Ukuhlolwa Okusheshayo Kwe-SARS-CoV-2

Incazelo emfushane:

I-Dual Biosafety System Device ye-SARS-CoV-2 Antigen Test isetshenziselwa ukuthola ikhwalithi ye-novel coronavirus (SARS-CoV-2) nucleocapsid (N) antigen kumasampuli womuntu we-Throat / Nasopharyngeal swab in vitro. Ikhithi kufanele isetshenziswe kuphela njengenkomba yokungezelela noma isetshenziswe ngokuhlangana nokutholwa kwe-nucleic acid ekutholeni amacala okusolwa we-COVID-19. Ayikwazi ukusetshenziswa njengesisekelo sodwa sokuxilongwa nokushiywa ngaphandle kweziguli ze-pneumonitis ezitheleleke nge-coronavirus yenoveli, futhi ayifanele ukuhlolwa kwabantu abaningi. Amakhithi afanele kakhulu ukusetshenziselwa ukuhlolwa okukhulu emazweni nasezifundeni lapho ukuqubuka kwenoveli coronavirus kusakazeka ngokushesha, kanye nokunikeza ukuxilongwa nokuqinisekiswa kokutheleleka nge-COVID-19.

OKUBALULEKILE: Lo mkhiqizo uhlose ukusetshenziselwa ubuchwepheshe kuphela, HHAYI UKUZIVIVINYA NOMA UKUHLOLA EKHAYA!


Imininingwane yomkhiqizo

Amathegi womkhiqizo

UKUSETSHENZISWA okuhlosiwe
TheStrongStep®I-SARS-CoV-2 Antigen Rapid Test iyindlela yokuhlola esheshayo ye-immunochromatographic yokuthola i-antigen ye-COVID-19 kuya ku-SARS-CoV-2 virus ku-Swroat / Nasopharyngeal swab yabantu. Isilingo sisetshenziselwa usizo lwe-asan ekutholeni i-COVID-19.

ISINGENISO
Ama-coronaviruses amanoveli angawohlobo lwe- β. I-COVID-19 iyisifo esithathelwanayo sokuphefumula. Abantu bavame ukuthambekela. Njengamanje, iziguli ezitheleleke nge-coronavirus yenoveli zingumthombo oyinhloko wokutheleleka; abantu abangenwe yigciwane bangaba futhi umthombo othathelanayo. Ngokuya ngophenyo lwamanje lwezifo, isikhathi sokufukamela izinsuku ezi-1 kuye kwezingu-14, ikakhulu izinsuku ezi-3 kuye kwezi-7. Ukubonakaliswa okuyinhloko kufaka phakathi umkhuhlane, ukukhathala nokukhwehlela okomile. Ukucinana kwamakhala, ikhala eligobayo, umphimbo obuhlungu, i-myalgia nohudo kutholakala ezimweni ezimbalwa.

ISIMISO
IStrongStep®I-SARS-CoV-2 Antigen Test isebenzisa ithuluzi lokuhlola ukuhamba kwe-chromatographic lateral ngefomethi yekhasethi. I-Latex conjugated antibody (Latex-Ab) ehambelana ne-SARS- CoV-2 ayomile-incobilized ekugcineni komugqa we-nitrocellulose ulwelwesi. Ama-antibody akwaSARS-CoV-2 ayizibopho e-Test Zone (T) kanti iBiotin-BSA iyisibopho e-Control Zone (C). Lapho isampula lengezwa, lifuduka ngokusabalalisa kwe-capillary ukuvuselela i-latex conjugate. Uma ekhona kusampula, ama-antigen akwa-SARS-CoV- 2 azobopha ngama-antibodies amancane ahlanganisiwe enza izinhlayiya. Lezi zinhlayiya zizoqhubeka nokuthuthela eceleni komugqa kuze kube yiTest Zone (T) lapho zifakwa khona ngamasosha omzimba akwaSARS-CoV-2 akhiqiza umugqa obomvu obonakalayo. Uma awekho ama-anti- SARS-CoV-2 antigen kusampula, awukho umugqa obomvu owakhiwa eTest Zone (T). I-streptavidin conjugate izoqhubeka nokufuduka yodwa ize ibanjwe ku-Control Zone (C) yi-Biotin-BSA ehlanganiswe kulayini, ekhombisa ukuba semthethweni kwesivivinyo.

IZINHLANGANO ZEKIT

Amadivayisi wokuhlola apakishwe ngawodwana

Idivayisi ngayinye iqukethe umugqa onama-conjugates anemibala nama-reagents asebenzayo asatshalaliswe kusengaphambili elihambisanayo.

2 Iziqukathi zeBuffer

I-0.1 M Phosphate salered saline (P8S) ne -0.02% ye-sodium azide.

