I-China Squarestep System yeNkqubo yeNkqubo ye-China ye-SARS-cov-2 antign Antiid Priid kunye nabathengisi

Isixhobo senkqubo eqinileyo ye-SARS-cov-2 antign

Inkcazo emfutshane:

Bhala	I-500210	Ukucaciswa	1 Uvavanyo / ibhokisi
Umgaqo-siseko wokufumana	I-Immunocromatographic Assay	IMIHLA	Amathe
Ukusetyenziswa kwenjongo	AmandlaIsixhobo senkqubo yenkqubo ye-SARS-2ntig-2Antign isebenzisa u-Ignocgrographromagraphromagraphroomatographrographromatographromatographromapographrographromatographroomatographroomatographroomatographroomatographroomatographroomatographroomatographroomatographroomatographrographroomatographroomatographroomatographroomatographrographromatographromatographroomatographroomatographrographroomatographroomatographroomatographroomatographroomatographroomatographroomatographrographromatographromatographromatographroomatographroomatographroomatographroomatographroomatographroomatografi eyokufumana i-SARS-COV-2 nucleocapsid antign kwithenda yabantu. Olu vavanyo lusetyenziswa kuphela kwaye lwenzelwe ukuzivavanya. Kucetyiswa ukuba usebenzise olu vavanyo kwiintsuku ezisi-7 zophawu lwangaphakathi. I-LT ixhaswe luvavanyo lwentsebenzo yedayisi.

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Iinkcukacha zemveliso

Iimpawu zeMveliso

Ukusetyenziswa kwenjongo

Isixhobo seNkqubo ye-Squerstep® ye-SARS-2 antign yovavanyo isebenzisa uvavanyo lobuchwephesha be-Ignocchromatographromatographromatographromatographromatographromatographromatographromatographromatographromatographromatographromatographroomatographrogragraphroomatographroomatographrographroomatographroomatographrographroomatographrographroomatographroomatographrographroomatographroomatographrographroomatographroomatographrogragraphroomatographroomatographroomatographrographroomatographroomatographroomatographroomatographroomatographroomatographroomatographroomatographroomatographroomatographroomatographrogragraphroomatographroomatografi e-Inyeocapsid antign kwithenda yabantu. Olu vavanyo lusetyenziswa kuphela kwaye lwenzelwe uvavanyo lwe-sei. Kucetyiswa ukuba usebenzise olu vavanyo kwiintsuku ezisi-7 zophawu lwangaphakathi luxhaswa luvavanyo lwentsebenzo yeklinikhi.

Intshayelelo

I-noves coronavirus ye-0 genus. ICod-19 sisifo esosulelayo sokuphefumla. Abantu ngokubanzi bachaphazeleka. Okwangoku, abaguli bosulelwe yiNovel Coronavirus ngowona mthombo ophambili wosulelo ngokusekelwe kuphando lwangoku lwe-Epidemiological, ixesha lokubengwa yintsuku ezi-1 ukuya kwezi-14, uninzi lweentsuku ezi-3 ukuya kwezi-7. Ezona zinto zibonakalayo zibandakanya umkhuhlane, ukudinwa kunye nokukhohlela okukodwa. Ukuxinana kwe-Nasal, impumlo ebalekayo, umqala obuhlungu, iMylua kunye norhudo lufumaneka kwiimeko ezimbalwa.

Umgaqo

Isixhobo senkqubo ye-cestep ® yenkqubo ye-SARS-2 ye-Antign-2 isebenzisa uvavanyo lwe-uJunocndopogramatographic, le kit iqokelela iisampulu ze-Sativa kwikhadi lovavanyo, kwaye iisampulu ze-saliva zihamba phambili phantsi kwesenzo se-capite. Ukuba isampulu iqulethe i-SARS-2 pro protein.ign.it ichongiwe kwaye iboshwe zii-antibodies ezingena kwi-antibodies kumphezulu we-latex ukwenza i-Lamplex engakhuselekanga. Xa okwenziweyo imizimba ifudukayo kwi-Nitric Fid Fiid Fid Fiber Fid Membrane I-Antibon, Ukuchonga i-antigrings ye-fuchsia kwaye ibonise i-fuchsia yokuchonga (i-T-bigs), i-SARS-2 antign elungileyo; Ukuba i-T-Umgca awubonisi mbala, sisiphumo esibi. Omnye umgca kwi-firric fiber membrane igcwele ii-antibodin ze-Antibodin njengomgca wokunqongophala komgangatho (C Umnxeba), ukubonisa inkqubo yokuvavanya impumelelo.

