UKUSETSHENZISWA OKUHLOSIWE
IStrongStep^®Ukuhlolwa kwe-SARS-CoV-2 IgM/IgG kuwukuhlola okusheshayo kwe-immuno-chromatographic ukuze kutholwe ngesikhathi esisodwa amasosha omzimba e-IgM ne-IgG kugciwane le-SARS-CoV-2 egazini lonke lomuntu, i-serum noma i-plasma.I-assay isetshenziswa njengosizo ekuxilongweni kwe-COVID-19.

ISINGENISO
ICoronavirus iyigciwane le-RNA elimboziwe elisatshalaliswa kabanzi phakathi kwabantu, ezinye izilwane ezincelisayo nezinyoni, okubangela izifo zokuphefumula, ze-enteric, i-hepatic kanye ne-neurologic.Izinhlobo eziyisikhombisa ze-coronavirus zaziwa ngokubangela izifo zabantu.Izinhlobo ezine zamagciwane - 229E, OC43, NL63 kanye ne-HKU1 - zigcwele futhi ngokuvamile zibangela izimpawu ezivamile zamakhaza kubantu abangenawo amandla omzimba.Ezinye izinhlobo ezintathu - i-acute acute respiratory syndrome coronavirus (SARS-CoV), Middle East Respiratory Syndrome coronavirus (MERS-CoV) kanye ne-Novel Coronavirus (COVID-19) ka-2019 - ziyimvelaphi ye-zoonotic futhi ziye zaxhunyaniswa nokugula okubulalayo kwesinye isikhathi, iCoronavirus. i-zoonotic, okusho ukuthi zingadluliselwa phakathi kwezilwane nabantu.Izimpawu ezijwayelekile zokutheleleka zihlanganisa izimpawu zokuphefumula, imfiva, ukukhwehlela, ukuphelelwa umoya kanye nobunzima bokuphefumula.Ezimweni ezimbi kakhulu, ukutheleleka kungabangela inyumoniya, isifo sokuphefumula esinamandla kakhulu, ukwehluleka kwezinso ngisho nokufa.Amasosha omzimba e-IgM kanye ne-IgG kuya ku-2019 Novel Coronavirus angatholwa ngeviki elingu-1-2 ngemuva kokuchayeka.I-IgG ihlala inethemba, kodwa izinga le-antibody liyehla ngesikhathi esengeziwe.

ISIMISO
IStrongStep^®Ukuhlolwa kwe-SARS-CoV-2 IgM/IgG kusebenzisa isimiso se-Immuno-chromatography.Idivayisi ngayinye iqukethe imicu emibili, lapho i-SARS-CoV-2 ethize ye-recombinant antigen inganyakazi kulwelwesi lwe-nitrocellulose ngaphakathi kwewindi lokuhlola ledivayisi.Igundane elimelene nomuntu i-IgM kanye nama-anti-human IgG amasosha omzimba ahlanganiswe nobuhlalu be-latex obunemibala awanyakazi kuphedi ye-conjugate yemicu emibili ngokulandelanayo.Njengoba isampula yokuhlola igeleza kulwelwesi ngaphakathi kwedivayisi yokuhlola, igundane elinombala i-IgM ne-anti-human IgG amasosha omzimba akha ama-latex conjugate complexes anamasosha omzimba womuntu (IgM kanye/noma i-IgG).Le nkimbinkimbi iqhubekela phambili kulwelwesi iye endaweni yokuhlola lapho ithathwe khona yi-SARS-CoV-2 ethize ye-recombinant antigen.Uma amasosha omzimba akwa-SARS-CoV-2 e-IgG/IgM ekhona kusampula, okuholela ekwakhekeni kwebhande elinemibala futhi kukhombisa imiphumela yokuhlolwa eqondile.Ukungabikho kwaleli bhendi elinemibala ngaphakathi kwewindi lokuhlola kubonisa umphumela wokuhlola ongemuhle.Le nkimbinkimbi iqhubekela phambili kulwelwesi ukuya endaweni yokulawula lapho ibanjwa khona i-anti-mouse anti-mouse bese yenza ulayini wokulawula obomvu okuwumugqa wokulawula owakhelwe ngaphakathi oyohlala uvela efasiteleni lokuhlola lapho ukuhlolwa kwenziwa kahle, kungakhathaliseki ukuthi yini. ukuba khona noma ukungabi khona kwama-anti-SARS-CoV-2 virus amasosha omzimba esibonelweni.

IZINTO ZEKHITHI
1. Isinyathelo Esiqinile^®Ikhadi lokuhlola i-SARS-CoV-2 IgM/IgG esikhwameni se-foil
2. Sample Buffer
3. Imiyalo Yokusetshenziswa

IZINTO EZIDINGEKAYO KODWA AKUNIKEZWE
1. Isitsha sokuqoqa ama-Sepcimen
2. 1-20μL Pipetter
3. Isikhathi

Ukuhlola kukhawulelwe e-US ukuthi kusakazwe ezindaweni zokucwaninga ezigunyazwe yi-CLIA ukuze zenze ukuhlola okuyinkimbinkimbi.

Lokhu kuhlolwa akuzange kubuyekezwe yi-FDA.

Imiphumela engemihle ayikuvimbeli ukutheleleka okukhulu kwe-SARS-CoV-2.

Uma kusolakala ukuthi unegciwane eliyingozi, ukuhlolwa okuqondile kwe-SARS-CoV-2 kuyadingeka.

Imiphumela yokuhlolwa kwe-antibody akufanele isetshenziselwe ukuxilonga noma ukukhipha ukutheleleka kwe-SARS-CoV-2 okuyingozi.

Imiphumela emihle ingase ibe ngenxa yokutheleleka kwangaphambilini noma kwamanje ngezinhlobo ze-coronavirus ezingezona ze-SARS-CoV-2, njenge-coronavirus HKU1, NL63, OC43, noma 229E.