I-COVID-19 Anti-2019-nCoV yaseTshayina iKhorona eNtsha

Iinkcukacha eziKhawulezayo

I-COVID-19 Anti-2019-nCoV yaseTshayina iKhorona eNtsha

Ukupakishwa kunye nokuhanjiswa

Iinkcukacha

[OKUHLOSIWEYO UKUSETYENZISWA]
I-AMRDT100 IgG/IgM Rapid Test Cassette yi-lateral flow chromatographic immunoassay ukwenzela ukubhaqwa komgangatho we-antibodies (IgG kunye ne-IgM) ukuya kwiNoveli coronavirus kwiGazi Lonke lomntu/iSerum/Plasma.
Ibonelela ngoncedo ekuxilongeni usulelo lweNovel coronavirus.

[USHWANKATHELO]
Ekuqaleni kukaJanuwari ka-2020, inoveli coronavirus (i-SARS-CoV-2, eyayifudula ibizwa ngokuba yi-2019-nCoV) ichongiwe njenge-arhente eyosulelayo ebangela ukuqhambuka kwenyumoniya e-Wuhan, e-China, apho amatyala okuqala aneempawu zawo ngoDisemba ka-2019.
IiCoronavirus zintsholongwane zeRNA ezigutyungelweyo ezisasazwa ngokubanzi phakathi kwabantu, ezinye izilwanyana ezincancisayo, kunye neentaka kwaye ezibangela izifo zokuphefumla, ukungena, isibindi, kunye nezifo zemithambo-luvo.Iintsholongwane ezine-229E, OC43, NL63, kunye ne-HKU1 zixhaphakile kwaye ngokuqhelekileyo zibangela iimpawu ezibandayo ezixhaphakileyo kubantu abangenamandla omzimba.Ezinye iintlobo ezimbini ze-acute respiratory syndrome (i-SARS-CoV) kunye ne-Middle East yokuphefumla isifo se-coronavirus (MERS-CoV) zinemvelaphi yezoonotic kwaye ziye zanxulunyaniswa nesigulo esibulalayo ngamanye amaxesha.
IiCoronaviruses zi-zoonotic, okuthetha ukuba zidluliselwa phakathi kwezilwanyana kunye nabantu.Iimpawu eziqhelekileyo zosulelo ziquka iimpawu zokuphefumla, umkhuhlane, ukukhohlela, ukuphefumla nzima kunye nobunzima bokuphefumla.Kwiimeko ezimandundu, usulelo lunokubangela inyumoniya, isifo sokuphefumla esiqatha, ukusilela kwezintso kunye nokufa.
Izindululo ezisemgangathweni zokuthintela ukusasazeka kosulelo ziquka ukuhlamba izandla rhoqo, ukuvala umlomo kunye neempumlo xa ukhohlela kwaye uthimla, ukupheka ngokucokisekileyo inyama namaqanda.Kulumkele ukusondelelana naye nabani na obonisa iimpawu zesigulo sokuphefumla njengokukhohlela kunye nokuthimla.

