产品说明：
产品优势：
1.一卡双测，一滴血即可检测IGG/IGM两个抗体；
2快速检测，从血液样本采集到检测完毕仅需20分钟；
3全能抗原捕捉技术、独特稀释提高产品灵敏度；
Product advantages:
1. One card double test, one drop of blood can detect IgG / IgM two antibodies;
2. Rapid detection, from the blood sample collection to the end of detection only takes 20 minutes;
3. all-round antigen capture technology、Unique dilution will be more than sensitivity,
【预期用途】
本试剂盒用于体外定性检测人血清、血浆或全血样本中新型冠状病（COVID-19）IgG/IgM抗体。
Intended use
This product is used for the qualitative detection of SARS-CoV-2 (COVID-19) IgM and IgG Antibodies in human serum, plasma, whole blood or fingertip blood
【检验原理】
本试剂卡工作原理：本试剂盒为胶体金免疫层析试剂盒，用于定性检测人血清、血浆、全血或指端血中抗新型冠状病毒（2019-nCoV）IgG/IgM抗体。采用抗原-抗体夹心一步法进行检测，结合垫上含有胶体金标记重组新型冠状病毒抗原，硝酸纤维素膜上分别包被有鼠抗人IgG抗体（检测线，G线）、鼠抗人IgM抗体（检测线，M线）。质控线(C线)是由位于结合垫上含有胶体金标记兔IgG和包被于硝酸纤维素膜上的羊抗兔IgG抗体组成。样本中的抗新型冠状病毒IgM或IgG抗体流经结合垫首先与金标记重组新型冠状病毒抗原结合，然后继续移动并与包被固定在硝酸纤维素膜上鼠抗人IgM抗体（M线）或鼠抗人IgG抗体（G线）形成免疫复合物，并在检测线出现红色条带。同时，结合垫上的金标记兔IgG与硝酸纤维素膜上的羊抗兔IgG抗体结合呈红色质控线（C线）条带。
Principle
This kit is a colloidal gold immunochromatographic testing product for the qualitative determination of IgM and IgG antibodies against novel coronavirus (COVID-19) in human serum, plasma, whole blood or fingertip blood. Antibody-antigen sandwich onestep assay has been used in this detection. For the test line (M line and G line), colloidal gold conjugated COVID-19 antigen is used as a detector and coated on the conjugate pad, and mouse anti-human IgM antibody and mouse anti-human IgG antibody are used as the two captures and coated separately on nitrocellulose membrane. For the quality control line (C-line), colloidal gold conjugated rabbit IgG is used as a detector and coated on the conjugate pad and goat antirabbit IgG antibody is used as the capture and coated on nitrocellulose membrane. When a sample is loaded on the conjugate pad, the IgM or IgG antibody against the virus antigen in the sample specifically binds to the virus antigen that is conjugated with gold, forms an IgM or IgG antibody-antigen gold complex, then the complex migrates on the nitrocellulose membrane and is captured by mouse anti-human IgM or IgG antibodyand immobilized on the nitrocellulose membrane, and then red bands appear on the detection line (M line and G line). The gold labeled rabbit IgG is captured by goat anti rabbit IgG antibody and forms a red quality control line (C line) on the nitrocellulose membrane at the same time.
【产品性能指标】
1.经过一个独立临床实验室评价显示，新型冠状病毒(COVID-19) IgG/ IgM抗体检测试剂盒(胶体金法)与荧光RT-PCR方法相比较，灵敏度达到91.4%特异性达到 97.1% 。
2.我们实验室评估新型冠状病毒(COVID-19) IgG/ IgM抗体检测试剂盒(胶体金法）检测20个阳性质控品，阳性率达到 100%，检测200个健康人血清，阴性率达到99%。
[Performance characteristics]
1.Tests evaluated by an independent clinical laboratory showed that Novel Coronavirus (COVID-19) IgG/IgM Antibody Test Kit (Colloidal Gold) gave 91.4% of
sensitivity and 97.1% of specificity compared to fluorescence RT-PCR assay.
2. Tests evaluated in our laboratory showed that Novel Coronavirus (COVID-19) IgG/IgM Antibody Test Kit (Colloidal Gold) gave 100% positive response in 20 of the positive control and 99% negative response in 200 of health human serum samples.
【检测方法】
1．使用前请详细阅读说明书，将检测盒和样本恢复至室温。
2．沿铝箔袋切口部位撕开，取出试剂盒放置于水平台面上并按样本编号。
3．取一个稀释液管，加入5微升血清、血浆或全血样本，混匀。
4．向检测卡的加样孔内加入60μl混匀后液体，开始计时。
5．等待1-20分钟，直到测试线显示为红色并将结果记录为阳性。 如果测试线在20分钟时没有显示为红色，则记录为阴性
[Testing procedure]
1.Read the instruction carefully before using the test kit,and restore the test kit and sample to room temperature.
2.Take out the test card from the foil bag, put it on the level table and mark it;
3.Add 5μl serum or plasma sample or whole blood sample into the dilution buffer tube and turn upon & down to mix it, and then transfer 60μl into the sample well of the card with dispette or pipette, start timing;
4.Wait for 1-15 minutes until the test line appear as red and record the result as a positive. If the test line does not appear as red at 15 minutes, it is recorded as a negative.
Storage method储存条件
Room temperature 4-30 ℃, storage for 12 months （室内温度4-30度，保质期12个月）
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