This kit is used for the in vitro qualitative detection of 2019-nCoV antigen from human nasopharyngeal swabs.
PRODUCT NAME
2019-nCoV Antigen Test Kit (colloidal gold method)
PACKAGE SPECIFICATION
1 Test/Kit; 20 Tests/Kit
INTENDED USE
This kit is only used for the in vitro qualitative detection of 2019-nCoV antigen from human nasopharyngeal swabs.
This kit is suitable for the auxiliary diagnosis of COVID-19, the results are for clinical reference only and cannot be used as the sole basis for diagnosis and exclusion decision. The clinical diagnosis and treatment of patients should be considered in combination with their symptoms/signs, medical history, other laboratory tests and treatment responses.
Positive test result needs to be further confirmed, negative result does not preclude 2019-nCoV infection.
This kit is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of in vitro diagnostic procedures.
TEST PRINCIPLE
The kit is immunochromatographic and uses double-antibody sandwich method to detect 2019-nCoV antigen. During detection, the treated samples are loaded to the sample wells of the test card. When the concentration of 2019-nCoV antigen in specimen is higher than the minimum detection limit, the viral antigen will form complexes with labeled antibodies first. Under chromatography, the complexes move forward along the nitrocellulose membrane till captured by pre-coated monoclonal antibodies of 2019-nCoV in detection zone on nitrocellulose film (T) to form a pink/purple reaction line on the detection zone, at this point the result is positive; conversely, if there is no viral antigen or the concentration of antigen in specimen is below the minimum detection limit, no pink/purple reaction line appears in the detection zone, at this point the result is negative. Regardless of whether the sample contains viral antigens or not, a pink/purple reaction line will appear in the quality control zone (C), the pink/purple reaction line that appears in the quality control zone (C) is the criterion for determining if the chromatography process is normal.
TEST PROCEDURE
Please read the instruction manual seriously before testing.If the reagents in kit are stored in refrigerator, please take them out and leave them at room temperature before testing. The test should be done at room temperature.
I. Specimen extraction (see Figure 1).
1. Add 8 drops (approximately 400 μL) of sample diluent vertically to the sample extraction tube.
2. Insert the sampled swab into the solution in the sample extraction tube, squeeze the villi part of the swab in the tube through the outer wall of the tube with your finger 5 times to dissolve the potential viral antigen into solution from swab as much as possible, then remove and discard the swab.
3. Cover the dropper on the sample extraction tube after sampling.
II. Testing procedures (see Figure 1).
1. Remove the test card by opening it along the tear opening of the foil pouch and lay it flat.
2. Add 2 drops (approximately 80 μL) of the treated sample into the sample well of the test card.
3. Please read the chromogenic results in the detection zone between 15~20 minutes to ensure proper test performance. Do not read results after 30 minutes. Results read after 30 minutes are invalid.