[UMGAQO]
I-AMRDT100IgG/IgM Rapid Test Cassette lumgangatho inwebu strip esekelwe immunoassay ukubhaqa izilwa-buhlungu (IgG kunye IgM) ukuya kwiNoveli coronavirus kwigazi Lonke lomntu/Serum/Plasma.Ikhasethi yovavanyo ine: 1) i-burgundy colored conjugate pad equlathe i-antigens ye-envelope ye-Novel coronavirus edityaniswe negolide ye-Colloid (i-Novel coronavirus conjugates), 2) i-nitrocellulose membrane strip equlethe imigca emibini yovavanyo (imigca ye-IgG kunye ne-IgM) kunye nomgca wolawulo ( Umgca C).Umgca we-IgM uqatywe ngaphambili kunye ne-Mouse anti-Human IgM antibody, umgca we-IgG uqatywe nge-Mouse anti-Human IgG antibody.Xa umthamo owaneleyo wovavanyo lovavanyo lukhutshwa kwisampulu yequla lekhasethi yovavanyo, umzekelo ufuduka ngesenzo se-capillary kwikhasethi.I-IgM ye-anti-Novel coronavirus, ukuba ikhona kumzekelo, iya kuzibophelela kwi-Novel coronavirus conjugates.I-immunocomplex ke ibanjwe yi-reagent efakwe ngaphambili kwi-IgM band, yenza umgca we-IgM ombala we-burgundy, obonisa i-Novel coronavirus IgM isiphumo sovavanyo oluhle.I-IgG ye-anti-Novel coronavirus ukuba ikhona kumzekelo iya kubophelela kwi-Novel coronavirus conjugates.I-immunocomplex ke ibanjwe yi-reagent ecatyiswe kumgca we-IgG, yenze umgca we-IgG we-burgundy onemibala, ebonisa i-Novel coronavirus IgG isiphumo sovavanyo oluhle.Ukungabikho kwayo nayiphi na imigca ye-T (i-IgG kunye ne-IgM) ibonisa umphumo ongalunganga.Ukuze usebenze njengolawulo lwenkqubo, umgca wombala uya kuhlala ubonakala kummandla wolawulo obonisa ukuba umthamo ofanelekileyo we-specimen wongeziwe kwaye i-membrane wicking yenzeke.

[IZILUMKISO KUNYE NEMIGAQO]
Kubasebenzi bezempilo kunye neengcali kwindawo yeendawo zokhathalelo.
Musa ukusebenzisa emva komhla wokuphelelwa.
Nceda ufunde lonke ulwazi olukweli phetshana phambi kokuba wenze uvavanyo.
Ikhasethi yovavanyo kufuneka ihlale kwisingxobo esivaliweyo de isetyenziswe.
Yonke imizekelo kufuneka ithathwe njengeyingozi kwaye iphathwe ngendlela efanayo ne-arhente eyosulelayo.
Ikhasethi yovavanyo esetyenzisiweyo kufuneka ilahlwe ngokungqinelana ne-federal, karhulumente kunye nemimiselo yendawo.

[UHLELO]
Uvavanyo luqulethe i-membrane strip eqatywe nge-Mouse anti-Human IgM antibody kunye ne-Mouse anti-Human IgG antibody kumgca wovavanyo, kunye nephedi yedayi equlethe igolide ye-colloidal edityaniswa ne-Novel coronavirus recombinant antigen.
Ubungakanani beemvavanyo zaprintwa kwiileyibhile.
Izixhobo ezibonelelweyo
Vavanya ikhasethiIpakeji yokufaka
Isithinteli
Izinto Eziyimfuneko Kodwa Ezingabonelelwanga
Isampulu yengqokelela yesikhongozeliTimer

[UGCINA KUNYE NOZInzo]
Gcina njengoko zipakishwe kwisingxobo esitywiniweyo kwiqondo lobushushu (4-30℃ okanye 40-86℉).Ikhithi izinzile ngaphakathi komhla wokuphelelwa oshicilelwe kwilebhile.
Nje ukuba uvule isingxobo, uvavanyo kufuneka lusetyenziswe kwiyure enye.Ukuba sesichengeni ixesha elide kwindawo eshushu nefumileyo kuya kubangela ukuwohloka kwemveliso.
I-LOT kunye nomhla wokuphelelwa kwexesha zaprintwa kwilebhile.

