Idivaysi yesistimu ye-GrostStep ye-SARS-Cov-2 Antigen Rapid Test
Ukusetshenziswa okuhlosiwe
Idivaysi yesistimu ye-GROSTSTEP Lokhu kuhlola kusetshenziswa okukodwa kuphela futhi kuhloswe ukuhlolwa kwe-SEI. Kunconywa ukusebenzisa lolu vivinyo kungakapheli izinsuku eziyi-7 zokuqala uphawu kusekelwa ukuhlolwa kokusebenza komtholampilo.
Ukuqalisa
Ama-coronaviruses angamanoveli angowoluhlobo lwe-0. I-COVIIL-19 yisifo esibuhlungu sokuphefumula. Abantu ngokuvamile bathambekele. Njengamanje, iziguli ezitheleleke yi-coronavirus yenoveli zingumthombo oyinhloko wokutheleleka ngokususelwa ophenyweni olungelona olwalususelwa khona, isikhathi sokufakwa kwezinsuku ezi-1 kuye kwezingu-14, iningi lezinsuku ezi-3 kuye kwezingu-3. Ukubonakaliswa okuyinhloko kufaka umkhuhlane, ukukhathala kanye nokukhwehlela owomile. Ukuxinana kwamakhala, ikhala eligijimayo, umphimbo obuhlungu, i-myalgia kanye nesifo sohudo kutholakala ezimweni ezimbalwa.
Isimiso
Idivaysi yohlelo lwe-COSTSTEP® ye-SARS-Cov-2 Antigen Test isebenzisa isivivinyo se-Immunochrogatographic, le khithi iqoqa amasampula amathe avela phambi kwekhadi lokuhlola, futhi amasampula amathe aqhubekela phambili ngaphansi kwesenzo se-capillary. Uma isampula liqukethe i-SARS-Cov-2 n Protein Antigen.it ikhonjwa futhi iboshwe ngama-antibodies abhalwe phansi e-latex ebusweni. Lapho kumiswa izinhlaka ze-immuncy zisuka kumugqa wokutholwa kwe-nitric acid fiber membrane, ukukhomba ama-antibodies agcwele futhi kwakha umugqa wokutholwa kwe-fuchsia (ama-t-lins), okubonisa ama-SARS-cov-2 antigen ahle; Uma i-T-line ingakhombisi umbala, kungumphumela omubi. Omunye umugqa ku-nitric acid ulwelwelwelwelwelwelwesi lwe-nitric acid fiber lugcwele ama-antibodies we-strptavidin njengomugqa wokulawula osezingeni eliphezulu (umugqa we-C), ukukhombisa inqubo yokuhlola esebenzayo.
IZINYATHELO ZOKUZIVIKELA
• Le khithi ingeyokusetshenziswa kokuxilongwa kwe-vitro kuphela.
• Le khithi ingahanjiswa ngabasebenzi bezokwelapha noma abangezona ezokwelashwa ngokulandela imiyalo yokusebenza.
• Funda imiyalo ngokucophelela ngaphambi kokwenza isivivinyo.
• Lo mkhiqizo awunazo izinsiza zomthombo wabantu.
• Musa ukusebenzisa okuqukethwe kwe-Kit ngemuva kosuku lokuphelelwa yisikhathi.
• phatha zonke izinhlobo zezinhlobo njengokutheleleka.
• Musa ukwenza i-Pipette reagent ngomlomo futhi akukho ukubhema noma ukudla ngenkathi wenza izincazelo.
• Gqoka amagilavu phakathi nenqubo yonke.
Ukugcinwa nokuqina
Izikhwama ezivalekile ekhishini lokuhlola zingagcinwa phakathi kuka-2-30 ° C ubude besikhathi sempilo njengoba kukhonjisiwe esikhwameni.
Ukuqoqwa kweqoqo nesitoreji
Isibonakaliso esihle kakhulu se-saliva kufanele siqoqe ekuseni ngemuva kokuvuka nje. Ungadli noma uphuze noma yini imizuzu engama-30 ngaphambi kokuqoqa isampula yethe lakho. Kwenze ngaphambi kokuba nekhofi, udla ibhulakufesi, noma ukuxubha amazinyo akho - noma ulinde kuze kube yilapho ungasebenzisi lutho emizuzwini engama-30 yangaphambilini.
Indlela yokwenza izinto
Letha izivivinyo zokushisa kwegumbi (15-30 ° C) ngaphambi kokusebenzisa.
Isinyathelo 1:
Vula isikhwama, khipha idivaysi yokuhlola, vula isembozo sokuphela kwensiza yokuhlola.
Isinyathelo 2:
• Bamba i-cassette ye-lest, faka induku ye-sadiva adsorption ngaphansi kolimi, yenza induku ye-adsorption kanye nolimi kufanelekile ngokuqinile okungenani imizuzu eyi-120.
