I-SARS-cov-2 antign yovavanyo olukhawulezayo (i-nasal)
Imveliso inearhente ekhethekileyo eNew Zealand. Ukuba unomdla wokuthenga, ulwazi loqhakamshelwano lulandelayo:
I-Mick Dienhoff
Umlawuli jikelele
Inombolo yefowuni: 0755564763
Inombolo yefowuni: 0492 009 534
E-mail: enquiries@nzrapidtests.co.nz
Ukusetyenziswa kwenjongo
StrongStep® SARS-CoV-2 Antigen Rapid Test Cassette employs immunochromatography technology to detect the SARS- CoV-2 nucleocapsid antigen in human anterior nasal swab specimen. Olu ncedo lungahambi kakuhle kwaye lwenzelwe ukuzivavanya. Iyahlanjululwa ukuze isebenzise olu vavanyo kwiintsuku ezi-5 zophawu lwe-Out. Ixhaswa luvavanyo lwentsebenzo yeklinikhi.
Intshayelelo
I-noves coronavirus ye-Tooverie ye-ge genus. ICod-19 sisifo esosulelayo sokuphefumla. Abantu ngokubanzi bachaphazeleka. Okwangoku, abaguli bosulelwe yiNoveli CXJROvinis ngowona mthombo ophambili wosulelo; Abantu abasulelekanga baka-Asymptomminatic banokuba ngumthombo wosulelo. Ngokusekwe ku-1he ngoku i-pideniological yophando, ixesha lokufakwa kwe-bumbation liyintsuku ezi-1 ukuya kwezi-14, ubukhulu becala kwiintsuku ezi-3 ukuya kwezi-7. Ezona zinto zibonakalayo zibandakanya umkhuhlane, ukudinwa kunye nokukhohlela okukodwa. Ukuxinana kwe-Nasal, impumlo ebalekayo, umqala obuhlungu, iMylua kunye norhudo lufumaneka kwiimeko ezimbalwa.
Umgaqo
Uvavanyo lwe-SARSTESTEP® ye-SARS-Cov-2 Uvavanyo lwe-Antign lisebenzisa uvavanyo lwe-uJunocromatographic. I-Latex ehlanganisiweyo (i-Latex-AB) ehambelana ne-SARS-cov-2 yomile-inqabile ekupheleni kwe-nitrocellulose ye-nitrocellulose. I-SARS-cov-2 antibodies ibodwa kwindawo yovavanyo (T) kunye ne-biotin-BSA yenziwa kwindawo yolawulo (c). Xa isampulu yongezwa, ifudukela ngokuma kwe-capillary yokuphinda isayensi. Ukuba ikhoyo kwisampuli, i-SARS-2 i-adovns iya kubopha ngee-antibodies ezihlanganisiweyo zenza amasuntswana. La masuntswana aya kuqhubeka nokufudukela kwi-Strip kude kube yindawo yovavanyo (t) apho bathatyathwa yi-SARS-cov-2 antibodies evelisa umgca obomvu obonakalayo. Ukuba akukho sas-cov-2 i-agoricns kwisampulu, akukho mgca ubomvu usekwe kwindawo yovavanyo (T). I-Conmpagin ye-Convavin iya kuqhubeka nokufudukela yedwa de ifakwe kwindawo yolawulo (c) nge-biotin-BSA igxile kumgca oluhlaza, obonisa ubunyani bovavanyo.
