ʻO COVID-19 IgM/IgG Mea ʻImi ʻAiʻi
COVID-19 IgM/IgG Antibody Detection Kit
（Colloidal Gold Immunochromatography Method) Product Manual
【PRODUCT NAME】COVID- 19 IgM/IgG Antibody Detection Kit （Colloidal Gold Immunochromatography Method) 【PACKAGING SPECIFICATIONS】 1 Ho'āʻo/Kīkini ,10 Hoʻāʻo/Kīkini
【ABSKAUKA】
Aia nā coronaviruses hou i ka genus β. ʻO COVID-19 kahi maʻi maʻi ʻeha hanu. Hiki ke maʻalahi nā kānaka. I kēia manawa, ʻo nā maʻi i loaʻa i ka coronavirus novel ke kumu nui o ka maʻi; Hiki i nā kānaka maʻi asymptomatic ke lilo i kumu maʻi. Ma muli o ka noiʻi epidemiological o kēia manawa, ʻo ka manawa incubation he 1 a 14 mau lā, ʻo ka hapa nui he 3 a 7 mau lā. ʻO nā hōʻike nui e pili ana i ke kuni, ka luhi a me ka ʻū maloʻo. Loaʻa ka nasal congestion, runny ihu, ʻeha ʻāʻī, myalgia a me ka diarrhea i kekahi mau hihia.
【EXPECTED USAGE】
He kūpono kēia kit no ka ʻike qualitative o COVID-19 ma ka ʻike ʻana i nā antibodies 2019-nCoV IgM/IgG i loko o ka serum kanaka, plasma, a i ʻole ke koko holoʻokoʻa. ʻO nā hōʻailona maʻamau o ka maʻi me 2019-nCoV e pili ana i nā hōʻailona hanu, ke kuni, ka ʻū, ka pōkole o ka hanu, a me ka dyspnea. I nā hihia koʻikoʻi loa, hiki i ka maʻi ke hoʻoulu i ka maʻi pneumonia, ka maʻi hanu acute koʻikoʻi, ka hōʻole ʻana o ke kīkī, a me ka make. Hiki ke hoʻokuʻu ʻia ka 2019 nCoV ma o ka hanu ʻana a i ʻole ka lawe ʻia ʻana ma o ka wai waha, ka ʻū, ka hoʻopili kino ʻana, a me nā kulu lewa.
【PRINCIPLES OF THE PROCEDURE】
ʻO ke kumu o ka immunochromatography o kēia kit: ʻo ka hoʻokaʻawale ʻana o nā ʻāpana i loko o kahi hui ʻana ma o ke ʻano me ka hoʻohana ʻana i ka ikaika capillary a me ka paʻa kikoʻī a me ka wikiwiki o kahi antibody i kona antigen. Aia i loko o kēia ho'āʻo ʻelua cassette, kahi cassette IgG a me kahi cassette IgM.
