Ngwa nyocha COVID-19 IgM/IgG
COVID-19 IgM/IgG Antibody Detection Kit
(Colloidal Gold Immunochromatography Method) Product Manual
【PRODUCT NAME】 COVID- 19 IgM/IgG Ngwa nchọpụta ihe mgbochi (Colloidal Gold Immunochromatography Method) 【PACKAGING SPECIFICATIONS】 1 Nnwale/Kit, Nnwale 10/Kit
【ABSTRACT】
Akwụkwọ akụkọ coronaviruses bụ nke β genus. COVID-19 bụ nnukwu ọrịa na-efe efe nke iku ume. Ndị mmadụ na-adịkarị mfe. Ugbu a, ndị ọrịa bu ọrịa coronavirus ọhụrụ bụ isi ihe na-ebute ọrịa; ndị butere ọrịa asymptomatic nwekwara ike bụrụ ebe na-efe efe. Dabere na nyocha ọrịa na-efe efe ugbu a, oge nnabata bụ ụbọchị 1 ruo 14, ọkachasị ụbọchị 3 ruo 7. Ihe ngosi ndị bụ isi gụnyere ahụ ọkụ, ike ọgwụgwụ na ụkwara akọrọ. A na-ahụ mkpọchi imi, imi na-agba agba, akpịrị akpịrị, myalgia na afọ ọsịsa n'ọnọdụ ole na ole.
【EXPECTED USAGE】
Ngwa a dabara adaba maka nchọpụta qualitative nke COVID-19 site na ịchọpụta ọgwụ mgbochi 2019-nCoV IgM/IgG n'ime ọbara mmadụ, plasma ma ọ bụ ọbara dum. Ihe mgbaàmà a na-ahụkarị nke ọrịa na 2019-nCoV gụnyere mgbaàmà iku ume, ahụ ọkụ, ụkwara, mkpụmkpụ ume, na dyspnea. N'ọnọdụ ndị ka njọ, ọrịa nwere ike ịkpata oyi baa, nnukwu ọrịa iku ume iku ume, ọdịda akụrụ, na ọbụna ọnwụ. Enwere ike ịpụpụ 2019 nCoV site na ihe nzuzo iku ume ma ọ bụ bufee ya site na mmiri ọnụ, uzere, kọntaktị anụ ahụ, na site na ụmụ irighiri mmiri.
【PRINCIPLES OF THE PROCEN'OGEE】
Ụkpụrụ nke immunochromatography nke ngwa a: nkewa nke ihe ndị dị na ngwakọta site na ọkara na-eji ike capillary na kpọmkwem na njikọ ngwa ngwa nke mgbochi na antigen ya. Nnwale a nwere kaseti abụọ, kaseti IgG na kaseti IgM.
Maka YXI-CoV-IgM&IgG-1 na YXI-CoV- IgM&IgG- 10: Na IgM cassette, ọ bụ akọrọ nkụ nke ejirila 2019-nCoV recombinant antigen (“T” test line) na ewu mgbochi òké kpuchie ya iche. polyclonal mgbochi (akara akara "C"). The colloidal gold-labeled antibodies, mouse anti-human IgM (mIgM) dị na ntọhapụ pad ngalaba. Ozugbo diluted serum, plasma, ma ọ bụ ọbara dum na-etinye aka na sample pad ngalaba (S), mIgM mgbochi ga-ejikọta na 2019- nCoV IgM ọgwụ mgbochi ma ọ bụrụ na ha dị, na-eme mgbagwoju mIgM-IgM. Mgbagwoju mIgM-IgM ga-agafe n'ofe nitrocellulose filter (NC filter) site na ọrụ capillary. Ọ bụrụ na mgbochi 2019-nCoV IgM dị na nlele ahụ, ahịrị nnwale (T) ga-ejikọta mIgM-IgM mgbagwoju wee mepụta agba. Ọ bụrụ na enweghị ọgwụ mgbochi 2019-nCoV IgM na nlele, mIgM efu agaghị ejikọta na ahịrị nnwale (T) na enweghị agba ga-etolite. MIgM efu ga-ejikọta na akara njikwa (C); Ekwesịrị ịhụ akara njikwa a mgbe usoro nchọpụta ahụ gasịrị ka nke a na-egosi na ngwa ahụ na-arụ ọrụ nke ọma. Na cassette IgG, ọ bụ ihe na-ekpo ọkụ na-ekpo ọkụ na-ekpuchi ya iche na mouse anti-Human IgG ("T" test line) na oke bekee. antichicken IgY mgbochi (akara njikwa "C"). Ọgwụ mgbochi akpọrọ colloidal ọla edo, 2019-nCoV recombinant antigen na ọkụkọ IgY mgbochi nọ na ngalaba ntọhapụ. Ozugbo etinyere serum, plasma, ma ọ bụ ọbara dum na mpaghara pad sample (S), ndị