Amashubhu wokukhipha ama-20

Ngokusetshenziswa kokulungiselela ama-specimens.

1 Indawo yokusebenza

Indawo yokuphatha izigaxa zamashubhu namashubhu.

1 Iphakheji efakiwe

Ukufundiswa kokusebenza.

IZINTO ZOKUDINGEKA ZIDINGEKA KODWA AZINIKEZELWA

Isikhathi Ukusetshenziswa kwesikhathi. 
Isigaxa somqala / se-Nasopharyngeal Okokuqoqwa kwesibonelo

IZINYATHELO ZOKUZIVIKELA
Le kit isetshenziselwa IN VITRO ukusetshenziswa kokuxilonga kuphela. 
Le kit is for Medical Professional Use Only. 
Funda imiyalo ngokucophelela ngaphambi kokwenza isivivinyo.
Lo mkhiqizo awunazo izinto zomthombo womuntu.
Ungasebenzisi okuqukethwe kwekithi ngemuva kosuku lokuphelelwa yisikhathi.
Phatha zonke izibonelo njengezingahle zitheleleke.
Landela inqubo ejwayelekile yeLab kanye nemihlahlandlela yokuphepha yokuphatha nokulahla okokusebenza okungatheleleka. Lapho inqubo ye-assay isiqediwe, lahla ama-specimens ngemuva kokuwathwebula ngo-121 ℃ okungenani imizuzu engama-20. Ngenye indlela, zingelashwa nge-0.5% Sodium Hypochlorite amahora amane ngaphambi kokulahlwa.
Ungafaki i-pipette reagent ngomlomo futhi ungabhemi noma udle ngenkathi wenza izilingo.
Gqoka amagilavu ​​ngesikhathi senqubo yonke.

UKUGCINWA NOKUQINISEKA
Izikhwama ezivaliwe kusikhwama sokuhlola zingagcinwa phakathi kuka-2- 30 ℃ isikhathi sempilo yeshalofu njengoba kukhonjisiwe esikhwameni.

UKUQOQWA OKUKHETHEKILE NOKUGCINWA
Isampula yeNasopharyngeal Swab: Kubalulekile ukuthola uketshezi oluningi ngangokunokwenzeka. Ngakho-ke, ukuqoqa isampula yeNasopharyngeal Swab, faka ngokucophelela iSwabile oyinyumba emakhaleni aletha imfihlo kakhulu ngaphansi kokuhlolwa okubukwayo. Gcina i-Swab eduzane naphansi kwe-septum yekhala ngenkathi ucindezela ngobumnene i-Swab ku-nasopharynx engemuva. Zungezisa i-Swab kaningana. Isigaxa somqala: Cindezela ulimi ngenkemba yolimi noma ngesipuni. Lapho uswayipha umphimbo, qaphela ukuthi ungathinti ulimi, izinhlangothi noma ngaphezulu komlomo ngeSwab. Hlikihla i-Swab ngemuva komphimbo, kumathoni nakunoma iyiphi enye indawo lapho kukhona ububomvu, ukuvuvukala noma ubomvu. Sebenzisa ama-swabs anezinhlamvu ze-rayon ukuqoqa ama-specimens. Ungayisebenzisi i-calcium alginate, ukotini ocijisiwe noma okhonsi kushaft.
Kunconywa ukuthi ama-swab specimens acutshungulwe ngokushesha okukhulu ngemuva kokuqoqwa. Ama-Swabs angabanjelwa kunoma iyiphi ithubhu epulasitiki ehlanzekile, eyomile noma umkhono ongafika emahoreni angama-72 ekamelweni lokushisa (15 ° C kuye ku-30 ​​° C), noma efrijini (2 ° C kuye ku-8 ° C) ngaphambi kokucutshungulwa.

