SARS-CoV-2 Antigen Rapid Test Cassette

UKUSETYENZISWA OKUHLOSIWEYO

ISARS-CoV-2 Antigen Rapid Test Cassetteluvavanyo olukhawulezayo lwe-chromatographic immunoassay ekubhaqweni komgangatho we-antigen ye-SARS-CoV-2 kwi-swabs ye-Oropharyngeal yabantu. Uchongo lusekwe kwi-monoclonal antibodies ezikhethekileyo kwi-Nucleocapsid (N) Protein ye-SARS-CoV-2.Yenzelwe ukunceda ekuncedeni ukuxilongwa ngokukhawuleza kokwahlukana kweI-COVID 19usulelo.

Iinkcukacha zePhakeji

Iimvavanyo ze-25 / ipakethe, iimvavanyo ezingama-50 / ipakethe, iimvavanyo ezili-100 / ipakethe

INTSHAYELELO

Inoveli coronaviruses yeyodidi lwe-β.I-COVID 19Abantu badla ngokuba sesichengeni. Okwangoku, abaguli bosulelwe yinoveli coronavirus ngoyena mthombo wosulelo;abantu abosulelekileyo banokuba ngumthombo wosulelo.Ngokusekelwe kuphando lwangoku lwe-epidemiological, ixesha lokufukamela ngu-1 ukuya kwiintsuku ezili-14, ubukhulu becala 3 ukuya 7 iintsuku. Iimpawu eziphambili ziquka umkhuhlane, ukukhathala kunye nokukhwehlela okomileyo. Ukuxinana kweempumlo, ukuvuza kweempumlo, umqala obuhlungu, i-myalgia kunye norhudo zifumaneka kwiimeko ezimbalwa.

REAGENTS

Ikhasethi yovavanyo ine-anti-SARS-CoV-2 Nucleocapsid protein particles kunye ne-anti-SARS-CoV-2 Nucleocapsid protein egqunywe kwi-membrane.

UKULUMKELA

Nceda ufunde yonke ingcaciso kolu fakelo lwephakheji phambi kokuba wenze uvavanyo.

1.Ukusetyenziswa koxilongo lwe-in vitro kuphela. Musa ukusebenzisa emva komhla wokuphelelwa.

2.Uvavanyo kufuneka luhlale kwisingxobo esitywiniweyo de ulungele ukusetyenziswa.

3.Yonke imizekelo kufuneka ithathwe njengeyingozi kwaye iphathwe ngendlela efanayo ne-arhente yosulelo.

4.Uvavanyo olusetyenzisiweyo kufuneka ilahlwe ngokwemigaqo yendawo.

5.Kuphephe ukusebenzisa iisampulu ezinegazi.

6.Wear iiglavu wen unikezela iisampuli, ugweme ukubamba inwebu ye-reagent kunye nesampuli kakuhle.

UKUGCINWA NOZINZI

Ixesha lokuqinisekisa iinyanga ezili-18 ukuba le mveliso igcinwe kwindawo engqongileyo

2-30℃. Uvavanyo luzinzile ngomhla wokuphelelwa komhla oprintiweyo kwingxowa etywiniweyo. Uvavanyo maluhlale kwisingxobo esitywiniweyo de lusetyenziswe..USUKUMNIKEZI.Musa ukusebenzisa ngaphaya komhla wokuphelelwa.

UKUQOKELELWA KOMSEBENZI NOKULUNGISELELA

I-1.Ingqokelela yokuphuma komqala: Faka i-swab eyinyumba emqaleni ngokupheleleyo ukusuka emlonyeni, ugxile eludongeni lomqala kunye nendawo ebomvu yeetoni zenkalakahla, sula iitoni ze-pharyngeal ezimbini kunye nodonga lwangasemva lwepharyngeal ngokumodareyitha.

ngamandla, kunqande ukubamba ulwimi kwaye ukhuphe i-swab.

