I-COVID-19&Influenza A+B Antigen Combo Rapid test Kit Yempumlo eneSatifikethi se-TGA
COVID-19/Influenza A+B Antigen Combo Rapid Test Cassette
[OKUHLOSIWEYO UKUSETYENZISWA]
I-COVID-19/Influenza A+B Antigen Combo Rapid Test Cassette yindlela yokuhlola esecaleni ejoliswe ekubhaqweni okusemgangathweni kwe-SARSCoV-2, umkhuhlane A kunye ne-antigens ye-viral nucleoprotein yomkhuhlane B kwi-nasopharyngeal swab evela kubantu ekurhanelwa ukuba banosulelo lwentsholongwane yokuphefumla. -19 ngumboneleli wabo wezempilo.I-COVID-19/Influenza A+B Antigen Combo Rapid Test Cassette yenzelwe ukuba isetyenziswe ngabasebenzi abaqeqeshiweyo baselebhu yezonyango abayalelwe ngokukodwa kwaye baqeqeshelwe iinkqubo zokuxilonga kwi-vitro.
[UHLELO]
Izinto eziNikelwe kuVavanyo lweCassette: ikhasethi yovavanyo iquka i-COVID-19 Antigen Test Strip kunye ne-Influenza A+B Test Strip, ezimiliselwe ngaphakathi kwisixhobo seplastiki.
· I-Reagent yokukhupha: I-Ampoule equlethe i-0.4 mL ye-reagent yokukhupha
· I-Swab enezintsholongwane
· Umbhobho wokutsalwa
· Ingcebiso yokulahla
· Isitishi sokuSebenza
· Faka ipakethe
Ubungakanani beemvavanyo zaprintwa kwiileyibhile.Izinto ezifunekayo kodwa azibonelelwangaIsibali-xesha
[UGCINA KUNYE NOZInzo]
· Gcina njengoko zipakishwe kwisingxobo esitywiniweyo kwiqondo lobushushu (4-30℃ okanye 40-86℉).Ikhithi izinzile ngaphakathi komhla wokuphelelwa oshicilelwe kwilebhile.
· Wakuba uvule isingxobo, uvavanyo kufuneka lusetyenziswe kwiyure enye.Ukuba sesichengeni ixesha elide kwindawo eshushu nefumileyo kuya kubangela ukuwohloka kwemveliso.I-LOT kunye nomhla wokuphelelwa kwawo zashicilelwa kwilebhile.
[UMBONO]
Iisampulu ezifunyenwe kwangoko ngexesha lokuqala kweempawu ziya kuqulatha ezona titer zentsholongwane egazini;imizekelo efunyenwe emva kweentsuku ezintlanu zeempawu kunokwenzeka ukuba ivelise iziphumo ezingalunganga xa ithelekiswa novavanyo lwe-RT-PCR.Ukungaqokelelwa kwesampulu enganelanga, ukuphathwa ngendlela engafanelekanga kwesampulu kunye/okanye uthutho lusenokuvelisa iziphumo ezingalunganga;ke ngoko, uqeqesho kwingqokelela yesampulu lucetyiswa kakhulu ngenxa yokubaluleka komgangatho womzekelo wokuvelisa iziphumo zovavanyo ezichanekileyo.
Ingqokelela yoMfanekiso
Kuphela i-swab ebonelelwe kwikhithi mayisetyenziswe kwi-nasopharyngeal swabcollection.Faka i-swab ngokusebenzisa i-nostril parallel ukuya kwinkalakahla (hayi phezulu) de kube ukuchasana kuhlangatyezwane nayo okanye umgama ulingana nowokusuka kwabo ukuya kwimpumlo yesigulane, ebonisa. ukudibana ne-nasopharynx.I-Swab kufuneka ifikelele kubunzulu obulingana nomgama ukusuka kwiimpumlo ukuya ekuvulekeni ngaphandle kwendlebe.Gcoba ngobunono kwaye uqhube i-swab.Shiya i-swab kwindawo imizuzwana emininzi ukuze ufunxe iimfihlo.Susa iswab kancinane ngelixa uyijikelezisa.Iimpawu zingaqokelelwa kumacala omabini usebenzisa i-swab efanayo, kodwa akuyomfuneko ukuqokelela imizekelo kumacala omabini ukuba i-minutia ihluthiswe ngolwelo olusuka kwingqokelela yokuqala.Ukuba i-septum etenxileyo okanye ukuvaleka kubangela ubunzima ekufumaneni umfuziselo kwimpumlo enye, sebenzisa i-swab efanayo ukufumana umfuziselo kwenye impumlo.
Umzekelo wezoThutho kunye noGcino
Musa ukubuyisela i-nasopharyngeal swab kwi-package ye-swab yokuqala.
Iisampulu ezisanda kuqokelelwa kufuneka ziqwalaselwe ngokukhawuleza, kodwa
kungadlulanga iyure enye emva kokuqokelelwa komfanekiso.Isampulu eqokelelweyo inga
zigcinwe kwi-2-8℃ ngaphandle kweeyure ezingama-24;Gcina kwi -70 ℃ ixesha elide,
kodwa uphephe imijikelo ephindaphindiweyo yokunyibilikisa.
[UKULUNGISELELA UMBONO]
1. Khulula isiciko se-reagent yokutsalwa.Yongeza yonke i-reagent ye-specimen extraction kwi-tube yokukhupha, kwaye uyibeke kwisikhululo somsebenzi.
2. Faka isampuli ye-swab kwi-tube yokukhupha equlethe i-reagent yokukhupha.Roll swab ubuncinane amaxesha ama-5 ngelixa ucinezela intloko ngezantsi kunye necala lombhobho wokukhupha.Shiya i-swab kwi-tube yokukhupha ngomzuzu omnye.
3. Susa i-swab ngelixa ucinezela amacala ombhobho ukukhupha ulwelo kwi-swab.Isisombululo esithathiweyo siya kusetyenziswa njengomzekelo wovavanyo.
4. Faka i-tip ye-dropper kwi-tube yokukhupha ngokuqinileyo.
[INKQUBO YOVAVANYO]
Vumela isixhobo sovavanyo kunye neesampulu ukuba zilingane nobushushu (15-30℃okanye 59-86℉) phambi kovavanyo.
1. Susa ikhasethi yovavanyo kwisingxobo esivaliweyo.
2. Ukubuyisela umva ityhubhu yokutsalwa kwe-specimen, ubambe ityhubhu yokutsalwa kwe-specimen ngokuthe tye, udlulise amathontsi ama-3 (malunga ne-100μL) kwi-specimen nganye kakuhle (S) yekhasethi yovavanyo, emva koko uqalise isibali-xesha.Jonga umfanekiso ongezantsi.
3. Linda imigca enemibala ivele.Ukutolika iziphumo zovavanyo ngemizuzu eyi-15.Sukuzifunda iziphumo emva kwemizuzu engama-20.