COVID-19 IgG/IgM Rapid Test Cassette

Ukusetyenziswa kobuchule kunye ne-vitro diagnostic kuphela.

UKUSETYENZISWA OKUHLOSIWEYO

ICOVID-19 IgG/IgM Rapid Test Cassetteluvavanyo olusecaleni lokugobhoza umzimba oluyilelwe ukufunyaniswa okusemgangathweni kwe-IgG kunye ne-IgM ye-antibodies kwintsholongwane ye-SARS-CoV-2 egazini lilonke, i-serum okanye isampuli zeplasma ezivela kubantu ekurhanelwa ukuba bosulelwe yi-COVID -19 ngumboneleli wabo wezempilo.

UVavanyo oluKhawulezayo lwe-CO VID-19 IgG/IgM luncedo ekufunyanisweni kwezigulana ekurhaneleka ukuba usulelo lwe-SARS -CoV-2 ludityaniswe nenkcazo yezonyango kunye neziphumo zolunye uvavanyo lwaselebhu.Kucetyiswa ukuba kusetyenziswe njengesalathiso sovavanyo olongezelelweyo kumatyala akrokrelekayo anovavanyo olubi lwe-nucleic acid yenoveli coronavirus okanye lusetyenziswe kunye novavanyo lwe-nucleic acid kwiimeko ezikrokrelekayo.Iziphumo ezivela kuvavanyo lwe-antibody akufuneki zisetyenziswe njengekuphela kwesiseko sokuxilonga okanye ukungabandakanyi usulelo lwe-SARS -CoV-2 okanye ukwazisa imeko yosulelo.

Iziphumo ezibi aziluthinteli usulelo lwe-SARS -CoV-2, ngakumbi kwabo baye banxibelelana nabantu abaziwayo abosulelekileyo okanye kwiindawo ezinokwanda kosulelo olusebenzayo.Uvavanyo olulandelelweyo ngoxilongo lwemolekyuli kufuneka luthathelwe ingqalelo ukuze lukhuphe usulelo kwaba bantu.

Iziphumo ezincumisayo zisenokuba ngenxa yosulelo lwangaphambili okanye lwangoku lwe-non-SARS-CoV-2 ye-coronavirus .

Uvavanyo lwenzelwe ukuba lusetyenziswe kwiilabhoratri zeklinikhi okanye ngabasebenzi bezempilo kwindawo yokhathalelo, hayi ukusetyenziswa ekhaya.Uvavanyo akufunekanga lusetyenziswe xa kujongwa igazi elinikelwe.

USHWANKATHELO

Inoveli coronavirus yeyodidi lwe-p.I-COVID 19sisifo esosulelayo esinamandla sokuphefumla.Ngokuqhelekileyo abantu basengozini.Okwangoku, izigulana ezosulelwe yinoveli coronavirus ngoyena mthombo wosulelo;Abantu abatofwayo abangenazimpawu nabo banokuba ngumthombo wosulelo.Ngokusekelwe kuphando lwangoku lwe-epidemiological, ixesha lokufukamela yi-1 ukuya kwiintsuku ze-14, ubukhulu becala iintsuku ezi-3 ukuya kwezi-7.Iimpawu eziphambili ziquka umkhuhlane, ukukhathala kunye nokukhwehlela okomileyo.Ukuxinana kweempumlo, iimpumlo, umqala obuhlungu, i-myalgia kunye ne-diarrhea zifumaneka kwiimeko ezimbalwa.

Xa intsholongwane ye-SARS-CoV2 yosulela into ephilayo, i-RNA, imathiriyeli yemfuza yentsholongwane, luphawu lokuqala olunokubonwa.Iprofayile yomthamo wentsholongwane egazini ye-SARS-CoV-2 iyafana naleyo yomkhuhlane, efikelela incopho ngexesha lokuqalisa kweempawu, emva koko iqalise ukwehla.Ngophuhliso lwekhosi yesifo emva kokusuleleka, inkqubo yomzimba yokuzikhusela iya kuvelisa amajoni omzimba, phakathi kwawo i-IgM yi-antibody yokuqala eveliswa ngumzimba emva kosulelo, ebonisa isigaba esibukhali sosulelo.Izilwa-buhlungu ze-IgG kwi-SARS-CoV2 ziye zibonakale kamva emva kosulelo.Iziphumo ezilungileyo kuzo zombini i-IgG kunye ne-IgM zinokuvela emva kosulelo kwaye zinokubonisa usulelo oluqatha okanye lwamva nje.I-IgG ibonisa isigaba sokuchama sosulelo okanye imbali yosulelo oludlulileyo.