• Gcina idivaysi iqonde futhi uvumele uketshezi lwe-saliva ukunyukela phezulu kuze kube yilapho ufinyelela ngaphezulu kwe-C, bese uvimba i-cap emuva.
• Beka insiza evundlile kwisikhwama somsebenzi.
Isinyathelo 3:
Isikhathi futhi ufunde ukutholwa kabusha imizuzu engu-15 kamuva.
Lahla ngokuphepha imfucuza esitsheni se-biohaz-ard.
IKHWALITHI YOKULAWULA
Izilawuli zenqubo zangaphakathi zifakiwe esivivinyweni. Ibhendi eluhlaza okwesibhakabhaka evela esifundeni sokulawula (c) ibhekwa njengethuluzi lenqubo yangaphakathi. Iqinisekisa ivolumu eyanele lenqubomgomo nenqubo efanele inqubo.
Ukulinganiselwa ku-Test
1. Ikhithi ihloselwe ukuyisebenzisa ukutholwa kwezimpawu ze-SARS-Cov-2 ama-antigen avela kumathe.
2. Lokhu kuvivinya kubona bobabili abasebenzayo (bukhoma) nabangasebenzi kwe-SARS-cov-2. Ukusebenza kokuhlola kuya ngenani le-virus (antigen) kwisampula futhi kungenzeka noma kungahle kungahambelani nemiphumela yesiko legciwane elenziwa kwisampula efanayo.
I-3. Umphumela ongemuhle wokuhlola kungenzeka uma izinga le-antigen kwisampula lingaphansi komkhawulo wokutholwa kwesivivinyo noma uma isampula liqoqwe noma lihanjiswe ngokungafanele.
4. Ukwehluleka ukulandela inqubo yokuhlola kungathinta kabi ukusebenza kokuhlola kanye / noma kusebenze umphumela wokuhlolwa.
I-5. Ikhithi yokuhlolwa kokugabadela kuphela. Imiphumela emibi ayibusisi i-SARS-Cov-2 Ukutheleleka futhi umuntu angatheleleki. Uma izimpawu zikhona, funa ukuhlolwa okuqhubekayo ngokushesha.
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7. Imiphumela yokuhlola okuhle ayisusi ukutheleleka ngokubambisana namanye amagciwane futhi ayikwazi ukunquma ukuthi umuntu uyatheleleka yini.
8. Imiphumela yokuhlolwa kabi ayihloselwe ukubusa kwezinye izifo ezingezona amagciwane noma izifo zamagciwane.
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10. Izici zokuqina zokuqina zisuselwa kwimininingwane yokuqina evela ekuhlolweni komkhuhlane kanye nokusebenza kungenzeka kwehlukile nge-SARS-Cov-2. Abasebenzisi kufanele bahlole ama-specimentens ngokushesha ngangokunokwenzeka ngemuva kokuqoqwa kwe-specimen.
11. Ukuzwela kwe-RT-PCR ASSAY ekuhlolweni kwe-Covid-19 kungama-50% -80% ngenxa yekhwalithi yesampula engeyinhle (etc.sars-Cov-2 I-Antiged Test Studen isORetically phansi ngenxa yendlela yalo.
12. Amanani aqagelayo namangalisayo okubikezela ancike kakhulu kumanani akwabele.
Imiphumela emihle yokuhlola kungenzeka imele imiphumela emihle ngezikhathi ezithile ze-Little / No Cov-2 umsebenzi lapho izifo imiphumela engemihle kungenzeka lapho izifo ezingezinhle zibangelwa yi-SARS-Cov-2 ziphezulu.
13. Ama-antibodies we-monoclonal angahluleka ukuthola, noma athole ukuzwela okuncane, amagciwane akhuthazayo we-SARS
14. Ukusebenza kwalolu vivinyo akuhlaziywa ukusetshenziswa ezigulini ngaphandle kwezimpawu nezimpawu zokutheleleka kokuphefumula kanye nokusebenza kungahluka kubantu abase-asymptomatic.
15. Inani le-antigen kwisampula lingancipha njengoba ubude bokugula lukhuphuka.
Izinhlobo eziqoqwe ngemuva kosuku lwe-7 lokugula kungenzeka ukuthi zibe zimbi kakhulu ngokuqhathaniswa ne-RT-PCR ASSAY.
Ukuzwela kokuhlolwa ngemuva kwezinsuku eziyisikhombisa zokuqala kwezimpawu kuye kwaziwe ngokuncipha ngokuqhathaniswa ne-RT-PCR ASSAY.
16. Akuncomi ukusebenzisa ama-virus ezokuhamba media media media media (VTM) kulolu vivinyo, uma amakhasimende egcizelela ukusebenzisa lolu hlobo lwesampula, amakhasimende kufanele aqinisekise.
