Covid-19 Antigen Rapid Test Cassette
A lateral flow immunoassay intended for the qualitative detection SARS-Cov-2 nucleocapsid antigens in nasopharyngeal swab, nasal swab or oropharyngeal swab from individuals who are suspected of COVID-19 by their healthcare provider.
- For In Vitro Diagnostic Only.
- For healthcare professionals and individuals trained in point of care settings.
- Do not use this product as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status of COVID-19
- Do not use this product after the expiration date.
- Please read all the information in this leaflet before performing the test.
- The test cassette should remain in the sealed pouch until use.
- All specimens should be considered potentially hazardous and handled in the same manners as an infectious agent.
- The used test cassette should be discarded according to federal, state and local regulations.
Specimen obtained early during symptoms onset will contain the highest viral titers; specimens obtained after five days of symptoms are more likely to produce negative result when compared to an RT-PCR assay. Inadequate specimen collection, improper specimen handling and/or transport may yield false results; therefore, training in specimen collection is highly recommended due to the importance of specimen quality to obtain accurate test results.
Acceptable specimen type for testing is a direct swab specimen or a swab in viral transport media (VTM) without denaturing agents. Use freshly collected direct swab specimens for best test performance. Prepare the extraction tube according to the Procedure and use the sterile swab provided in the kit for specimen collection.
Nasopharyngeal Swab Specimen Collection
1. Remove the swab from the package.
2. Tilt patient’s head back about 70°
3. Insert the swab through the nostril parallel to the palate (not upwards) until resistance is encountered or the distance is equivalent to that from the ear to the nostril of the patient, indicating contact with the nasopharynx. (Swab should reach equal to distance from nostrils to outer opening of the ear). Gently rub and roll the swab. Leave swab in place for the several seconds to absorb secretions.
4. Slowly remove swab while rotating it.
Specimens can be collected from both sides using the same swab, but it is not necessary to collect specimens from both sides if the tip of swab is saturated with fluid from the first collection. If a deviated septum or blockage creates difficulty in obtaining the specimen from one nostril, use the same swab to obtain the specimen from the other nostril.
Nasal Swab Specimen Collection
1. While gently rotating the swab, insert swab about 2.5cm (1 inch) into nostril until resistance is met at turbinates.
2. Rotate the swab several times against nasal wall and repeat in other nostril using the same swab.
Oropharyngeal Swab Specimen Collection
1. Insert swab into the posterior and tonsillar areas. Rub swab over both tonsillar pillars and posterior oropharynx and avoid touching tongue, teeth, and gums.
NOTE: Allow the test cassettes, reagents and specimen to equilibrate to room temperature (15-30°C or 59-86°F) prior to testing.
1. Put an extraction tube on the work station.
2. Unscrew the lid of an extraction reagent. Add all of the extraction reagent into the extraction tube.
3. Sampling refers to section ‘Specimen Collection’
Direct Swab Test Procedure
1. Insert the swab specimen into the extraction tube which contains extraction reagent. Roll the swab at least 5 times while pressing the head against the bottom and side of the extraction tube. Leave the swab in the extraction tube for one minutes.
2. Remove the swab squeezing the sides of the tube to extract the liquid from the swab. The extracted solution will be used as test sample.
3. Cover the extraction tube with a dropper tip tightly.
4. Remove the test cassette from the sealed pouch.
5. Reverse the specimen extraction tube, holding the tube upright , transfer 3 drops(approximately 100uL) slowly to the specimen well(S) of the test cassette, then start the timer.
6. Wait for colored lines to appear. Interpret the result at 15 minutes. Do not read results after 20 minutes.