Nangona kunjalo, zombini i-IgM kunye ne-IgG zinexesha lefestile ukusuka kusulelo lwentsholongwane ukuya kwimveliso ye-antibody, i-IgM iphantse yavela emva kokuqalisa kwesifo iintsuku ezininzi, ngoko ke ukufunyanwa kwazo kuhlala kusilela ngasemva kokufunyanwa kwe-nucleic acid kwaye akukhathali kangako kunokufumanisa i-nucleic acid.Kwiimeko apho iimvavanyo ze-nucleic acid amplification zingalunganga kwaye kukho ikhonkco elinamandla le-epidemiologicalI-COVID 19usulelo, iisampulu zeserum ezidityanisiweyo (kwinqanaba elibukhali kunye nenqanaba lokuchacha) kunokuxhasa ukuxilongwa.

UMGAQO

I-COVID-19 ye-IgG/IgM yeKhasethi yoVavanyo oluKhawulezayo (WB/S/P) luluhlu lwenwebu olusemgangathweni olusekwe kuvavanyo lwe-immunoassay ukuze kufunyanwe izilwa-buhlungu (i-IgG kunye ne-IgM) kwiNoveli coronavirus kwiGazi eliPheleleyo lomntu/iSerum/plasma.Ikhasethi yovavanyo ine:2两ugates), i-2) i-nitrocellulose membrane strip equkethe imigca emibini yokuvavanya (imigca ye-IgG kunye ne-IgM) kunye nomgca wokulawula (umgca weC).Umgca we-IgM uqatywe ngaphambili kunye ne-Mouse anti-Human IgM antibody, umgca we-IgG uqatywe I-anti-Human IgG ye-antibody, xa umthamo owaneleyo we-specimen ukhutshwa kwisampulu yequla lekhasethi yovavanyo.Lo mzekelo ufuduka nge-capillary action kwikhasethi.I-IgM ye-anti-Novel coronavirus, ukuba ikhona kumzekelo, iya kuzibophelela kwiNoveli coronavirus coiyugates.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 ekhoyo kumzekelo iya kubophelela kwi-conjugates yeNoveli ye-coronavirus.I-immunocomplex ithi emva koko ibanjwe yi-reagent eqatywe kumgca we-lhe we-IgG, yenze umgca we-IgG onemibala ebomvu, ebonisa i-Novel coronavirus ye-IgG iziphumo zovavanyo olulungileyo.Ukungabikho kwayo nayiphi na imigca ye-T (IgG kunye ne-IgM) icebisa a

isiphumo esibi.Ukuze usebenze njengolawulo lwenkqubo, umgca wombala uya kuhlala ubonakala kummandla wolawulo obonisa ukuba umthamo ofanelekileyo we-specimen wongeziwe kwaye i-membrane wicking yenzeke.

IZILUMKISO NEMIGAQO

• Ukusetyenziswa kwe-in vitro diagnostic kuphela.
• Kumaziko okhathalelo lwempilo kunye neengcali kwindawo zokhathalelo.

•Ungasebenzisi 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 ngokwemithetho yomanyano, karhulumente kunye neyengingqi.

UHLELO

Uvavanyo luqulethe umtya wenwebu oqatywe ngeMouse anti-Human IgM antibody kunye neMouse anti-Human IgG antibody

umgca wovavanyo, kunye nephedi yedayi equlethe igolide ye-colloidal edityaniswa neNovel corona virus recombinant antigen.Ubungakanani beemvavanyo zaprintwa kwiileyibhile.

Izixhobo ezibonelelweyo

• Ikhasethi yovavanyo • Faka ipakethe
• Isithinteli • Idropha
• I-Lancet

Izinto Eziyimfuneko Kodwa Ezingabonelelwanga

•Isikhongozeli sengqokelela yomfanekiso • Isibali-xesha

UKUGCINWA NOZINZI

•Gcina njengePakhelwe kwisingxobo esitywiniweyo kwiqondo lobushushu(4-30″Cor 40-86°F).Ikhithi izinzile ngaphakathi komhla wokuphelelwa oshicilelweyo kwilebhile.

• Nje ukuba uvule isingxobo, i-lest kufuneka isetyenziswe kwiyure enye.Ukuba sesichengeni ixesha elide kwindawo eshushu nefumileyo kuya kubangela ukuwohloka kwemveliso.

•I-LOT kunye nomhla wokuphelelwa kwawo zaprintwa kwilebhile ethi SPECIMEN

•Uvavanyo lunokusetyenziselwa ukuvavanya iisampuli zegazi/iSerum/Plasma.

•Ukuqokelela igazi elipheleleyo, i-serum okanye isampuli zeplasma ezilandela iinkqubo zarhoqo zelebhu yonyango.

•Yahlula i-serum okanye iplasma egazini ngokukhawuleza ukuthintela ukopha.Sebenzisa kuphela iisampulu ezicacileyo ezingenayo i-hemolyzed.