Izinto zekhithi
1 Uvavanyo / ibhokisi ye-5 / iimvavanyo ezi-5:
I-pail ye-foil ye-joyiki epakishwe izibophelelo zovavanyo | Isixhobo ngasinye siqukethe imitya enemibala enombala kunye ne-Regegents irejista yasasazeka kwindawo ehambelanayo. |
I-vils ye-Buffer Buffer | I-0.1 M phosphate ye-phosphate ye-saline (PBs) kunye ne-0.02% ye-sodium aze. |
Ukukhupha iityhubhu | Ukusetyenziswa kwengqondo yokusetyenziswa. |
Iipakethi zeSwab | Ukuqokelelwa kwengqondo. |
Indawo yokusebenza | Indawo yokubamba i-vials ye-buffer kunye neetyhubhu. |
Iphakheji | Uqeqesho lokusebenza. |
Iimvavanyo ezi-20 / ibhokisi
Izixhobo ezingama-20 zovavanyo | Isixhobo ngasinye sinomhluzi onombala onombala kunye nokusebenza kwakhona kwe-Redgents kwangaphambili kwizitshisi ezihambelanayo. |
I-2 yokukhupha i-buffer vials | I-0.1 M phosphate ye-phosphate ye-saline (p8s) kunye0.02% sodium Atside. |
Iityhubhu ezingama-20 | Ukusetyenziswa kwengqondo yokusetyenziswa. |
1 Umsebenzi wokusebenza | Indawo yokubamba i-vials ye-buffer kunye neetyhubhu. |
I-1 yephakheji | Uqeqesho lokusebenza. |
Izinto ezifunekayo kodwa azibonelelwanga
Ixesha | Ukusetyenziswa kwexesha. |
Nasiphi na isixhobo esifanelekileyo sokukhusela |
UKULUMKELA
I-kit ye-vitro yokusebenzisa kuphela.
- Funda imiyalelo ngononophelo ngaphambi kokuba wenze uvavanyo.
- Le mveliso ayinazixhobo zomntu.
-Ngaba ungasebenzisi iziqulatho zeKit emva komhla wokuphelelwa.
Nxiba iigloves ngexesha lenkqubo yonke.
Ukugcinwa kunye nokuzinza
Iipayi ezitywiniweyo zekhithi yovavanyo zinokugcinwa phakathi kwe-2-30 c ixesha lobomi beshelufu njengoko kubonisiwe kwingxowa.
Ukuqokelelwa kwengqokelela kunye nokugcina
Isampulu ye-ANAAL ye-ANASAN ye-chable ingaqokelelwa okanye i-perfofmlm ye-perfofmng ye-swab.
Abantwana abangaphantsi kweminyaka eli-18 ubudala, kufuneka balwenziwe ngokubekwa esweni kwabo. Abantu abadala abaneminyaka eli-18 nangaphezulu banokwenza i-swab engaphandle ye-swab yedwa. Nceda ulandele izikhokelo zakho zendawo ukuqokelelwa kwabantwana.
, Faka i-swab enye kwimpumlo enye yesigulana. I-Swabct iphumela kufuneka ifakwe kwi-2,5 cm (i-intshi enye) ukusuka kumda wempumlo. Qengqa i-swab amaxesha ama-5 kwi-MUCOSA ngaphakathi kwempumlo yokuqinisekisa ukuba zombini ii-Mucus ziqokelelwa.
• Sebenzisa i-swab efanayo, uphinda le nkqubo ye-charl ukuqinisekisa ukuba isampulu eyaneleyo iqokelelwa kwimigubasi yempumlo.
Kucetyiswa ukuba iimpungutye zibeigqityiwengokukhawuleza emva kokuba kunokwenzeka emva kokuqokelelwa. Iisampulu zinokubanjwa kwi-pument iyure enyukayo kwi-Moma iqondo lobushushu (i-15 ° C ukuya kwi-30 "c), okanye ukuya kuthi ga kwiiyure ezingama-24 xa i-5 ° C ukuya kwi-8eC) Ngaphambi kokuba isebenze.
Inkqubo
Yiza nezixhobo zovavanyo, iisampulu, i-buffer kunye / okanye ulawulo kubushushu begumbi (15-30 ° C) sebenzisa.
♦Iplagi® iqokele ityhubhu kwindawo echongiweyo kwindawo yokusebenza.
♦Cofa yonke i-buffer ye-dilution kwi-tube ye-radion ex ext.
♦Beka i-swimplen swible kwityhubhu. Ngamandla dibanisa isisombululo ngokujikeleza i-swab ngamandla e-tube kali-15 ubuncinci (ngelixa ungenachaphaza). Iziphumo ezilungileyo zifunyanwa xa i-curimen idityaniswa ngamandla kwisisombululo.
♦Vumela i-swab ukuba ithole kwi-buffer yokukhupha umzuzu omnye ngaphambi kwenyathelo elilandelayo.
