I-COVID-19 Antigen Rapid Test Cassette (Colloidal Gold)
UKUSETSHENZISWA OKUHLOSIWE
I-COVID-19 Antigen Rapid Test Cassette (Colloidal Gold) iyi-lateral flow immunoassay ehloselwe ukuthola ama-antigen e-SARS-CoV-2 ama-nucleocapsid e-swab yamakhala evela kubantu abasolwa ngokuba ne-COVID-19 ngumhlinzeki wabo wezempilo.
Imiphumela ingeyokuhlonza i-SARS-CoV-2 nucleocapsid antigen.I-Antigen ivame ukutholakala ku-swab yamakhala ngesikhathi sesigaba esibucayi sokutheleleka.Imiphumela emihle ibonisa ukuba khona kwama-antigen egciwane, kodwa ukuhlobana komtholampilo nomlando wesiguli kanye nolunye ulwazi lokuxilonga kuyadingeka ukuze kunqunywe isimo sokutheleleka.Imiphumela emihle ayikukhiphi ukutheleleka ngebhaktheriya noma ukutheleleka okuhlangene namanye amagciwane.I-ejenti etholiwe ingase ingabi imbangela eqondile yesifo.
Imiphumela engemihle ayikukhiphi ukutheleleka kwe-SARS-CoV-2 futhi akufanele isetshenziswe njengesisekelo sodwa sokwelashwa noma izinqumo zokuphatha isiguli, okuhlanganisa nezinqumo zokulawula ukutheleleka.Imiphumela engemihle kufanele icatshangelwe esimweni sokuchayeka kwesiguli kwakamuva, umlando kanye nokuba khona kwezimpawu zomtholampilo kanye nezimpawu ezihambisana ne-COVID-19, futhi kuqinisekiswe ngokuhlolwa kwamangqamuzana, uma kudingekile ukuze kuphathwe isiguli.Le khithi ingeyokusetshenziswa ekhaya ngabantu abavamile endaweni okungeyona eyaselabhorethri (njengekhaya lomuntu noma iziza ezithile okungezona ezendabuko ezifana namahhovisi, imicimbi yezemidlalo, izikole njll.).Imiphumela yokuhlolwa yale khithi ingeyenkomba yomtholampilo kuphela.Kunconywa ukwenza ukuhlaziya okuphelele kwesimo ngokusekelwe ekubonakalisweni komtholampilo kweziguli nokunye ukuhlolwa kwelabhorethri.
ISIFINYEZO
I-novel coronaviruses (i-SARS-CoV-2) iyingxenye yohlobo lwe-β.I-COVID-19 yisifo esithathelwanayo sokuphefumula esinamandla.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, izikhathi eziningi 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.
ISIMISO
I-COVID-19 Antigen Rapid Test Cassette (I-Nasal Swab) iyi-lateral flow immunoassay esekelwe kumgomo wesu lesemishi le-double-antibody.I-SARS-CoV-2 nucleocapsid protein monoclonal antibody ehlanganiswe nama-microparticles anombala isetshenziswa njengomtshina futhi ifuthwe ku-conjugation pad.Ngesikhathi sokuhlolwa, i-antigen ye-SARS-CoV-2 kusifanekiso isebenzisana ne-SARS-CoV-2 antibody ehlanganiswe nama-microparticles anemibala enza i-antigen-antibody ebhalwe ukuthi inkimbinkimbi.Le nkimbinkimbi ifuduka kulwelwesi ngesenzo se-capillary kuze kube umugqa wokuhlola, lapho izothathwa khona i-SARS-CoV-2 efakwe ngaphambili i-nucleocapsid protein monoclonal antibody.Ulayini wokuhlola onemibala (T) uzobonakala efasiteleni lemiphumela uma ama-antigen akwa-SARS-CoV-2 ekhona kusifanekiso.Ukungabikho komugqa T kuphakamisa umphumela ongemuhle.Ulayini wokulawula (C) usetshenziselwa ukulawula inqubo, futhi kufanele uvele njalo uma inqubo yokuhlola yenziwe kahle.
