Ihoseyili ye-COVID-19 ye-Antigen Rapid Test Cassette (iGolide ye-Colloidal) abavelisi kunye nababoneleli |HEO

COVID-19 Antigen Rapid Test Cassette (Colloidal Gold)

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UKUSETYENZISWA OKUHLOSIWEYO

Ikhasethi yoVavanyo oluKhawulezayo lwe-COVID-19 ye-Antigen (iGolide ye-Colloidal) luvavanyo olusecaleni lwe-immunoassay eyenzelwe ukufunyaniswa okusemgangathweni kwee-antigens ze-SARS-CoV-2 ze-nucleocapsid kwi-swab yeempumlo ezivela kubantu ekurhanelwa ukuba bane-COVID-19 ngumboneleli wabo wezempilo.

Iziphumo zezokuchongwa kwe-SARS-CoV-2 nucleocapsid antigen.I-Antigen ibonakala ngokubanzi kwi-swab yeempumlo ngexesha lesigaba esinzima sosulelo.Iziphumo ezilungileyo zibonisa ubukho be-antigens yentsholongwane, kodwa ukulungelelaniswa kweklinikhi kunye nembali yesigulane kunye nolunye ulwazi lokuxilonga luyimfuneko ukumisela imeko yokusuleleka.Iziphumo ezincomekayo azilukhuhli usulelo lwebhaktiriya okanye ukosuleleka kunye nezinye iintsholongwane.I-arhente efunyenweyo ayinakuba ngunobangela oqinisekileyo wesifo.

Iziphumo ezibi azilukhupheli ngaphandle usulelo lwe-SARS-CoV-2 kwaye akufuneki lusetyenziswe njengesona siseko sonyango okanye izigqibo zolawulo lwesigulana, kubandakanya nezigqibo zolawulo losulelo.Iziphumo ezibi kufuneka ziqwalaselwe kumxholo wokuvezwa kwesigulana kutshanje, imbali kunye nobukho beempawu zonyango kunye neempawu ezihambelana ne-COVID-19, kwaye zingqinwe ngovavanyo lwemolekyuli, ukuba kuyimfuneko kulawulo lwesigulana.Le khithi yenzelwe ukusetyenziswa ekhaya ngabantu abangaqeqeshwanga emsebenzini kwindawo engeyiyo elebhu (njengekhaya lomntu okanye iindawo ezithile ezingezizo ezesintu ezifana nee-ofisi, imisitho yezemidlalo, izikolo njl.njl.).Iziphumo zovavanyo zale khithi zezereferensi yezonyango kuphela.Kucetyiswa ukuba kuqhutywe uhlalutyo olubanzi lwemeko esekelwe kwizigulane ukubonakaliswa kweklinikhi kunye nezinye iimvavanyo zebhubhoratri.

USHWANKATHELO

Inoveli coronaviruses (SARS-CoV-2) zezohlobo lwe-β.I-COVID-19 sisifo esosulelayo esinamandla sokuphefumla.Ngokuqhelekileyo abantu basengozini.Okwangoku, izigulana ezosulelwe yinoveli coronavirus ngoyena mthombo wosulelo;abantu abosulelekileyo abangenazimpawu nabo banokuba ngumthombo wosulelo.Ngokusekelwe kuphando lwangoku lwe-epidemiological, ixesha lokufukamela yi-1 ukuya kwiintsuku ze-14, ubukhulu becala iintsuku ezi-3 ukuya kwezi-7.Iimpawu eziphambili ziquka umkhuhlane, ukukhathala kunye nokukhwehlela okomileyo.Ukuxinana kweempumlo, iimpumlo, umqala obuhlungu, i-myalgia kunye ne-diarrhea zifumaneka kwiimeko ezimbalwa.

UMGAQO

Ikhasethi yoVavanyo oluKhawulezayo lwe-COVID-19 ye-Antigen (i-Nasal Swab) luvavanyo lwe-immunoassay olusecaleni olusekwe kumgaqo-nkqubo wesangweji ye-antibody ephindwe kabini.I-SARS-CoV-2 nucleocapsid protein monoclonal antibody edityaniswe nemicroparticles enemibala isetyenziswa njengesixhobo kwaye itshizwe kwi-conjugation pad.Ngexesha lovavanyo, i-antigen ye-SARS-CoV-2 kumzekelo inxibelelana ne-SARS-CoV-2 i-antibody edityaniswe ne-microparticles enemibala eyenza i-antigen-antibody ebhalwe ngobunzima.Olu bunzima lufudukela kwi-membrane ngesenzo se-capillary de kube kumgca wovavanyo, apho luya kuthinjwa yi-SARS-CoV-2 ye-nucleocapsid protein monoclonal antibody efakwe ngaphambili.Umgca wovavanyo olunemibala (T) uya kubonakala kwifestile yeziphumo ukuba ii-antigens ze-SARS-CoV-2 zikhona kumzekelo.Ukungabikho komgca we-T kubonisa umphumo ongalunganga.Umgca wolawulo (C) usetyenziselwa ulawulo lwenkqubo, kwaye kufuneka uhlale ubonakala ukuba inkqubo yokuvavanya yenziwa ngokufanelekileyo.

