COVID-19 Neutralizing Antibody Rapid Test

Intended Use

COVID-19 Neutralizing Antibody Rapid Test is an in vitro immunoassay for the direct and qualitative detection of neutralizing antibodies against SARS-CoV-2 in human whole blood, serum, or plasma. COVID-19 Neutralizing Antibody Rapid Test is for professional use only.

What is a Neutralizing Antibody(Nab)?

- A NAb is an antibody that is responsible for defending cells from pathogens, which are organisms that cause disease.

- NAb attach to the virus and stop it from entering healthy cells

- Only a small subset of the many antibodies that bind a virus are capable of neutralization

How do neutralizing antibodies work?

A neutralizing antibody might block the interactions of Spike protein with the receptor, or might bind to a viral capsid in a manner that inhibits uncoating of the genome.

Materials

● Individually packed test devices

● Buffer

● Disposable pipettes

● Package insert

Procedure:

Allow the COVID-19 Neutralizing Antibody Rapid Test Device, 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 the test device from the sealed pouch and use it as soon as possible.

2. Place the test device on a clean and level surface. Label the test with the patient or control identification.

3. Add the specimen.

For Serum or Plasma Specimens

a) Using the provided disposable pipette, transfer 3 full drops of serum or plasma (appr. 75 µL) into the specimen well of the test device and start the timer.

For Venous Whole Blood Specimens

a) Using the provided disposable pipette, transfer 2 full drops (appr. 50 µL) of the whole blood into the specimen well of the test device, then add two drops of buffer and start the timer.

4. Wait for the colored line to appear. The results should be read at 15 minutes. Do not interpret the result after 20 minutes.

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