Ifamọ ati Ni pato: Awọn 2019-nCOV/COVID-19 IgG/IgM Ohun elo Idanwo Rapid ti jẹ afiwera si aṣari iṣowo RT-Idanwo PCR nipa lilo awọn apẹrẹ ile-iwosan. Awọn abajade fihan pe 2019-nCoV/COVID-19 IgG/IgM Ohun elo Idanwo Rapid ni ifamọ ati pato.

Fun idanwo IgG:

Ifamọ ibatan:233/268=86.94%(95%CI*:82.35%-90.49%)

Ojulumo pato:287/289=99.31% (95%CI*:97.52%-99.92%)

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

* Aarin Igbẹkẹle

Fun idanwo IgM

Ifamọ ibatan:223/268=83.21% (95%CI*:78.19%-87.48%)

Ojulumo pato:282/289=97.58% (95%CI*: 95.07%-99.02%)

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

* Aarin Igbẹkẹle

Awọn 2019-nCOV/COVID-19 IgG/IgM Igbeyewo Dekun Device is a dekun chromatographic immunoassay fun wiwa qualitative ti IgG&IgM antibody ti Coronavirus Arun 2019 ni gbogbo ẹjẹ eniyan, omi ara, tabi pilasima bi ohun iranlowo ni okunfa ti COVID-19 akoran.

LILO TI a pinnu: 2019-nCOV/COVID-19 IgG/IgM Igbeyewo Rapid Device jẹ imunoassay chromatographic iyara fun wiwa agbara ti IgG&IgM antibody ti Arun Coronavirus 2019 ninu gbogbo ẹjẹ eniyan, omi ara, tabi pilasima gẹgẹbi iranlọwọ ninu iwadii aisan ti awọn akoran COVID - 19.

KỌRỌ: COVID-19 jẹ arun ajakalẹ-arun ti atẹgun nla kan. Awọn eniyan ni ifaragba gbogbogbo. Lọwọlọwọ, awọn alaisan ti o ni arun coronavirus aramada jẹ orisun akọkọ ti ikolu; asymptomatic eniyan ti o ni akoran tun le jẹ orisun aarun. Da lori iwadii ajakale-arun lọwọlọwọ, akoko isubu jẹ ọjọ 1 si 14, pupọ julọ ọjọ 3 si 7. Awọn ifihan akọkọ pẹlu iba, rirẹ ati Ikọaláìdúró gbigbẹ. Imu imu, imu imu, ọfun ọfun, myalgia ati gbuuru ni a rii ni awọn iṣẹlẹ diẹ.

Awọn itọnisọna fun LILO: Gba ohun elo idanwo, apẹẹrẹ, ifipamọ, ati/tabi awọn idari lati de iwọn otutu yara (15-30°C) ṣaaju idanwo. 1. Mu apo kekere wa si iwọn otutu ṣaaju ṣiṣi. Yọ ẹrọ idanwo kuro ninu apo ti a fi edidi ki o lo ni kete bi o ti ṣee. 2. Gbe ẹrọ idanwo naa si ori mimọ ati ipele ipele. ? Fun Omi ara tabi Plasma Awọn ayẹwo: Lilo pipette isọnu 10μL ti a pese, fa apẹrẹ naa si Laini Fill, ati gbe 10μL omi ara / pilasima si apẹrẹ daradara ti ẹrọ idanwo, lẹhinna ṣafikun 2 silė ti ifipamọ ki o bẹrẹ aago naa. ? Fun Gbogbo Ẹjẹ (Venipuncture / Fingerstick) Awọn apẹẹrẹ: Lilo pipette isọnu 10μL ti a pese, ati gbigbe 1 ju ti gbogbo ẹjẹ (isunmọ 20μL) si apẹrẹ daradara ti ẹrọ idanwo, lẹhinna ṣafikun 2 silė ti ifipamọ ki o bẹrẹ aago naa. Akiyesi: Awọn apẹẹrẹ tun le lo ni lilo micropipette kan. 3. Duro fun ila (s) awọ lati han.Ka awọn esi ni awọn iṣẹju 10. Maṣe ṣe itumọ esi lẹhin awọn iṣẹju 15.

Ilana: Ohun elo yii nlo imunochromatography. Kaadi idanwo naa ni: 1) goolu colloidal-labeled recombinant novel coronavirus antigen and quality control antibody gold asami;2) awọn ila wiwa meji (IgG ati IgM ila) ati ọkan didara Iṣakoso laini (C ila) ti nitrocellulose awo. Laini M jẹ aibikita pẹlu ẹyọ monoclonal kan - antibody IgM eniyan fun wiwa aramada coronavirus IgM antibody; laini IgG jẹ aibikita pẹlu reagent fun wiwa aramada coronavirus IgG antibody; ati laini C jẹ aibikita pẹlu ọlọjẹ iṣakoso didara kan. Nigbati iye ti o yẹ ti ayẹwo idanwo ba wa ni afikun si iho ayẹwo ti kaadi idanwo naa, ayẹwo naa yoo lọ siwaju pẹlu kaadi idanwo labẹ iṣẹ ti capillary.Ti ayẹwo naa ba ni antibody IgM kan, agboguntaisan naa yoo sopọ mọ goolu colloidal-ti a fi aami aramada coronavirus antigen. Ilera ajẹsara yoo gba nipasẹ egboogi - antibody IgM eniyan aibikita lori awọ ara ilu lati ṣe laini pupa kan - laini pupa, ti n fihan pe aramada coronavirus IgM antibody jẹ rere. Ti ayẹwo naa ba ni egboogi-egbogi IgG kan, aporo-ara naa yoo sopọ mọ goolu colloidal - aramada coronavirus antijeni ti a samisi, ati pe eka ajẹsara yoo gba nipasẹ reagent aibikita lori awo awọ lati ṣe awọ-awọ-awọ-awọ-awọ-awọ-awọ-awọ-awọ-awọ-awọ-awọ-awọ-awọ-awọ pupa IgG, ti o nfihan pe aramada coronavirus IgG antibody jẹ rere. Ti idanwo IgG ati awọn ila IgM ko ba ni awọ, abajade odi ti han. Kaadi idanwo naa tun ni laini iṣakoso didara kan C. Laini iṣakoso didara fuchsia C yẹ ki o han laibikita boya laini idanwo kan han.Laini iṣakoso didara jẹ ẹgbẹ awọ ti iṣakoso didara antibody ajẹsara. Ti laini iṣakoso didara C ko ba han, abajade idanwo ko wulo, ati pe ayẹwo naa nilo lati ni idanwo lẹẹkansi pẹlu kaadi idanwo miiran.