北京灵宝科技有限公司
新型冠状病毒(COVID-19) IgM/IgG 抗体检测试剂盒
一、临床意义
IgM 是在急性感染期出现的抗体，患者发病后 3~7 天左右即可检出，一般
在感染发生后的 1 到 2 个月消失；IgG 则是感染中、后期产生的抗体，阳性提示
患者处于恢复期或为既往感染。临床上同时检测 IgM 与 IgG 抗体，可动态监测
患者感染的过程。
新型冠状病毒具有传播快、传染性强、发病急、病程进展快等特点，患者感
染初期可能无明显症状，但依旧具有很强传染性。患者在感染新冠病毒后，自身
免疫系统启动免疫防御反应，一般在 3~7 天左右首先产生 IgM 抗体，其后 IgG
抗体逐渐升高。因此，在开展核酸检测的同时进行血清学的检测，作为一个特异
性的免疫学诊断方法，可有效地鉴别新冠病毒感染。具体地，IgM 可用于新冠病
毒早期疑似病例筛查，IgG 可用于新冠肺炎患者的病程监测和回顾性诊断。
二、检测原理
本品采用免疫层析和胶体金技术定性检测人体指尖血、全血、血清、血浆中
的新型冠状病毒 IgM/IgG 抗体。
将待测样本加入至检测卡的加样孔中，随着层析作用，若样本中含有 IgM
抗体，则会与胶体金标记的新冠病毒重组抗原 CovAg 结合，该免疫复合物沿着
硝酸纤维素试纸条移动时，可被检测线（M 线）处的抗人 IgM 抗体捕获到，形
成“抗人 IgM 抗体-待测 IgM 抗体-CovAg-Au”复合物，形成肉眼可见的红色条带，
提示新冠病毒 IgM 抗体阳性。同理，如样本中含有 IgG 抗体，则可被检测线（G）
处抗人 IgG 抗体捕获到，形成肉眼可见的红色条带，提示新冠病毒 IgG 抗体阳
性
如果检测线 M 和 G 都不显色，则提示阴性结果。如果质控线 C 出现，则检
测结果有效，反之无效，需更好检测试剂重新检测。
三、检测方法
1. 将检测卡、缓冲液取出，置于室温（18～25℃）；
2. 拆开检测卡的铝箔袋包装，将检测卡放置在平稳表面；
3. 用酒精棉擦拭手指端，用配套的采血针采集指尖血；
4. 滴加 2 滴指尖血至检测卡加样孔内，随即立刻加入 2 滴缓冲液到检测卡；
5. 10 分钟内判读结果。
四、判读示意图
五、产品优势
本试剂盒已于一家省级疾控中心和一家定点收治医院开展前期临床评
估，结果表明：
检出率高：按照国家卫健委最新版诊疗指南的临床判断标准，对临床诊
断阳性患者的检出率达 93.3%（152/163）；
特异性好：对健康人群检测的特异性达 99.1%（112/113）；
操作简单：无需仪器设备，不受场地限制，目测即可判定结果；
采血方便：附带采血针采集指尖血即可检测。
六、应用场景
本产品可弥补核酸检测试剂检出率低的缺点，配合使用能够极大地提高新冠
病毒感染的肺炎患者阳性检出率和诊断准确性，可用于各级医院、CDC、社区、
诊所、县乡村等医疗卫生机构的辅助诊断手段。同时，也可应用于第三方医学检
验所开展的企事业单位和学校等复工复学的筛查、家庭自测以及海关检验检疫等
场景需要。
北京灵宝科技有限公司
联系:01056205725;13911873657（同微信）;18515624029
郑威 Email:380721775@qq.com
Beijing Lingbao Technology Co., Ltd
Contact: 01056205725; 13911873657 (the same as wechat); 18515624029
Zheng Wei email: 380721775@qq.com
Novel coronavirus (COVID-19) IgM/IgG antibody detection kit
█、 Clinical significance
IgM is the antibody that appears in the acute infection stage. It can be detected in about 3-7 days after the onset of the disease, generally
IgG is the antibody produced in the middle and later stage of the infection, which is positive
The patient is in recovery or has a previous infection. Both IgM and IgG antibodies can be detected simultaneously in clinic, which can be monitored dynamically
The process of infection.
The novel coronavirus has the characteristics of fast transmission, strong infection, acute onset and rapid progression.
There may be no obvious symptoms at the initial stage of infection, but it is still highly infectious. After infection with the new coronavirus, the patient
The immune system starts the immune defense reaction, and generally produces IgM antibody first in about 3-7 days, then IgG
The antibody increased gradually. Therefore, the detection of nucleic acid and serology should be carried out at the same time as the detection of nucleic acid
The new coronavirus infection can be effectively identified by the method of immunological diagnosis. Specifically, IgM can be used in new crown diseases
The novel coronavirus pneumonia screening is possible in early stage. IgG can be used for the monitoring and retrospective diagnosis of new crown pneumonia.
█、 Detection principle
This product uses immunochromatography and colloidal gold technology to qualitatively detect fingertip blood, whole blood, serum and plasma
A novel coronavirus IgM/IgG antibody.
Add the sample to be tested into the sample hole of the test card. With the chromatography, if the sample contains IgM
The antibody will bind to covag, a new coronavirus recombinant antigen labeled by colloidal gold. The immune complex
When the nitrocellulose test strip moves, it can be captured by the anti human IgM antibody at the detection line (M line), and
A compound of "anti human IgM antibody to be tested IgM antibody covag Au" is formed, forming a red band visible to the naked eye,
It is suggested that IgM antibody of new coronavirus is positive. Similarly, if the sample contains IgG antibody, it can be detected by line (g)
The red band was formed by the capture of anti human IgG antibody, indicating that the IgG antibody of new coronavirus was positive nature
If the detection lines m and G do not show color, it indicates a negative result. If QC line C appears, check
The test result is valid, otherwise it is invalid, so it is necessary to detect the reagent better.
█、 Detection method
1. Take out the test card and buffer and place them at room temperature (18-25 ℃);
2. Unpack the aluminum foil bag of the test card and place the test card on a stable surface;
3. Wipe the finger end with alcohol cotton, and collect the fingertip blood with matching blood sampling needle;
4. Add 2 drops of fingertip blood to the sample hole of the test card, and then immediately add 2 drops of buffer solution to the test card;
5. Read the result within 10 minutes.
█、 Interpretation diagram
█、 Product advantages
This kit has been evaluated in a provincial CDC and a designated hospital
The results show that:
High detection rate: according to the clinical judgment standard of the latest version of diagnosis and treatment guide issued by the national health and Health Commission
The positive rate was 93.3% (152 / 163);
Good specificity: 99.1% (112 / 113) was detected in healthy people;
Simple operation: no need for instruments and equipment, no site restrictions, visual inspection can determine the results;
Blood collection convenience: blood collection at fingertip with blood collection needle can be detected.
█、 Application scenario
This product can make up for the defect of low detection rate of nucleic acid detection reagent, and can greatly improve the new crown when used together
The positive detection rate and diagnostic accuracy of pneumonia patients infected with virus can be used in hospitals, CDCs, communities and so on
Auxiliary diagnosis means of medical and health institutions such as clinics, counties and villages. At the same time, it can also be applied to the third-party medical examination
The screening of enterprises, institutions, schools, etc. to return to work and study, family self-test, customs inspection and quarantine, etc Scene needs.