I-2.Process isampuli ngokukhawuleza kunye nesisombululo sokutsalwa kwesampula esinikezelwe kwikiti emva kokuba isampuli iqokelelwe. Ukuba ayinakucutshungulwa ngokukhawuleza, isampuli kufuneka igcinwe kwityhubhu yeplastiki eyomileyo, inzalo kwaye ivalwe ngokungqongqo. Inokugcinwa kwi-2-8℃ kwiiyure ze-8, kwaye inokugcinwa ixesha elide kwi-70℃.

3. Iisampulu ezingcoliseke kakhulu ziintsalela zokutya ngomlomo azinakusetyenziselwa uvavanyo lwale mveliso. Iisampulu eziqokelelwe kwi-swabs ebonakala kakhulu okanye i-agglomerated ayikhuthazwa ukuba kuhlolwe le mveliso. Ukuba i-swabs ihlanjululwe ngexabiso elikhulu legazi, ayikhuthazwa ukuba ihlolwe. Akukhuthazwa ukusebenzisa iisampulu ezicutshungulwayo kunye nesisombululo sokutsalwa kwesampulu esingabonelelwanga kule khithi yokuvavanya le mveliso.

AMANQAKU EKIT

Izixhobo ziyabonelela

Izinto ezifunekayo kodwa aziboneleli

Iinkcukacha25

iimvavanyo / ipakethe50

iimvavanyo/pack100

iimvavanyo / ipakethe iSample Extraction Reagent25 iimvavanyo / ipack50 iimvavanyo / pack100 iimvavanyo / ipakethe iSample extraction

tube≥25 tests/pack≥50 tests/pack≥100 tests/packInstructionReference ku

packageJonga kwi

packageJonga kwi

ipakethe

IZIKHOKELO ZOKUSETYENZISWA

Vumela uvavanyo, umfuziselo, isithinteli sokutsalwa silingane neqondo lobushushu begumbi(15-30℃) phambi kovavanyo.

1. Susa ikhasethi yovavanyo kwisingxobo sefoil esitywiniweyo kwaye uyisebenzise kwimizuzu eli-15. Iziphumo ezilungileyo ziya kufumaneka ukuba uvavanyo lwenziwa ngokukhawuleza emva kokuvula isikhwama se-foil.

2.Beka i-Extraction Tube kwisikhululo somsebenzi.Bamba ibhotile ye-reagent ye-extraction ijonge phantsi ngokuthe nkqo.Cwangcisa ibhotile kwaye uvumele zonke isisombululo (i-Approx,250μL) yehle kwi-tube yokukhupha ngokukhululekile ngaphandle kokuchukumisa umda wombhobho ukuya kwi-Extraction. Umbhobho.

3.Faka i-specimen ye-swab kwi-Extraction Tube.Jikelezisa i-swab malunga nemizuzwana ye-10 ngelixa ucinezela intloko ngaphakathi kwe-tube ukukhulula i-antigen kwi-swab.

4.Susa i-swab ngelixa ucinezela intloko ye-swab ngaphakathi kwe-Extraction Tube njengoko uyisusa ukukhupha ulwelo oluninzi kangangoko kunokwenzeka ukwenza i-swab.

5.Faka i-tip ye-dropper phezu kombhobho wokukhupha.Beka i-cassette yokuvavanya kwindawo ecocekileyo kunye nenqanaba.

6.Yongeza amathontsi ama-2 esisombululo(approx,65μL) kwisampulu kakuhle uze uqalise isibali-xesha.Funda umphumo obonisiweyo phakathi kwemizuzu engama-20-30, kwaye iziphumo ezifundwe emva kwemizuzu engama-30 ayisebenzi.

UKUTOLIKWA KWEZIPHUMO

Umgca omnye onemibala ubonakala kwingingqi yolawulo (C). Akukho mgca uvelayo kwindawo yovavanyo (T). Isiphumo esibi sibonisa ukuba i-antigen ye-SARS-CoV-2 ayikho kumzekelo, okanye ikhona ngaphantsi kwenqanaba elibonakalayo lovavanyo.