colloidalgold-2019-nCoV recombinant antigen ga-ejikọta na ọgwụ mgbochi 2019-nCoV IgG ma ọ bụrụ na ha dị, na-eme ka colloidalgold-2019-nCoV recombinant antigen-IgG complex. Mgbagwoju anya ga-agafe n'ofe nitrocellulose filter (NC filter) site na ọrụ capillary. Ọ bụrụ na mgbochi 2019-nCoV IgG dị na nlele ahụ, eriri ule (T) ga-ejikọta ya na colloidalgold-2019-nCoV recombinant antigen-IgG complex ma mepụta agba. Ọ bụrụ na enweghị ọgwụ mgbochi 2019-nCoV IgG na nlele ahụ, free colloidalgold-2019-nCoV recombinant antigen agaghị ejikọta na ahịrị nnwale (T) na enweghị agba ga-etolite. The free colloidal gold-ọkụkọ IgY mgbochi ga-ejikọta na akara akara (C); Ekwesịrị ịhụ ahịrị njikwa a mgbe usoro nchọpụta ahụ gasịrị ka nke a na-egosi na ngwa ahụ na-arụ ọrụ nke ọma.
Maka YXI-CoV-IgM&IgG-02-1 na YXI-CoV- IgM&IgG-02-10: Ụkpụrụ nke immunochromatography nke ngwa a: nkewa nke akụrụngwa na ngwakọta site na ọkara na-eji ike capillary na kpọmkwem na ngwa ngwa njikọ nke ihe mgbochi maka antigen ya. Ngwa COVID-19 IgM/IgG Antibody Detection Kit bụ immunoassay sitere na akpụkpọ ahụ dị mma maka nchọpụta IgG na IgM ọgwụ mgbochi SARS-CoV-2 n'ime ọbara dum, serum ma ọ bụ plasma. Nnwale a nwere akụrụngwa abụọ, akụrụngwa IgG na akụrụngwa IgM. Na mpaghara IgG, mgbochi IgG mmadụ bụ mkpuchi na mpaghara ahịrị ule IgG. N'oge ule, ihe nlere ahụ na-emeghachi omume na ihe mgbochi SARS-CoV-2 antigen na cassette ule. Ngwakọta ahụ na-akwaga n'akụkụ n'akụkụ akpụkpọ ahụ chromatographically site na omume capillary wee meghachi omume na IgG na-emegide mmadụ na mpaghara ahịrị ule IgG, ma ọ bụrụ na ụdị ahụ nwere ọgwụ mgbochi IgG na SARSCoV-2. Ahịrị nwere agba ga-apụta na mpaghara ahịrị ule IgG n'ihi nke a. N'otu aka ahụ, mkpuchi IgM na-emegide mmadụ na mpaghara ahịrị ule IgM ma ọ bụrụ na ihe nlere ahụ nwere ọgwụ mgbochi IgM na SARS-CoV-2, conjugate ụdịdị mgbagwoju anya na-emeghachi omume na IgM na-emegide mmadụ. Ahịrị nwere agba na-apụta na mpaghara ahịrị ule IgM n'ihi nke a. Yabụ, ọ bụrụ na ihe nlere ahụ nwere ọgwụ mgbochi SARS-CoV-2 IgG, ahịrị nwere agba ga-apụta na mpaghara ahịrị ule IgG. Ọ bụrụ na ihe nlere ahụ nwere ọgwụ mgbochi SARS-CoV-2 IgM, ahịrị nwere agba ga-apụta na mpaghara ahịrị ule IgM. Ọ bụrụ na ụdị ahụ enweghị ọgwụ mgbochi SARS-CoV-2, ọ nweghị ahịrị nwere agba ga-apụta na mpaghara ahịrị nnwale ahụ, na-egosi nsonaazụ na-adịghị mma. Iji jee ozi dị ka njikwa usoro, eriri agba ga-apụta mgbe niile na mpaghara akara akara, na-egosi na agbakwunyere olu kwesịrị ekwesị nke ihe nlere anya na akpụkpọ anụ ahụ emeela.
