Solving the Need for Wide Scale Testing

There is an urgent need for a rapid, point of care, simple to use, and accurate serological test to identify COVID-19 infected individuals as well as those who have developed an immune response or who have recovered.

It’s widely accepted that the Immunoglobulin M (IgM) antibody provides the first line of defense during viral infections, followed by the generation of adaptive, high affinity Immunoglobulin G (IgG) antibody responses for long-term immunity and immunological memory. 
Therefore, testing of SARS-CoV2 IgM and IgG antibodies are an effective tool in addition to molecular testing for the rapid detection of antibodies that are a immune response to a COVID-19 infection. We are a distributor of test kits that effectively and accurately tests for IgM and IgG antibodies that are produced in reaction to the SARS-CoV2 virus that causes the COVID-19 disease.
A lateral flow IgM/IgG Antibody Rapid test kit should be used as a screening tool in a health care professionals took kit that compliments PCR testing or which can be confirmed by RT-PCR testing. Any positives with an antibody test should be confirmed with a RT-PCR test. Antibody tests and RT-PCR tests should not be looked at as being mutually exclusive. Each test method has their place, and their own advantages and disadvantages. To avoid false negatives and false positives it is recommended that the antibody test be used as a screening test  for asymptomatic individuals and the RT-PCR test be used as a confirmation test. Our COVID-19 IgG/IgM rapid test devices compliment RT-PCR tests due to the following antibody test characteristics:
  • A simple test administered at the point-of-care with results obtained in 10 minutes or less;
  • Results with over 100% sensitivity and 97.5% specificity to screen and isolate carriers immediately; 
  • Ease of use
  • No special training is required
  • Can be used on patients who are asymptomatic.
  • Results are clear and easy to read.
  • Venipuncture IgG/IgM antibody tests can sometimes be a remedy to some false negatives inherent in respiratory swab samples taken for PCR tests, in the case where there is a low concentration of the virus in mucus due to dryness, the stage of the infection, faulty test administration or other reason. (Infections can move from the nose and throat into the lungs.)
  • Use as a tool with a PCR confirmation test to help identify Individuals who have acquired an adaptive immunity due to SAR-CoV-2 so that they can go back to their normal lives and so we can get our economy moving again. 
  • Single Use
The following 4 quadrant chart explains 4 possible scenarios, whereby a rapid IgG/IgM antibody test and PCR test can either be consistent or inconsistent.
The four scenarios are:
  1. Antibody Test/PCR –  Positive/Positive – Top Right Quadrant
  2. Antibody Test/PCR –  Positive/Negative – Top Left Quadrant 
  3. Antibody Test/PCR –  Negative/Positive – Bottom Right Quadrant
  4. Antibody Test/PCR –  Negative/Negative – Bottom Left Quadrant
IgM begins to appear generally from 7 to 14 days after initial exposure and may peak 14 to 21 days after initial exposure, followed by IgG in the middle and late stages of the infection.  IgM/IgG antibody tests can be an important tool to determine whether a patient recently or previously was infected by the SAR-Cov-2 virus.  It can also be used as a tool to help determine if a person has acquired an adaptive immunity to the virus.  Please note that researchers are still determining the exact incubation period and whether a person can get re-infected. The chart above is not intended to give exact periods of time. Each person may have a different incubation/infection period and period of symptoms, assuming they even have symptoms.
This test kit is a colloidal gold immunoassay device. The way that most lateral flow immunoassay devices works is that a colormetric bio strip detects antibodies that are secreted by a person’s immune system. The immune system  secretes these antibodies in reaction to an antigen such as SAR-COV2.  
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