SARS-CoV-2 Neutralizing antibody rapid test

Quick, cheap, effective

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.
For professional in vitro diagnostic use only.

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PL Flag Manufactured in Poland

covid-background-7

How does SARS-CoV-2 Neutralizing antibody test work?

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.

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Components

Materials Provided
  • Materials Provided
  • Foil pouches, with test cassettes
  • Disposable droppers
  • Assay buffer
  • Lancet
  • Instruction for use
Materials Required But Not Provided
  • Specimen collection container
  • Centrifuge (for plasma only)
  • Timer

*Instructions show how to perform the test for a whole blood sample using a micropipette. Detailed instructions can be viewed in the downloads section at the end of the page.

Interpretation of test 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.

Relative Sensitivity, Specificity and Accuracy

Performance characteristics

Method Reference (PCR) All results
SARS-CoV-2 neutralizing
antibodies Test (COVID-19 Ab)
Results Positive Negative
Positive 49
0 49
Negative 5 120 125
All results 54 120 174

Relative Sensitivity: 96.97%(95%CI:83.35%~99.99%)
Relative Specificity: 100.00%(95%CI:97.29%~100.00%)
Accuracy: 99.50%(95%CI:96.94%~99.99%

Quality control

Invalid results

Internal procedural controls are included in the test. A colored line appearing in the control region (C) is an internal procedural control. It confirms sufficient specimen volume and correct procedural technique. Control standards are not supplied with this kit; however, it is recommended that positive and negative controls be tested as a good laboratory practice to confirm the test procedure and to verify proper test performance.

Downloadable materials

Certificate

Instruction for use

Detailed instructions containing additional information about the SARS-CoV-2(COVID-19) neutralizing antibody test