IZIXWAYISO NEZIQINISEKISO
•Okokuzihlolela ukusetshenziswa kokuxilongwa kwe-in vitro kuphela.Le khasethi le-tset elokusetshenziswa kanye nje futhi alikwazi ukuphinda lisetshenziswe noma lisetshenziswe abantu abaningi.
•Ungasebenzisi lo mkhiqizo njengesisekelo sodwa sokuxilonga noma ukukhipha ukutheleleka kwe-SARS-CoV-2 noma ukwazisa isimo sokutheleleka nge-COVID-19.
•Sicela ufunde lonke ulwazi olukuleli pheshana ngaphambi kokwenza ukuhlolwa.
•Ungawusebenzisi lo mkhiqizo ngemva kosuku lokuphelelwa yisikhathi.
•Ikhasethi lokuhlola kufanele lihlale esikhwameni esivaliwe kuze kube yilapho lisetshenziswa.
•Zonke izifanekiso kufanele zibhekwe njengeziyingozi futhi ziphathwe ngendlela efanayo ne-ejenti ethelelanayo.
•Ukuhlolwa kwezingane kanye nabantu abasha kufanele kusetshenziswe nomuntu omdala.
•Ikhasethi lokuhlola elisetshenzisiwe kufanele lilahlwe ngokuvumelana nemithetho kahulumeni, yesifunda neyendawo.
•Ungakusebenzisi ukuhlolwa ezinganeni ezingaphansi kweminyaka emi-2 ubudala.
•Izingane ezincane kufanele zigezwe ngosizo lomuntu wesibili omdala.
•Geza izandla kahle ngaphambi nangemuva kokubamba.
COMPOSITION
Izinto Ezinikeziwe
•Hlola Amakhasethi: ikhasethi ngalinye eline-desiccant esikhwameni se-foil ngasinye
•Ama-reagents Okukhipha Asesepakishwe:
•Izinsalela zeSwabs: ukusetshenziswa okukodwa kweswabhu eyinyumba yokuqoqwa kwesifanekiso
•Iphakheji Faka
Izinto Ezidingekayo Kodwa Ezinganikezwanga
•Isibali sikhathi
ISITOREJI NOKUZInza
•Gcina njengoba kupakishwe esikhwameni esivaliwe ezingeni lokushisa (4-30℃ noma 40-86℉).Ikhithi izinzile phakathi nedethi yokuphelelwa yisikhathi ephrintwe kulebula.
•Uma usuvule isikhwama, ukuhlola kufanele kusetshenziswe phakathi nehora elilodwa.Ukuchayeka isikhathi eside endaweni eshisayo neswakeme kuzodala ukuwohloka komkhiqizo.
•UNGAMMISI.
I-SPECIMEN
Izibonelo ezitholwe kusenesikhathi ngesikhathi kuqala izimpawu zizoqukatha ama-viral titer aphezulu kakhulu;izifanekiso ezitholwe ngemva kwezinsuku ezinhlanu zezimpawu kungenzeka ziveze imiphumela engemihle uma ziqhathaniswa nokuhlolwa kwe-RT-PCR.Ukungaqoqwa kwesifanekiso esinganele, ukuphathwa kwesampula okungafanele kanye/noma ukuthutha kungase kuveze imiphumela engamanga;ngakho-ke, ukuqeqeshwa ekuqoqweni kwesampula kunconywa kakhulu ngenxa yokubaluleka kwekhwalithi yesifanekiso ukuze kutholwe imiphumela yokuhlolwa enembile.Uhlobo lwesampula olwamukelekayo lokuhlola isampula ye-swab yamakhala eqondile etholwe indlela yokuqoqa i-dual nares.Lungiselela ishubhu yokukhipha ngokuvumelana Nenqubo Yokuhlola futhi usebenzise i-swab oyinyumba enikezwe kukhithi ukuqoqwa kwesifanekiso.