【MAIN COMPONENTS】
Cat. No. | YXI-CoV-IgM&IgG-1 | YXI-CoV-IgM&IgG-10 | YXI-CoV-IgM&IgG-02-1 | YXI-CoV-IgM&IgG-02-10 |
Components | |
Product Pic. | ||||||
Name | Specification | Quantity | Quantity | Quantity | Quantity | |
test strip ụdị 1 | 1 ule/akpa | / | / | 1 | 10 | Nitrocellulose akpụkpọ ahụ, ihe eji ejikọta, mpe mpe akwa, akpụkpọ anụ filtration ọbara, akwụkwọ na-amị amị, PVC |
test strip ụdị 2 | 1 ule/akpa | 1 | 10 | / | / | Nitrocellulose akpụkpọ ahụ, ihe eji ejikọta, mpe mpe akwa, akpụkpọ anụ filtration ọbara, akwụkwọ na-amị amị, PVC |
sample diluent tube | 100 μL / vial | 1 | 10 | 1 | 10 | Phosphate, Tween-20 |
desiccant | 1 ibe | 1 | 10 | 1 | 10 | silicon dioxide |
dropper | 1 ibe | 1 | 10 | 1 | 10 | Plastic |
Mara: Enweghị ike ịgwakọta ma ọ bụ gbanwee ihe ndị dị na ngwa ngwa dị iche iche.
【MATERIALS TO BE PROVIDED BY USER】
• mmanya mmanya
• Ọbara na-ewere agịga
【SNKWUKWU NA EXPIRATION】
Debe ngwa n'ebe dị jụụ na nkụ na 2 - 25 Celsius.
Ajụla oyi.
Ngwa echekwara nke ọma na-adị irè maka ọnwa iri na abụọ.
【SAMPLE REQUIREMENTS】
Assay dabara adaba maka ọbara mmadụ, plasma, ma ọ bụ ihe nlele ọbara dum. Ekwesịrị iji ihe nlele mee ngwa ngwa o kwere mee mgbe anakọtara. Mkpokọta ọbara na plasma: Ekwesịrị ikewapụ serum na plasma ozugbo enwere ike ịnakọta ọbara iji zere hemolysis.
【SAMPLE PRESERVATION】
Ekwesịrị iji serum na plasma mee ngwa ngwa o kwere omume mgbe nchịkọta ma chekwaa na 2-8 Celsius maka ụbọchị 7 ma ọ bụrụ na ejighị ya ozugbo. Ọ bụrụ na achọrọ nchekwa ogologo oge, biko chekwaa na -20 Celsius maka oge na-erughị ọnwa 2. Zere oyi ugboro ugboro na agbaze.
Ekwesịrị ịnwale nlele ọbara zuru oke ma ọ bụ nke dị n'akụkụ n'ime awa 8 ka anakọtara.
Agaghị eji hemolysis siri ike na nlele ọbara lipid mee nchọpụta.
