Medicalsystem

Reliable and quick
results within minutes

In the war against COVID-19, utilizing multiple Tests for different settings and stages of a person's infection is crucial, from high-volume lab capabilities to fast solutions that give results on the spot, from tests that detect the active virus to tests that detect Antibodies in people who were previously infected.

The COVID-19 IgG/IgM Rapid Test has emerged as a critical part of this arsenal, delivering swift diagnosis - with results in 15 minutes or less - in a variety of locations such as physicians' offices, urgent care clinics and other point-of-care locations.

Because of its portability and speed, rapid IVD testing has been crucial in battling COVID-19 across the globe.

FEATURES + BENEFITS
  • Qualitative detection of IgG and IgM antibodies that bind to COVID-19 causing virus
  • Simple and easy to use
  • Healthcare providers can administer tests at the point-of care or laboratories
  • Results delivered within minutes
DISCLAIMER
  • COVID-19 IgG/IgM Rapid Test is a solid phase immunochromatographic assay used in the rapid, qualitative and differential detection of IgG and IgM antibodies to the 2019 novel coronavirus in human whole blood, serum or plasma.
  • 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.
  • 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.
  • 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.
  • It is not known whether persons having antibodies to SARS-CoV-2 are not infectious, can be re-infected or may experience COVID-19 in the future.
  • Not for use in blood screening.
  • For use only by clinical laboratories and healthcare workers at the point-of-care. All other use is prohibited.
  • Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.
  • Manufactured in China by MedicalSystem Biotechnology Co., Ltd (SHE: CN: 300439), a publicly traded Chinese company, distributed in the US by RapidIVD, a PMT
    • Medical company
  • MedicalSystem Biotechnology has notified the FDA that they have validated and will begin offering the COVID-19 IgG/IgM Rapid Test. The test is being made available under compliance with Section IV.D. of the FDA's Policy for Diagnostic Tests for Coronavirus Disease-2019 during the Public Health Emergency. Updated FDA guidance, issued on March 16, 2020, allows the distribution of this product for diagnostic use by professionals within highly complex settings and or pharmacies. The updated policy can be viewed by clicking here.
  • This test is FDA EUA approved, but has not been reviewed by the FDA.
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