♦Cofa njengamanzi amaninzi kangangoko kunokwenzeka kwi-swab ngokucinezela icala le-cube eguqukayo njengoko i-Swab isuswe. Ubuncinci i-1 / 2Ofttie isampula yesisombululo se-buffer kufuneka ihlale kwityhubhu yokufuduka eyaneleyo. Beka i-cap kwi-ihe tube.
♦Lahla i-swab kwi-bioharser yenkunkuma efanelekileyo yenkunkuma.
♦I-capimens ekhutshiweyo inokugcina kubushushu begumbi kangangemizuzu engama-30 ngaphandle kokuchaphazela iziphumo zovavanyo.
♦Susa isixhobo sovavanyo lwe-ths kwisingxobo sayo esitywiniweyo, kwaye siyibeka kwi-Dean, inqanaba. Faka ilebhile ifowuni kunye nokuchongwa kwesigulana okanye ukulawula. Ukufumana isiphumo esifanelekileyo, i-assay kufuneka yenziwe ngaphakathi kwemizuzu engama-30.
♦Yongeza amaconsi ama-3 (malunga ne-100 pl) yesampulu ekhutshelweyo kwityhubhu yokukhupha ukuya kwisixhobo sovavanyo.
Kulumkele ukubopha iibhubhu zomoya kwimodeli (s), kwaye ungalahle nasiphi na isisombululo kwifestile yokujonga. Njengoko uvavanyo luqala ukusebenza, uya kubona umbala uqhula ngaphaya kwe-membrane.
♦I-Wart yeqela lemibala (i) lemibala. Isiphumo kufuneka sifundwe ngababonwayo kwi-15 Minutas. Musa ukutolika iziphumo emva kwemizuzu engama-30.
•Beka ityhubhu yovavanyo equlethe i-Swab kunye nesixhobo sovavanyo esisetyenzisiweyo sibe yingxowa ye-biohazard ye-biohazard kwaye siyitywine, emva koko siyilahle kwisikhongozelo senkunkuma yenkunkuma efanelekileyo. Emva koko chitha izinto ezisele
•HlambaIzandla zakho okanye ziphinde zenze isicelo se-witizer yesandla.
Lahla i-tubs esetyenzisiweyo kunye nezixhobo zovavanyo kwi-bitcher yenkunkuma efanelekileyo ye-biohazardaus.
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Ukuncitshiswa kweendlela
1- Ikhithi yenzelwe ukuba isetyenziselwe ukutshintshwa komgangatho we-Cov-2 ukusuka kwi-nasal.
2.Imva kovavanyo olwenziweyo (bukhoma) kunye ne-SARS-cov-2. Ukusebenza kovavanyo kuxhomekeka kwinani lentsholongwane (Antign) kwisampulu kwaye kungakwazi ukwenza okanye kungangalungisi ngeziphumo ze-chicral Plays kwisampulu enye.
I-3.A I-Teat Poat ye-teat inokwenzeka ukuba inqanaba le-Antign kwisampulu lingaphantsi komda wokufunyanwa kovavanyo okanye ukuba isampulu yaqokelelwa okanye ihanjiswa ngokungafanelekanga.
Ukulandela ukulandela inkqubo yovavanyo kungachaphazela kakubi ukusebenza kovavanyo kunye / okanye kungasebenzi iziphumo zovavanyo.
Iziphumo 5. Iiphuli kufuneka zidityaniswe nembali yekliniki, idatha ye-pidemiological, kunye nezinye idatha ezikhoyo kwikliniki ivavanya isigulana.
Iziphumo zovavanyo ezifunekileyo aziyihli i-co-usulelo kunye nolunye uPathogens.
7. I-7NAGEITE IZIPHUMO ZESIFUNDO ASIKHETHA UKUZE UCWELE UKUTHENGA UKUTHENGA UKUTHENGISELWA KWEZITHUBEKO ZE-FARS OKANYE ZE-SARS okanye ZE-BACLINE.
8. Iziphumo ezi-8 ezinesiphene kwizigulana ezinophawu olungaphaya kweentsuku ezisixhenxe, kufuneka ziphathwe njengokukhukhumala kwaye ziqinisekiswe nge-FDA ye-FDA ye-FDA, ukuba ikho imfuneko, kuquka ulawulo lwekliniki.
