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ImmunoPass™ SARS-Cov-2 Neutralizing Antibody (NAb) Rapid Test is a rapid lateral flow chromatographic immunoassay intended for the semi-quantitative measurement of neutralizing antibody in human serum or plasma (sodium heparin, potassium and acid dextrose citrate).
The ImmunoPass™ SARS-Cov-2 Neutralizing Antibody (NAb) Rapid Test measures functional neutralizing antibodies (NAbs) within 10 minutes, unlike traditional test which require days. The ImmunoPass™ test kit does not utilize live biological materials and does not require the strict biosafety protocol associated with live virus samples.
The ImmunoPass™ Neutralizing Antibody (NAb) test demonstrates the ability of antibodies to BLOCK the binding of the RBD on spike protein to ACE2, the cellular receptor. RBD is the principle neutralizing determinant for SARS-CoV-2.
Why Are Neutralizing Antibodies Important?
- NEUTRALIZING ANTIBODIES BLOCK the COVID virus, providing immunity protection against infection and re-infection
- NEUTRALIZING ANTIBODIES inactivate the COVID-19 virus and are ASSOCIATED WITH IMMUNITY
- NON-NEUTRALIZING ANTIBODIES do not block or neutralize COVID, thus provide no protection against re-infection.
How are Neutralizing Antibodies Measured?
- The ImmunoPass™ Neutralizing Antibody tests measures titer levels, which indicate the amount of neutralizing antibodies in a blood sample.
- Titers are measured by ratios, where a higher ratio (1:320 compared to 1:8) indicates higher titer levels. A higher titer level means that the blood can be diluted many times and still produce a virus-neutralizing response.
The ImmunoPass™ Neutralizing Antibody (NAb) Rapid Test is intended for semi-quantitative measurement of neutralizing antibody levels in plasma or serum from individuals who have had recent or prior infection with SARS-CoV-2 and who have recovered from COVID-19. This product is intended for use as a clinical decision-making tool for therapeutic administration of convalescent plasma for treatment of patients fighting COVID-19. The Test is for professional use only.
FDA Emergency Use Authorization: Coming soon.