(888)866-4249 info@medsancovid.com

Antibody Rapid Test for Covid 19 (Pending FDA EUA Approval)

Manufactured and Packaged in Germany

The CDC is looking at data from antibody tests to estimate the total number of people who have been infected with SARS-CoV-2 in the United States. The CDC is also using antibody testing to learn more about how the body’s immune system responds to the virus and to explore how the virus spreads among people exposed to it.

MEDsan qSARS-CoV-2 IgG/IgM Rapid Test

Pending FDA Emergency Use Authorization

The MEDsan qSARS-CoV-2 IgG/IgM Rapid Test is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in serum, plasma (EDTA, citrate) or venipuncture whole blood specimens from patients suspected of COVID-19 infection by a healthcare provider.

Currently, the most widely used test in the Covid-19 pandemic is a molecular test which looks for signs of active infection and requires a swab at the back of the throat or in the nasal cavity, that is sent to a lab for a PCR test to detect the virus’s genetic material. This test can only help diagnose current cases and cannot tell whether a person has had the infection and recovered from it.

The MEDsan Covid-19 test is a serological test that detects the antibodies that the body produces to fight the virus. The antibodies, therefore, exist in the blood and tissues of people who have recovered from the virus. IgG/IgM tests are proving to be helpful in detecting cases of infection with mild or no symptoms. While there is no guarantee that having the antibodies will provide immunity, the serological test is rapidly assessing the need for quarantining and could reveal the extent of the pandemic.

MEDsan has a proven history of providing highly effective infectious disease tests that provide:

  • Self-contained, all-in-one kits with everything needed for testing, no machines or labs required to get results in minutes; and
  • Covid-19 Serologic tests with a total accuracy of 98% based on testing for serum blood and plasma

MEDsan is currently awaiting FDA Approval for EUA to use their product in the United States. The MEDsan tests have been used worldwide and have passed the testing standards for the European Economic Area earning them a CE certification.

INTENDED USE:

MEDsan COVID-19 IgM/IgG Rapid Test is a solid phase immunochromatographic assay for the rapid, qualitative and differential detection of IgM and IgG antibodies against novel coronavirus SARS-CoV-2 infected cells in human whole blood, serum or plasma. This test provides only a preliminary test result. Therefore, any reactive specimen with the MEDsan COVID-19 IgM/ IgG Rapid Test must be confirmed with alternative testing method(s) and clinical findings.

Coronavirus (Covid-19) Pandemic

Coronaviruses (CoV) are a large family of viruses that cause illnesses ranging from the common cold to more severe diseases such as Middle East Respiratory Syndrome (MERS-CoV).(1) The current outbreak of coronavirus disease was first reported from Wuhan, China in December 2019. After cases were identified in several countries, a global health emergency was declared with over 167,000 cases and thousands of deaths.(2)

 
Since its discovery in late 2019 in China, things have escalated rapidly in the U.S. On January 21, 2020 the first COVID-19 case was confirmed in Washington state and only seven weeks later, the U.S. declared a National Emergency with over 4,000 confirmed cases.(1) Risk factors for severe illness are not yet clear, although older patients and those with chronic medical conditions may be at higher risk.(1) Testing methods for the SARS-CoV-2 are still developing and are highly complex. Current molecular methods involve significant specimen handling time and nucleic acid extraction methods.(3)
1. Centers for Disease Control and Prevention. (2020). Coronavirus. Retrieved from https://www.cdc.gov/coronavirus/index.html.
2. World Health Organization. (2020). WHO statement on cases of COVID-19 surpassing 100 000. Retrieved from https://www.who.int/news-room/detail/07-03-2020-whostatement-on-cases-of-covid-19-surpassing-100-000.
3. Centers for Disease Control and Prevention. (2020). Real-time RT-PCR panel for detection 2019-novel coronavirus. Retrieved from https://www.cdc.gov/coronavirus/2019-ncov/lab/rt-pcr-detection-instructions.html.