Manufactured in Poland
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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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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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
1. Collect the sample and add 50µL to the specimen well (S)
2.1 Add 3 drops of buffer (approximately 90µL)
2.2 Wait 10-15 minutes
3. Interpret the results of SARS-CoV-2 Neutralizing Antibody Rapid Test
*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.