• COVID-19 Testing Solutions, Made in America

Disclosures

Legal Notice

Disclosures

  • This test has not yet been approved by the FDA.
  • This IgG/IgM antibody detection test is a rapid visual immunochromatographic assay for the qualitative detection of IgG and IgM antibodies from human whole blood or serum and provides a result in less than 15 minutes.
  • Results from this test should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
  • Rapid Result Tests are intended for point of care application - not for home use.
  • Positive results may be due to past or present infection with non-SARS-CoV-2 corona virus strains (coHKU1,NL63,OC43,or229E). Consider follow up testing with molecular diagnostic testing to rule out infection in these individuals.
  • Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Results from one antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.
  • To report adverse events please email compliance@acumen-inc.com
  • Validation studies, factsheets, and supplemental information are available upon request. Please email inquiries and requests to sales@acumen-inc.com