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

试剂条

全部单品

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.

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.