambisana ne-anther pathogen. Ngakho-ke, kufanele kucatshangelwe ukuthi kungenzeka yini ukutheleleka ngebhaktheriya engabonakali.
8. Imiphumela engemihle ayikukhiphi ukutheleleka kwe-SARS-CoV-2, ikakhulukazi kulabo abake bahlangana naleli gciwane. Ukuhlolwa kokulandelela ngokuxilonga amangqamuzana kufanele kubhekwe ukuze kukhishwe ukutheleleka kulaba bantu.
9. Imiphumela emihle ingase ibe ngenxa yokutheleleka nge-coronavirus okungeyona i-SARS-CoV-2, njenge-coronavirus HKU1, NL63, OC43, noma 229E.
10. Imiphumela yokuhlolwa kwe-antigen akufanele isetshenziswe njengesisekelo sodwa sokuxilonga noma ukukhipha ukutheleleka kwe-SARS-CoV-2 noma ukwazisa isimo sokutheleleka.
11. I-reagent yokukhipha inamandla okubulala igciwane , kodwa ayikwazi ukuvala igciwane elingu-100%.Indlela yokuvala igciwane kungabhekiselwa kuyo: iyiphi indlela etuswa yi-WHO/CDC, noma ingaphathwa ngokuvumelana nemithetho yendawo.

IZIMPAWU ZOKUSEBENZA

UkuzwelafuthiUkucaciswa

Ikhasethi le-SARS-CoV-2 Antigen Rapid Test Cassette liye lahlolwa ngezibonelo ezitholwe ezigulini.I-PCR isetshenziswa njengendlela eyinkomba ye-SARS-CoV-2 Antigen Rapid Test Cassette.Izibonelo zazibhekwa njenge-positive uma i-PCR ibonise umphumela omuhle.

Ukuzwela Okuhlobene :95.0%(95%CI*:83.1%-99.4%)

Ukucaciswa okuhlobene:99.2%(95%CI*:97.6%-99.8%)

*Izikhawu Zokuzethemba

Umkhawulo Wokuthola

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

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.

Umphumela we-HOOK

Lapho okuqukethwe kwegciwane kusampula ezohlolwa kufinyelela ku-4.0*10⁵I-TCID₅₀/ml, umphumela wokuhlola awukawubonisi umphumela we-HOOK.

I-Cross-Reactivity

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

Iukuphazamisa Izinto

Imiphumela yokuhlolwa ayiphazanyiswa into ekugxilweni okulandelayo:

I-IBBLIOGRAPHY

1.Weiss SR,Leibowitz JZ.Coronavirus pathogenesis. I-Adv Virus Res 2011;81:85-164
2.Cui J,Li F,Shi ZL.Umsuka kanye nokuvela kwe-pathogenic coronaviruses.Nat Rev Microbiol 2019;17:181-192.
3.Su S,Wong G,Shi W,et al.Epidemiology,ukuhlanganiswa kabusha kofuzo, kanye nesifo se-coronavirus. I-TrendsMicrobiol 2016; 24:490-502.