• Specimen Collection
For proper test performance, use the swabs supplied in the kit.
Nasopharyngeal swab sample:
It is important to obtain as much secretion as possible. Therefore, to collect a nasopharyngeal swab sample, carefully insert the sterile swab into the nostril that presents the most secretion under visual inspection. Keep the swab near the septum floor of the nose while gently pushing the swab into the posterior nasopharynx. Rotate the swab several times.
Oropharyngeal swab sample:
It is important to obtain as much secretion as possible. Therefore, for the oropharyngeal swab, insert the sterile swab provided in this kit all the way down the back of the throat and swipe over
the tonsils and other inflamed areas of the throat. Do not touch your tongue, cheeks or teeth with the swab.
It is recommended that specimens be obtained primarily with a nasopharyngeal swab for more
accurate results.
• Specimen Transport and Storage:
Specimens should be tested as soon as possible after collection. If transport of the samples is required, the following transport media are recommended and have been tested and shown not to interfere with the performance of the test: Hank’s BalanceMKd salt solution, M5 Media, or
saline. Alternatively, samples may be stored refrigerated (2-8℃), or at room temperature(15-30℃), in a clean, dry, closed container for up to eight hours prior to testing.
• Procedure
Bring tests, specimens, and/or controls to room temperature (15-30°C) before use.
1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with patient or control identification. For best results, the assay should be performed within one hour.
2. Gently mix Extraction reagent solution. Add 8 drops(about 250ul) of the Extraction Solution into the Extraction tube.
3. Place the patient swab specimen into the Extraction Tube. Roll the swab at least 20 times while pressing the swab against the bottom and side of the Extraction Tube. Roll the swab head against the inside of the Extraction Tube as you remove it. Try to release as much liquid as possible. Dispose of the used swab in accordance with your biohazard waste disposal protocol.
4. Put on the tube tip, then add 3 drops of extracted sample into the sample well. Do not handle or move the Test Device until the test is complete and ready for reading.
5. As the test begins to work, color will migrate across the membrane. Wait for the colored band(s) to appear. The result should be read at 10 minutes. Do not interpret the result after 20 minutes.