Easy to Use
Rapid Results in 10 Minutes
Requires No Additional Equipment
ImmunoPass™ SARS-Cov-2 Neutralizing Antibody (NAb) Rapid Test is a rapid lateral flow chromatographic immunoassay intended for the sem-iquantitative 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.
Validated by Empowered Diagnostics, LLC. CovClear has been validated, but the FDA’s independent review of this validation is pending.
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.
Back to Work and Back to School
- Test employees to determine NAb levels, providing insight into their immunity effectiveness
- Test teachers and students to monitor their level of immune protection
- Longitudinal monitoring of NAbs to track changes in immunity protection
- Identification of vaccine efficacy in patients based on their responding NAb levels.
- Continued repetitive NAb screening to track waning or persistent titers to understand length of vaccine effectiveness and provide insight into the need for additional vaccine booster.
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.
For informational purposes only. Testing is limited to laboratories and patient care settings operating under a high complexity CLIA Certificate.
Allow the kit components to reach room temperature (15-30°C) prior to testing.
- Place the test cassette on a clean and level surface. Remove the top label. Use the micropipette to collect a 15µl sample, filling to the fill line, designated by the third plastic tick mark from the tip. Dispense 15µl of specimen to the sample port of the test cassette, then add 3 drops of buffer to the sample port and start the timer.
- Wait for the colored line(s) to appear. The test result should be read at 10 minutes. Do not interpret the result after 30 minutes. If the test does not respond within 1-2 minutes, this may indicate that an air bubble has formed within the buffer solution. If this occurs, add 1 additional drop of buffer solution.
Clean finger with the Alcohol Wipe
Pierce the side of a finger with the spring-loaded lancet
Use the Capillary Pipette to collect sample. Fill to the third tick mark.
Expel sample into test port. Wait 15 seconds to allow the blood to be absorbed.
Add 3 drops of Buffer Solution. A fourth drop may be required if the test does not respond after 1 minute. Read results at 10 minutes.
Interpretation of Results
NAb RESULTS KEY
HIGH VIRUS-NEUTRALIZING ACTIVITY. No visible line.
MODERATELY HIGH NAb
MODERATELY HIGH VIRUS-NEUTRALIZING ACTIVITY. Faint line.
MODERATE VIRUS-NEUTRALIZING ACTIVITY. Medium line.
NOT DETECTABLE NAb
NO VIRUS-NEUTRALIZING ACTIVITY. Strong green line.
It is uncertain to what degree and for how long individuals with antibodies (neutralizing or total) are protected against reinfection with SARS-CoV-2 or what concentration of antibodies may be needed to provide such protection. (CDC 2020)