IZILUMKISO NEMIGAQO

•Kuvavanyo lweSelf in vitro diagnostic use only.Le tset cassette yeyokusetyenziswa kanye kwaye ayinakuphinda isetyenziswe okanye isetyenziswe ngabantu abaninzi.

•Ungasebenzisi le mveliso njengekuphela kwesiseko sokufumanisa okanye ukukhuphela ngaphandle usulelo lwe-SARS-CoV-2 okanye ukwazisa imeko yosulelo lwe-COVID-19.

•Nceda ufunde lonke ulwazi olukweli phetshana phambi kokuba wenze uvavanyo.

•Musa ukusebenzisa le mveliso emva kokuphelelwa kwexesha.

•Ikhasethi yovavanyo kufuneka ihlale kwisingxobo esivaliweyo de isetyenziswe.

•Yonke imizekelo kufuneka ithathwe njengeyingozi kwaye iphathwe ngendlela efanayo ne-arhente eyosulelayo.

•Uvavanyo lwabantwana kunye nolutsha kufuneka lusetyenziswe nomntu omdala.

•Ikhasethi yovavanyo esetyenzisiweyo kufuneka ilahlwe ngokwemithetho yomanyano, karhulumente kunye neyengingqi.

•Musa ukulusebenzisa uvavanyo kubantwana abangaphantsi kweminyaka emi-2 ubudala.

•Abantwana abancinci kufuneka baswayithwe ngoncedo lomntu omdala wesibini.

•Hlamba izandla kakuhle phambi nasemva kokubamba.

UHLELO

Izixhobo ezibonelelweyo

•Iikhasethi zoVavanyo: ikhasethi nganye ene-desiccant kwisingxobo sefoil

•Iizinto eziSetyenzwa kwangaphambili:

• IiSterilised Swabs: sebenzisa enye iswab enyumba yokuqokelela isampuli

•Ipakeji Faka

Izixhobo ezifunekayo kodwa ezingabonelelwanga

•Isibali-xesha

UKUGCINWA NOZINZI

•Gcina njengoko zipakishwe kwisingxobo esitywiniweyo kwiqondo lobushushu (4-30℃ okanye 40-86℉).Ikhithi izinzile ngaphakathi komhla wokuphelelwa oshicilelwe kwilebhile.

• Nje ukuba uvule isingxobo, uvavanyo kufuneka lusetyenziswe kwiyure enye.Ukuba sesichengeni ixesha elide kwindawo eshushu nefumileyo kuya kubangela ukuwohloka kwemveliso.

•UNGAMKHENKISI.

UMBONO

Iisampulu ezifunyenwe kwangoko ngexesha lokuqala kweempawu ziya kuqulatha ezona titer zentsholongwane egazini;imizekelo efunyenwe emva kweentsuku ezintlanu zeempawu kusenokwenzeka ukuba ivelise iziphumo ezingalunganga xa ithelekiswa novavanyo lwe-RT-PCR.Ukungaqokelelwa kwesampulu enganelanga, ukuphathwa ngendlela engafanelekanga kwesampulu kunye/okanye uthutho lunokuvelisa iziphumo ezingezizo;ke ngoko, uqeqesho kwingqokelela yesampulu lucetyiswa kakhulu ngenxa yokubaluleka komgangatho womzekelo ukufumana iziphumo zovavanyo ezichanekileyo.Uhlobo lomzekelo owamkelekileyo wovavanyo luphawu lwempumlo oluthe ngqo olufunyenwe ngendlela yokuqokelela iinares ezimbini.Lungiselela ityhubhu yokukhupha ngokweNkqubo yoVavanyo kwaye usebenzise i-swab engenazintsholongwane enikezelwe kwikhithi yokuqokelela isampuli.

Ukuqokelelwa kweSampule yeempumlo zeswab

1.Susa i-swab kwiphakheji.

2.Tilt intloko yesigulane ngasemva malunga ne-70 °.

3.1-2Ngelixa ujikeleza ngobunono iswab, faka i-swab malunga ne-2.5 cm (i-intshi eyi-1) kwi-nostril de ukuchasana kuhlangatyezwe kwii-turbinates.