UKULUMKELA

• Le khit yenzelwe ukusetyenziswa kwe-vitro kuphela.
• Le khit inokulawulwa ngabasebenzi kwezonyango okanye kwezonyango ngokulandela imiyalelo yokusebenza.
Funda imiyalelo ngononophelo ngaphambi kokuba wenze uvavanyo.
• Le mveliso ayinazixhobo zomntu.
• Musa ukusebenzisa iziqulatho zeKit emva komhla wokuphelelwa.
• phatha zonke iisampulu njengoko usuleleke.
• Musa ukuqesha umbhobho ngomlomo kwaye kungabikho utshaya okanye utye ngelixa usenza i-assays.
• Nxiba iigloves ngexesha lenkqubo yonke.

Ukugcinwa kunye nokuzinza

Iipayi ezitywiniweyo zekhithi yovavanyo zinokugcinwa phakathi kwe-2-30 ° C kwixesha lobomi beshelufu njengoko kubonisiwe kwingxowa yengxowa.

Ukuqokelelwa kwengqokelela kunye nokugcina

Eyona nto iphambili i-saliva i-carimen kufuneka iqokelele ekuseni emva kokuba ndivuke. Ungadli okanye usele nantoni na kangangemizuzu engama-30 ngaphambi kokuqokelela isampulu yakho ye-saliva. Kwenze ngaphambi kwekofu, ukutya isidlo sakusasa, okanye ukuxubha amazinyo - okanye ulinde de ungayiphumi nto kwimizuzu engama-30.

Inkqubo

Yiza neemvavanyo kubushushu begumbi (15-30 ° C) ngaphambi kokusetyenziswa.
Inyathelo 1:
Vula ibhegi, thatha isixhobo sovavanyo, vula isiciko sesixhobo sovavanyo.
Inyathelo 2:
• Bamba i-Casesette yekhasethi, faka intonga ye-SAMIva Adsorvar phantsi kolwimi, yenza intonga yolwazi kunye nolwimi luhambelana ngokuqinileyo kwimizuzwana eyi-120.
• Gcina isixhobo sithe nkqo kwaye uvumele amafutha amanzi ukuba anyukele phezulu de afikelele kumgca we-C, emva koko iplagi i-cap.
Beka isixhobo ngokuthe tyaba kwi-Ordedch.
Inyathelo 3:
Ixesha kwakhona kwaye ufunde ukuqaphela kwakhona kwimizuzu eli-15 kamva.
Phosa ngokukhuselekileyo inkanuko kwindawo ye-biohaz-ahrd.

ULAWULO LWEMEKO

Ulawulo lwenkqubo lwangaphakathi lubandakanyiwe kuvavanyo. Ibhendi eblue evele kwingingqi yolawulo (c) ithathwa njengolawulo lwenkqubo yangaphakathi. Iqinisekisa ivolumu eyoneleyo kunye nenkqubo yenkqubo efanelekileyo.

