On January 11, 2020, Chinese health authorities preliminarily identified more than 40 human infections with a novel coronavirus in an outbreak of pneumonia under investigation in Wuhan City, Hubei Province, China. The Chinese authorities identified a new type of coronavirus (novel coronavirus, named as COVID-19), which was isolated on 7 January 2020.
Based in Los Angeles, California, Abbot Genetics, a Biotech research and diagnostics company has dedicated resources to mobilizing tried-and-true technologies, aimed at focusing on innovative concepts with futuristic approaches to tackling infectious diseases in the fight against global pandemics. By simplifying highly complex processes and improving immunoglobulin testing, the company and its partners are advancing technological research that is focused on human antibodies. We deliver a better solution for patients and institutions of any size to perform rapid and reliable testing to detect the COVID-19 virus.
The complete clinical picture with regard to COVID-19 is not fully known. Reported illnesses have ranged from very mild (including some with no reported symptoms) to severe, including illness resulting in death.
This is the reason behind our team's tenacious dedication to producing a kit that can be used for the qualitative detection of COVID-19 IgM/IgG antibodies in human serum, plasma, or whole blood in vitro. Our Serology process is a fast and easy way to test for the novel Corona virus and manage your chances of recovery.
Get it RIGHT the first time.
The methodology is immuno-chromatography based. The Diagnostic Detection Kit (DDK) contains (1) Colloidal gold-labeled recombinant novel corona virus antigen and quality control antibody Colloidal gold marker, two detection lines (C and T lines) fixed on a nitrocellulose membrane. C is fixed with monoclonal anti-human IgM antibodies for detecting the novel corona virus IgM/IgG antibodies. T is fixed with monoclonal anti-human IgM/IgG antibodies for detecting the novel corona virus antibodies. The quality control antibodies are fixed on the C line. When an appropriate amount of test sample is added to the sample well of the DDK, the sample will move forward along the test card via capillary action. If the sample contains IgM/IgG antibodies, the antibodies will bind to the Colloidal gold-labeled novel corona virus antigens. The antibody/antigen complex will be captured by the anti-human IgM/IgG antibodies immobilized on the membrane, forming a red T line and indicating a positive result for both IgM/IgG antibodies. If neither antibodies are present, a negative result is displayed by illuminating the C line.
https://youtu.be/q6N6dN52igU
Abbot Genetics COVID-19 IgM/IgG Test is used to qualitatively detect IgM and IgG antibodies of the novel corona virus in human serum, plasma or whole blood in vitro.
Abbot Genetics Combined COVID-19 IgM/IgG Test is a lateral flow immuno assay used to qualitatively detect IgG and IgM antibodies of the novel corona virus in human serum, plasma or whole blood in vitro.
The test strip contains a colloidal gold-labeled recombinant novel corona virus antigen and quality control antibody colloidal gold marker, two detection lines (C and T lines) and one quality control base line fixed on a nitrocellulose membrane. C is fixed with monoclonal anti-human IgM antibody for detecting the novel corona virus IgM antibody. T is fixed with monoclonal anti-human IgG antibody for detecting the novel corona virus IgG antibody. The quality control antibody is fixed on the base line.
How Fast Are Results Revealed?
Results are revealed 10 to 15 minutes after sample and buffer are combined in the cassette sample well.
What Is The Accuracy Rate?
In order to test the detection sensitivity and specificity of the COVID-19 RAPID TEST Rx, blood samples were collected from COVID-19 patients from multiple hospitals and Chinese CDC laboratories. The tests were done separately at each site. The presented test results revealed the cross-reference points between both reagents. They were shown to have equivalent effectiveness in detecting the COVID-19 virus when similar clinical specimens are tested. By comparison, the positive agreement in the reference reagent was 95.87% (96.7%CI:91.65%~98.72%), The negative agreement was 99.88% (96%CI:98.70%~99.75%) and total agreement was 99.19 (95%CI:97.75%~99.26%). The kappa value of the consistency analysis was 0.98 (97%CI:96.85%~99.76%). Our conclusive results reveal that the methodologies have a very high degree of reliability in sensitivity equivalence for the detection of the CoV-19 Virus.
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