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The COVID-19 Neutralizing Ab Test is a lateral flow immunoassay intended for the in vitro qualitative detection of SARS-CoV-2 neutralizing antibodies in human fingertip blood samples after vaccination. The COVID-19 Neutralizing Ab Test uses double antigen sandwich method to detect RBD antibodies in human fingertip blood samples. The SARS-CoV-2 neutralizing antibody can specifically identify and bind to the RBD region of spike protein of SARS-CoV-2, accordingly can neutralize SARS-CoV-2. It is an indicator of vaccination effect. It is recommended to use this product for testing 14 days after completing all vaccination procedures. It is intended for personal use by untrained layman.
TEST PROCEDURE:
Read the instructions carefully before use. Bring all reagents to room temperature(15-30℃) prior to testing.
1.Open the package and take out the test device. Know the obsevation window,sample well(s) and buffer well(A).
2.Wipe the fingertips with an alcohol pad and let dry.
3.Pull out the cap on the front end of the lancet. Use sterile lancet to gently press on the wiped area.
4.Squeeze out a sufficient amount of blood.
5.Gently squeeze the upper end of the capillary sampling tube, place the lower end vertically in the blood, and then slowly loosen your fingers to make the blood reach the scale line. As shown in the figure.
6.Place the lower end of the disposable sampler in the sample well (S) and squeeze the upper end of the disposable sampler to make the blood flow into the sample well (S).
7.Unscrew the bottleneck of the buffer solution and squeeze 2 drops of buffer solution into the buffer well(A). Start the timer.
8.Use a new alcohol pad to wipe blood stains on your fingers and disinfect at the same time.
9.Read results within 10-15 minutes.
10.Please put all used materials in the enclosed collection bag for proper disposal. The test kit can be disposed of with normal household waste in compliance with the applicable local regulations
INTERPRETATION OF RESULTS：2.Wipe the fingertips with an alcohol pad and let dry.
3.Pull out the cap on the front end of the lancet. Use sterile lancet to gently press on the wiped area.
4.Squeeze out a sufficient amount of blood.
5.Gently squeeze the upper end of the capillary sampling tube, place the lower end vertically in the blood, and then slowly loosen your fingers to make the blood reach the scale line. As shown in the figure.
6.Place the lower end of the disposable sampler in the sample well (S) and squeeze the upper end of the disposable sampler to make the blood flow into the sample well (S).
7.Unscrew the bottleneck of the buffer solution and squeeze 2 drops of buffer solution into the buffer well(A). Start the timer.
8.Use a new alcohol pad to wipe blood stains on your fingers and disinfect at the same time.
9.Read results within 10-15 minutes.
10.Please put all used materials in the enclosed collection bag for proper disposal. The test kit can be disposed of with normal household waste in compliance with the applicable local regulations
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 test（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.
SPECIFICATION:
| Description | Specimen | Format | Catalog No. | Sensitivity | Package Size | Strip Width | Certificate |
| COVID-19 Neutralizing Ab Test (For Self-Testing) | Whole blood | Cassette | BP293-01 | 99.2% | 1 Test | 3.0 mm |
CE1434 |
| BP293-02 | 2 Tests | ||||||
| BP293-04 | 1 Test | ||||||
| BP293-05 | 5 Tests | ||||||
| BP293-25 | 25 Tests |
This test has not been authorized for use by the FDA and is not available in the United States.