CorDx

COVID-19 Neutralizing Ab Test

COVID-19 Neutralizing Ab Test is used for qualitative detection of the Neutralizing antibodies in patients who have recovered from Novel Coronavirus Pneumonia or those who have been vaccinated.

 

INTENDED USE

COVID-19 Neutralizing Ab Test is used for qualitative detection of the Neutralizing antibodies in patients who have recovered from Novel Coronavirus Pneumonia or those who have been vaccinated.

 

INTRODUCTION

The neutralizing antibody protects the host from infection by neutralizing the activity of the virus. It is a specific antibody that can block the virus from invading cells. The neutralizing antibody is produced by the immune response after a person is vaccinated or infected with a virus. Its titer will directly determine the body\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\’s ability to neutralize the virus, that is, the body\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\\’s ability to avoid virus infection. Coretests® COVID-19 Neutralizing Ab Test can detect neutralizing antibodies faster, and the test only takes 10-15 minutes.

 

SPECIMEN PREPARATION

  1. The specimen is human serum/plasma and whole blood, including clinical anticoagulants (EDTA, heparin, sodium citrate) origin prepared serum or whole blood.
  2. Do the test immediately after specimen collection. The speci- men could be stored at 2 to 8℃ up to 5 days if testing can,t be done after specimen collection. The specimens should be frozen at -20℃ for longer storage. Avoid multiple freeze-thaw cycles. Anticoagulant whole blood specimen, do not store longer than 72 hours at room temperature and not longer than 7 days at 2 to 8℃.
  3. Bring the specimen and test components to room tempera- ture if refrigerated or frozen. Mix the specimen well prior to assay once thawed. The precipitate should be removed by centrifugation prior to the test if clearly visible particles existed in the specimen.
  4. Do not do the test if specimen including massive lipid, hemo- lysis or turbidity against invalid test result.

 

TEST PROCEDURE

Read the instruction first prior to testing. Bring the pouched test to room temperatureprior to testing. Do not open the pouch until ready to begin testing.

  1. Remove the test from the sealed pouch. Lay it on a flat, clean and dry surface.
  2. Using the provided pipette, add 1 drop specimen to the sample well.
  3. Hold the buffer bottle vertically and add 2 drops (approximate 80μl -100μl)of buffer to sample well.
  4. Read results within 10-15 minutes.

 

INTERPRETATION OF RESULTS

Positive: Control(C)line and test(T)line appear in the show window.

Negative: Only one line appears in control(C)area, no line appears in test(T)area.

Invalid: If no line appears in the control(C)area, the test results are invalid regardless of the presence or absence of line in the tes(t T)area. The direction may not been followed correctly or the test may be deteriorated. It is recommended that repeat the test using a new device. If the problem persist, please stop to use the product and contact local distributor.

Storage: store at 2~30℃. Shelf life: 24 months.