ImmunoPass Neutralizing Antibody Test

Neutralizing Antibody Rapid Test

ImmunoPass is not available for sale or distribution in the United States.

 

 

 

 

 

 

Easy to UseEasy to Use

Requires No Additional EquipmentRequires No Equipment

Requires No Additional EquipmentTests Adaptive Immune Response

Results in 10 MinutesRapid Results in 10 Minutes

 

The ImmunoPass™ COVID-19 Neutralizing Antibody Rapid Test detects functional, virus-neutralizing antibodies (NAbs) within 10 minutes, unlike traditional neutralization tests which take days. The ImmunoPass™ test kit does not utilize live virus samples and does not require strict BSL3 biosafety protocol.

PERFORMANCE

100% Sensitivity
94%

Sensitive

97.7% Specificity
97%

Specific

ImmunoPass Science

ImmunoPass™ Science

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, preventing the virus from infecting cells.
  • NEUTRALIZING ANTIBODIES are Associated with ADAPTIVE ImmunE RESPONSE.
  • NON-NEUTRALIZING ANTIBODIES do not block or neutralize COVID and only indicate past infection.

Intended Use


The ImmunoPass™ COVID-19 Neutralizing Antibody Rapid Test is a lateral flow assay intended for qualitative detection of neutralizing antibodies against SARS-CoV-2 Spike Receptor Binding Domain (RBD) protein in human fingerstick blood. The ImmunoPass is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. The ImmunoPass should not be used to diagnose or exclude acute SARS-CoV-2 infection.

 

Instructions are for informational purposes only. Testing is limited to only authorized countries and settings. ImmunoPass is not available for sale or distribution in the United States.

Test Instructions

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 2 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.
ImmunoPass - Step 11

Clean finger with the Alcohol Wipe

ImmunoPass - Step 22

Pierce the side of a finger with the spring-loaded lancet

ImmunoPass - Step 3 3

Use the Capillary Pipette to collect sample. Fill to the third tick mark.

ImmunoPass - Step 4 4

Expel sample into test port. Wait 15 seconds to allow the blood to be absorbed.

ImmunoPass - Step 5 5

Add 2 drops of Buffer Solution. A third drop may be required if the test does not respond after 1 minute. Read results at 10 minutes.