Ukuncitshiswa kweendlela

1. Ikhithi yenzelwe ukuba isetyenziselwe ukufunyanwa okukumgangatho we-SARS-2 ye-quec-2 ukusuka kumathe.
2. Olu vavanyo lubona zombini ezisebenzayo (zihlala) kunye ne-SARS-2. Ukusebenza kovavanyo kuxhomekeka kwinani lentsholongwane (Antigen) kwisampulu kwaye kungakwazi ukwenza okanye kungangahambelani neziphumo zentsholongwane ezenziwe kwisampulu yentsholongwane.
3. Isiphumo sovavanyo esingesosiphumo sinokwenzeka ukuba inqanaba le-Antign kwisampulu lingaphantsi komda wokufunyanwa kovavanyo okanye ukuba isampulu yaqokelelwa okanye ihanjiswa ngokungafanelekanga.
4. Ukusilela ukulandela inkqubo yovavanyo kungachaphazela kakubi intsebenzo yovavanyo kunye / okanye isebenzise iziphumo zovavanyo.
I-5. Ikhithi yeyokuhlolwa kwengqondo kuphela. Iziphumo ezibi azilawuli isulele i-SARS-2 isulele kwaye umntu akanakusulela. Ukuba iimpawu zikhona, funa uvavanyo oluqhubekayo.
I-6. Iziphumo zovavanyo kufuneka zidityaniswe nembali yekliniki, idatha ye-pidemiological, kunye nezinye idatha ezikhoyo kwikliniki ivavanya isigulana.
7. Iziphumo ezifanelekileyo zovavanyo azithethi kakuhle usulelo kunye nolunye uPathogens kwaye akunyanzelekanga ukuba zibone ukuba umntu akasuleleki.
I-8. Iziphumo zovavanyo ezimbi zenzekile ukuba zilawule kwezinye izinto ezingezizo ze-SARS okanye intsholongwane.
9. Iziphumo ezibi ezivela kwizigulana ezinempawu, kufuneka ziphathwe njengokukhukhumala kwaye ziqinisekiswe nge-FDA ye-FDA ye-FDA, ukuba iyimfuneko, kuquka ulawulo lonyango.
10. Iingcebiso zokuzinza ezichaziweyo zisekwe kwidatha yokuzisela evela kuvavanyo lwe-influenza kunye nokusebenza kunokwahluka kwi-SARS-2. Abasebenzisi kufuneka bavavanye iimodeli ngokukhawuleza emva kokuba kuqokelelwe ukuqokelelwa kwengqondo.
11. Imvakalelo ye-RT-PCR ASSEAY ekufunyanisweni kweCovid-19 yi-50% kuphela -80% yesenzo esemgangathweni okanye ixesha lesifo kwiSigaba sokuKhangela kwakhona, i-Antign-2 Antign-2 Antign-2 antign-2 antign-2 antign-2 ye-Antign-2 ye-Antign-2 ye-Antign-2 ye-Antign-2 ye-Antign-2 ye-Antign-2 ye-Antign-2 ye-Antign-2 ye-Antign-2 ye-Antign-2 ye-Antign-2 ye-Antign-2 ye-Antign - isezantsi ngenxa yendlela yayo.
I-12. Iinqobo eziqinisekisiweyo nezingalunganga zixhomekeke kakhulu kumazinga okwanda.
Iziphumo zovavanyo ezilungileyo zinokwenzeka ukuba zimele iziphumo ezilungileyo ze-SOS / HAYI
13. Ii-antibodies ze-monoclon zinokusilela ekufumaneni, okanye zifumane iintsholongwane, i-Sars-2 ye-Fov-2 ye-Fov-2 ye-Ofluenzaenza.
14. Ukusebenza kolu vavanyo akukhange kuvavanywa ukuze kusetyenziswe kwizigulana ngaphandle kwemiqondiso kunye neempawu zosulelo lokuphefumla kunye nokusebenza kunokwahluka kwabantu abakwi-Asymptomic.
15. Isixa se-Antign kwisampulu sinokuncipha njengoko ixesha lokugula liyanda.
Iimodeli eziqokelelwe emva kosuku 7 lokugula kunokwenzeka ukuba zingafakwanga kwi-RT-PCR ASSEAY.
Imvakalelo yovavanyo emva kweentsuku ezisixhenxe zokuqalisa iimpawu zaziwa ukuba incitshiswe xa kuthelekiswa ne-RT-PCR ASSEAY.
16. Ayisincomeki ukusebenzisa imithombo yeendaba yentsholongwane (VTM) kolu vavanyo, ukuba abathengi banyanzelisa ukusebenzisa olu hlobo lwesampulu, abathengi kufuneka baqinisekise.
17. Ukuvavanywa rhoqo kuyimfuneko ukwandisa ubuntununtumo bokuqonda kweCovid-19.
18. Akukho siphoso semvakalelo xa sithelekiswa nohlobo lwasendle ngokubhekisele kwezi zinto zilandelayo -b.1.1.7; B.1.351; B.1.2; B.1.1.28; B.1.617; B.1.1.529.
I-19. Iziphumo ezihle zibonisa ukuba i-atsige ye-ntsholongwane ifunyenwe kwisampulu ethathiweyo, nceda walongamele uvelise kwaye wazise ugqirha wakho wosapho kwaye / okanye isebe lezempilo lendawo ngokweemfuno zikarhulumente.

