SARS-CoV-2 IgM/IgG Antibody Rapid Test（20tests/box）

预期用途
TheStrongStep ® SARS-CoV-2 IgM/IgG 检测是一种快速免疫层析检测，用于同时检测人全血、血清或血浆中针对 SARS-CoV-2 病毒的 IgM 和 IgG 抗体。该测定被用作诊断 COVID-19 的辅助手段。

介绍
Coronavirus is enveloped RNA virus distributed broadly among humans, other mammals and birds, which cause respiratory, enteric, hepatic and neurologic diseases. Seven coronavirus species are known to cause human disease. Four virus strains - 229E, OC43, NL63 and HKU1 – are prevalent and typically cause common cold symptoms in immuno-competent individuals. The three other strains – severe acute respiratory syndrome coronavirus (SARS-CoV), Middle East respiratory syndrome coronavirus (MERS-CoV) and 2019 Novel Coronavirus (COVID-19) – are zoonotic in origin and have been linked to sometimes fatal illness, Coronavirus is zoonotic, which meaning they can be transmitted between animals and people. Common signs of infection include respirator symptoms, fever, cough, shortness of breath and breathing difficulties. In more severe cases, infection can cause pneumonia, severe acute respiratory syndrome, kidney failure and even death. IgM and IgG antibodies to 2019 Novel Coronavirus can be detected with 1-2 weeks after exposure. IgG remains positive, but the antibody level drops overtime.

PRINCIPLE
TheStrongStep®SARS-CoV-2 IgM/IgG Test utilizes the principle of Immuno-chromatography. Each device contain two strips, where SARS-CoV-2 specific recombinant antigen immobilized on the nitrocellulose membrane within test window of device. Mouse anti-human IgM and anti-human IgG antibodies conjugated with colored latex beads are immobilized on the conjugate pad of the two strips respectively. As the test sample flows through the membrane within the test device, the colored mouse anti-human IgM and anti-human IgG antibodies form latex conjugate complexes with human antibodies (IgM and/or IgG). This complex moves further on the membrane to the test region where it is captured by SARS-CoV-2 specific recombinant antigen. If SARS-CoV-2 virus IgG/IgM antibodies present in the sample, which is leading to formation of a colored band and it indicates a positive test results. Absence of this colored band within the test window indicates a negative test result. This complex moves further on the membrane to the control region where it is captured by goat anti-mouse antibody and forms red control line which is a built-in control line that will always appear in the test window when the test is performed properly, regardless of the presence or absence of anti-SARS-CoV-2 virus antibodies in the specimen.

套装组件
1. 铝箔袋中的StrongStep ® SARS-CoV-2 IgM/IgG 测试卡
2. 样品缓冲液
3。使用说明

需要
但未提供的材料1. 标本收集容器
2。1-20μL移液器
3．发生时间

该测试在美国认证于传递给 CLIA 的实验室，以执行高强度测试。

该测试尚未经过 FDA 审查。

简单粗暴的SARS-CoV-2感染。

怀疑如果是急性感染，则需要直接检测 SARS-CoV-2。

抗体检测结果不透诊断或急性急性 SARS-CoV-2 感染。

真正的结果可能是由于过去或现在感染了非 SARS-CoV-2 冠状病毒株，例如冠状病毒 HKU1、NL63、OC43 或 229E。