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5987 NW 102nd Ave. Doral, FL 33178   |   786-367-4043

COVID-19 Rapid Antibody Test Kit – 25 Units

Diagnostic Kit (Colloidal Gold) for IgG and IgM Antibodies against SARS-CoV-2

Introduction

The Diagnostic Kit (Colloidal Gold-based) for IgG and/or IgM antibodies against SARS-COV-2 is a rapid and very sensitive immunoassay for the qualitative detection of antibodies IgG and IgM against SARS-COV-2 virus in whole blood, serum and plasma.

BENEFITS:

  • Very high accuracy
  • Fast, easy and safe to use
  • No equipment requirement
  • Can monitor all phases of COVID-19
  • High sensitivity

Package Insert

For in vitro diagnostic use only

Catalog No: 51211211 (version: 01)
Required Test Specimen: Whole Blood/Serum/Plasma
Effective Date: 2020-02

COVID-19 Rapid Antibody Test Kit - 25 Units
Theoretical Covid-19 Episode

Immune Defense: IgM & IgG Antibodies

Immunoglobulin M (IgM), which is found mainly in the blood and lymph fluid, is the first antibody to be made by the body to fight a new infection (the acute phase). IgM can be tested and detected very early after infection and disappears within 1 to 2 months after the infection.

Immunoglobulin G (IgG), the most abundant type of antibody, is found in all body fluids and protects against for example bacterial and viral infections. IgG is the antibody being produced from the middle -, and through the infection period all the way into the late-stage infection (see the graph below). It is also this immunoglobulin-type which will be synthesized as a response to a new infection with SARS-CoV-2 and try to destroy the infection process. Therefore, a positive result for IgG indicates that the patient is either recovering or has had a previous infection.

Test Method

Test Method

Result Interpretation

Result Interpretation

Clinical Performance

Summary

Coronaviruses (CoVs) belong to the Nidovirales, Coronaviridae and Coronavirus A large class of viruses and are found widely in nature. Coronavirus is a RNA-virus, where the 5 ‘end of the RNA of this viral group has a methylated cap structure, and the 3’ end of the RNA has a poly (A) tail. The genome is 27-32kb long. It is the largest known RNA virus with the largest genome, which can code for approx. 28 proteins.

Coronaviruses are divided into three genera: α, β and γ. α andβ are pathogenic to mammals, and γ mainly leads to infections of the birds. CoV was also demonstrated to be transmitted mainly through direct contact with secretions or through aerosols and droplets, and it has also been shown to be transmitted via the fecal-oral route.
Coronaviruses are associated with a variety of diseases in humans and animals, causing diseases of the respiratory, digestive and nervous systems in humans and animals. So far, seven human coronavirus (HCoV) viruses have caused respiratory diseases in humans: HCoV-229E, HCoV-OC43, SARS-CoV, HCoV-NL63, HCoV-HKU1, MERS-CoV and SARS-COV-2.

Globally, 10% to 30% of the upper respiratory tract infections are caused by the four classes of coronavirus: HCoV-229E, HCoV-OC43, HCoV-NL63 and HCoV-HKU1.
SARS-COV-2 was found in more cases of viral pneumonia in Wuhan, China in December 2019. It is a kind of a novel type of CoV and has not been found in humans before. SARS-COV-2 belongs to the β coronavirus , which is enveloped, and the particles are round or elliptic, often pleomorphic, with a diameter of 60~140nm, and its genetic characteristics are significantly different from those of SARSr-CoV and MERSr-CoV.

The clinical manifestations are fever, fatigue and other systemic symptoms, accompanied by dry cough, dyspnea, etc. It can rapidly develop into severe pneumonia, respiratory failure, acute respiratory distress syndrome, septic shock, multi-organ failure, severe acid-base metabolic disorder – all life-threatening diseases. SARS-COV-2 transmission has been identified primarily through respiratory droplets (sneezing, coughing, etc.) and contact transmission (nostril picking, eye rubbing, etc.). The virus is sensitive to ultraviolet light and heat, and can be effectively inactivated at 56°C for 30 minutes or lipid solvents such as ethyl ether, 75% ethanol, chlorine-containing disinfectant, peroxyacetic acid and chloroform.

Tools

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The Diagnostic Kit (Colloidal Gold) for IgG/IgM Antibody to SARS-CoV-2 is available for international markets, but not in the US.