A rapid test for the qualitative detection of antigens of the new Coronavirus with oral-pharyngeal smear. The New Coronavirus Antigen Detection Rapid Test Cassette (SARS-Cov-2) is an in vitro diagnostic test for the qualitative detection of new coronavirus antigen in an oral-pharyngeal smear, using the rapid immunochromatography method.
The detection is based on monoclonal antibodies specific for the new coronavirus antigens.
Provides information to clinicians for proper medication prescription.
The New Coronavirus Antigen Detection Rapid Test Cartridge (SARS-Cov-2) is an immunochromatographic test membrane that uses highly sensitive monoclonal antibodies to the new coronavirus.
The test device consists of the following three parts:
The entire strip is placed inside a plastic device. The reagent membrane contains colloidal gold conjugated to the new coronavirus monoclonal antibodies. The reaction membrane contains secondary antibodies to the new coronavirus and polyclonal antibodies to mouse globin, which are immobilized on the membrane.
When the sample is placed in the sample well, the dried conjugates in the reagent well dissolve and move with the sample. If a new coronavirus is present in the sample, a complex formed between the conjugation of the coronavirus and virus antibodies will be blocked by the specific monoclonal antibody of the new coronavirus, which is coated in the T region.
Whether or not the sample contains the virus, the solution continues to move to meet another reagent (an antibody to mouse IgG) that binds the remaining conjugates, creating a red line in the C region.
Use newly collected samples for optimal diagnostic performance.
Inadequate sample collection or mishandling of the sample can give a false - negative result.
For orthopharyngeal smear: Insert the sterile swab supplied with the kit into the back of the pharynx, the tonsils and other inflamed areas. Avoid touching the tongue, cheeks and teeth with the swab.
Take a bottle of exhaust buffer, remove the cap, place all of the exhaust buffer in the exhaust tube supplied with the kit and place it in the tube housing.
Add oral pharyngeal smear. Insert the swab into the exhaust pipe containing the test exhaust buffer. Rotate the swab into the tube in a circular motion so that the base of the exhaust pipe moves and the liquid is extracted and reabsorbed by the swab.
Remove the swab. The extraction solution will be used as a test sample.
Allow the test apparatus, sample and exhaust buffer to reach room temperature (15-30 ° C) before testing.
Remove the test device from the sealed aluminum package and use it as soon as possible. Place the test device on a clean, flat surface. Immediate testing after opening the package gives better and more accurate results.
Unscrew the sample collection tube cap.
Take a bottle of exhaust buffer, remove the cap and add all of the buffer into the exhaust tube.
Insert the sterile swab with the coating into the test extraction buffer. Rotate the swab for about 10 seconds while simultaneously pushing its head inside the tube to release the antigens from the swab.
Remove the sterile swab, while at the same time pressing its head inside the tube as you remove it, in order to extract as much liquid as possible from the swab. Dispose of the sterile swab according to the hazardous waste disposal protocol.
Place and tighten the cap on the sample collection tube, then shake the collected sample vigorously to mix the sample and the extraction buffer. See illustration 4.
Add 3 drops of solution (approx. 80ul) to the sample well and start the timer. Read the results in 10-20 minutes. Do not interpret the results after 20 minutes.
POSITIVE: Two red lines appear. A red line appears in the control area (C) and a red line in the test area (T). The shade of color can vary, but in any case it should be considered positive, even if the line is faint.
NEGATIVE: Only one red line appears in the control area (C) and no line in the test area (T). Negative results indicate that it does not exist molecules of the new coronavirus in the sample or that the number of viral molecules is below the level of detection.
INVALID: No red line appears in the control area (C). The test is invalid even if there is a line in the test area (T). Insufficient sample size or incorrect procedural techniques are the most likely reasons for control line failure.
Test the test procedure and repeat the test using a new test device. If the problem persists, stop using the test immediately and contact your local distributor.