• Gcina imizekelo kwi-2-8 °C (36-46T) ukuba ayivavanywanga ngokukhawuleza.Gcina iisampuli kwi-2-8 °C ukuya kwiintsuku ezisi-7.Imizekelo kufuneka ifakwe emkhenkceni kwi -20 °C (-4°F) ukuze igcinwe ixesha elide.Musa ukukhenkcisa iisampuli zegazi elipheleleyo,

•Kuphephe imijikelo emininzi yokunyibilikisa emkhenkceni, phambi kovavanyo, yiza imizekelo ekhenkcezisiweyo kwiqondo lobushushu begumbi ngokucothayo kwaye uxube ngobunono.

Iisampulu eziqulethe i-particle ebonakalayo kufuneka icaciswe nge-centrifugation ngaphambi kokuvavanya.

•Ungasebenzisi iisampulu ezibonisa i-gross lipemia gross hemolysis okanye i-turbidity ukuze uthintele ukuphazamiseka ekutolikweni kweziphumo.

INKQUBO YOVAVANYO

Vumela isixhobo sovavanyo kunye neesampulu ukuba zilingane nobushushu (15-30 C okanye 59-86 T ) phambi kovavanyo.

1. Susa iCassette yovavanyo kwisingxobo esivaliweyo.
2. Bamba idropha ngokuthe nkqo kwaye udlulisele ithontsi e-1 (malunga ne-10 ul) yomzekelo ukuya kwindawo ephezulu yequla lomfanekiso (S) uqinisekise ukuba akukho amaqamza omoya.Ukuchaneka okungcono, ukudlulisa isampuli ngepipette ekwazi ukuhambisa i-10 ul yomthamo.Jonga lo mzekeliso ungezantsi.
3. Emva koko, yongeza amathontsi ama-2(malunga nama-70 ul) wesithinteli ngoko nangoko kwiqula lomfuziselo(S).
4. Qala isibali-xesha.
5. ukuze kuvele imigca enemibala.Ukutolika iziphumo zovavanyo ngemizuzu eyi-15.Sukuzifunda iziphumo emva kwemizuzu engama-20.

Indawo yoMfanekiso

(Umfanekiso ubhekiselele kuphela, nceda ubhekisele kwinto ephathekayo.)

UKUTOLIKWA KWEZIPHUMO

amajoni omzimba.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.

Engalunganga:Umgca omnye onemibala ubonakala kummandla wokulawula (C), Akukho mgca wembala obonakalayo ovela kummandla wovavanyo.

Ayisebenzi:Umgca wolawulo uyasilela ukubonakala.Umthamo ongonelanga wesampulu okanye ubuchule obungachanekanga benkqubo zezona zizathu zinokwenzeka ukuba fbr ulawulo lokungaphumeleli komgca.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 nolungalunganga luvavanywe njengenkqubo efanelekileyo yaselabhoratri ukuqinisekisa inkqubo yovavanyo kunye nokuqinisekisa ukusebenza kakuhle kovavanyo.

IMIDA

• I-COVID-19 IgG/IgM Rapid Test Cassette (WB/S/P) ilinganiselwe ukunika umgangatho

ukubhaqwa.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.

•Isiphumo sovavanyo esinegethivu sibonisa ukuba izilwa-buhlungu ze-Novel coronavirus mhlawumbi azikho okanye zikumanqanaba angenakubonwa luvavanyo.

IIMPAWU ZOKUSEBENZA

Ukuchaneka

Idatha yesishwankathelo ye-CO VID-19 ye-IgG/IgM yoVavanyo oluKhawulezayo njengalapha ngezantsi

Ngokumalunga novavanyo lwe-IgG, sibale izinga elifanelekileyo lezigulane ezingama-82 ngexesha lokuchacha.

I-COVID-19 IgG:

Iziphumo zivelise ubuntununtunu be-97.56%

Ngokuphathelele uvavanyo lwe-IgM, ukuthelekiswa kwesiphumo kwi-RT-PCR.

I-COVID-19 IgM:

Uthelekiso lweenkcukacha-manani lwenziwe phakathi kweziphumo ezivelisa ubuntununtunu be-88.61%, i-97.67% ethile kunye nokuchaneka kwe-93.33%.

Cross-Reactivity kunye nokuphazamiseka

I-1 .Ezinye ii-causative agents ezixhaphakileyo zezifo ezithathelwanayo ziye zavandlakanywa ukuze ziphinde zisebenze kunye novavanyo.Eminye imizekelo emihle yezinye izifo ezosulelayo eziqhelekileyo ziye zafakwa kwiNoveli ye-coronavirus eqinisekileyo kunye neesampulu ezingalunganga kwaye zavavanywa ngokwahlukeneyo.Akukho kuphinda kusebenze kwakhona kwabonwa ngeesampulu ezivela kwizigulane ezosulelwe yi-HIV, HA ^ HBsAg, HCV TP, HTIA ^ CMV FLUA, FLUB, RSy MP, CP, HPIVs.

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 zovavanyo lwangaphakathi zibe yi-100%.Isivumelwano phakathi kwamaziko sasiyi-100%.