ZEA SARS-COV-2 AG 10 SALIVARY TESTS

ZEA SARS-CoV-2 Antigen Rapid Test Cassette

Professional use

The test cassette is used for the qualitative detection of SARS-CoV-2 antigen in the saliva sample or of individuals suspected of COVID-19 by your physician within the first seven days of onset of symptoms.
The cassette has a monophasic lateral flow chromatographic immunoassay. The reaction strip in the device includes: a conjugated buffer containing the anti-SARS-CoV-2 nucleocapsid protein antibody, the Chicken IgY antibody, all conjugated with colloidal gold and nitrocellulose membrane containing a test line (line T) and a control line (line C).
The T line is coated with the nucleocapsid anti-SARS-CoV-2 protein antibody, when the sample is added, it migrates by capillary diffusion to hydrate the gold conjugate, if present in the sample, the SARS-CoV-2 nucleocapsid protein and the its antibody labeled with antigen-antibody complexes formed by orocolloidal. These complexes will continue to migrate along the strip to the T line, where they are captured by the anti-SARS-CoV-2 nucleocapsid protein antibody, generating a red-violet line visible in the T-line area.
If the sample does not contain SARS-CoV-2 or the SARS-CoV-2 level in the sample is below the detection limit of the test, the T line will not appear.
Line C is coated with goat anti-chicken antibodies which should bind to the gold-chicken IgY antibody conjugate and form a red-violet line, regardless of the presence of the SARS-CoV-2 nucleocapsid protein.
For single use only.

How to use

1. Sample collection:
Type: saliva sample.
Use the diluent tube to collect 1ml of saliva. Rinse your mouth before taking the sample.

2. Transport and storage of samples:
Samples should be used as soon as possible after being collected, within 1 hour, at room temperature (15-30 ° C).
After mixing the saliva sample with the sample extraction solution, the sample must be analyzed within 30 minutes.

3. Test instructions:
Do not open the pouch until you are ready to test. Use the test in low ambient humidity conditions (RH ≤70%) within 1 hour.
Allow all test cassette components and samples to reach room temperature between 15 ° C and 30 ° C prior to testing.
Remove the test cassette from the foil pouch and place it on a dry and clean surface. Prepare a test cassette for each sample.
Unscrew the lid of the sample tube containing the diluent, screw in the salivary funnel and collect the saliva until the measurement of 3 ml on the tube is reached.
Unscrew the salivary funnel, screw the cap onto the tube, turn it upside down and mix well. Then take the solution with the dropper and dispense 4 drops into the hole of the cassette test.
Interpret the test results at 15-20 minutes. Do not interpret the results after 20 minutes.
Discard the used tube and test device in a special biohazard waste container.

4. Interpretation of results:
INVALID: If the C line is not displayed, the result is invalid, regardless of whether the T line appears or not, as shown in the figure. Prepare another test cassette and another sample to rerun the test. the volume of sample addition.

POSITIVE: Both T and C lines are displayed.

NEGATIVE: the T line does not appear, while the C line appears.

Warnings

For in vitro diagnostic use only.

Format

Pack of 10 salivary tests