OKUHLEIZIPHUMO:

Imigca emibini ibonakala.umgca ombala omnye kufuneka ube kwindawo yokulawula (C) kwaye omnye umgca ocacileyo kufuneka ube kwindawo yovavanyo (T).Isiphumo esihle sibonisa ukuba i-SARS-CoV-2 ifunyenwe kumzekelo.

IZIPHUMO EZINGAVUMI:

Umgca wolawulo uyasilela ukuvela.Umlinganiselo onganelanga wesampulu okanye ubuchule benkqubo obungachanekanga zizizathu ezininzi ezinokuba zizizathu zokusilela komgca wolawulo. Hlaziya inkqubo kwaye uluphinde uvavanyo ngovavanyo olutsha. Ukuba ingxaki iyaqhubeka, yeka ukusebenzisa ikiti yovavanyo ngoko nangoko kwaye uqhagamshelane nomsasazi wakho wendawo.

PHAWULA:

Ubunzulu bombala kumgca wovavanyo (T) buya kwahluka ngokuxhomekeke kuxinzelelo lwe-SARS-CoV-2 Antigen ekhoyo kumzekelo. Ngoko ke, nawuphi na umthunzi wombala kwingingqi yovavanyo (T) kufuneka ithathwe njengelungileyo.

ULAWULO LWEMEKO

• Ulawulo lwenkqubo lufakiwe kuvavanyo. Umgca onemibala ovela kummandla wolawulo (C) uthathwa njengolawulo lwangaphakathi lwenkqubo.Uqinisekisa i-membrane wicking eyaneleyo.
• Imigangatho yolawulo ayibonelelwanga nale khithi; nangona kunjalo, kucetyiswa ukuba ulawulo oluqinisekileyo nolungalunganga luvavanywe njengenkqubo efanelekileyo yaselabhoratri ukuqinisekisa inkqubo yovavanyo kunye nokuqinisekisa ukusebenza kovavanyo olufanelekileyo.

IMIDAYOVAVANYO

1. I-SARS-CoV-2 Antigen Rapid Test Cassette yeyokusetyenziswa kobungcali kwi-vitro diagnostic kuphela. Uvavanyo kufuneka lusetyenziselwe ukuchongwa kwe-SARS-CoV-2 Antigen kwi-Oropharyngeal Swab. Ugxininiso lwe-CoV-2 lunokumiselwa ngolu vavanyo lomgangatho.
2. Ukuchaneka kovavanyo kuxhomekeke kumgangatho wesampulu ye-swab.Izinto ezimbi ezingezizo ezinokuthi zibangele ukugcinwa kweesampuli ezingafanelekanga.
3. I-SARS-CoV-2 Antigen Rapid Test Cassette iya kubonisa kuphela ubukho be-SARS-CoV-2 kumzekelo we-SARS-CoV-2 ye-coronavirus esebenzayo kunye nengasebenziyo.
4. Njengazo zonke iimvavanyo zokuxilonga, zonke iziphumo kufuneka zitolikwe kunye nolunye ulwazi lwekliniki olukhoyo kugqirha.
5. Isiphumo esibi esifunyenwe kule khithi kufuneka siqinisekiswe yi-PCR.Isiphumo esibi sinokufunyanwa ukuba ukuxinana kwe-SARS-CoV-2 ekhoyo kwiswab ayonelanga okanye ingaphantsi kwenqanaba elibonwayo lovavanyo.
6. Igazi eligqithisileyo okanye i-mucus kwi-specimen ye-swab inokuphazamisana nokusebenza kwaye inokuvelisa umphumo ongeyonyani.
7. Iziphumo ezilungileyo ze-SARS-CoV-2 azikuthinteli ukosuleleka kunye ne-anther pathogen. Ngoko ke kufuneka kuqwalaselwe ukuba nokwenzeka kosulelo lwebhaktiriya engafanelekanga.
8. Iziphumo ezibi azilukhuhli usulelo lwe-SARS-CoV-2, ngakumbi kwabo bebekhe badibana nentsholongwane. Uvavanyo olulandelelweyo ngoxilongo lwemolekyuli kufuneka luthathelwe ingqalelo ukuze lukhuphe usulelo kwaba bantu.
9. Iziphumo ezincomekayo zisenokuba ngenxa yosulelo olukhoyo kwiintlobo ze-coronavirus ezingezizo i-SARS-CoV-2, ezifana ne-coronavirus HKU1, NL63, OC43, okanye 229E.
10. Iziphumo ezivela kuvavanyo lwe-antigen akufuneki zisetyenziswe njengesona siseko soxilongo okanye singabandakanyi usulelo lwe-SARS-CoV-2 okanye ukwazisa imeko yosulelo.
11. I-reagent yokukhupha inamandla okubulala intsholongwane, kodwa ayikwazi ukwenza i-100% yentsholongwane ingasebenzi.Indlela yokuvala intsholongwane ingabhekiswa kuyo: yeyiphi indlela ekhuthazwa yi-WHO / CDC, okanye inokuphathwa ngokwemigaqo yendawo.

