VivaDiag SARS-CoV-2 Ag Rapid Test 25 Test

VivaDiag SARS-CoV-2 Ag Rapid Test - Medical Device

SARS-CoV-2 Ag Rapid Test is for the rapid and qualitative detection of SARS-CoV-2 nucleocapsid protein antigen in samples collected from nasal, oropharyngeal and nasopharyngeal swabs. The test is for in vitro diagnostic use only. For professional use only. It is designed for clinical laboratories and healthcare professionals such as Point-Of-Care Testing. Not for home use.
The test is based on immunoassay technology. Each test has an anti-SARS-CoV-2 monoclonal antibody line on the detection line and a polyclonal anti-mouse IgG antibody line on the control line. When the extracted sample is inserted into the well, it reacts with the antibodies, forming a complex that migrates through the membrane thanks to the capillary action and interacts with the SARS-CoV-2 antigen. If the detection line turns red / purple, the test indicates positive SARS-CoV-2 antigen. Otherwise the test is negative. The product also has a control line which, if it does not appear, indicates that the test is invalid, even if the detection line appears.
Sensitivity: 90.90%. Specificity: 100%. Accuracy: 98.79%.

How to use

Collection of samples
It is important to get as many secretions as possible.
Nasal swab: Insert the sterile swab into one nostril. The tip of the swab should be within 2.5 cm of the opening of the nostril. Rotate the swab 5 times in the mucosa to ensure that both mucus and cells are collected. Repeat the process for the other nostril to ensure that an adequate amount of sample is collected.
Oropharyngeal swab: Insert the sterile swab into the throat, above the tonsils. Rub lightly on the tonsils and throat walls to obtain the sample. Do not touch the tongue while removing the swab.
Nasopharyngeal Swab: Insert the sterile swab into the nostril that has multiple secretions from visual inspections. Hold the swab close to the nasal septal wall as you gently push the swab into the posterior nasopharynx. Then rotate the swab 5 times and remove.
Collected samples should be evaluated as soon as possible. It is essential that the procedures are followed correctly.
Test procedure
Bring the test and solution to a temperature between 15 ° C and 30 ° C before proceeding.
Hold the sealed pouch vertically and let the solution slide into the bulb Break the tip and squeeze the bulb to pour the solution into the extraction tube Insert the swab into the extraction tube and rotate the swab while pressing the head against the base and sides of the extraction tube. Remove the swab while squeezing the sides of the tube to draw the liquid out of the swab. Try to squeeze out as much liquid as possible. Dispose of the used swab as biohazard waste. Close with the tip of the tube. Take a test from the foil pouch and place it on a clean, flat surface. Apply 3 drops (approximately 60 mcl) of the extracted sample to the sample well. Avoid forming bubbles during the process.
The results are readable within 15-20 minutes. Some positive results may appear earlier. Do not read the results after 20 minutes, they could be wrong.
Interpretation of the results
Positive: Both control and detection lines appear.
Negative: Only the control line appears.
Invalid: A colored control line should always appear in the control area, regardless of the test result. If the control line is not visible, repeat the test with a new Test Cassette.

Warnings

For use by prescription only.

Format

Pack of 25 tests.