【TESTING METHOD】
Maka YXI-CoV- IgM&IgG- 1 na YXI-CoV- IgM&IgG- 10:
Gụọ ntuziaka ndị a nke ọma tupu ojiji. Weta mpempe ule, ihe nlele tube diluent, na nlele n'ime ụlọ okpomọkụ tupu nnwale.
1. Tinye 50 µl nke ọbara dum ma ọ bụ nke dị n'akụkụ ma ọ bụ 20 µl Serum na plasma na tube diluent Sample ma gwakọta nke ọma. Tinye 3-4 tụlee na ngalaba mpempe akwụkwọ sample.
2. Hapụ na ụlọ okpomọkụ maka nkeji 5 ka ị hụ nsonaazụ ya. Rịzọlt a tụrụ ka nkeji ise gachara abaghị uru ma ekwesịrị ịtụfu ya. Maka YXI-CoV- IgM&IgG-02- 1 na YXI-CoV- IgM&IgG-02-10:
Gụọ ntuziaka ndị a nke ọma tupu ojiji. Weta mpempe ule, ihe nlele tube diluent, na nlele n'ime ụlọ okpomọkụ tupu nnwale.
1. Tinye 25µl nke ọbara dum ma ọ bụ nke dị n'akụkụ ma ọ bụ 10µl Serum na plasma na tube diluent Sample ma gwakọta nke ọma. Tinye 4 tụlee na pad sample
ngalaba.
2. Hapụ na ụlọ okpomọkụ maka nkeji 5 iji hụ nsonaazụ ya. Rịzọlt a tụrụ ka nkeji ise gachara abaghị uru ma ekwesịrị ịtụfu ya.
【[INTERPRETATION OF Nnwale RESULTS】
YXI-CoV- IgM&IgG-1 na YXI-CoV- IgM&IgG-10 | YXI-CoV- IgM&IgG-02-1 na YXI-CoV- IgM&IgG-02-10 |
★ IgG EZIOKWU: ahịrị abụọ pụtara. Otu ahịrị nwere agba kwesịrị ịdị na mpaghara akara akara (C), na ahịrị acha na-egosi na mpaghara akara ule IgG. Nsonaazụ dị mma maka 2019- nCoV kpọmkwem-IgG mgbochi. ★lgM POSITIVE: Ahịrị abụọ pụtara. Otu ahịrị agba kwesịrị ịdị na mpaghara akara akara (C), na akara agba na-apụta na mpaghara akara ule lgM. Nsonaazụ dị mma maka ọgwụ mgbochi 2019-nCoV kpọmkwem-lgM.★IgG na lgM POSITIVE: Ma akara ule ( T) na ahịrị njikwa mma (C) na-acha na kaseti IgG na cassette lgM. ★ adịghị mma: Otu ụgha na-acha na-egosi na mpaghara nchịkwa (C) .Ọ dịghị ahịrị mara mma pụtara na mpaghara ule lgG ma ọ bụ lgM (T).
★ INVALID: akara njikwa anaghị apụta. ezughị oke sample ma ọ bụ usoro usoro na-ezighi ezi bụ ihe kpatara ọdịda akara akara. Nyochaa usoro ahụ wee jiri cassette ọhụrụ megharịa ule ahụ. Ọ bụrụ na nsogbu ahụ dịgidere, kwụsị iji ngwa ule ozugbo. ma kpọtụrụ onye nkesa mpaghara gị.
| ★IgG POSITIVE: Ahịrị abụọ pụtara. Otu ahịrị nwere agba kwesịrị ịdị na mpaghara akara akara (C), na ahịrị nwere agba pụtara na mpaghara ahịrị ule IgG. Nsonaazụ a dị mma maka ọgwụ mgbochi SARS-CoV-2 kpọmkwem-IgG. ★IgM POSITIVE: Ahịrị abụọ pụtara. Otu ahịrị agba kwesịrị ịdị na mpaghara akara akara (C), na ahịrị nwere agba na-apụta na mpaghara ahịrị ule IgM. Nsonaazụ a dị mma maka ọgwụ mgbochi SARS-CoV-2 kpọmkwem-IgM. ★IgG na IgM POSITIVE: Ahịrị atọ pụtara. Otu ahịrị agba kwesịrị ịdị na mpaghara akara akara (C), na ahịrị abụọ nwere agba kwesịrị ịpụta na mpaghara ahịrị ule IgG yana mpaghara ahịrị ule IgM. ★ adịghị mma: Otu ahịrị na-acha na-egosi na mpaghara nchịkwa (C). Mba ahịrị na-acha pụtara ìhè na-egosi na mpaghara ule IgG ma ọ bụ IgM (T).