[UMBONO]
Uvavanyo lunokusetyenziselwa ukuvavanya iGazi Elipheleleyo/iSerum/imizekelo yePlasma.
Ukuqokelela igazi elipheleleyo, i-serum okanye iisampulu zeplasma ezilandela iinkqubo eziqhelekileyo zelebhu yezonyango.
Yahlula i-serum okanye iplasma egazini ngokukhawuleza ukuthintela ukopha.Sebenzisa kuphela iisampulu ezicacileyo ezingenayo i-hemolyzed.
Gcina iisampuli ku-2-8℃ (36-46℉) ukuba awuvavanywanga kwangoko.Gcina iisampuli kwi-2-8℃ ukuya kwiintsuku ezisi-7.Imizekelo kufuneka ifakwe emkhenkceni
-20℃ (-4℉) yokugcina ixesha elide.Musa ukukhenkcisa iisampuli zegazi elipheleleyo.
Kuphephe imijikelo emininzi yokunyibilikisa.Ngaphambi kovavanyo, zisa iisampulu ezikhenkcezisiweyo kwiqondo lobushushu begumbi ngokucothayo kwaye udibanise ngobunono.Iisampulu eziqulethe i-particle ebonakalayo kufuneka icaciswe nge-centrifugation ngaphambi kokuvavanya.
Musa ukusebenzisa iisampulu ezibonisa i-gross lipemia, hemolysis enkulu okanye i-turbidity ukuze uthintele ukuphazamiseka ekutolikweni kweziphumo.

[INKQUBO YOVAVANYO]
Vumela isixhobo sovavanyo kunye neesampulu ukuba zilingane nobushushu (15-30℃okanye 59-86℉) phambi kovavanyo.
1.Susa ikhasethi yovavanyo kwisingxobo esitywiniweyo.
2.Bamba idropha ngokuthe nkqo kwaye udlulisele ithontsi eli-1 lesampulu kwi-specimen well(S) yesixhobo sovavanyo, emva koko wongeze amathontsi ama-2 e-buffer (malunga ne-70μl) kwaye uqalise isibali-xesha.Jonga lo mzekeliso ungezantsi.
3.Lindela imigca enemibala ivele.Ukutolika iziphumo zovavanyo kwimizuzu eyi-15.Sukuzifunda iziphumo emva kwemizuzu engama-20.

[UKUTOLIKWA KWEZIPHUMO]
Okuhle: Umgca wokulawula kwaye ubuncinane umgca wokuvavanya omnye ubonakala kwi-membrane.Inkangeleko yomgca wovavanyo we-IgG ibonisa ubukho beNovel coronavirus echanekileyo ye-IgG antibodies.Inkangeleko yomgca wovavanyo we-IgM ibonisa ubukho beNovel coronavirus ethile ye-IgM antibodies.Kwaye ukuba zombini umgca we-IgG kunye ne-IgM uyavela, oko kubonisa ukuba ubukho bazo zombini ii-IgG ze-IgG kunye ne-IgM ze-IgM zobukho be-coronavirus.
Okubi: Umgca omnye onemibala ubonakala kummandla wokulawula (C) .Akukho mgca wombala obonakalayo ovela kummandla wovavanyo.
Ayisebenzi: Umgca wolawulo awubonakali.Umthamo wesampulu engonelanga okanye ubuchule benkqubo obungachanekanga zezona zizathu ezinokuthi zibe kho zokungaphumeleli komgca wolawulo.Hlaziya inkqubo kwaye uluphinde uvavanyo ngekhasethi entsha yovavanyo.Ukuba ingxaki iyaqhubeka, yeka ukusebenzisa ikiti yovavanyo ngoko nangoko kwaye uqhagamshelane nomsasazi wakho wendawo.

[ULAWULO LWEMEKO]
Ulawulo lwenkqubo lufakiwe kuvavanyo.Umgca wombala ovela kummandla wolawulo (C) uthathwa njengolawulo lwangaphakathi lwenkqubo.Iqinisekisa umthamo owaneleyo we-specimen, i-membrane eyaneleyo ye-wicking kunye nobuchule obuchanekileyo benkqubo.
Imigangatho yolawulo ayibonelelwanga nale khithi.Nangona kunjalo, kucetyiswa ukuba ulawulo oluqinisekileyo kunye nolungalunganga luvavanywe njengenkqubo efanelekileyo yaselabhoratri ukuqinisekisa inkqubo yovavanyo kunye nokuqinisekisa ukusebenza ngokufanelekileyo kovavanyo.