4.Jikelezisa iswabhu kaninzi eludongeni lwempumlo kwaye uphinde kwenye impumlo usebenzisa iswabhu efanayo.

Umzekelo wezoThutho kunye noGcino

Musa ukubuyisela iswazi kwipakethelo yokuqala yeswab.Iisampulu ezisandula ukuqokelelwa kufuneka ziqwalaselwe ngokukhawuleza, kodwa kungadlulanga iyure enye emva kokuqokelelwa komfuziselo.

INKQUBO YOVAVANYO

Phawula:Vumela iikhasethi zovavanyo, iirejenti kunye nemizekelo ukuba zilingane nobushushu begumbi (15-30℃ okanye 59-86℉) phambi kovavanyo.

1.Beka ityhubhu yokukhupha kwindawo yokusebenzela.

2.Hlubula i-aluminium foil seal ukusuka phezulu kwityhubhu yokukhupha equlethe ityhubhu yokukhupha equlethe isithinteli sokukhupha.

3.Isampling ibhekisa kwicandelo 'Ingqokelela yoMfanekiso'.

4.Faka i-specimen ye-nasal swab kwityhubhu yokukhupha equlethe i-reagent yokukhupha.Roll swab ubuncinane amaxesha ama-5 ngelixa ucinezela intloko ngezantsi kunye necala lombhobho wokukhupha.Shiya i-swab yeempumlo kwityhubhu yokukhupha umzuzu omnye.

5.Susa i-swab yeempumlo ngelixa ucinezela amacala ombhobho ukukhupha ulwelo kwi-swab.Isisombululo esithathiweyo siya kusetyenziswa njengesampulu yovavanyo.6.Guqula ityhubhu yokukhupha ngencam yedropha ngokuqinileyo.

7. Susa ikhasethi yovavanyo kwisingxobo esivaliweyo.

8.Buyisa umva ityhubhu yokutsalwa komzekelo, ubambe ityhubhu ngokuthe nkqo, udlulise amathontsi ama-3 (malunga ne-100 μL) ngokucothayo kumthombo womzekelo (S) wekhasethi yovavanyo, emva koko uqalise isibali-xesha.

9.Lindela imigca enemibala ivele.Ukutolika iziphumo zovavanyo ngemizuzu eyi-15.Sukuzifunda iziphumo emva kwemizuzu engama-20.

UKUTOLIKWA KWEZIPHUMO

Okuhle

C T

Kuvela imigca emibini.Umgca omnye onemibala ubonakala ubukhulu bomgca wokuvavanya.

Ibi

Umgca omnye onemibala ubonakala kwindawo yokulawula (C), kwaye akukho mgca uvela kwindawo yokuvavanya (T).

Ayisebenzi

C T

Ulawulo umgca iyasilela to vela. Umthamo wesampulu engonelanga okanye ubuchule benkqubo obungachanekanga zezona zizathu ezinokuthi zibe kho zokungaphumeleli komgca wolawulo.Jonga inkqubo kwaye uluphinde uvavanyo usebenzisa ikhasethi entsha yovavanyo.Ukuba ingxaki iyaqhubeka, yeka ukusebenzisa iqashiso ngoko nangoko kwaye uqhagamshelane nomsasazi wakho wendawo.

ULAWULO LWEMEKO

Ulawulo lwenkqubo lufakiwe kuvavanyo.Umgca wombala ovela kummandla wolawulo (C) uthathwa njengolawulo lwangaphakathi lwenkqubo.Iqinisekisa umthamo owaneleyo we-specimen, i-membrane eyaneleyo ye-wicking kunye nobuchule obuchanekileyo benkqubo.

Imigangatho yolawulo ayibonelelwanga nale khithi.Nangona kunjalo, kucetyiswa ukuba ulawulo oluqinisekileyo kunye nolungalunganga luvavanywe njengenkqubo efanelekileyo yaselabhoratri ukuqinisekisa inkqubo yovavanyo kunye nokuqinisekisa ukusebenza ngokufanelekileyo kovavanyo.

IMIDA

•Imveliso ilinganiselwe ukunika ubhaqo olusemgangathweni.Ubunzima bomgca wovavanyo abudibanisi ukudibanisa nokuxininisa kwe-antigen yeesampuli.

•Iziphumo ezibi aziluthinteli usulelo lwe-SARS-CoV-2 kwaye ukuba iimpawu zikhona kufuneka ufune uvavanyo olongezelelekileyo olukhawulezileyo ngeNdlela ye-PCR.

