博辉瑞进新型冠状病毒中和抗体检测试剂盒(2019-nCoV NAbs Detection Kit )中英文产品介绍


作者:本站编辑    发布日期:2021-01-26


产品名称:新型冠状病毒(2019-nCoV)中和抗体检测试剂盒(胶体金免疫层析法)

Product Name:Novel Coronavirus (2019-nCoV) Neutralizing Antibody Detection Kit (Colloidal Gold Immune-Chromatography)

预期用途:评价新冠疫苗人体免疫接种和感染康复后中和抗体水平。

Intended Use:To evaluate the level of neutralizing antibodies in humans after being vaccinated with 2019-nCoV vaccine and recovering from infection.

主要组成:

A型

1.检测试纸盒 1人份,2.使用说明书1份,3.稀释液1瓶,4. 比色卡。

B型

1.检测试纸盒 1人份,2.使用说明书1份,3.稀释液1瓶,4. 比色卡。5. 滴管, 6.采血针,7.棉棒,8. 酒精片

Main Components:

Type A

1. Detection kit for one person, 2. One Specification, 3. One bottle of diluent    , 4. Colorimetric card.

Type B

1. Detection kit for one person, 2. One Specification, 3. One bottle of diluent , 4. Colorimetric card, 5. Dropper, 6. Blood sampling needle, 7. Cotton swab, 8. Alcohol pad.

主要组成

Main Components

配件

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试剂条

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全部单品

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检验方法:

1.将待检样品(全血、血清、血浆)、稀释液平衡至室温;

3.外周血样本

    2)打开采血针帽,压到消毒的指尖,针刺指尖;

   4)挤出第二滴血,取10-20微升样本(1滴),加入样品孔,加80微升稀释液(3滴),用棉棒按压止血;

4. 血清或血浆:取5-10微升样本(1滴),加入样品孔,加80微升稀释液(3滴),反应15min,30分钟后结果失效;


Note: Please read instruction manual of this test reagent carefully before all operations.

2.Mark the sample number and remove the outer package of the test reagent (note: the test reagent without the outer package should be used within 1 hour, and it should be used immediately when the room temperature exceeds 30℃ or in high humidity environment)

    1)Tear off disposable alcohol tablets, wipe fingertips and dry naturally.

    3)Squeeze out the first drop of blood and wipe it off with a cotton swab.

    5)After 15 minutes of reaction, the result gets invalid after 30 minutes.

5. Venous whole blood: Take 10-20 μL sample (1 drop), add into the sample hole, add 80 μL diluent (3 drops), react for 15 minutes, the result gets invalid after 30 minutes.

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1.阳性:观察窗内在T线和C线区有两条紫红色条带,表明样本中新冠中和抗体为阳性。

3.无效:观察窗内C线区无紫红色条带,T线区有或没有条带,表明试验无效。

1.Positive:Two purplish red bands in the T line and C line area in the observation window, indicating that the 2019-nCoV neutralizing antibody in the sample is positive.

Invalid:No purplish red band in the C line, with or no band in the T line, indicating that the test is invalid.

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证书明细

CE证书

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企业海关出口资质

中华人民共和国海关报关单位注册登记证书.png


出入境检验检疫报检企业备案表.jpg

对外贸易经营备案表.jpg



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