[IMIDA]
I-AMRDT100 IgG/IgM yeCassette yoVavanyo oluKhawulezayo ikhawulelwe ukubonelela ngokubhaqwa komgangatho.Ubunzulu bomgca wovavanyo abudibanisi nokuxinana kwe-antibody egazini.
Iziphumo ezifunyenwe kolu vavanyo zenzelwe ukuba zibe luncedo ekuxilongeni kuphela.Ugqirha ngamnye kufuneka atolike iziphumo ngokubambisana nembali yesigulane, ukufunyaniswa komzimba, kunye nezinye iinkqubo zokuxilonga.
Iziphumo zovavanyo ezingalunganga zibonisa ukuba izilwa-buhlungu ze-Novel coronavirus azikho okanye zikumanqanaba angenakubonwa luvavanyo.

[IIMPAWU ZOKUSEBENZA]
Ukuchaneka
Uthelekiso olusecaleni lwenziwe kusetyenziswa iNovel coronavirus IgG/IgM Rapid Test kunye nePCR ehamba phambili yorhwebo.Imizekelo yeklinikhi eyi-120 evela kwindawo yobuNgcali bokuKhathalela iye yavavanywa.Ezi ziphumo zilandelayo zidweliswe kolu phando lwezonyango:
Uthelekiso lweenkcukacha-manani lwenziwe phakathi kweziphumo ezivelisa ubuntununtunu be-90.00%, i-speciality ye-97.78% kunye nokuchaneka kwe-95.83%.
Cross-Reactivity kunye nokuphazamiseka
I-1.Ezinye ii-agent eziqhelekileyo ze-causative zezifo ezithathelwanayo ziye zavandlakanywa ukuba zisebenze kwakhona kunye novavanyo.Eminye imizekelo emihle yezinye izifo ezixhaphakileyo ezosulelayo ziye zafakwa kwiNoveli ye-coronavirus yesampulu elungileyo kunye nengalunganga kwaye yavavanywa ngokwahlukeneyo.Akukho reactivity cross yabonwa kunye nemizekelo evela kwizigulane ezosulelwe yi-HIV, i-HAV, i-HBsAg, i-HCV, i-HTLV, i-CMV, i-FLUA, i-FLUB, i-RSV kunye ne-TP.
2. Izinto ezinokuthi zisebenze kwi-endogenous endogenous eziquka izinto eziqhelekileyo zeserum, ezinje ngelipids, i-hemoglobin, i-bilirubin, zifakwe kwindawo ephezulu kwi-Novel coronavirus imizekelo emihle kunye nembi kwaye yavavanywa ngokwahlukeneyo.Akukho reactivity cross okanye ukuphazamiseka kwabonwa kwisixhobo.
3.Abanye abahlalutyi bebhayoloji abaqhelekileyo baye bafakwa kwiNoveli coronavirus iisampulu ezilungileyo nezingalunganga kwaye zavavanywa ngokwahlukeneyo.Akukho luphazamiso lubalulekileyo luye lwabonwa kumanqanaba adweliswe kwitheyibhile engezantsi.

Ukuvelisa kwakhona
Uphononongo lokuphinda lwenzelwe uVavanyo oluKhawulezayo lweNoveli ye-coronavirus ye-IgG/IgM kwiilebhu ezintathu zeeofisi zikagqirha (POL).Imizekelo engamashumi amathandathu (60) yeklinikhi ye-serum, i-20 engalunganga, i-20 ye-borderline positive kunye ne-20 enhle, isetyenziswe kolu phononongo.Umboniso ngamnye wawuqhutywa kathathu kangangeentsuku ezintathu kwiPOL nganye.Izivumelwano ze-intra-assay beziyi-100%.Isivumelwano phakathi kwamaziko sasiyi-100%.

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