No YXI-CoV- IgM&IgG- 1 a me YXI-CoV- IgM&IgG- 10: Ma ka cassette IgM, he mea maloʻo ia i uhi ʻia me ka 2019-nCoV recombinant antigen ( "T" laina hōʻike) a me ka anti-iole kao. polyclonal antibodies ( "C" laina mana). ʻO nā antibodies colloidal gula-labeled, mouse anti-human IgM (mIgM) aia ma ka ʻāpana papa hoʻokuʻu. nCoV IgM antibodies inā aia lākou, e hana ana i kahi mIgM-IgM paʻakikī. A laila e neʻe ka paʻakikī mIgM-IgM ma luna o ka kānana nitrocellulose (Kānana NC) ma o ka hana capillary. Inā loaʻa ka antibody 2019-nCoV IgM i ka laʻana, e hoʻopaʻa ʻia ka laina hoʻāʻo (T) e ka mIgM-IgM complex a hoʻomohala i ke kala. Inā ʻaʻohe 2019-nCoV IgM antibody i loko o ka laʻana, ʻaʻole e paʻa ka mIgM manuahi i ka laina hoʻāʻo (T) a ʻaʻohe kala e ulu. Na ka mIgM manuahi e hoʻopaʻa i ka laina hoʻomalu (C); Pono e ʻike ʻia kēia laina mana ma hope o ke kaʻina ʻike no ka mea e hōʻoia ana kēia i ka hana pono o ka pahu. antichicken IgY antibody ( "C" laina hoʻomalu). Aia nā antibodies colloidal gula-labeled, 2019-nCoV recombinant antigen a me ka moa IgY antibody ma ka ʻāpana papa hoʻokuʻu. Ke hoʻohana ʻia ka serum i hoʻoheheʻe ʻia, ka plasma, a i ʻole ke koko holoʻokoʻa i ka ʻāpana pad sample (S), ka
E hoʻopaʻa ka colloidalgold-2019-nCoV recombinant antigen i nā antibodies 2019-nCoV IgG inā aia lākou, e hana ana i kahi colloidalgold-2019-nCoV recombinant antigen-IgG complex. A laila e neʻe ka paʻakikī i ka kānana nitrocellulose (NC filter) ma o ka hana capillary. Inā loaʻa ka antibody 2019-nCoV IgG i ka laʻana, e hoʻopaʻa ʻia ka laina hōʻike (T) e ka colloidalgold-2019-nCoV recombinant antigen-IgG complex a hoʻomohala i ka kala. Inā ʻaʻohe 2019-nCoV IgG antibody i loko o ka laʻana, free colloidalgold-2019-nCoV recombinant antigen ʻaʻole e hoʻopaʻa i ka laina hoʻāʻo (T) a ʻaʻohe kala e ulu. E hoʻopaʻa ʻia ka antibody IgY moa gula colloidal manuahi i ka laina hoʻomalu (C); e ʻike ʻia kēia laina mana ma hope o ke kaʻina ʻike no ka mea e hōʻoia kēia i ka hana pono o ka pahu.
No ka YXI-CoV- IgM&IgG-02- 1 a me YXI-CoV- IgM&IgG-02- 10: ʻO ke kumu o ka immunochromatography o kēia kit: ka hoʻokaʻawale ʻana o nā ʻāpana i loko o ka hui ʻana ma o ka mea hoʻohana i ka ikaika capillary a me ka paʻa kikoʻī a me ka wikiwiki. he antibody i kona antigen. ʻO ka COVID-19 IgM/IgG Antibody Detection Kit kahi immunoassay e pili ana i ka membrane qualitative no ka ʻike ʻana i nā antibodies IgG a me IgM iā SARS-CoV-2 i loko o ke koko holoʻokoʻa, serum a i ʻole plasma specimens. Aia kēia ho'āʻo i ʻelua ʻāpana, kahi ʻāpana IgG a me kahi ʻāpana IgM. Ma ka ʻāpana IgG, ua uhi ʻia ka anti-human IgG i ka ʻāpana laina hoʻāʻo IgG. I ka wā o ka hoʻāʻo ʻana, hoʻopili ka specimen me nā ʻāpana antigen-coated SARS-CoV-2 i ka cassette hōʻike. A laila neʻe ka hui ʻana ma ka ʻaoʻao o ka membrane chromatographically e ka hana capillary a pane aku me ka IgG antihuman ma ka ʻāpana laina hoʻāʻo IgG, inā loaʻa i ka specimen nā antibodies IgG i SARSCoV-2. E ʻike ʻia kahi laina kala ma ka ʻāpana laina hoʻāʻo IgG ma muli o kēia. Pēlā nō, uhi ʻia ka anti-human IgM i ka ʻāpana laina hoʻāʻo IgM a inā loaʻa i ka specimen nā antibodies IgM i SARS-CoV-2, e hoʻopili ka conjugate specimen complex me antihuman IgM. Hōʻike ʻia kahi laina kala ma ka ʻāpana laina hoʻāʻo IgM ma muli o ka hopena. No laila, inā loaʻa i ka specimen nā antibodies SARS-CoV-2 IgG, e ʻike ʻia kahi laina kala ma ka ʻāpana laina hōʻike IgG. Inā loaʻa i ka hōʻailona nā antibodies SARS-CoV-2 IgM, e ʻike ʻia kahi laina kala ma ka ʻāpana laina hōʻike IgM. Inā ʻaʻole i loaʻa nā antibodies SARS-CoV-2 i ka specimen, ʻaʻohe laina kala e ʻike ʻia ma kekahi o nā ʻāpana laina hōʻike, e hōʻike ana i kahi hopena maikaʻi ʻole. No ka lawelawe ʻana ma ke ʻano he mana kaʻina hana, e ʻike mau ʻia kahi laina kala i ka ʻāpana laina mana, e hōʻike ana ua hoʻohui ʻia ka leo kūpono o ka specimen a ua hana ʻia ka membrane wicking.