• Ugqirha kufuneka atolike iziphumo ngokubambisana nembali yesigulane, iziphumo zomzimba, kunye nezinye iinkqubo zokuxilonga.

•Isiphumo esibi esifunyenwe kule Khithi kufuneka siqinisekiswe yi-PCR.Isiphumo esibi singenzeka ukuba ubuninzi bee-antigens ze-SARS-CoV-2 ezikhoyo kwisampulu zingaphantsi komda wokubonwa we-assay, okanye intsholongwane iye yatshintsha (ii) ezincinci ze-amino acid kwingingqi ye-epitope ekujoliswe kuyo evunyiweyo zii- monoclonal antibodies. isetyenziswe kuvavanyo.

•Ubuninzi begazi okanye umfinyila kumfanekiso weswab kunokuphazamisana nokusebenza kwaye kunokuvelisa iziphumo ezingezizo.

IIMPAWU ZOKUSEBENZA

Ukusebenza kweklinikhi

I-antigen ye-COVID-19		I-RT-PCR		Totale
I-antigen ye-COVID-19		Okuhle	Ibi	Totale
HEO®	Okuhle	212	0	212
HEO®	Ibi	3	569	572
Iyonke		215	569	784

PPA =98.60% (212/215), (95%CI: 95.68%~99.71%) NPA =100% (569/569), (95%CI: 99.47%~100%).

I-PPA - IsiVumelwano sePhesenti esiNgxamisekileyo (Uvakalelo) NPA - IsiVumelwano sepesenti esiNegative (Ingcaciso) 95% *Amaxesha okuzithemba

Iintsuku ukusuka uphawu	I-RT-PCR	I-HEO TECHNOLOGY	Isivumelwano(%)
0-3	95	92	96.84%
4-7	120	120	100%

Ixabiso leCT	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%

Umda wokuFumana (Uvakalelo loHlalutyo)

Uphononongo lusebenzise intsholongwane ye-SARS-CoV-2 ekhulisiweyo, engasebenziyo ubushushu kwaye ifakwe kumzekelo we-swab yeempumlo.Umda wokuFumana (i-LoD) ngu-1.0 × 102 TCID50 / mL.

UkuNqabelelana kweReactivity (Ingcaciso yoHlahlo)

I-Cross reactivity ihlolwe ngokuvavanya i-32 commensal kunye ne-pathogenic microorganisms enokuthi ibe khona kwi-nasal cavity.Akukho-cross-reactivity yabonwa kunye neprotheni ye-MERS-CoV NP xa ivavanywa kwi-concentration ye-50 pg / mL.

Akukho-cross-reactivity yabonwa kunye nezi ntsholongwane zilandelayo xa zivavanywa kwi-concentration ye-1.0 × 106 PFU / mL: I-Influenza A (H1N1), i-Influenza A (H1N1pdm09), i-Influenza A (H7N9), i-Influenza A (H3N2), i-Influenza B ( Yamagata), i-Influenza B (Victoria), i-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 kuphinda-phinda kusebenze kwabonwa kunye nale bhaktheriya ilandelayo xa ivavanywa kuxinaniso lwe-1.0 × 107 CFU/mL: Mycoplasma pneumoniae, Chlamydia pneumoniae, Legionella pneumophila, Haemophilus influenzae, Streptococcus pyogenes (iqela A), Streptococcus pneumoniae, Albicans Staphylococcus aureus.

Ukuphazamiseka

Ezi zinto zilandelayo zophazamiseko ezinokubakho ziye zavavanywa kunye ne-COVID-19 Antigen Rapid Test Cassette (eNasal Swab) kugxininiso oludweliswe ngezantsi kwaye zifunyenwe zingachaphazeli ukusebenza kovavanyo.

Iziyobisi	Ukugxila	Iziyobisi	Ukugxila
Mucin	2%	Igazi elipheleleyo	4%
Benzocaine	5 mg/mL	Menthol	10 mg/mL
Ukutshiza ngeempumlo ezinetyuwa	15%	Phenylephrine	15%
Oxymetazoline	15%	Mupirocin	10 mg/mL
Tobramycin	5 μg/mL	IZanamivir	5 mg/mL
I-oseltamivir phosphate	10 mg/mL	I-Ribavirin	5 mg/mL
Arbidol	5 mg/mL	Dexamethasone	5 mg/mL
I-Fluticasone propionate	5%	Histamine idihydrochloride	10 mg/mL
Triamcinolone	10 mg/mL	Histamine idihydrochloride	10 mg/mL

I-High-dose Hook Effect

I-COVID-19 Antigen Rapid Test Cassette (Colloidal Gold) yavavanywa ukuya kuthi ga kwi-1.0×10 5 TCID50 /mL ye-SARS-CoV-2 engasebenziyo kwaye akukho siphumo se-hook sedosi ephezulu sibonwayo.