Iingcebiso zokuzi kuzinzo ze-9.Specimien Abasebenzisi kufuneka bavavanye iimodeli ngokukhawuleza emva kokuba kuqokelelwe ukuqokelelwa kwengqondo.
Imvakalelo ye-RT-PCR ASSEAY ekufumanekeni kweCovid-19 yi-50% kuphela -80% yesenzo esemgangathweni okanye ixesha lesifo kwisigaba sokubuyela umva, i-Antign-2 Antign-2 antign-2 antign-2 antign-2 ye-Antign-2 ye-Antign-2 ye-Antign-2 ye-Antign-2 ye-Antign-2 ye-Antign-2 ye-Antign-2 ye-Antign-2 ye-Antign-2 ye-Antign-2 ye-Antign-2 ye-Antign - isezantsi ngenxa yendlela yayo.
11.Umyalelo wokufumana intsholongwane eyaneleyo, kucetyiswa ukusebenzisa i-swabs ezimbini okanye ngaphezulu ukuqokelela iisayithi ezahlukeneyo zesampulu kwaye ikhuphe yonke i-swab kwityhubhu efanayo.
Ixabiso eliqinisekileyo le-12.posti lingaxhomekeki kakhulu kumazinga okwanda.
Iziphumo zovavanyo ezili-13. phezulu.
I-Antibooklon ye-14 ka-14monoClonal inokusilela ukufumana, okanye ifumane intabalala ye-Invelous, i-SARS-2 ye-FOV-2 ye-FOP-2 ye-FOP.
15.Ukwenziweyo kolu vavanyo azange kuvavanywe ukuze isetyenziswe kwizigulana ngaphandle kwemiqondiso kunye neempawu zosulelo lokuphefumla kunye neparafini zinokwahluka kwabantu abakwi-Asympumatic.
16. Isixa se-Antign kwisampulu sinokuncipha njengoko ixesha lokugula liyanda. Iimodeli eziqokelelweyo emva kosuku lwe-5 lokugula zinokwenzeka ukuba zingalunganga xa kuthelekiswa ne-RT-PCR ASSEAY.
Ukuboniswa kweentsuku ezintlanu zokuqala zokuqala kweempawu zempawu kubonakalisiwe ukuncitshiswa xa kuthelekiswa ne-RT-PCR ASSEAY.
18. Icetyiswa ukuba isebenzise i-Sciestep® SARS-Cov-2 IGM
I-19.it ayikucebisi ukusebenzisa intsholongwane yokuThuthuka kwe-medla (VTM) kolu vavanyo, ukuba abathengi banyanzelisa ukusebenzisa olu hlobo lwesampulu, abathengi kufuneka baqinisekise.
I-20.Ivavanyo lwe-Sorstep® ye-SARS-Cov-2 antign iqinisekisiwe nge-swabs ebonelelwe kwikhithi. Ukusetyenziswa kwezinye izinto ezinokutshaya kunokubangela iziphumo zobuxoki.
21. Uvavanyo olwenziweyo luyimfuneko ukwandisa ubuntununtunu bokuqonda kweCovid-19.
22Akwayila kwimvakalelo xa uthelekiswa nohlobo lwasendle elidlwengulwe kwezi zinto zilandelayo - i-VOC1 Kent, eK, B.1 :.7 kunye ne-voc2 eMzantsi Afrika, b.1.351.
23 Gcina ungafikeleli ebantwaneni.
I-24. Iziphumo eziKhoyo zibonisa ukuba i-adoltigens ye-vilgenul ifunyenwe kwisampulu ethathiweyo, nceda walongamele uvelise kwaye wazise ugqirha wakho wosapho ngokukhawuleza.
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I-NanunJing I-Bio-Iimveliso Com., Ltd.
Hayi. I-12 yeNdlela yeHuayuan, i-nanjung, jiangsu, 210042 P CHI CHICHI.
I-Tel: +86 (25) 85288506
Ifeksi: (0086) 25 85476387
I-imeyile:sales@limingbio.com
Iwebhusayithi: www.limingbio.com
Technical support: poct_tech@limingbio.com
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