【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 | |
| ʻano hoʻāʻo ʻano 1 | 1 hoao/eke | / | / | 1 | 10 | ʻO ka membrane Nitrocellulose, ka paʻa paʻa, ka pad sample, ka membrane kānana koko, ka pepa absorbent, PVC |
| ʻano pahu hoʻāʻo 2 | 1 hoao/eke | 1 | 10 | / | / | ʻO ka membrane Nitrocellulose, ka paʻa paʻa, ka pad sample, ka membrane kānana koko, ka pepa absorbent, PVC |
| hāpana paipu hoʻoheheʻe | 100 μL / vial | 1 | 10 | 1 | 10 | Phosphate, Mawaena-20 |
| desiccant | 1 apana | 1 | 10 | 1 | 10 | silika dioxide |
| mea kulu wai | 1 apana | 1 | 10 | 1 | 10 | Palaki |
'Ōlelo Aʻo: ʻAʻole hiki ke hoʻohui a hoʻololi ʻia nā ʻāpana o nā pahu pahu like ʻole.
【MATERIALS TO BE PROVIDED BY USER】
•Papa waiʻona
•Nila lawe koko
【STORAGE A ME EXPIIOLEION】
E mālama i nā pahu i kahi maloʻo a maloʻo ma 2 - 25 ° C.
Mai maloʻo.
He 12 mahina nā pahu i mālama pono ʻia.
【SAMPLE REQUIREMENTS】
Ua kūpono ʻo Assay no ke kanaka serum, plasma, a i ʻole nā mea hoʻohālike koko holoʻokoʻa. Pono e hoʻohana koke ʻia nā laʻana ma hope o ka hōʻiliʻili ʻana. ʻO ka hōʻiliʻili serum a me ka plasma: Pono e hoʻokaʻawale ʻia ka serum a me ka plasma ma hope o ka hōʻiliʻili ʻana i ke koko e pale i ka hemolysis.
【SAMPLE PRESERVATION】
Pono e hoʻohana koke ʻia ka serum a me ka plasma ma hope o ka hōʻiliʻili ʻana a mālama ʻia ma 2-8 ° C no 7 mau lā inā ʻaʻole hoʻohana koke. Inā makemake ʻia ka mālama ʻana no ka wā lōʻihi, e ʻoluʻolu e mālama ma -20 °C no nā manawa ma lalo o 2 mahina. E pale i ka maloo a me ka hooluu.
Pono e ho'āʻo ʻia ke koko holoʻokoʻa a puni paha i loko o 8 mau hola ma hope o ka ʻohi ʻana.
ʻAʻole e hoʻohana ʻia ka hemolysis koʻikoʻi a me ke koko lipid no ka ʻike.
【TESTING METHOD】
No YXI-CoV- IgM&IgG- 1 a me YXI-CoV- IgM&IgG- 10:
E heluhelu pono i nā kuhikuhi ma mua o ka hoʻohana ʻana. E lawe mai i ka pahu ho'āʻo, Sample diluent tube, a me ka laʻana i ka lumi wela ma mua o ka hoʻāʻo ʻana.
1. Hoʻohui i 50 µl o ke koko holoʻokoʻa a i ʻole 20 µl Serum a me ka plasma i loko o ka Sample diluent tube a hui pono. E hoʻohui i nā kulu 3-4 i ka ʻāpana pad sample.
