Your Immunity Passport

The ImmunoPass SARS-Cov-2 Neutralizing Antibody Rapid Test is currently in development and is not commercially available in the United States at this time. Please check back soon.

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.

PERFORMANCE
97% Sensitivity
98%

Accuracy

96.8% Positive
96.8%

Sensitivity

99.1% Negative
99.1%

Specificity

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, 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.

Use Cases

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

Plasma Donation / Plasma Prioritization – Save a life Campaign

  • Identification of donors with high levels of NAbs
  • Utilization of high quality plasma to enhance patient care
  • Repetitive NAb screening to provide longitudinal tracking of waning or persistent titers

Vacine Efficacy

  • 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.

Military Mission Readiness

  • Identification of personnel with high levels of Nabs to enable mission readiness
  • Longitudinal monitoring of waning or persistent NAb titers to identify at-risk military personnel

Intended Use


ImmunoPass (NAb) 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 COVID19. 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.

Test Instructions

Allow the test cassette, specimen, buffer, and/or controls to reach room temperature (15-30°C) prior to testing.

  1. Bring the pouch to room temperature before opening. Remove test cassettes from the sealed pouch and use within one hour.
  2. Place the test cassette on a clean and level surface.

For Plasma and Whole Blood Specimens:

  • To use the included capillary pipets: Hold the capillary vertically and insert the tip into specimen without pressing the bulb, let the specimen travel to the fill line (approximately 10μl), and transfer the specimen to the sample well (S) of the test cassette by pressing the bulb, then add 2 drops of buffer (approximately 50μl) to the sample well (S) and start the timer.
  • To use a micropipette: Pipette and dispense 10μl of specimen to the sample well (S) of the test cassette, then add 2 drops of buffer (approximately 50μl) to the buffer well (S) and start the timer.
1

Clean finger with the Alcohol Wipe

2

Pierce skin with spring-loaded Lancet

3

Touch Pipette tip to blood drop. DO NOT SQUEEZE

4

Squeeze capillary to expel sample into test port. Wait 20 seconds to allow the blood to be absorbed

5

Add 2 drops of buffer solution. Read results at 10 minutes*. Reference NAb Results Key.

Interpretation of Results

NAb RESULTS KEY

HIGH NAb

HIGH VIRUS-NEUTRALIZING ACTIVITY. No visible or near-transparent line indicates a high neutralizing antibody immunity response to COVID-19.

MODERATELY HIGH NAb

MODERATELY HIGH VIRUS-NEUTRALIZING ACTIVITY. A visible faint line, indicates a moderately high neutralizing antibody immunity response to COVID-19.

MODERATE NAb

MODERATE VIRUS-NEUTRALIZING ACTIVITY. An easily noticeable test line, indicates a moderate neutralizing antibody immunity response to COVID-19.

NOT DETECTABLE NAb

NO VIRUS-NEUTRALIZING ACTIVITY. A Bold green test line, indicates no or a very low neutralizing antibody immunity response to COVID-19.