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新型冠状病毒(COVID-19)IgG/IgM抗体检测试剂盒

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COVID-19 IgM/IgG Rapid Test

BioMedomics has developed and launched one of the world’s first rapid point-of-care lateral flow immunoassays for the diagnosis of coronavirus infection. The test has been used widely by the Chinese CDC to combat infections and is now available globally. This test detects both early marker and late marker, IgM/IgG antibodies in human finger-prick or venous blood samples. 

It can be used for rapid screening of carriers of the virus that are symptomatic or asymptomatic. Recent studies suggest that a high percentage of patients show no clinical symptoms of the virus, thus screening patients is vitally important. The test is ideally suited for hospitals, clinics and test laboratories. The test can also be effectively deployed in businesses, schools, airports, seaports and train stations, etc., giving it the potential to become a compelling force in the fight against this global threat. 

NOTE: Updated USFDA guidance issued on March 16, 2020, allows the distribution of this product for diagnostic use in laboratories or by healthcare workers at the point-of-care. The updated policy can be viewed by clicking here. Please see FAQ’s below for more detailed information.

This product has CE-IVD registration. You can download the Certificate of Conformity here.

 

Features & Benefits

 

BioMedomics Rapid IgM-IgG Combined Antibody Test for COVID-19 is used to qualitatively detect IgG and IgM antibodies of the novel coronavirus in human serum, plasma or whole blood in vitro.

 

Precise

 

· Works with whole blood, serum, & plasma
· Tests for both IgM and IgG antibodies
· Validated using PCR

 

Fast

 

· 15 minutes per test
· Intuitive visual interpretation
· No special equipment needed

 

Steps

1

 

How It Works

4

3

2

1. Collect blood/serum/plasma sample.

2. Add blood/serum/plasma sample to sample well.

3. Place 2-3 drops of buffer in sample well.

4. Read results after 15 minutes.

Results

 

项目介绍

新冠病毒肆虐,对疑似病人和密切接触人群进行现场快速初筛,并利用有限的医疗资源隔离和治疗感染患者非常重要,以实时荧光PCR为代表的核酸检测技术暴露出非常多的问题,例如咽拭子采样质量难控制、病毒RNA易降解等原因导致的假阴性;核酸气溶胶污染导致的假阳性;设备昂贵、对场地和人员要求高等,导致目前的分子筛查方法在疫情爆发时远远无法满足初筛的需求。

免疫层析技术无需设备、成本低、检测耗时极短,完全可满足新冠疫情的即时快速初筛。在硝酸纤维素膜试纸条上利用标记(胶体金颗粒或有色微球)的重组抗原与待测血清中的新冠病毒特异抗体(IgG/IgM)结合,当通过检测线时,可被对应二抗特异性捕获,即可实现新冠病毒特异抗体(IgG/IgM)即时快速检测。

 

检测步骤

1准备检测时,从撕口处打开铝箔袋,将检测卡取出,平放于水平桌面上;

2将检测卡上标注样本号;

3用移液器从样本管中吸取待测血清、血浆10μL或全血样本15μL于检测卡上样本孔内,

  立即在样本孔内滴加3滴样本稀释液,并保证过程中没有气泡产生;

4计时,15分钟左右判读结果,30分钟后无效。

 

 

 

 

新冠病毒检测试剂盒

COVID-19 IgM/IgG Rapid Test

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