The COVID-19 Antigen Rapid Test Kit (Colloidal Gold Method) is a rapid visual immunoassay for the qualitative, presumptive detection of COVID-19 antigens form nasal swabs and nasopharyngeal swab specimens. The test is intended for use as an aid in the rapid differential diagnosis of acute COVID-19 virus infection.
Nasal swab sample:
For proper test performance, use the swabs supplied in the kit.
It is important to obtain as much secretion as possible. Therefore, to collect a nasal swab sample, insert the sterile swab into the nostril that presents the most secretion under visual inspection. Using gentle rotation, push the swab until resistance is met at the level of the turbinates (less than one inch into the nostril). rotate the swab a few times against nasal wail.
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.
Specimen Transport and Storage:
Specimens should be tested as soon as possible after collection. If transport of the samples is required, the swab should be store in the transport tube without media. 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. Nasal wash/aspirate specimens may also be stored frozen(-70℃ or colder) for up to one month.
Bring tests, specimens, and/or controls to room temperature (15-30°C) before use.
- 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.
- Gently mix Extraction reagent solution.For bottle buffer: Add 5 drops (about 300ul) of the Extraction Solution into the Extraction tube.For single buffer: transfer all buffer (about 300ul) into the extraction tube.
Place the patient swab specimen into the Extraction Tube. Roll the swab at least 10 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.
- Put on the tube tip, then add 2 drops (80ul）of extracted sample into the sample well. Do not handle or move the Test Device until the test is complete and ready for reading.
- 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.