Sars-CoV-2 Neutralizing Antibody Rapid Test

INTENDED USE

The SARS-CoV-2 Neutralizing Antibody Rapid Test is a rapid chromatographic immunoassay for the qualitative or quantitative detection of neutralizing antibodies to SARS-CoV-2 in whole blood, serum, or plasma.

TEST PROCEDURE

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

1. 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. 2.Place the test device on a clean and horizontal surface.
3. A.For Serum or Plasma Specimens (quantitative):

Use a pipette to collect the serum or plasma. Use the pipette to transfer 25mL of the specimen into the specimen well (S) of the test device, then add exactly 75mL of buffer into the specimen well and start the timer.

B.For Fingerpick Whole Blood Specimens (quantitative): 

To use a micropipette: Hold the pipette vertically onto the puncture site, suck the whole blood directly and place 50 µL into the specimen well (S) of the test device, then add exactly 50 µL of buffer into the specimen well and start the timer. See illustration below.

1. For Fingerpick Whole Blood Specimens (qualitative):

To use a capillary dropper: Hold the dropper vertically onto the puncture site, and transfer 5 drops of whole blood (approximately 50 µL) into the specimen well (S) of the test device, then add 1 drop of buffer (approximately 45-50 uL) and start the timer. See illustration below.

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

RAPID TEST READER

• 1. Press and hold the white start button for 2 ~ 3 seconds to start the machine
• 2. Swipe the calibrator card onto the card reading area, to introduce the calibration curve into the reader.
• 3. Insert the test card into the detection cavity of the reader on the right side. Make sure the window of card in while sample well out.  
• 4. Read the results on the display of the reader.

INTERPRETATION OF RESULTS

• 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 likely reasons for control line failure. Review the procedure and repeat the test with a new test. If the problem persists, discontinue using the test kit immediately and contact your local distributor.