Iqoqo Lesampula Leswab Yamakhala
1.Susa i-swab ephaketheni.
2.Jikisa ikhanda lesiguli emuva cishe ngo-70°.
3.1-2Ngenkathi uphendukisa kahle i-swab, faka i-swab cishe ngo-2.5 cm (1 iyintshi) ekhaleni kuze kube yilapho ukumelana kuhlangatshezwana nayo kuma-turbinate.
4.Zungezisa i-swab izikhathi eziningana odongeni lwamakhala futhi uphinde kwenye ikhala usebenzisa i-swab efanayo.
I-Special Transport and Storage
Ungabuyisi i-swab ekufakweni kwe-swab yasekuqaleni.Izibonelo ezisanda kuqoqwa kufanele zicutshungulwe ngokushesha ngangokunokwenzeka, kodwa kungakapheli ihora elilodwa ngemva kokuqoqwa kwesifanekiso.
INQUBO YOKUHLOLA
Qaphela:Vumela amakhasethi okuhlola, ama-reagents nezifanekiso ukuthi zilingane nezinga lokushisa legumbi (15-30℃ noma 59-86℉) ngaphambi kokuhlolwa.
1.Beka ithubhu yokukhipha endaweni yokusebenza.
2.Hlubula isivalo se-aluminium foil kusukela phezulu kweshubhu yokukhipha eliqukethe ishubhu yokukhipha eliqukethe isigcinalwazi sokukhipha.
3.Ukusampula kubhekisa esigabeni 'Ukuqoqwa Kwesampula'.
4.Faka isifanekiso se-swab yamakhala eshubhuni yokukhipha equkethe into ekhipha isikhunta.Roll swab okungenani izikhathi ezi-5 ngenkathi ucindezela ikhanda phansi kanye nohlangothi lweshubhu yokukhipha.Shiya i-swab yamakhala eshubhuni yokukhipha umzuzu owodwa.
5.Susa i-swab yamakhala ngenkathi ucindezela izinhlangothi zeshubhu ukuze ukhiphe uketshezi ku-swab.Isixazululo esikhishiwe sizosetshenziswa njengesampula yokuhlola.6.Mboza ithubhu yokukhipha ngethiphu ye-dropper ngokuqinile.
7.Khipha ikhasethi lokuhlola esikhwameni esivaliwe.
8.Hlehlisa ishubhu lokukhipha isifanekiso, ubambe ishubhu liqondile, dlulisa amaconsi ama-3 (cishe u-100 μL) kancane uye esibonelweni somthombo (S) wekhasethi lokuhlola, bese uqala isibali sikhathi.
9.Linda ukuthi kuvele imigqa enemibala.Humusha imiphumela yokuhlolwa ngemizuzu eyi-15.Ungafundi imiphumela ngemuva kwemizuzu engama-20.
UKUTOLIZWA KWEMIPHUMELA
| Okuhle | C T | C T | Kuvela imigqa emibili.Kuvela umugqa owodwa onombala wokushuba komugqa wokuhlola. |
| Okubi | CT | Umugqa owodwa onombala uvela endaweni yokulawula (C), futhi awukho umugqa ovela endaweni yokuhlola (T). | |
| Akuvumelekile | C T | CT | Lawula umugqa yehluleka to avele. Ivolumu yesampula enganele noma izindlela zenqubo ezingalungile yizona zizathu okungenzeka kakhulu zokwehluleka komugqa wokulawula.Buyekeza inqubo bese uphinda ukuhlola usebenzisa ikhasethi elisha lokuhlola.Uma inkinga iqhubeka, yeka ukusebenzisa inkatho ngokushesha futhi uxhumane nomsabalalisi wangakini. |
IKHWALITHI YOKULAWULA
Ukulawulwa kwenqubo kufakiwe ekuhlolweni.Ulayini onombala ovela endaweni yokulawula (C) uthathwa njengokulawula kwenqubo yangaphakathi.Iqinisekisa ivolumu eyanele yesifanekiso, i-membrane wicking eyanele kanye nezindlela ezilungile zenqubo.
