Inoveli yeCoronavirus COVID-19 IgG/IgM yoDiagnostic Rapid

Iinkcukacha eziKhawulezayo

I-COVID-19 Anti- 2020-nCoV ICoronavirus Entsha
ikiti yovavanyo lwe-coronavirus ye-COVID-19 ikhithi yovavanyo olukhawulezayo lwe-IgM/IgG yovavanyo lwe-TUV
Inoveli yeCoronavirus COVID-19 IgG/IgM yoDiagnostic Rapid

Ukupakishwa kunye nokuhanjiswa

Iinkcukacha

I-AMRPA68
COVID-19 IgM/IgG Antibody Rapid Test Kit
(I-Immunochromatography)
IGAMA LEMVELISO
COVID-19 IgM/IgG Antibody Rapid Test Kit
(I-Immunochromatography)
UKUSETYENZISWA OKUHLOSIWEYO
I-reagent isetyenziselwa ukukhangela i-Corona Virus-19 IgM/IgG Antibody ngaphakathi
i-serum/plasma/igazi elipheleleyo ngokomgangatho.
UMGAQO WOKUVAVANYA
Le khithi isekwe kumgaqo weleyibhile yegolide yovavanyo lwe-immunochromatographic kwaye isebenzisa indlela yokubamba ukubona i-antibody ye-COVID-19 ye-IgM/IgG kwisampulu.

UMGAQO WOKUVAVANYA

I-COVID-19 IgM
Xa isampuli ine-antibody ye-COVID-19 ye-IgM, yenza into entsonkothileyo ene-antigen yeleyibhile yegolide (i-COVID-19 recombinant antigen).I-complex iqhubela phambili phantsi kwesenzo se-chromatography kwaye idibanisa kunye ne-antibody edibeneyo (i-Mouse anti-human IgM monoclonal antibody) kumgca we-T ukwenza umbala onzima kunye nokuphuhlisa umbala (umgca we-T), osisiphumo esihle.Xa isampuli ingenayo i-antibody ye-COVID-19 ye-IgM, akukho ntsokothi inokwakheka kumgca we-T, kwaye akukho bhendi libomvu livelayo, esisisiphumo esibi.
Nokuba i-antibody ye-COVID-19 ye-IgM iqulethwe kwisampulu, i-antibody yolawulo lomgangatho weleyibhile yegolide (i-antibody yomvundla we-IgG) iyakubopha kunye ne-antibody egqunyiweyo (i-antibody ye-IgG yebhokhwe) kumgca we-C ukuze yenze into entsonkothileyo kwaye iphuhlise. umbala (umgca C).

I-COVID-19 IgG
Xa isampulu iqulethe i-antibody ye-COVID-19 ye-IgG, yenza into entsonkothileyo ene-antigen yeleyibhile yegolide (i-COVID-19 recombinant antigen).I-complex iqhubela phambili phantsi kwesenzo se-chromatography kwaye idibanisa kunye ne-antibody edibeneyo (i-Mouse anti-human IgG monoclonal antibody) kumgca we-T ukwenza umbala onzima kunye nokuphuhlisa umbala (umgca we-T), osisiphumo esihle.Xa isampuli ingenayo i-antibody ye-COVID-19 ye-IgG, akukho ntsokothi inokwakheka kumgca we-T, kwaye akukho bhendi libomvu livelayo, esisiphumo esibi.
 

Nokuba i-antibody ye-COVID-19 ye-IgG iqulethwe kwisampulu, i-antibody yolawulo lomgangatho weleyibhile yegolide (i-antibody ye-Rabbit IgM) iyakubopha kunye ne-antibody egqunyiweyo (i-antibody ye-IgG yebhokhwe) kumgca we-C ukuze yenze into entsonkothileyo kwaye iphuhlise. umbala (umgca C).

AMANQAKU APHAMBILI
I-COVID-19 IgM: Umgca we-T oqatywe ngempuku echasene nomntu we-IgM monoclonal antibody, ileyibhile yegolide pad isigaba esiqinileyo se-COVID-19 i-antigen ephinda iphinda-phinda, i-antigen yomvundla ye-IgG, i-C-line eqatywe nge-anti-mvundla ye-IgG yebhokhwe.

I-COVID-19 IgG: Umgca we-T oqatywe ngempuku echasene nomntu we-IgG monoclonal antibody, ipadi yegolide yesigaba esiqinileyo se-COVID-19 i-antigen, i-antigen yomvundla ye-IgM, i-C-line eqatywe nge-anti-mvundla ye-IgM yebhokhwe.Isampulu yokuxutywa: yenziwe nge-20 mM yesisombululo se-phosphate buffer (PBS)

UKUGCINA KUNYE NOKUPHELA KWEXESHA
Gcina njengoko zipakishwe kwisingxobo esitywiniweyo ku-4-30 ℃, kunqande ubushushu kunye nelanga, indawo eyomileyo, esebenzayo kangangeenyanga ezili-12.MUSA UKUMKHENZA.Amanye amanyathelo okukhusela kufuneka athathwe ehlotyeni kunye nasebusika obubandayo ukuphepha ukushisa okuphezulu okanye ukunyibilika komkhenkce.Musa ukuvula ukupakishwa kwangaphakathi de ukulungele, kufuneka isetyenziswe kwiyure enye ukuba ivuliwe (Ukufuma≤60%, Temp: 20℃-30℃).Nceda usebenzise ngokukhawuleza xa ukufuma-60%.

