About Our Test

Our COVID-19 rapid test identifies the body's response to coronavirus after the onset of infection, and gives qualitative results as to who has been exposed. Implementing rapid screening for COVID-19 has huge time and cost savings when compared to laboratory screening, and will help to control the spread of the virus by identifying infection rapidly and accurately. The test cassette is easy to use, needing only a finger-prick sample to function, much like a blood glucose test.

Reliable Results in COVID-19 (SARS-COV-2) Serology Testing

CV19RapidTest™ is for the qualitative detection of antibodies (lgG and lgM) to SARS-CoV-2 in human whole blood, serum, or plasma as a screening aid in the diagnosis of primary and secondary SARSCo V-2 infections. This is a lateral flow immunoassay test and operates in a similar way to a pregnancy test. Embedded into the test strip are antibodies that bind to a COVID-19 specific biomarker, Immunoglobulin G (IgG), and another infection biomarker, Immunoglobulin M (IgM). When a sample (blood, serum or plasma) is added to one end of the test, it flows along the test strip and interacts with these antibodies. If the patient has contracted COVID-19, the biomarkers in their blood will bind to the antibodies on the test strip, leaving a visible test line. If the patient doesn’t have COVID-19, no biomarkers should be present in their blood and only a control line will be visible to indicate a positive result. There are separate test lines for IgG and IgM and control.

Easy to perform point of care test that provides reliable test results within 15 minutes.

Can be performed on location by or at the direction or a medical professional.

Can inform individuals and employers who currently have active IgM or IgG antibodies suggesting who should seek further physician care or has possibly run the course of the virus.

Perfect for companies to test their workforce and minimize risks or outbreaks in work environments which lead to expensive downtimes.

On location testing services for easily large scale employee Covid 19 screening.

These test are available under the FDA Emergency Use Authorization under the provisions in section D of FDA guidance Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency:

DISCLAIMERS

  • 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.

About COVID-19 TESTING

While PCR is still the gold standard for detecting SARS-CoV2 infections, the test protocol is complex and expensive, and requires large, centralized diagnostic laboratories. Tests typically take 4–6 hours to complete and the logistical requirement to ship clinical samples means long turn around times. (https://www.nature.com/articles/d41587-020-00010-2)

Working with our test kit development partners, CV19RapidTest™ is offering an immunoassay lateral-flow COVID-19 IgM/IgG Rapid Test that can reliably detect SARS-CoV-2 antibodies in whole blood and serum samples, which are produced by the body in as little as 7 days after the onset of infection. Our tests can be performed on location and at point of care and provide reliable results within 15 minutes with only a few drops of blood pricked from the finger.

With an incubation period of up to 14 days for COVID-19, before symptoms are shown, the chances of virus transmission within the population and workplace prove hard to contain. Current Molecular based tests are typically performed, as instructed by health authorities, only if the particular COVID-19 symptoms are shown or if they are showing high-risk. Therefore many individuals may be carrying this virus for 14 days without being aware due to not showing symptoms yet, while they continue to function normally in the workplace.

An increase in the need for molecular testing has caused a shortage of swabs and the FDA has approved Emergency Use Authorization (EUA) for immunoassay kit developers as a viable alternative. With the announcement that many flock swab manufacturers are in short supply across Europe and the US, immunoassay kits such as CV19RapidTest™, that require no swabs or specialized laboratory equipment, provide a viable complimentary test protocol to manage the outbreak and help employers significantly reduce risk.