★ INVALID: akara njikwa anaghị apụta. Oke sample ezughi oke ma ọ bụ usoro usoro na-ezighi ezi bụ ihe kachasị kpatara ọdịda akara njikwa. Nyochaa usoro ahụ wee jiri cassette ọhụrụ megharịa ule ahụ. Ọ bụrụ na nsogbu ahụ dịgidere, kwụsị iji ngwa ule ozugbo wee kpọtụrụ onye nkesa mpaghara gị.
|
【LIMITATION OF ChọpụtaION METHOD】
a. Emebere ngwaahịa a naanị maka iji serum mmadụ, plasma, ihe nlele ọbara niile maka nchọpụta qualitative nke 2019 -nCoV IgM na IgG antibody.
b. Dị ka ọ dị na nyocha nyocha niile, nchọpụta ụlọ ọgwụ doro anya ekwesịghị ịdabere na nsonaazụ otu ule kama ọ ga-emerịrị ka emechara ya mgbe enyochachara nyocha ụlọ ọgwụ niile ma kwenye na usoro nchọpụta ndị ọzọ.
c. Ihe ọjọọ ụgha nwere ike ime ma ọ bụrụ na ọnụọgụ 2019-nCoV IgM ma ọ bụ IgG antibody dị n'okpuru ọkwa nchọpụta nke ngwa ahụ.
d. Ọ bụrụ na ngwaahịa ahụ riri mmiri tupu ejiri ya, ma ọ bụ echekwara ya na-ezighi ezi, ọ nwere ike ibute nsonaazụ na-ezighi ezi.
e. Nnwale a bụ maka nchọpụta qualitative nke 2019-nCoV IgM ma ọ bụ IgG n'ime ọbara mmadụ, plasma ma ọ bụ ihe nlele ọbara na-egosighi ọnụọgụ ọgwụ mgbochi.
【kpachara anyaIONS】
a. Ejila ngwaahịa kubie ume ma ọ bụ mebiri emebi.
b. Jiri naanị mgbaze dabara na ngwugwu kit. Enweghị ike ịgwakọta ihe ndị sitere na ngwa ngwa dị iche iche.
c. Ejila mmiri mgbata, mmiri dị ọcha ma ọ bụ mmiri distilled dị ka njikwa na-adịghị mma.
d. Ekwesịrị iji ule ahụ mee ihe n'ime awa 1 ka emepechara. Ọ bụrụ na ọnọdụ okpomọkụ dị elu karịa 30 ℃, ma ọ bụ ebe nnwale ahụ dị iru mmiri, a ga-eji Cassette nchọpụta mee ihe ozugbo.
e. Ọ bụrụ na ọ dịghị mmegharị nke mmiri mmiri mgbe 30 sekọnd nke mmalite ule, ọzọ dobe nke sample ngwọta kwesịrị ịgbakwunye.
f. Kpachara anya ka ị gbochie ohere nke ibute nje mgbe ị na-anakọta ihe nlele. Yiri gloves, ihe mkpuchi, wdg, wee saa aka gị ma emechaa.
g. Emebere kaadị ule a maka otu oge, otu oge. Mgbe ejirichara ya, a ga-ewere kaadị ule na ihe nlele ahụ dị ka ihe mkpofu ọgwụ nwere ihe ize ndụ nke ọrịa nje ma tụfuo ya nke ọma dịka iwu obodo siri dị.