Umbuzo osoloko ubuzwa

1.Lusebenza njani uvavanyo lwe-SARS-CoV-2 Antigen Rapid?Uvavanyo lolokubona umgangatho wee-antigens ze-SARS-CoV-2 kwiisampulu eziqokelelweyo zeswab.Iziphumo ezilungileyo zibonisa ii-antigens ze-SARS-CoV-2 ezikhoyo kumzekelo.

Kufuneka lusetyenziswe nini uvavanyo?

I-antigen ye-SARS-CoV-2 inokubonwa kwintsholongwane ye-acute yokuphefumla, kuyacetyiswa ukuba uqhube uvavanyo xa iimpawu ezibandakanya ukuqala ngesiquphe kokunye kwezi zilandelayo: ukukhohlela, umkhuhlane, ukuphefumla, ukudinwa, ukuncipha kokutya, i-myalgia.

Ngaba isiphumo asichanekanga?

Iziphumo zichanekile njengoko imiyalelo ihlonitshwa ngononophelo.Nangona kunjalo, isiphumo sisenokungachanekanga ukuba isampulu yesampulu ayiyonelanga okanye i-SARS-CoV-2 Antigen Rapid Test iba manzi ngaphambi kokwenza uvavanyo, okanye ukuba inani le-buffer ye-extraction yehla lingaphantsi kwe-3 okanye ngaphezulu kwe-4. Ngaphandle koko, ngenxa yemigaqo ye-immunological ababandakanyekayo, kukho amathuba eziphumo zobuxoki kwiimeko ezinqabileyo.Ukubonisana nogqirha kuhlala kunconywa kwiimvavanyo ezinjalo ezisekelwe kwimigaqo ye-immunological.

Indlela yokutolika uvavanyo ukuba umbala kunye nokuqina kwemigca kuyahluka?Umbala kunye nobunzulu bemigca akubalulekanga ekutolikweni kwesiphumo.Imigca kufuneka ibe homogeneous kwaye ibonakale ngokucacileyo.Uvavanyo kufuneka luthathwe njengento elungileyo nokuba ubungakanani bombala womgca wovavanyo.5.Yintoni ekufuneka ndiyenze ukuba isiphumo sisithi negative?

Isiphumo esinegative sithetha ukuba awunayo okanye umthamo wentsholongwane egazini usezantsi kakhulu

ukuba abonwe luvavanyo.Nangona kunjalo, kuyenzeka ukuba olu vavanyo lunike iziphumo ezingalunganga ezingachanekanga (ubuxoki obungalunganga) kwabanye abantu abane-COVID-19.Oku kuthetha ukuba usenayo i-COVID-19 nangona uvavanyo luthi awunayo.

Ukuba ufumana iimpawu ezifana nentloko, i-migraines, umkhuhlane, ukulahlekelwa yimvakalelo yokuvumba kunye nencasa, qhagamshelana neziko lezonyango elikufutshane usebenzisa imigaqo yegunya lendawo yakho.Ukongeza, unokuphinda uvavanyo ngekhithi yovavanyo entsha.Kwimeko yokurhanelwa, phinda uvavanyo emva kweentsuku ezi-1-2, njengoko i-coronavirus ayinakubonwa ngokuchanekileyo kuzo zonke izigaba zosulelo.Imithetho yomgama kunye nococeko kufuneka igcinwe.Nokuba kukho iziphumo zovavanyo ezibi, umgama kunye nemithetho yococeko kufuneka ijongwe, ukufuduka/ukuhamba, ukuya kwimisitho njalo njalo kufuneka ulandele izikhokelo/iimfuno ze-COVID zasekuhlaleni.6.Yintoni ekufuneka ndiyenze ukuba iziphumo zi-positive?

Iziphumo ezilungileyo zithetha ubukho be-SARS-CoV-2 antigens.Iziphumo ezilungileyo zithetha ukuba kusenokwenzeka ukuba une-COVID-19.Khawuleza uzibeke wedwa ngokuhambelana nezikhokelo zasekhaya kwaye ngoko nangoko uqhagamshelane nogqirha / ugqirha wakho okanye isebe lezempilo lendawo yakho ngokuhambelana nemiyalelo yabasemagunyeni kwindawo yakho.Iziphumo zovavanyo lwakho ziya kujongwa luvavanyo loqinisekiso lwePCR kwaye uya kucaciswa ngamanyathelo alandelayo.