IIMPAWU ZOKUSEBENZA

UvakalelokwayeUkuchaza ngokuthe ngqo

I-SARS-CoV-2 Antigen Rapid Test Cassette iye yavavanywa kunye nemizekelo efunyenwe kwizigulana.I-PCR isetyenziswa njengendlela yereferensi ye-SARS-CoV-2 Antigen Rapid Test Cassette.Iisampulu zithathwe njenge-positive ukuba i-PCR ibonise isiphumo esihle.

I-Relative Sensitivity :95.0%(95%CI*:83.1%-99.4%)

Inkcazo ehambelanayo: 99.2% (95% CI *: 97.6% -99.8%)

*Amaxesha okuzithemba

Ukufunyanwa komda

Xa umxholo wentsholongwane ungaphezulu kwe-400TCID₅₀/ml, izinga lokubona eliqinisekileyo likhulu kune-95%. Xa umxholo wentsholongwane ungaphantsi kwe-200TCID₅₀/ml, izinga lokubona elilungileyo lingaphantsi kwe-95%, ngoko ke umda wokubona ubuncinci wale mveliso yi-400TCID₅₀/ml.

Ukuchaneka

Iibhetshi ezintathu ezilandelelanayo ze-reagents zavavanywa ngokuchanekileyo. Iibhetshi ezahlukeneyo ze-reagents zisetyenziselwe ukuvavanya isampuli efanayo engalunganga ngamaxesha angama-10 ngokulandelelana, kwaye iziphumo zazingalunganga. Iibhetshi ezahlukeneyo ze-reagents zisetyenziselwe ukuvavanya isampula elungileyo amaxesha angama-10 ngokulandelelana, kwaye iziphumo zonke zilungile.

I-HOOK isiphumo

Xa umxholo wentsholongwane kwisampulu oza kuvavanywa ufikelela kwi-4.0 * 10⁵I-TCID₅₀/ml, iziphumo zovavanyo azisabonisi isiphumo se HOOK.

Cross-Reactivity

I-Cross-reactivity yeKit iye yavavanywa. Iziphumo zibonise ukuba akukho reactivity emnqamlezweni nalo mzekelo ulandelayo.

Iukuphazamisana nezinto

Iziphumo zovavanyo aziphazaniswa neziyobisi kolu xinzelelo lulandelayo:

IBHAYIBHLIYOGRAFI

1.Weiss SR,Leibowitz JZ.Coronavirus pathogenesis. I-Adv Virus Res 2011;81:85-164
2.Cui J,Li F,Shi ZL.Imvelaphi kunye nokuvela kwe-pathogenic coronaviruses.Nat Rev Microbiol 2019;17:181-192.
3.Su S, Wong G, Shi W, et al.Epidemiology, ukudityaniswa kwakhona kwemfuzo, kunye ne-pathogenesis ye-coronavirus. TrendsMicrobiol 2016;24:490-502.