3 in 1 COVID-19/Influenza A+B Ag Combo Rapid Test kit (Self test)
COVID-19/Influenza A+B Antigen Combo Rapid Test Cassette
[INTENDED USE]
The COVID-19/Influenza A+B Antigen Combo Rapid Test Cassette is a lateral flow immunoassay intended for the qualitative detection of SARSCoV-2, influenza A and influenza B viral nucleoprotein antigens in nasopharyngeal swab from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider. The COVID-19/Influenza A+B Antigen Combo Rapid Test Cassette is intended for use by trained clinical laboratory personnel specifically instructed and trained in vitro diagnostic procedures.
[COMPOSITION]
Materials Provided Test Cassette: a test cassette includes the COVID-19 Antigen Test Strip and the Influenza A+B Test Strip, which are fixed inside a plastic device
· Extraction Reagent: Ampoule containing 0.4 mL of extraction reagent
· Sterilized Swab
· Extraction Tube
· Dropper Tip
· Work Station
· Package Insert
The quantity of tests was printed on the labeling. Materials required but not provided Timer
[STORAGE AND STABILITY]
· Store as packaged in the sealed pouch at the temperature (4-30℃ or 40-86℉). The kit is stable within the expiration date printed on the labeling.
· Once open the pouch, the test should be used within one hour. Prolonged exposure to hot and humid environment will cause product deterioration. The LOT and the expiration date were printed on the labeling.
[SPECIMEN]
Specimens obtained early during symptom onset will contain the highest viral titers; specimens obtained after five days of symptoms are more likely to produce negative results when compared to an RT-PCR assay. Inadequate specimen collection, improper specimen handling and/or transport may yield a falsely negative result; therefore, training in specimen collection is highly recommended due to the importance of specimen quality for generating accurate test results.
Specimen Collection
Only the swab provided in the kit is to be used for nasopharyngeal swabcollection.Insert the swab through the nostril parallel to the palate (not upwards) until resistance is encountered or the distance is equivalent to that from their to the nostril of the patient, indicating contact with the nasopharynx. Swab should reach depth equal to distance from nostrils to outer opening of the ear. Gently rub and roll the swab. Leave swab in place for several seconds to absorb secretions. 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 minutia is saturated with fluid from the first collection. If 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.
Specimen Transport and Storage
Do not return the nasopharyngeal swab to the original swab packaging.
Freshly collected specimens should be processed as soon as possible, but
no later than one hour after specimen collection. Specimen collected may
be stored at 2-8℃ for no more than 24 hours; Store at -70℃ for a long time,
but avoid repeated freeze-thaw cycles.
[SPECIMEN PREPARATION]
1. Unscrew the lid of an extraction reagent. Add the entire specimen extraction reagent into an extraction tube, and put it on the work station.
2. Insert the swab sample 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 minute.
3. Remove the swab while squeezing the sides of the tube to extract the liquid from the swab. The extracted solution will be used as test specimen.
4. Insert a dropper tip into the extraction tube tightly.
[TEST PROCEDURE]
Allow the test device and specimens to equilibrate to temperature (15-30℃or 59-86℉) prior to testing.
1. Remove the test cassette from the sealed pouch.
2. Reverse the specimen extraction tube, holding the specimen extraction tube upright, transfer 3 drops (approximately 100μL) to each specimen well (S) of the test cassette, then start the timer. See illustration below.
3. Wait for colored lines to appear. Interpret the test results at 15 minutes. Do not read results after 20 minutes.