Isivumelwano sepesenti esiqinisekileyo: (PPA) = 98.02% (93.03% ~ 99.76%) *

Isivumelwano sepesenti esingalunganga: (NPA) = 100% (98.23% ~ 100%) *

Ixabiso elipheleleyo lokulinganisa = 98.76%

* I-95% intelekelelo yokuphumla

Ukuhlalutya ukusebenza

a) umda wokufumana (indawo yokuhlala):

Umda wokufunyanwa (indawo yokuhlala) wovavanyo uzimisele ukusebenzisa imida yokunciphisa imida ye-SARS-2. Kukulungiselela i-Coronavirus enxulumene ne-SARS-2 (i-SARS-CoV-2), i-STAT kwi-CDC yase-CDC, ebingasebenzi ngu-β-propiolatch. Lo mbandela wanikwa iqanda kwi-tcid ye-tcid₅₀ye-5.00 x10⁵/ ml.
Ukufumanisa i-SARS-cov-2 ukubonisa i-assay xa usebenzisa amathe ngqo. Kolu phononongo malunga ne-50μl ye-ntsholongwane i-rictions yayihamba ngesampula ye-stiva engalunganga.
Indawo yokuhlala yagqitywa kumanyathelo amathathu:

1. I-Ad

I-10-Storsulelo ye-10 ye-Storsulelo yentsholongwane engafakwanga yenziwa kumathe angenayo kwaye ilungiselelwe isifundo ngasinye njengoko kuchaziwe apha ngasentla. Ezi zixhobo zivavanywa kubini. Uxinzelelo ukubonisa iiposti ezi-3 ze-3 ze-3 ze-ROOTIS.

I-2. Indawo yokufumana

Izihlanu (5) Izilongo zenziwe nge-TCID₅₀ye-5.00 x10²/ I-ML Ukugxininisa kumathe Alvava egqityiweyo kwisifundo njengoko kuchaziwe apha ngasentla. Ezi zixhobo zivavanywa kubini. Uxinzelelo lubonisa iiposti ezi-3 ze-3 ze-3 ze-Poputives zolawulo.

I-3. I-HOSIC

I-Tcid yoxinzelelo₅₀ye-2.50 x10²I-duilution dilution yavavanywa kwiziphumo ezimashumi mabini (20). Ubuncinci ishumi elinesithoba (19) yeziphumo ezingamashumi amabini (20) bezinethemba.
ISIQINISEKISO:
Ngokusekwe kolu vavanyo uxinzelelo lwaqinisekiswa njenge:
Indawo yokuhlala: I-TCID₅₀2.50 x10²/ ml

b) Ukuwela kwakhona:

Ukucamngca komnqamlezo weSquistep® System System-Cov-2 Uvavanyo lwe-Antign luvavanyiwe ngokuvavanya i-microorganisms ezahlukeneyo (10⁶ CFU / ML) kunye ne-matrixes (10⁵) kunye ne-cerixes enqabileyo Isixhobo seSixhobo seSystem-cov-2 antigen Antigen.
Intsebenzo nganye nentsholongwane yayivavanywa ngokutshata. Ngokusekwe kwidatha eveliswe kolu phononongo, isixhobo senkqubo ye-cestestep® ye-SARS-2 ye-Antign-2 ye-Antign-2 ayisebenzi-i-ofisini yezinto ezizimeleyo okanye i-vir.

c) Ukuphazamisa into:

Izinto ezinokubakho eziphazamisayo ze-Substep® yovavanyo lwe-Antign-2 yavavanywa ngokuvavanya izinto ezahlukeneyo ezingezantsi ezinokuthi ziphazamise uvavanyo lwe-Sundstep® ye-Antig-2 antign. Impahla nganye yavavanywa kwisithathu. Ngokusekwe kwidatha eveliswe kolu phononongo, i-Substep® ye-SARS-COV-2 Uvavanyo lwe-Antign-2 alunakuphazamiseka kwezinto ezivavanyiweyo.

d) i-hookf

Eyona nto iphakamileyo kakhulu ye-SARS-i-SOV-2 isitokhwe esikhoyo (i-TCID₅₀ye-5.00 x 10⁵/ ml) kuvavanywa. Kwakungekho mpembelelo yesiphumo esifunyenweyo.