Coronavirus COVID-19 IgM ELISA Assay Kit
Coronavirus COVID-19 IgM ELISA Assay Kit was developed and manufactured in the US
Size: 1×96 wells
Sensitivity: Cut-off control
Incubation Time: 1 Hour, 20 minutes
Sample Type: Serum
Species Sample: Human
Sample Size: 20 µL
Alternative Names: Serology, Coronavirus, COVID-19, Corona, Serological
IVD, CE-Marked
Controls Included
Cross Reactivity
Panels were studied with a minimum of five confirmed disease state samples with this serology assay. No interference was observed for the following disease or infectious agents:
- Anti-influenza A
- Anti-influenza B
- Hepatitis C (HCV)
- Antinuclear Antibodies (ANA)
- Respiratory Syncytial (RSV)
Assay Principle
The COVID-19 IgM ELISA Assay Kit is designed, developed, and produced for the qualitative measurement of the COVID-19 IgM antibody in serum samples. This COVID-19 serology ELISA assay utilizes the microplate based enzyme immunoassay technique.
Assay controls and samples, as well as the biotinylated COVID-19 specific peptide antigens are added to the microtiter wells of a microplate that was coated with a anti-human IgM specific antibody. After the first incubation period, the unbound protein matrix is removed with a subsequent washing step. A horseradish peroxidase (HRP) labeled streptavidin is added to each well. After an incubation period, an immunocomplex of ” Anti-hIgM antibody – human nCoV IgM antibody – HRP labeled COVID-19 antigen” is formed if there is novel coronavirus IgM antibody present in the tested materials. The unbound tracer antibody is removed by the subsequent washing step. HRP-labeled COVID-19 antigen tracer bound to the well is then incubated with a substrate solution in a timed reaction and then measured in a spectrophotometric microplate reader. The enzymatic activity of the tracer antibody bound to the coronoavirus IgM on the wall of the microtiter well is proportional to the amount of the coronavirus IgM antibody level in the tested material.
Information for US Customers
During this crisis, steps are being taken to ensure that we can provide access to quality products for diagnostic testing. The Food and Drug Administration (FDA) has issued guidance which allows for distribution of the serological tests. At this time, the kits are released for sale in the United States under the provisions outlined in Section D of Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency.
The kits are registered under product code QKO, the submission number is D376537.
Per the aforementioned guidance, the following statements are required:
- This test has not been reviewed by the FDA.
- Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus.
- Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
- Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
- Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
This kit is only provided for use by clinical laboratories or to healthcare workers for point-of-care testing, and not for at home testing.
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EagleBio的5α-雄甾烷-3α，17β-二醇葡糖醛酸化物是C19类固醇，缩写为3α-DiolG，5α二醇G或简称为α二醇G。它主要作为睾丸激素和二氢睾丸激素（DHT）的代谢产物生产。它主要在目标外围组织（例如皮肤）中产生，尤其是在毛囊周围。大量的3α-DiolG刺激会导致过多的头发形成，特别是在女性通常不存在头发的地方。近年来，在研究患有特发性多毛症的妇女的临床研究人员中，人们对这种类固醇的测量越来越感兴趣。已知是3α-DiolG前体的类固醇包括脱氢表雄酮（DHEA），硫酸脱氢表雄酮（DHEAS），二氢睾丸酮（DHT），雄烯二酮和睾丸激素。已显示只有3α-DiolG随多毛症增加而随治疗减少。这种相关性在多囊卵巢综合征（PCO）患者中也得到了证明。3α-DiolG的测定因此被证明是多种方式的有用指标，包括监测特发性多毛症和PCO妇女的治疗进展。此外，接受环孢霉素A治疗的糖尿病患者（无论男女）均显示3α-DiolG水平升高，这种副作用导致以前无毛的区域出现了头发。3α-DiolG的测定因此被证明是多种方式的有用指标，包括监测特发性多毛症和PCO妇女的治疗进展。此外，接受环孢霉素A治疗的糖尿病患者（无论男女）均显示3α-DiolG水平升高，这种副作用导致以前无毛的区域出现了头发。3α-DiolG的测定因此被证明是多种方式的有用指标，包括监测特发性多毛症和PCO妇女的治疗进展。此外，接受环孢霉素A治疗的糖尿病患者（无论男女）均显示3α-DiolG水平升高，这种副作用导致以前无毛的区域出现了头发。
