Inkcazo eneenkcukacha

Ukusetyenziswa okucetywayo
I-LYHER® COVID-19 kunye neKit yoVavanyo lwe-Antigen yoMkhuhlane yi-in vitro immunoassay. Uvavanyo lolokuchongwa ngokuthe ngqo kunye nomgangatho we-antigen ye-SARS-CoV-2 kunye noMkhuhlane A/B ukusuka kwincindi ye-nasopharyngeal kunye ne-oropharyngeal secretions. Ikhithi isetyenziselwa ukuxilongwa kwe-in vitro.

Malunga ne-COVID-19
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.

WechatIMG1795

Ikhithi iqulathe

Iinkcukacha zepakethe: 25 T/kit
1) SARS-CoV-2 antigen test Cassette
I-2) I-tube yokukhupha kunye nesisombululo sokukhutshwa kwesampuli kunye nengcebiso
3) I-cotton swab
4) IFU: 1 piece / kit
5) Ukuma kweTubu: 1 piece / kit
Imathiriyeli eyongezelelweyo efunekayo: iwotshi/ isibali-xesha/ istopwotshi
Qaphela: Musa ukudibanisa okanye ukutshintshiselana ngeebhetshi ezahlukeneyo zeekhithi.

Iinkcukacha

Into yovavanyo Isampulu Uhlobo Imeko yoGcino
i-antigen ye-SARS-CoV-2 kunye noMkhuhlane A/B I-Nasopharyngeal swab / i-oropharyngeal swab 2-30
Indlela yokusebenza Ixesha lovavanyo Beka ubomi kwishelufa
Igolide yeColloidal Imizuzu eyi-15 Iinyanga ezingama-24

Ukusebenza

Ukuqokelelwa komfanekiso kunye noGcino

I-1.Le mveliso ingasetyenziselwa iisampuli ze-nasopharyngeal okanye i-oropharyngeal swab. Iisampuli ze-Nasopharyngeal swab zicetyiswa ngamandla.
2.Amanyathelo okhuseleko aya kuthathwa xa kuqokelela iisampulu kwaye iisampulu ziya kuqokelelwa ngokuhambelana neendlela zokuqokelela ezinelayisensi.
3.Ngaphambi kokuqokelela isampuli, qinisekisa ukuba ityhubhu yomzekelo ivaliwe kwaye isithinteli sokutsalwa asivuzi. Emva koko krazula itywina kwityhubhu esele ifakwe ngaphambili - ezaliswe ngesithinteli kwaye uyibeke ngobunono kwindawo yokumisa ityhubhu.
4.Ukuqokelelwa kwemizekelo:
I-Oropharyngeal specimen: Ngentloko yesigulana iphakanyiselwe phezulu, kunye nomlomo ovulekileyo, iitoni zesigulane ziyabonakala. Nge-swab ecocekileyo, iitoni zesigulane zixutywe ngobunono emva nangaphambili ubuncinane amaxesha ama-3, kwaye emva koko udonga lwangasemva lwe-pharyngeal lwesigulane luhlanjululwa ngasemva nangaphandle ubuncinane ngamaxesha angama-3.
I-Nasopharyngeal specimen: Vumela intloko yesigulane ikhululeke ngokwemvelo. Jika uswayi eludongeni lwempumlo kancinane ungene empumlweni, uye kwinkalakahla yeempumlo, uze ujikethe ngeli xesha usosulayo kwaye uyisuse kancinane.
Unyango lwe-Specimen: Faka intloko ye-swab kwisithinteli sokutsalwa emva kokuqokelela i-specimen, xuba kakuhle, ucinezele i-swab 10-15 amaxesha ngokucinezela iindonga zetyhubhu ngokuchasene ne-swab, kwaye uyivumele ime umzuzu omnye ukugcina iisampuli ezininzi njengoko kunokwenzeka kwisithinteli sokutsalwa komzekelo. Lahla iswab.
5.Iisampulu zeswab kufuneka zivavanywe ngokukhawuleza emva kokuqokelela. Sebenzisa iisampulu ezisanda kuqokelelwa ukwenza uvavanyo olungcono.
6.Ukuba ayivavanywanga ngokukhawuleza, imizekelo ye-swab ingagcinwa phakathi kwe-2 - 8 ° C kwiiyure ze-4 emva kokuqokelela okanye igcinwe kwiqondo lokushisa kwi-1 iyure. Ukuba kufuneka ugcino lwexesha elide, kufuneka lugcinwe ku--70℃ ukunqanda imijikelo yomkhenkce ephindaphindwayo.
7.Musa ukusebenzisa iisampuli ezinokuthi zingcolise igazi, njengoko kunokuphazamisa ukuhamba kwesampuli kunye nokutolikwa kweziphumo zovavanyo.

