Ikhithi Yokuhlola Esheshayo ye-COVID-19 Antigen (Colloidal Gold)
Ukulinganiselwa
1.Le rejenti isetshenziselwa kuphela ukuxilongwa kwe-in vitro.
2.Lesi siphehli sisetshenziswa kuphela ukuthola ama-swabs womuntu wamakhala/i-oropharyngeal swabs specimen.Imiphumela yezinye izifanekiso ingase ibe yiphutha.
3.Lesi senzo sisetshenziselwa ukuhlonza ikhwalithi kuphela futhi asikwazi ukubona izinga lenoveli ye-corona virus antigen esibonelweni.
I-4.Le reagent iyithuluzi lokuxilonga elisiza emtholampilo.Uma umphumela uhle, kunconywa ukusebenzisa ezinye izindlela zokuhlola okuqhubekayo ngesikhathi futhi ukuxilongwa kukadokotela kuzophumelela.
5.Uma umphumela wokuhlolwa uthi awunayo futhi izimpawu zomtholampilo ziyaqhubeka.Kunconywa ukuphinda amasampula noma usebenzise ezinye izindlela zokuhlola ukuze uhlole.Umphumela ongemuhle awukwazi ukuvimba amathuba okuchayeka noma ukutheleleka ngegciwane le-SARS-CoV-2 nganoma yisiphi isikhathi.
6. Imiphumela yokuhlolwa yekhithi yokuhlola ingeyereferensi yodokotela kuphela, futhi akufanele isetshenziswe njengesisekelo sokuxilongwa komtholampilo kuphela.Ukuphathwa komtholampilo kweziguli kufanele kucatshangelwe ngokugcwele kuhlanganiswe nezimpawu/izimpawu zazo, umlando wezokwelapha, okunye ukuhlolwa kwaselabhorethri nezimpendulo zokwelashwa, njll.
7.Ngenxa yomkhawulo wendlela ye-reagent yokuthola, umkhawulo wokutholwa kwalesi sici ngokuvamile uphansi kunalowo wama-nucleic acid reagent.Ngakho-ke, abasebenzi bokuhlola kufanele banake kakhulu imiphumela engemihle futhi badinge ukuhlanganisa eminye imiphumela yokuhlola ukuze benze isinqumo esibanzi.Kunconywa ukusebenzisa ukuhlolwa kwe-nucleic acid noma izindlela zokuhlukanisa igciwane nezindlela zokuhlonza isiko ukuze ubuyekeze imiphumela engemihle enokungabaza.
8.Imiphumela yokuhlolwa emihle ayikushiyi ngaphandle ukutheleleka kanye namanye amagciwane.
9. Imiphumela engemihle yamanga ingase yenzeke lapho izinga le-antigen le-SARS-CoV-2 kusampula liphansi kunomkhawulo wokutholwa kwekhithi noma ukuqoqwa kwesifanekiso nokokuthutha kungafanele.Ngakho-ke, noma ngabe imiphumela yokuhlolwa ithi ayinayo, amathuba okutheleleka nge-SARS-CoV-2 ngeke akhishwe.
10.Amanani aqagelayo amahle kanye namabi ancike kakhulu emazingeni okuvama.Imiphumela yokuhlolwa emihle kungenzeka imele imiphumela engelona iqiniso ngezikhathi zomsebenzi omncane/ongekho we-SARS-CoV-2 lapho ukutholakala kwezifo kuphansi.Imiphumela yokuhlolwa engemihle yamanga maningi amathuba okuba uma ukwanda kwezifo ezibangelwa i-SARS-CoV-2 kuphezulu.
11. Ukuhlaziywa kokuthi kungenzeka kube nemiphumela engemihle engamanga:
(1)Ukuqoqwa kwesifanekiso esingenangqondo, ukuthuthwa nokucutshungulwa, i-virus titer ephansi kusampula, akukho sampuli entsha noma ukuqandisa nokuncibilika kwamabhayisikili kwesampula kungaholela emiphumeleni engemihle engamanga.
(2)Ukuguqulwa kwesakhi sofuzo segciwane kungaholela ekushintsheni kwezinqumo ze-antigenic, okuholela emiphumeleni engemihle.
(3)Ucwaningo lwe-SARS-CoV-2 alukenziwa kahle ngokuphelele;igciwane lingashintsha futhi libangele umehluko ngesikhathi esingcono kakhulu sokuthatha isampula (i-virus titer peak) kanye nendawo yokusampula.Ngakho-ke, esigulini esifanayo, singaqoqa amasampula ezindaweni eziningi noma silandele izikhathi eziningi sinciphise amathuba emiphumela engemihle engamanga.
12.Amasosha omzimba e-Monoclonal angase ehluleke ukuthola, noma ukuthola ngokuzwela okuncane, amagciwane e-SARS-CoV-2 athole izinguquko ezincane ze-amino acid endaweni ehlosiwe ye-epitope.
