博輝瑞進新型冠狀病毒中和抗體檢測試劑盒（2019-nCoV NAbs Detection Kit ）中英文產品介紹

作者：本站編輯發布日期：2021-01-26

產品名稱：新型冠狀病毒(2019-nCoV)中和抗體檢測試劑盒（膠體金免疫層析法）

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

預期用途：評價新冠疫苗人體免疫接種和感染康復后中和抗體水平。

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

主要組成：

A型

1.檢測試紙盒 1人份，2.使用說明書1份，3.稀釋液1瓶，4. 比色卡。

B型

1.檢測試紙盒 1人份，2.使用說明書1份，3.稀釋液1瓶，4. 比色卡。5. 滴管, 6.采血針，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.

主要組成

Main Components

配件

試劑條

全部單品

檢驗方法：

1．將待檢樣品（全血、血清、血漿）、稀釋液平衡至室溫；

3．外周血樣本

2）打開采血針帽，壓到消毒的指尖，針刺指尖；

4）擠出第二滴血，取10-20微升樣本（1滴），加入樣品孔，加80微升稀釋液（3滴），用棉棒按壓止血；

4. 血清或血漿：取5-10微升樣本（1滴），加入樣品孔，加80微升稀釋液（3滴），反應15min，30分鐘后結果失效；

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．陽性：觀察窗內在T線和C線區有兩條紫紅色條帶，表明樣本中新冠中和抗體為陽性。

3．無效：觀察窗內C線區無紫紅色條帶，T線區有或沒有條帶，表明試驗無效。

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.