S5
Neutralizing
Antibody
Vaccine
Effectiveness
Test
10
Minutes
Pre or Post Vaccine / Post Infection
Two Drops Of Blood
94.73%+
Sensitivity
{ Learn More } 99.9%
Specificity
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S5
Neutralizing
Antibody Test

The Novel Coronavirus Neutralizing Antibody Test Kit (ERCSSO5350) is a rapid chromatographic immunoassay for the qualitative detection of neutralizing antibody of Coronavirus Disease 2019 in human whole blood, serum, or plasma as an aid in the evaluation levels of human anti-novel coronavirus neutralizing antibody titer.

Detection of SARS-COV-2 neutralizing antibody (NAb) can be used to determine the immunity status post infection or pre / post vaccination. 

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Science Of Neutralizing Antibody

SARS-CoV-2 has several structural proteins including spike (S), envelope (E), membrane (M) and nucleocapsid (N). The spike protein (S) contains a receptor binding domain (RBD), which is responsible for recognizing the cell surface receptor, angiotensin converting enzyme-2 (ACE2). It is found that the RBD of the SARS-CoV-2 S protein strongly interacts with the human ACE2 receptor leading to endocytosis into the host cells of the deep lung and viral replication.

Infection with the SARS-CoV-2 initiates an immune response, which includes the production of antibodies in the blood. The secreted antibodies provide protection against future infections from viruses, because they remain in the circulatory system for months to years after infection and will bind quickly and strongly to the pathogen to block cellular infiltration and replication. These antibodies are named neutralizing antibodies.

94.73%
Sensitivity

99.99%
Specificity

99.62%
Accuracy

Clinical
Validation

The Novel Coronavirus Neutralizing Antibody Rapid Test Kit (Chromatographic Immunoassay) and Novel Coronavirus Neutralizing Antibody Titer test (MNA method) test were conducted simultaneously and the Sensitivity (positive coincidence rate), Specificity (negative coincidence rate), and Accuracy (total coincidence rate) were calculated.

In this clinical trial, total, 523 test samples (146 positive and 377 negative) were included for the unit and all test samples included are tested.

Cross
Reactivity
Study

The cross-reactivity of Novel Coronavirus Neutralizing Antibody Rapid Test Kit was evaluated with positive specimens of different respiratory diseases.

The results showed no cross-reactivity. No false positivity or false negativity was found with the following:

anti-Influenza A virusanti- Syphillis
anti-Influenza B virusanti-rheumatoid factor
anti-RSVanti-HIV
anti-Adenovirusanti-m pneumonia
anti-HBsAGanti-TP
anti-chlamydia pneumoniaeanti-HCV
anti-Haemophilus influenzaeanti-HBV
anti-229Eanti-NL63
anti-OC43anti-HKU1

Interfering
Substance
Study

The following substances have been tested using Novel Coronavirus Neutralizing Antibody Rapid Test Kit to evaluate potential endogenous and exogenous interference.

There was no interference observed with the following substances.

Interfering SubstancesConcentration
Ascorbic acid20 mg/ml
Hemoglobin1000 mg/ml
Bilirubin60 mg/ml
Oxalic acid100 mg/ml
Human serum albumin2000 mg/ml
Triglycerides5000 mg/ml
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Discover your
Immune
response in
10 Minutes

Measure effectiveness of vaccine in human body pre and post vaccination or post infection to control multi-wave relapse of the pandemic.

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