Amazinga okulawula awanikezwanga nale khithi.Kodwa-ke, kuyanconywa ukuthi izilawuli ezinhle nezingezinhle zihlolwe njengomkhuba omuhle waselabhorethri ukuze kuqinisekiswe inqubo yokuhlola kanye nokuqinisekisa ukusebenza kahle kokuhlolwa.
IMIKHAWULO
•Umkhiqizo ukhawulelwe ukuze unikeze ukutholwa kwekhwalithi.Ukuqina komugqa wokuhlola akuhambisani ngempela nokugxila kwe-antigen yezibonelo.
•Imiphumela engemihle ayikuvimbeli ukutheleleka kwe-SARS-CoV-2 futhi uma izimpawu zikhona kufanele ufune ukuhlolwa okwengeziwe ngokushesha NgeNdlela Ye-PCR.
•Udokotela kufanele ahumushe imiphumela ngokuhambisana nomlando wesiguli, okutholwe ngokomzimba, nezinye izinqubo zokuxilonga.
•Umphumela ongemuhle otholwe kule Kit kufanele uqinisekiswe yi-PCR.Umphumela ongemuhle ungenzeka uma inani lama-antigen e-SARS-CoV-2 akhona kusifanekiso lingaphansi komkhawulo wokutholwa we-assay, noma igciwane lishintshe (ama) ama-amino acid amancane endaweni ye-epitope ehlosiwe ebonwa amasosha omzimba e-monoclonal. isetshenziswe ekuhlolweni.
•Igazi eliningi noma amafinyila kusampula ye-swab kungase kuphazamise ukusebenza futhi kungase kuveze umphumela ongelona iqiniso.
IZIMPAWU ZOKUSEBENZA
Ukusebenza Komtholampilo
Ukulawulwa kwenqubo kufakiwe ekuhlolweni.Ulayini onombala ovela endaweni yokulawula (C) uthathwa njengokulawula kwenqubo yangaphakathi.Iqinisekisa ivolumu eyanele yesifanekiso, i-membrane wicking eyanele kanye nezindlela ezilungile zenqubo.
Amazinga okulawula awanikezwanga nale khithi.Kodwa-ke, kuyanconywa ukuthi izilawuli ezinhle nezingezinhle zihlolwe njengomkhuba omuhle waselabhorethri ukuze kuqinisekiswe inqubo yokuhlola kanye nokuqinisekisa ukusebenza kahle kokuhlolwa.
| I-antigen ye-COVID-19 | I-RT-PCR | Ingqikithi | ||
| Okuhle | Okubi | |||
| I-HEO® | Okuhle | 212 | 0 | 212 |
| Okubi | 3 | 569 | 572 | |
| Ingqikithi | 215 | 569 | 784 | |
I-PPA =98.60% (212/215), (95%CI: 95.68%~99.71%) NPA =100% (569/569), (95%CI: 99.47%~100%)
I-PPA - Isivumelwano Sephesenti Elihle (Ukuzwela) NPA - Isivumelwano Sephesenti Elinegethivu (Ukucaciswa) 95% *Izikhawu Zokuzethemba
| Izinsuku kusukela uphawu | I-RT-PCR | I-HEO TECHNOLOGY | Isivumelwano(%) |
| 0-3 | 95 | 92 | 96.84% |
| 4-7 | 120 | 120 | 100% |
| CT Inani | I-RT-PCR | I-HEO TECHNOLOGY | Isivumelwano(%) |
| Ct≤30 | 42 | 42 | 100% |
| Ct≤32 | 78 | 78 | 100% |
| Ct≤35 | 86 | 85 | 98.84% |
| ＜37 | 9 | 7 | 77.78% |
Umkhawulo Wokuthola (Ukuzwela Kokuhlaziya)
Lolu cwaningo lusebenzise igciwane le-SARS-CoV-2 elikhulisiwe, elingasebenzi futhi lafakwa esibonelweni se-nasal swab.Umkhawulo Wokutholwa (LoD) ngu-1.0 ×102 TCID50/mL.
