SARS-CoV-2 Neutralizing Antibody Rapid Test

Intended use

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.

Authorized certifications

1. CE Approved

2. China’s white list approved COVID 19 test kits manufacturer and SARS-CoV-2 Neutralizing Antibody Rapid Test (COVID-19 Ab)

Features

A. Blood testing, Fingerstick whole blood is workable.

B. Cutoff is 50ng/mL

C. Easy to operate, no additional material required to run the assay

D. Little Specimen is required. 10ul of serum, plasma or 20ul of whole blood are enough.

Test Procedures

Allow the test device, specimen, buffer, and/or controls to equilibrate to 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 horizontal surface.

For Serum or Plasma Specimens:

Hold the dropper vertically, draw the specimen up to the Fill Line (approximately 10 μL), and transfer the specimen to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 120 mL) and start the timer. See illustration below. Avoid trapping air bubbles in the specimen well (S).

For Whole Blood (Venipuncture/Fingerstick) Specimens:

To use a dropper: Hold the dropper vertically, draw the specimen 0.5-1 cm above the Fill Line, and transfer 2 drops of whole blood (approximately 20 µL) to the specimen well (S) of the test device, then add 2 drops of buffer (approximately 90 uL) and start the timer. See illustration below.

To use a micropipette: Pipet and dispense 20 µL of whole blood to the specimen well (S) of the test device, then add 3 drops of buffer (approximately 120 µL) and start the timer. See illustration below.

3) Wait for the colored line(s) to appear. Read results at 10 minutes. Do not interpret the result after 15 minutes.

- Positive (+): Only C line appears, or T line is equal to C line or weaker than C line. It indicates that there are SARS-CoV-2 neutralizing antibodies in the specimen.

- Negative (-): Both the T line and C line appear, when the intensity of T line is stronger than C line. It indicates that there is no SARS-CoV-2 neutralizing antibodies in the specimen, or else the titer of SARS-CoV-2 neutralizing antibodies are of very low level.

- Invalid: Control line fails to appear. Insufficient specimen volume or incorrect procedural techniques are the most