17. Ukuhlolwa njalo kuyadingeka ukwandisa ukuzwela kokuxilongwa kwe-Covil-19.
18. Akukho ukulahla ekukeni uma kuqhathaniswa nohlobo lwasendle maqondana nokuhluka okulandelayo -B.1.1.7; B.1.351; B.1.2; B.1.1.28; B.1.617; B.1.1.529.
19. Imiphumela emihle ikhombisa ukuthi ama-antigen angamagciwane atholwe kusampula ethathiwe, sicela uzenzele ukuzihlukanisa nokwazisa udokotela wakho womndeni ngokushesha kanye / noma umnyango wakho wezempilo wangakini ngokuya ngezidingo zombuso.
Isivumelwano Esihle Sesivumelwano: (PPA) = 98.02% (93.03% ~ 99.76%) *
Isivumelwano samaphesenti amabi: (NPA) = 100% (98.23% ~ 100%) *
Inani eliphelele lokuhlangana = 98.76%
* 95% isikhawu sokuzethemba
Ukusebenza kokuhlaziya
a) umkhawulo wokutholwa (lod):
Umkhawulo wokutholwa (iLod) yesivivinyo wayenqunywe kusetshenziswa ukunciphisa imikhawulo ye-SARSS-CoV-2. Kungukuhlelwa kwe-coronavirus ehlobene ne-SARS-2 (SARS-Cov-2), ehlukanisa iChina CDC, okuye kwafakwa yi-β-propuolactone. Okuhlinzekwayo kwakuhlinzekwa iqhwa esifundeni se-tcid50ka-5.00 x105/ ml.
Ukunquma ama-SARS-Cov-2 ukukhombisa i-assay lapho usebenzisa amathe aqondile. Kulolu cwaningo cishe ama-50μL e-virus dilution kwaqedwa ngesampula engemihle amathe.
Ilokhi lanqunywa ngezinyathelo ezintathu:
1. Ukuhlola i-Lod
I-10-fold dilcutions yegciwane elingaphakathi lenziwa ngamathe amabi futhi acubungulwa esifundweni ngasinye njengoba kuchaziwe ngenhla. Lezi zinkuzo zahlolwa ngamathathu. Ukuhlushwa okubonisa ama-positive ama-3 kwezingu-3 kwakhethwa ukutholakala kweLod Range.
2. I-Lord Range Ukuthola
Izindlela ezinhlanu (5) zenziwa kabili nge-tcid50ka-5.00 x102/ ml okuhlushwa ngamathe amabi acutshungulwe esifundweni njengoba kuchaziwe ngenhla. Lezi zinkuzo zahlolwa ngamathathu. Ukuhlushwa okubonisa ama-positive ama-3 kwezingu-3 kwakhethwa ukuqinisekiswa kweLod.
3. Ukuqinisekiswa kweLod
I-TCID yokuhlushwa50ka-2.50 x102/ I-ML dilution yahlolelwa imiphumela engamashumi amabili (20). Okungenani imiphumela eyishumi nesishiyagalolunye (19) yabangu-20 (20) yayinempilo.
Isiphetho:
Ngokusekelwe kulolu vivinya ukuqinisekiswa kwaqinisekiswa ngokuthi:
ILod: TCID50I-2.50 x102/ ml
b) Ukuqalisa kabusha Ukuqhubeka:
Ukuqalisa kabusha kwe-CrossStep® System System SOSTS SARS-Cov-2 Antigen Rapid Test kwahlolwa ngokuhlola ama-microorganisms ahlukahlukene (10⁶ CFU / ML), amagciwane (10⁵ PFU / ML) nama-matrixes amabi angasebenza nge-COSTSTEP® Idivayisi yesistimu ye-SARS-Cov-2 Antigen Rapid Test.
Umzimba ngamunye negciwane ngalinye kwahlolwa ngamathathu. Ngokusekelwe kwimininingwane ekhiqizwe lolu cwaningo, idivaysi yesistimu ye-COVSSTEP® ye-SARS-Cov-2 Antigen Rapid Test ayiphenduki ngezinto eziphilayo noma amagciwane ahlolwe.
c) Into ephazamisayo:
Izinto ezingaba khona eziphazamisayo ze-ConfStep® SARS-Cov-2 Antigen Rapid Test zahlolwa ngokuhlola izinto ezahlukahlukene ngokugxila ngezansi ezingase ziphazamise nge-GROSTSTEP ® SARS ukuhlolwa okusheshayo kwe-Antigep. Into ngayinye yavivinywa ngamathathu. Ngokusekelwe kwimininingwane ekhishwe lolu cwaningo, i-COSTSTEP® SARS-Cov-2 Antigen Rapid Test ayiphazamisi izinto ezihloliwe.
d) umphumela we-hook
Ukuhlushwa okuphezulu kakhulu kwe-SARS-inactivated SARS-Cov-2 stock etholakalayo (TCID50ka-5.00 x 105/ ml) wahlolwa. Kwakungekho mphumela we-hook.