I-Cross Reactivity (Ukucaciswa Kokuhlaziya)
Ukusebenza kabusha kwesiphambano kwahlolwa ngokuhlola ama-microorganisms angama-32 commensal kanye ne-pathogenic okungenzeka akhona emgodini wekhala.Akukho ukusabela okuphambanayo okubonwe nge-recombinant MERS-CoV NP amaprotheni lapho ihlolwa ekuhlanganiseni kwe-50 pg/mL.
Akukho ukusabela okuphambene okubonwe nalawa magciwane alandelayo lapho ehlolwa ku-1.0×106 PFU/mL: Umkhuhlane A (H1N1), Umkhuhlane A (H1N1pdm09), Umkhuhlane A (H7N9), Umkhuhlane A (H3N2), Umkhuhlane B ( Yamagata), Umkhuhlane B (Victoria), Adenovirus (uhlobo 1, 2, 3, 5, 7, 55), I-metapneumovirus yabantu,
Parainfluenza virus (uhlobo 1, 2, 3, 4), Respiratory syncytial virus, Enterovirus, Rhinovirus, Human coronavirus 229E, Human coronavirus OC43, Human coronavirus NL63, Human coronavirus HKU1.
Akukho ukusabela okuphambanayo okwabonwa namagciwane alandelayo lapho ehlolwa ekugxilweni kwe-1.0×107 CFU/mL: Mycoplasma pneumoniae, Chlamydia pneumoniae, Legionella pneumophila, Haemophilus influenzae, Streptococcus pyogenes (iqembu A), Streptococcus pneumoniae, Albicans Staphylococcus aureus.
Ukugxambukela
Izinto ezilandelayo ezingase zibe nokuphazamiseka zahlolwa nge-COVID-19 Antigen Rapid Test Cassette (Nasal Swab) ekugxiliseni okubhalwe ngezansi futhi kwatholakala ukuthi akuthinti ukusebenza kokuhlolwa.
| Into | Ukugxila | Into | Ukugxila |
| Mucin | 2% | Igazi lonke | 4% |
| I-Benzocaine | 5 mg/mL | I-Menthol | 10 mg/mL |
| Isifutho samakhala saline | 15% | I-Phenylephrine | 15% |
| I-Oxymetazoline | 15% | I-Mupirocin | 10 mg/mL |
| I-Tobramycin | 5 μg/mL | I-Zanamivir | 5 mg/mL |
| I-Oseltamivir phosphate | 10 mg/mL | I-Ribavirin | 5 mg/mL |
| I-Arbidol | 5 mg/mL | I-Dexamethasone | 5 mg/mL |
| I-Fluticasone propionate | 5% | I-Histamine i-dihydrochloride | 10 mg/mL |
| I-Triamcinolone | 10 mg/mL |
I-High-dose Hook Effect
I-COVID-19 Antigen Rapid Test Cassette (Colloidal Gold) ihlolwe yafika ku-1.0×10 5 TCID50 /mL ye-SARS-CoV-2 engacushiwe futhi akukho mphumela wedosi ophezulu obonwe.
Umbuzo Ovame Ukubuzwa
1.Isebenza kanjani i-SARS-CoV-2 Antigen Rapid Test?Ukuhlola okokuthola ikhwalithi yama-antigen e-SARS-CoV-2 ezibonelweni zeswab eziqoqwe ngokwazo.Umphumela omuhle ukhombisa ama-antigen e-SARS-CoV-2 akhona kusampula.
Kufanele kusetshenziswe nini ukuhlolwa?
I-antigen ye-SARS-CoV-2 ingatholwa ekuthelelekeni okubukhali komgudu wokuphefumula, kunconywa ukwenza ukuhlolwa lapho izimpawu ezibandakanya ukuqala okungazelelwe kokukodwa kwalokhu okulandelayo: ukukhwehlela, umkhuhlane, ukuphelelwa umoya, ukukhathala, ukuncipha kwesifiso sokudla, i-myalgia.