Inkqubo yoVavanyo

1.Ukulungiselela
1.1 Iisampulu eziza kuvavanywa kunye nee-reagents ezifunekayo ziya kususwa kwimeko yokugcinwa kwaye zilinganiswe kwiqondo lokushisa;
1.2 Ikhithi iya kususwa kwingxowa yokupakisha kwaye ibekwe mcaba kwibhentshi eyomileyo.

2.Uvavanyo
2.1 Beka ikhithi yovavanyo ngokuthe tye etafileni.
2.2 Yongeza umzekelo
Beka i-tip ye-dropper ecocekileyo kwi-tube ye-specimen kwaye uguqule ityhubhu ye-specimen ukwenzela ukuba i-perpendicular kwi-sampulu kakuhle (S) kwaye ungeze i-3 yehla (malunga ne-100 μl) yesampuli yesampula nganye kakuhle (S). Seta isibali-xesha semizuzu eyi-15.
2.3 Ukufunda iziphumo
Imizekelo emihle inokubonwa kwimizuzu eyi-15 emva komfanekiso wongeziweyo.

Ukutolikwa kweziPhumo

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OKUHLE:Imigca emibini enemibala ibonakala kwi-membrane. Umgca omnye ubonakala kummandla wolawulo (C) kwaye omnye umgca ubonakala kuvavanyo
EZINGABIYO:Umgca omnye wombala uvela kummandla wokulawula (C). Akukho mgca wombala obonakalayo uvela kwindawo yovavanyo (T).
AKUMELELEYO:Umgca wolawulo uyasilela ukubonakala.
NgoMkhuhlane A/B

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Umkhuhlane A OKUFANELEKILEYO:Ilungile kwi-antigen yoMkhuhlane ukuba imigca emibini eBomvu ivela. Omnye umgca oBomvu kufuneka ube kwindawo yokulawula umgca (C), kwaye enye ibonakala kwindawo yovavanyo lwe-A.
Umkhuhlane B OKUNAWO:Ilungile kwi-antigen yoMkhuhlane B ukuba kuvela imigca emibini eBomvu. Omnye umgca obomvu kufuneka ube kwindawo yokulawula umgca (C), kwaye omnye ubonakala kwindawo yovavanyo lwe-B.
Umkhuhlane A kunye no-B OKUNAWO:Ilungile kuzo zombini ii-antigens zoMkhuhlane A kunye noMkhuhlane B ukuba imigca emithathu eBomvu ivela. Omnye umgca oBomvu kufuneka ube kwindawo yokulawula umgca (C), kwaye enye emibini kufuneka ivele kwindawo yovavanyo lwe-A kunye nommandla wovavanyo lwe-B.
EZINGABIYO:Umgca oBomvu omnye ubonakala kummandla wolawulo (C). Akukho mgca ubomvu obonakalayo uvela kwindawo yovavanyo lwe-influenza A kunye no-B (T).

Ukusebenza kweklinikhi

Itheyibhile 1 - 1: Ikhithi yoVavanyo yaseLyher - I-COVID-19

Uvakalelo: 96.23% Inkcukacha: 100% Ukuchaneka: 98.96%

Itheyibhile 1-2: Ikhithi yoVavanyo yaseLyher - Umkhuhlane A

Uvakalelo: 100% Inkcukacha: 100% Ukuchaneka: 100%

Itheyibhile 1-3: Ikhithi yoVavanyo yaseLyher - Umkhuhlane B

Uvakalelo: 94.44% Inkcukacha: 100% Ukuchaneka: 99.48%