Ikhithi yoVavanyo oluKhawulezayo lwe-COVID Neutralizing Antibody
UVavanyo lwe-COVID Antibody oluNeutralizing Antibody Ikhithi yoVavanyo eKhawulezayo
UVavanyo lwe-COVID-19 lwe-Antibody oluNeutralizing Ab Rapid Test kukusebenzisa i-Lateral flow immunochromatographic assays ukuze kufunyaniswe i-SARS-COV-2 neutralizing antibody (NAb), enokusetyenziswa ukumisela ubume bokungakhuseleki emva kosulelo okanye ugonyo.
UMGAQO
UVavanyo oluKhawulezayo lwe-SARS-CoV-2 lwe-Neutralizing Antibody (i-COVID-19 Ab) yeyokufumanisa izilwa-buhlungu ze-SARS-CoV-2 okanye izitofu zayo zokugonya. I-cell surface receptor angiotensin converting enzyme-2 (ACE2) ifakwe kwingingqi yovavanyo kunye ne-recombinant receptor-binding domain (RBD) edibeneyo kunye neengqungquthela ezibonisayo. Ngexesha lovavanyo, ukuba kukho ii-antibodies ze-SARS-CoV-2 ezingathathi hlangothi kwisampulu, iya kusabela ngeprotein ye-RBD-particle conjugate kwaye ingasabeli ngeprotein eqatywe ngaphambili i-ACE2. Umxube ke ufudukela phezulu kwi-membrane yechromatographically ngesenzo se-capillary kwaye ayizukubanjwa yi-antigen eqatywe ngaphambili.
UVavanyo oluKhawulezayo lwe-SARS-CoV-2 Neutralizing Antibody Rapid (COVID-19 Ab) luqulathe amasuntswana eproteni e-RBD. Iprotheyini ye-ACE2 ifakwe kwindawo yovavanyo
Uphawu
A. Uvavanyo lwegazi: Iserum, isiyilelo-gazi, igazi elipheleleyo kunye nencam yomnwe zonke ziyafumaneka.
B. Iisampulu ezincinci ziyafuneka. I-Serum, i-plasma 10ul okanye igazi elipheleleyo i-20ul yanele.
C. Uvandlakanyo olukhawulezayo lwe-immunity kunye ne-10 min.
Iziqinisekiso ezigunyazisiweyo zovavanyo olukhawulezayo lwe-Antibodies ze-AB ze-Neutralizing
CE Ivunyiwe
Uluhlu olumhlophe lwaseTshayina luvunyiwe i-Neutralizing Antibody Rapid Tes
Inkqubo yoVavanyo
Umfundi wesiphumo
IMIDA
1. Uvavanyo lwe-SARS-CoV-2 lwe-Neutralizing Antibody Rapid Test (COVID-19 Ab) lolwe-in vitro diagnostic kuphela. Olu vavanyo kufuneka lusetyenziselwe ukuchongwa kwee-antibodies ze-SARS-CoV-2 okanye ugonyo lwayo kwigazi elipheleleyo, i-serum, okanye iplasma.
2. UVavanyo oluKhawulezayo lwe-SARS-CoV-2 Neutralizing Antibody (COVID-19 Ab) luya kubonisa kuphela ubukho bokuthintela izilwa-buhlungu ze-SARS-CoV-2 kumzekelo kwaye akufuneki zisetyenziswe njengenye inqobo yokugweba yendlela yokufumanisa i-antibody titer.
3. Kwizigulana ezibuyiselweyo, i-titer ye-SARS-CoV-2 ye-antibodies engathathi hlangothi inokuba ngaphezulu kwamanqanaba abonakalayo. I-positive yolu vavanyo ayikwazanga kuthathwa njengenkqubo yokugonya eyimpumelelo.
4. Ubukho obuqhubekayo okanye ukungabikho kwama-antibodies akunakusetyenziselwa ukugqiba ukuphumelela okanye ukungaphumeleli kwonyango.
5. Iziphumo ezivela kwizigulane ezine-immunosuppressed kufuneka zitolikwe ngokuqaphela.
6. Njengazo zonke iimvavanyo zokuxilonga, zonke iziphumo kufuneka zitolikwe kunye nolunye ulwazi lwekliniki olukhoyo kugqirha.
INGCACISO
I-Intra-Assay
Ukuchaneka okungaphakathi kokuqhutywa kuye kwamiselwa ngokusebenzisa i-15 replicates yemizekelo emibini: i-negative, kunye ne-spiked RBD antibody positive (5ug/mL). Imizekelo yayichongwe ngokuchanekileyo > 99% yexesha.
Inter-Assay
Ukuchaneka phakathi kwe-run kuchongwe ngovavanyo oluzimeleyo lwe-15 kwimizekelo emibini efanayo: i-negative, kunye ne-positive. Amaqashiso amathathu awohlukeneyo ovavanyo lwe-SARS-CoV-2 Neutralizing Antibody Rapid Test (COVID-19 Ab) luye lwavavanywa kusetyenziswa le mizekelo. Imizekelo yayichongwe ngokuchanekileyo > 99% yexesha.
IZILUMKISO
1.Ukusetyenziswa kokuxilongwa kwe-in-vitro kuphela.
2.Makangasebenzisi ikhithi ngaphaya komhla wokuphelelwa.
3.Sukuxuba amacandelo kwiikhithi ezinamanani ahlukeneyo eqashiso.
4.Kuphephe ukungcoliseka kwe-microbial ye-reagents.
5.Sebenzisa uvavanyo ngokukhawuleza emva kokuvula ukukhusela ukufuma.