INQUBO
Letha izivivinyo, ama-specimens, i-buffer kanye / noma izilawuli ekamelweni lokushisa (15-30 ° C) ngaphambi kokusetshenziswa.
1. Beka ithubhu elihlanzekile Lokukhipha endaweni eqokelwe indawo yokusebenza. Faka amaconsi ayi-10 we-Extraction Buffer kushubhu yokukhipha.
2. Faka i-swab yesibonelo ku-tube. Hlanganisa ngamandla isixazululo ngokushintshanisa amandla e-swab ngokuphelele ohlangothini lwebhubhu okungenani izikhathi eziyishumi (ngenkathi ucwilisiwe). Vumela i-swab ukuthi ingene ku-Isikhombi Sesikhashana umzuzu owodwa ngaphambi kwesinyathelo esilandelayo.
3. Cindezela uketshezi oluningi ngangokunokwenzeka kusuka kuswazi ngokucindezela uhlangothi lwethubhu lokukhipha eliguquguqukayo njengoba kususwa uswazi. Okungenani i-1/2 yesisombululo sesampula sesampula kufanele ihlale kuthubhu ukuze kwenzeke ukufuduka okwanele kwama-capillary. Beka ikepisi kushubhu ekhishiwe. Lahla i-swab esitsheni esifanele semfucuza ye-biohazardous.
4. Ama-specimens akhishiwe angawagcina ekamelweni lokushisa imizuzu engama-60 ngaphandle kokuthinta imiphumela yokuhlolwa. 
5. Susa isivivinyo esikhwameni saso esivaliwe, bese usibeka endaweni ehlanzekile, eqondile. Faka ilebula kudivayisi ngokuhlonza isiguli noma ukulawula. Ukuthola umphumela omuhle kakhulu, isivivinyo kufanele senziwe kungakapheli ihora elilodwa. 
6. Faka amaconsi ama-3 (cishe u-100 µL) wesampuli ekhishiwe ku-Tube Yokukhipha kuya kusampula kahle kwikhasethi lokuhlola. Gwema ukubamba ama-bubble womoya ku-specimen well (S), futhi ungaphosa isixazululo ewindini lokubuka. Njengoba isivivinyo siqala ukusebenza, uzobona umbala unyakazisa ulwelwesi.
7. Lindela amabhendi anemibala ukuthi avele. Umphumela kufanele ufundwe imizuzu eyi-15.

Ungahumushi umphumela ngemuva kwemizuzu engama-20. Lahla amashubhu wokuhlola asetshenzisiwe namakhasethi okuhlola esitsheni esifanele semfucumfucu esiyingozi.

details

UKUHUNYUSHWA KWEMIPHUMELA

IMIPHUMELA EMIHLESARS-CoV-2 Antigen kit-details1 Amaqembu amabili anemibala avela ngaphakathi kwemizuzu engu-15. Ibhendi elilodwa elinombala livela ku-Control Zone (C) kuthi elinye ibhande elinombala livele ku-Test Zone (T). Umphumela wokuhlolwa ulungile futhi uvumelekile. Akunandaba ukuthi ibhande elinemibala livela kangakanani kuZone Test (T), umphumela wokuhlolwa kufanele uthathwe njengomphumela omuhle.
IMIPHUMELA ENGABISARS-CoV-2 Antigen kit-details2 Amabhande owodwa anemibala avela ku-Control Zone (C) kungakapheli imizuzu eyi-15. Alikho ibhendi enombala evela ku-Test Zone (T). Umphumela wokuhlolwa awuvumelekile futhi uvumelekile.
IMIPHUMELA ENGAVUMELEKILESARS-CoV-2 Antigen kit-details3 Alikho ibhendi enombala evela ku-Control Zone (C) kungakapheli imizuzu engu-15. Umphumela wokuhlolwa awuvumelekile. Phinda isivivinyo ngedivayisi entsha yokuhlola.

IMIKHAWULO OF THE UVIVINYO
1. Isivivinyo esokutholakala kwekhwalithi ye-anti-SARS-CoV-2 antigen kumasampula womuntu we-Throat / Nasopharyngeal swab kanye nomthamo ongakhombisi ubuningi bama-antigen.
2. Isivivinyo esokusetshenziswa kwe-in vitro diagnostic kuphela.
3. Njengasendabeni yazo zonke izivivinyo zokuxilonga, ukuxilongwa okucacile komtholampilo akumele kusekelwe emphumeleni wokuhlolwa okukodwa kepha kufanele kwenziwe ngemuva kokuthi konke okutholakele emtholampilo sekuhloliwe, ikakhulukazi kuhlangene nokuhlolwa kwe-PCS kwe-SARS-CoV-2. 4. Ukuzwela kwesilingo se-RT-PCR ekutholeni i-COVID-19 kungama-30% -80% kuphela ngenxa yekhwalithi yesampula engalungile noma iphuzu lesikhathi sesifo esigabeni esibuyiselwe, njll. Ukuzwela kweDivayisi ye-Antigen Rapid Test yedivayisi kungokombono ephansi ngenxa yeMethodology yayo.

Uhla lwamagama wezimpawu

SARS-CoV-2 Antigen kit-details4

INanjing Liming Bio-Products Co, Ltd.
No. 12 Huayuan Road, Nanjing, Jiangsu, 210042 PR China.
Ucingo: +86 (25) 85288506
Ifekisi: (0086) 25 85476387
I-imeyili: sales@limingbio.com
Iwebhusayithi: www.limingbio.com
Ukwesekwa kobuchwepheshe: poct_tech@limingbio.com

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Product packaging6
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