IMFUNEKO YOMTHETHO
1. I-reagent ingasetyenziselwa i-serum, i-plasma kunye neesampuli zegazi elipheleleyo.
2. Iserum / iplasma / isampulu yegazi lonke kufuneka iqokelelwe kwisingxobo esicocekileyo nesomileyo.I-EDTA, i-sodium citrate, i-heparin ingasetyenziswa njenge-anticoagulants kwi-plasma / iisampulu zegazi elipheleleyo.Khangela ngokukhawuleza emva kokuqokelela igazi.
I-3.I-Serum kunye neesampuli ze-plasma zingagcinwa kwi-2-8℃ kwiintsuku ze-3 ngaphambi kovavanyo.Ukuba uvavanyo lulibaziseke ngaphezu kweentsuku ezi-3, isampuli kufuneka ifakwe emkhenkceni (-20℃ okanye ibanda).Phinda umkhenkce kwaye unyibilike ungadlulanga amaxesha ama-3.Iisampulu zegazi elipheleleyo ezine-anticoagulant zingagcinwa kwi-2-8℃ iintsuku ezi-3, kwaye akufanele zifakwe emkhenkceni;iisampulu zegazi elipheleleyo ngaphandle kwe-anticoagulant kufuneka zisetyenziswe ngokukhawuleza (ukuba isampuli ine-agglutination, inokubonwa nge-serum).

IINDLELA ZOKUVAVANYA
Imiyalelo mayifundwe ngokupheleleyo phambi kokuba kwenziwe uvavanyo.Vumela izixhobo zovavanyo zilawule ubushushu begumbi imizuzu engama-30 (20℃-30℃) phambi kovavanyo.Musa ukuvula ukupakishwa kwangaphakathi de ukulungele, kufuneka isetyenziswe kwiyure enye ukuba ivuliwe (Ukufuma≤60%, Temp: 20℃-30℃).Nceda usebenzise ngokukhawuleza xa ukufuma-60%.
KwiSerum/Plasma
1. Susa isixhobo sovavanyo kwisingxobo esivaliweyo, usibeke kwindawo ecocekileyo nekumgangatho kunye nesampulu kakuhle.
2. Yongeza enye (1) ithontsi epheleleyo ye-serum okanye i-plasma (10μl) ngokuthe nkqo kwisampulu yomthombo we-IgM kunye ne-IgG ngokwahlukileyo.
3. Yongeza ezimbini (2) amathontsi (80-100μl) yesampulu buffer kumthombo isampuli IgM kunye IgG ngokwahlukeneyo.
4. Jonga iziphumo zovavanyo ngokukhawuleza kwimizuzu eyi-15 ~ 20, iziphumo azikho mthethweni kwimizuzu engama-20.

I-COVID-19 IgG
Uhlalutyo lwenqanaba lokudibana kwe-COVID-19 IgG Ab yovavanyo olukhawulezayo kunye ne-nucleic acid reagent kwiisampulu zeserum:
Izinga lokuzenzekela okulungileyo=46 / (46+4) × 100% = 92%,
Izinga leziganeko ezibi =291 / (9+291) × 100% = 97%,
Iyonke ireyithi yeziganeko=(46+291) / (46+4+9+291) × 100% = 96.3%.

I-COVID-19 IgM
Uhlalutyo lwenqanaba lokudibana kwe-COVID-19 IgM Ab yovavanyo olukhawulezayo kunye ne-nucleic acid
I-reagent kwiisampuli ze-serum:
Izinga lokuzenzekela okulungileyo=41 / (41+9) × 100% = 82%,
Izinga lokuzenzekela okubi=282 / (18+282) × 100% = 94%,
Iyonke ireyithi yezenzeko=(41+282) / (41+9+18+282) × 100% = 92.3%

QAPHELA
1. Ukusetyenziswa kwe-IN VITRO yokuxilongwa kuphela.
2. Ii-reagents kufuneka zisetyenziswe ngokukhawuleza emva kokuvulwa.Esi sixhobo sokubuyisela amandla asinakuphinda sisetyenziselwe ukulahlwa.
3. Isixhobo sovavanyo kufuneka sihlale kwiipowutshi ezivaliweyo de sisetyenziswe.Ukuba ingxaki yokutywinwa iyenzeka, musa ukuvavanya.Musa ukusebenzisa emva komhla wokuphelelwa.
4.Zonke iisampuli kunye nee-reagents kufuneka zithathelwe ingqalelo ezinokuthi zibe yingozi kwaye ziphathwe ngendlela efanayo ne-arhente eyosulelayo emva kokusetyenziswa.