ʻIke a me ka kikoʻī: Ua hoʻohālikelike ʻia ka 2019-nCOV/COVID-19 IgG/IgM Rapid Test Device me kahi ʻoihana koʻikoʻi RT-PCR hoʻāʻo me ka hoʻohana ʻana i nā specimens.

No ka ho'āʻo IgG:

Pilikino Pili:233/268=86.94%(95%CI*:82.35%-90.49%)

ʻIkepili Pili:287/289=99.31% (95%CI*:97.52%-99.92%)

Pololei:520/557=93.36% (95%CI*: 90.96%-95.16%)

* Kūlana hilinaʻi

No ka ho'āʻo IgM

Pilikino Pili:223/268=83.21% (95%CI*:78.19%-87.48%)

ʻIkepili Pili:282/289=97.58% (95%CI*: 95.07%-99.02%)

Pololei: 505/557=90.66% (95%CI*: 87.94%-92.95%)

* Kūlana hilinaʻi

ʻO ka 2019-nCOV/COVID-19 IgG/IgM Rapid Test Device he immunoassay chromatographic wikiwiki no ka ʻike qualitative o IgG&IgM antibody o Coronavirus Disease 2019 i loko o ke koko holoʻokoʻa o ke kanaka, serum, a i ʻole ka plasma ma ke ʻano he kōkua i ka hōʻoia ʻana i nā maʻi COVID-19.

Hoʻohana ʻia: ʻO ka 2019-nCOV/COVID-19 IgG/IgM Rapid Test Device he immunoassay chromatographic wikiwiki no ka ʻike qualitative o IgG&IgM antibody o Coronavirus Disease 2019 i loko o ke koko holoʻokoʻa o ke kanaka, serum, a i ʻole ka plasma ma ke ʻano he mea kōkua i ka hōʻoia ʻana o nā maʻi COVID-19.

NUI: ʻO COVID-19 kahi maʻi maʻi maʻi 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 maʻi maʻi i kekahi mau hihia.

NĀ KUNU NO KA hoʻohana ʻana: E ʻae i ka mea hoʻāʻo, ka mea hoʻohālike, ka buffer, a/a i ʻole nā ​​mana e hiki i ka wela lumi (15-30°C) ma mua o ka hoʻāʻo ʻana. 1. E lawe mai i ka ʻeke i ka lumi wela ma mua o ka wehe ʻana. Wehe i ka mea hoʻāʻo mai ka ʻeke i hoʻopaʻa ʻia a hoʻohana koke i ka hiki. 2. E kau i ka mea ho'āʻo ma kahi maʻemaʻe a pae. ? No Serum a Plasma Specimens: Me ka hoʻohana ʻana i ka pipette disposable 10μL i hāʻawi ʻia, e huki i ka specimen a hiki i ka Fill Line, a hoʻololi i ka 10μL serum/plasma i ka pūnāwai specimen o ka mea hoʻāʻo, a laila hoʻohui i 2 kulu o ka buffer a hoʻomaka i ka manawa. ? No ke Koko holoʻokoʻa (Venipuncture/Fingerstick) Specimens: E hoʻohana ana i ka pipette 10μL i hāʻawi ʻia, a hoʻololi i 1 kulu o ke koko holoʻokoʻa (ma kahi o 20μL) i ka lua specimen o ka mea hoʻāʻo, a laila hoʻohui i 2 kulu o ka buffer a hoʻomaka i ka manawa. 'Ōlelo Aʻo: Hiki ke hoʻohana ʻia nā mea hoʻohālike me ka micropipette. 3. E kali a puka mai ka laina kala. E heluhelu i nā hopena ma 10 minuke. Mai wehewehe i ka hopena ma hope o 15 mau minuke.

PRINCIPLE: Ke hoʻohana nei kēia pahu i ka immunochromatography. Aia i loko o ke kāleka hōʻike: 1) colloidal gula-labeled recombinant novel coronavirus antigen a me ka quality control antibody gold markers;2) ʻelua laina ʻike (laina IgG a me IgM) a me hoʻokahi laina Mana maikaʻi (laina C) o ka membrane nitrocellulose. Hoʻokuʻu ʻia ka laina M me kahi antibody IgM monoclonal kanaka no ka ʻike ʻana i kahi antibody IgM coronavirus hou; ka laina IgG i immobilized me kahi reagent no ka ʻike ʻana i kahi antibody IgG coronavirus hou; a ua hoʻopaʻa ʻia ka laina C me kahi antibody control quality. Ke hoʻohui ʻia ka nui kūpono o ka hāpana hoʻāʻo i ka lua hāpana o ke kāleka hoʻāʻo, e neʻe ka hāpana i mua ma ke kāleka hōʻike ma lalo o ka hana a ka capillary. E hopu ʻia ka paʻakikī immune e ka anti-human IgM antibody i hoʻopaʻa ʻia ma ka membrane e hana i kahi laina ʻulaʻula M, e hōʻike ana he maikaʻi ka antibody coronavirus IgM antibody. Inā loaʻa i ka laʻana kahi antibody IgG, e hoʻopaʻa ʻia ka antibody i ke gula colloidal-labeled novel coronavirus antigen, a e hopu ʻia ka immune complex e ka reagent immobilized ma ka membrane e hana i kahi laina IgG ʻulaʻula, e hōʻike ana he maikaʻi ka antibody coronavirus IgG. Inā ʻaʻole kala ʻia nā laina IgG a me IgM hoʻāʻo, hōʻike ʻia kahi hopena maikaʻi ʻole. Aia pū i ka kāleka hōʻike kahi laina mana maikaʻi C. Pono e ʻike ʻia ka laina hoʻokele maikaʻi o fuchsia C me ka nānā ʻole ʻana i kahi laina hōʻike. Inā ʻaʻole ʻike ʻia ka laina hoʻokele maikaʻi C, ʻaʻole kūpono ka hopena hōʻike, a pono e hoʻāʻo hou ʻia ka hāpana me kahi kāleka hōʻike ʻē aʻe.