Safety Neutralizing Antibody Rapid Test MSLRDT120

A rapid test for the qualitative detection of the neutralizing antibodies to the SARS-CoV-2 or its vaccines in whole blood, serum, or plasma.

For professional in vitro diagnostic use only.
Package Specification: 40 T/kit, 20 T/kit, 10 T/kit, 1 T/kit

INTENDED USE
The SARS-CoV-2 Neutralizing Antibody Rapid Test (COVID-19 Ab) is a rapid chromatographic immunoassay for the qualitative detection of neutralizing antibodies to SARS-CoV-2 in whole blood, serum, or plasma.

PRINCIPLE
The SARS-CoV-2 Neutralizing Antibody Rapid Test (COVID-19 Ab) is for detection antibodies to SARS-CoV-2 or its vaccines. The cell surface receptor angiotensin converting enzyme-2 (ACE2) are coated in the test line region and the recombinant receptor-binding domain (RBD) conjugated with the indicate particles.

During testing, if there are SARS-CoV-2 neutralizing antibodies in the specimen, it would react with the protein RBD-particle conjugate and not react with the pre-coated protein ACE2. The mixture then migrates upward on the membrane chromatographically by capillary action and would not captured by the pre-coated antigen.
The SARS-CoV-2 Neutralizing Antibody Rapid Test (COVID-19 Ab) contains protein RBD-coated particles. The protein ACE2 are coated in the test line region.

Relative Sensitivity, Specificity and Accuracy
The SARS-CoV-2 Neutralizing Antibody Rapid Test (COVID-19 Ab) has been evaluated with specimens obtained from a population of positive and negative specimen. Results were confirmed by a commercial SARS-CoV-2 Neutralization Antibody Detection Kit (ELISA kit, cutoff 30% signal inhibition).

Physical and Chemical Properties
Appearance: Solid plastic card in foil pouch. Physical State: Solid.
Odor: Slight.
pH: Not applicable.
Melting point: Not determined. Boiling Point: Not available.
Flash point: Not applicable. Flammability: Not determined. Ignition temperature: Not available.
Decomposition temperature: Not available. Self-igniting: Product is not self-igniting.
Explosion Limits: Not available. Specific Gravity: Not available.