2. E waiho i ka lumi wela no 5 mau minuke e nānā i nā hopena. ʻAʻole kūpono nā hopena i ana ʻia ma hope o 5 mau minuke a pono e hoʻolei ʻia. No YXI-CoV- IgM&IgG-02- 1 a me YXI-CoV- IgM&IgG-02- 10:
E heluhelu pono i nā kuhikuhi ma mua o ka hoʻohana ʻana. E lawe mai i ka pahu ho'āʻo, Sample diluent tube, a me ka laʻana i ka lumi wela ma mua o ka hoʻāʻo ʻana.
1. E hoʻohui i 25µl o ke koko holoʻokoʻa a i ʻole 10µl Serum a me ka plasma i loko o ka pahu hoʻoheheʻe laʻana a hui maikaʻi. E hoʻohui i 4 kulu i ka pahu hāpana
pauku.
2. E waiho i ka lumi wela no 5 mau minuke e nānā i nā hopena. ʻAʻole kūpono nā hopena i ana ʻia ma hope o 5 mau minuke a pono e hoʻolei ʻia.
【[INTERPRETATION OF HOAO RESULTS】
| YXI-CoV- IgM&IgG-1 a YXI-CoV- IgM&IgG-10 | YXI-CoV- IgM&IgG-02-1 a YXI-CoV- IgM&IgG-02-10 |
| ★IgG POSITIVE: Hōʻike ʻia ʻelua laina. Pono ka laina kala hoʻokahi ma ka ʻāpana laina hoʻokele (C), a ʻike ʻia kahi laina kala ma ka ʻāpana laina hoʻāʻo IgG. He maikaʻi ka hopena no 2019- nCoV specific-IgG antibodies. ★lgM POSITIVE: Hōʻike ʻia ʻelua laina. Pono ka laina kala hoʻokahi ma ka ʻāpana laina mana(C), a ʻike ʻia kahi laina kala ma ka ʻāpana laina hoʻāʻo lgM. He maikaʻi ka hopena no 2019- nCoV specific-lgM antibodies.★IgG a me lgM POSITIVE: ʻO ka laina hoʻāʻo ʻelua ( ʻO T)a me ka laina hoʻomalu maikaʻi (C) i kala ʻia i kahi cassette IgG a me kahi cassette lgM. ★NEGATIVE: Hōʻike ʻia hoʻokahi wahaheʻe kala ma ka ʻāpana hoʻomalu (C).
★INVALID: ʻAʻole i ʻike ʻia ka laina hoʻokele. ʻAʻole lawa ka laʻana o ka laʻana a i ʻole nā ʻenehana kaʻina hana hewa ke kumu o ka hemahema o ka laina hoʻokele. a e hoʻokaʻaʻike i kāu mea hoʻolaha kūloko.
| ★IgG POSITIVE: Hōʻike ʻia ʻelua laina. Pono kekahi laina kala ma ka ʻāpana laina mana (C), a ʻike ʻia kahi laina kala ma ka ʻāpana laina hoʻāʻo IgG. He maikaʻi ka hopena no nā antibodies SARS-CoV-2 kikoʻī-IgG. ★IgM POSITIVE: Hōʻike ʻia ʻelua laina. Pono kekahi laina kala ma ka ʻāpana laina mana (C), a ʻike ʻia kahi laina kala ma ka ʻāpana laina hoʻāʻo IgM. Maikaʻi ka hopena no nā antibodies SARS-CoV-2 kikoʻī-IgM. ★IgG a me IgM POSITIVE: Hōʻike ʻia ʻekolu laina. Pono kekahi laina kala ma ka ʻāpana laina hoʻokele (C), a ʻike ʻia nā laina kala ʻelua ma ka ʻāpana laina hoʻāʻo IgG a me ka ʻāpana laina hoʻāʻo IgM. ★NEGATIVE: Hoʻokahi laina kala i ʻike ʻia ma ka ʻāpana hoʻomalu (C). ʻAʻole ʻike ʻia ka laina ʻulaʻula ma ka ʻāpana hoʻāʻo IgG a i ʻole IgM (T).
