SARS-CoV-2 LEPU Kit 25 Tests

SARS-CoV-2 LEPU Rapid Antigen Test Kit

(Immunochromatography with Colloidal Gold)
professional use

SARS-CoV-2 Rapid Antigen Test Kit, detects the qualitative of antigens against SARS-CoV-2 in clinical specimens (nasal swab).

The test card contains colloidal gold-labeled SARS-CoV-2 protein N monoclonal antibody, which is pre-coated on the combination pad, the matched SARS-CoV-2 protein N monoclonal antibody immobilized on the area of test (T) and the corresponding antibody in the quality control area (C).

During testing the N protein in the sample combines with the gold-labeled SARS-CoV-2 N colloidal protein monoclonal antibody, which is pre-coated on the combination pad. The conjugates migrate upward under capillary effect, and are subsequently captured by the immobilized protein N monoclonal antibody in the test area (T). The higher the protein N content in the sample, the higher the conjugate captures and the darker the color in the test area.

If there is no virus in the sample or if the virus content is below the detection limit, no color is shown in the test area (T).

Regardless of the presence or absence of virus in the sample, a purple stripe appears in the quality control area (C). The purple stripe in the quality control area (C) is a criterion for judging whether or not there is sufficient sample and whether the chromatographic procedure is normal or not.

How to use

Read the instructions for use carefully before performing the test. Bring the reagents and sample back to room temperature prior to testing.

During specimen collection the swab head should be fully inserted into the nasal cavity and gently rotated 5 times.

Repeat the operation in the other nostril as well, to ensure that there is enough sample.

Before testing the double-sided adhesive protection layer must be removed in advance to avoid liquid splashes. If the double-sided adhesive protection layer is removed after adding the diluent, it is easy for the liquid to splash.

Thread the swab sample through the bottom of well B into well A. Add 6 drops of diluent to well A. Do not pour the diluent into the other wells. Rotate the barrel twice in each direction.

During the test the test card must be placed on the horizontal plane. The test card must be fixed and must not be removed.

After covering the left side, press gently on the adhesive position to make the sides fit together completely and start timing. Wait until the purple stripe appears. The test result should be read within 15-20 minutes.

Interpretation of the results

POSITIVE: There are purple stripes in both the quality control area (C) and the test area (T).
NEGATIVE: There is only one purple stripe in the quality control area (C), and no purple stripe in the test area (T).
INVALID: There is no purple stripe in the quality control area (C), or there is a blue stripe in the quality control area (C), thereby indicating incorrect operating procedures or that the proof has already deteriorated. In this condition, the instructions for use must be read carefully again, and then the new test card must be used to carry out a new test. If the problem persists, stop using products with the same lot number and contact your local suppliers immediately.

Warnings

Each test card must be used within 1 hour after removing the seals.

Format

Pack of 25 Tests.