SARS CoV 2 IgG/IgM Rapid Antibody Test

SARS CoV 2 IgG/IgM Rapid Antibody Test is brought to you by Noviral Sweden AB

Size: 25 Test Cassettes
Run Time: <15 min
Sample Type: Serum, Plasma or Whole Blood
Species Sample: Human
Sample Size: 10 µL
Alternative Names: Serology, Coronavirus, COVID-19, Corona, Serological
IVD, CE-Marked

Lancets and Buffer included

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Assay Principle

The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is a lateral flow immunochromato-graphic assay. The test uses anti-human IgM antibody (test line IgM) , anti-human IgG (test line IgG) and rabbit IgG  (control line C) immobilised on a nitrocellulose strip. The burgundy colored conjugate pad contains colloidal gold conjugated to recombinant COVID-19 antigens conjugat-ed with colloid gold (COVID-19 conjugates). When a specimen followed by assay buffer is added to the sample well, IgM &/or IgG antibodies if present, will bind to COVID- 19 conjugates making antigen antibodies com-plex. This complex migrates through nitrocellulose mem-brane by capillary action. When the complex meets the line of the corresponding immobilized antibody (anti-hu-man IgM &/or anit-human IgG) the complex is trapped forming a burgundy colored band which confirm a reactive test result. Absence of a colored band in the test region indicates a non reactive test result.
To serve as a procedural control, a colored line will always change from blue to red in the control line region, indicat-ing that the proper volume of specimen has been added and membrane wicking has occurred.

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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 TBD

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。