★INVALID: ʻAʻole ʻike ʻia ka laina hoʻomalu. ʻO ka lawa ʻole o ka nui o ka laʻana a i ʻole nā ʻenehana kaʻina hana hewa ke kumu nui loa o ka hemahema o ka laina mana. E noʻonoʻo i ke kaʻina hana a hana hou i ka hoʻāʻo me kahi pahu hoʻāʻo hou. Inā mau ka pilikia, e hoʻopau koke i ka hoʻohana ʻana i ka pahu hoʻāʻo a e hoʻopili i kāu mea hoʻolaha kūloko.
|
【LIMITATION OF IKEION METHOD】
a. Hoʻolālā ʻia ka huahana no ka hoʻohana ʻana me ka serum kanaka, plasma, nā ʻāpana koko holoʻokoʻa no ka ʻike qualitative o 2019 -nCoV IgM a me IgG antibody.
b. E like me ka hihia o nā hoʻokolohua diagnostic āpau, ʻaʻole pono e hoʻokumu ʻia kahi hōʻailona hōʻoia ma ka hopena o kahi hoʻokolohua hoʻokahi akā pono e hana ʻia ma hope o ka loiloi ʻia ʻana o nā ʻike a pau a pono e hōʻoia ʻia e nā ʻano hana ʻike maʻamau.
c. Hiki ke loaʻa ka hewa hewa inā ʻoi aku ka nui o ka 2019-nCoV IgM a i ʻole IgG antibody ma lalo o ka pae ʻike o ka pahu.
d. Inā pulu ka huahana ma mua o ka hoʻohana ʻana, a i ʻole mālama pono ʻia, hiki ke kumu i nā hopena hewa.
e. ʻO ka hoʻāʻo ʻana no ka ʻike qualitative o 2019-nCoV IgM a i ʻole IgG antibody i loko o ke kanaka serum, plasma a i ʻole hoʻohālike koko a ʻaʻole hōʻike i ka nui o nā antibodies.
【MALAMAIONS】
a. Mai hoʻohana i nā huahana i hala a i ʻole nā huahana i pōʻino.
b. E hoʻohana wale i ka mea hoʻoheheʻe like i loko o ka pūʻolo kit. ʻAʻole hiki ke hui ʻia nā mea hoʻoheheʻe mai nā ʻāpana kit like ʻole.
c. Mai hoʻohana i ka wai paila, ka wai i hoʻomaʻemaʻe ʻia a i ʻole ka wai i hoʻomaʻemaʻe ʻia ma ke ʻano he mana maikaʻi ʻole.
d. Pono e hoʻohana ʻia ka hoʻāʻo i loko o 1 hola ma hope o ka wehe ʻana. Inā ʻoi aku ka kiʻekiʻe o ka mahana ambient ma mua o 30 ℃, a i ʻole ka haʻahaʻa o ka hoʻāʻo ʻana, pono e hoʻohana koke i ka Detection Cassette.
e. Inā ʻaʻohe neʻe o ka wai ma hope o 30 kekona o ka hoʻomaka ʻana i ka hoʻāʻo, pono e hoʻohui ʻia kahi kulu hou o ka hāpana hāpana.
f. E mālama i ka pale ʻana i ka hiki ʻana o ka maʻi maʻi ke hōʻiliʻili i nā laʻana. E hoʻohana i nā mīkina lima hoʻolele, nā maka, a me nā mea ʻē aʻe, a holoi i kou mau lima ma hope.
g. Hoʻolālā ʻia kēia kāleka hōʻike no ka hoʻohana hoʻokahi, hoʻokahi manawa. Ma hope o ka hoʻohana ʻana, pono e noʻonoʻo ʻia ke kāleka hōʻike a me nā laʻana e like me nā ʻōpala olakino me ka pilikia o ka maʻi olaola a hoʻolei pono ʻia e like me nā lula pili aupuni.
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