Ingabe umphumela ungaba ongalungile?
Imiphumela inembile njengoba imiyalelo ihlonishwa ngokucophelela.Noma kunjalo, umphumela ungaba ongalungile uma ivolumu yesampula enganele noma i-SARS-CoV-2 Antigen Rapid Test iba manzi ngaphambi kokuhlolwa, noma uma inani lehla lingaphansi koku-3 noma ngaphezulu kuka-4. Ngaphandle kwalokho, ngenxa yemigomo ye-immunology abathintekayo, akhona amathuba okuba nemiphumela engamanga ezimweni ezingavamile.Ukubonisana nodokotela kuhlale kunconywa ukuhlolwa okunjalo okusekelwe ezimisweni ze-immunology.
Indlela yokuhumusha ukuhlolwa uma umbala nokuqina kwemigqa kuhlukile?Umbala nokuqina kwemigqa akubalulekile ekuchazeni umphumela.Imigqa kufanele ibe yi-homogeneous kuphela futhi ibonakale ngokucacile.Ukuhlolwa kufanele kuthathwe njengokuphozithivu kungakhathaliseki ukuthi umbala womugqa wokuhlola ungakanani.5.Yini okufanele ngiyenze uma umphumela uthi awunayo?
Umphumela ongemuhle usho ukuthi awunayo noma inani legciwane egazini liphansi kakhulu
ukuze abonwe ukuhlolwa.Kodwa-ke, kungenzeka ukuthi lokhu kuhlolwa kunikeze umphumela ongemuhle ongalungile (i-negative engamanga) kwabanye abantu abane-COVID-19.Lokhu kusho ukuthi usengaba ne-COVID-19 nakuba ukuhlolwa kungenalo.
Uma uba nezimpawu ezinjengobuhlungu bekhanda, ukudumala kwekhanda, imfiva, ukulahlekelwa iphunga nokunambitha, xhumana nesikhungo sezokwelapha esiseduze usebenzisa imithetho yeziphathimandla zendawo yangakini.Ngaphezu kwalokho, ungaphinda ukuhlolwa ngekhithi yokuhlola entsha.Uma kunezinsolo, phinda ukuhlolwa ngemuva kwezinsuku ezi-1-2, njengoba i-coronavirus ingenakutholwa ngokunembile kuzo zonke izigaba zokutheleleka.Imithetho yebanga nenhlanzeko kusafanele igcinwe.Ngisho nomphumela wokuhlolwa ongemuhle, ibanga nemithetho yenhlanzeko kufanele ibhekwe, ukufuduka/ukuvakasha, ukuya emicimbini nokunye kufanele kulandele imihlahlandlela/izidingo zakho ze-COVID.6.Yini okufanele ngiyenze uma umphumela uthi positive?
Umphumela omuhle usho ukuba khona kwama-antigen akwa-SARS-CoV-2.Imiphumela emihle isho ukuthi maningi amathuba okuthi une-COVID-19.Zihlukanise ngokushesha ngokuhambisana neziqondiso zendawo bese uthintana nodokotela/ udokotela noma umnyango wezempilo wendawo ngokuhambisana nemiyalelo yeziphathimandla zendawo yangakini.Umphumela wakho wokuhlolwa uzobhekwa ukuhlolwa kokuqinisekisa kwe-PCR futhi uzochazwa ngezinyathelo ezilandelayo.
I-BIBLIOGRAFIE
Weiss SR,Leibowitz JZ.I-Coronavirus pathogensis, Adv Virus Res 2011;81:85-164
Cui J, li F, Shi ZL.Umsuka kanye nokuvela kwe-pathogenic coronaviruses.I-Nat Rev Microbiol 2019;17:181-192
U-Su S, Wong G, Shi W, et al.I-Epidemiology, i-genetic recombination, kanye ne-pathogenesis ye-coronavirus.I-TrendsMicrobiol 2016;24:4900502.
INHLOKO YEZIMPAWU
