• COVID-19 Testing Solutions, Made in America

Single-Line COVID-19 Antibody Detection Test

COVID-19 IgG/IgM/IgA Rapid Test Cassette

SAS™ Single-Line COVID-19 Total Antibody Detection Test

COVID-19 Total Antibody Detection tests are intended for point of care application, they are not intended for home use without oversight to interpret the test results.

Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Regular testing is recommended. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary. 

Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains (coHKU1, NL63, OC43, or 229E). Consider follow up testing with molecular diagnostic to rule out infection in these individuals. To mitigate risk of false positive results, consider follow-up testing using a second, different rapid test, ie; total antibody detection to dual line IgG/IgM assay, etc.

Results from one antibody test should not be used as the sole basis to diagnose or exclude SARS- CoV-2 infection or to inform infection status. Tests are intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

  • Manufactured at SAS™
  • Total Antibody Detection test detect IgM, IgG and IgA antibodies against SARS-CoV-2 showing results on one definitive line.
  • The primary advantage of total antibody detection is the increase in sensitivity and specificity.
  • These highly accurate tests can play a critical role in COVID-19 screening.
  • Results show in less than 15 minutes and do not require a machine or nasal swabbing – just a fingerstick.

Additional information including clinical validation studies, fact sheets, and supplemental information available upon request.

For early access, please contact our sales team.

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Example of Negative Results

The test is negative if a colored line appears only in the C area (control).

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Example of Positive Results

The test is positive for SARS-CoV-2 antibody if a colored line appears in the S area (sample).

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Notice:

Antibody Tests are primarily intended for point of care application, they are not yet intended for home use without the oversight of a clinician to interpret the test results, record and report data pertinent to public health, and develop/discuss an appropriate care plan if necessary.

Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Regular testing is recommended. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.

Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains (coHKU1, NL63, OC43, or 229E). Consider follow up testing with molecular diagnostic to rule out infection in these individuals. To mitigate risk of false positive results, consider follow-up testing using a second, different rapid test, i.e., total antibody detection to dual line IgG/IgM assay, etc.

Results from one antibody test should not be used as the sole basis to diagnose or exclude SARS- CoV-2 infection or to inform infection status. Tests are intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

Additional information including clinical validation studies, fact sheets, and specific recommendations for asymptomatic testing programs available to healthcare providers upon request.

This test has not yet been reviewed by the FDA.

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