EUA No. 220205
Rapid Self-Test Kit for SARS-CoV-2 Antigens is an accurate and easy-to-use solution for detecting COVID-19 manufactured by Genabio.
This non-prescription test is designed for self-testing at home with anterior nasal swab specimens. It is authorized for individuals aged 14 years or older, or adult-collected samples from individuals aged 2 years or older within the first 7 days of symptom onset. With improved performance in detecting Omicron variants, this Rapid Self-Test Kit provides reliable results that US FDA authority has approved for EUA.
Each test includes a short nasal swab, buffer tube with drop cap, foil-sealed test cassette, and clear instructions. Results are available within 15 minutes. This test comes in sizes of 1 test/pack and 2 tests/pack, and the compact packaging reduces costs and is more environmentally friendly. Manufactured in ISO13485 accredited Genabio facilities.
Test Procedures
Step 1: Sample Collection
• Remove the swab from the pouch (Note: Be careful not to touch the swab tip (soft end) with fingers.)
• Carefully insert the swab tip into one nostril about ½ to ¾ inch. Firmly and slowly rotate the swab 5 times, brushing against the inside walls of the nostril to ensure both mucus and cells are collected. (Note: 1. Do not push the swab further if you meet resistance. 2. For young children, do not insert more than ½ inch.)
• Using the same swab, repeat this process for the other nostril to ensure an adequate sample is collected from both nostrils. (Note: Failure to swab properly may cause incorrect results.)
Step 2: Sample Processing
• Insert the swab in tube to the bottom.
• Rotate the swab at least 10 times while pressing the swab head against the bottom and side of the tube.
• Remove the swab while squeezing the sides of the tube to express as much liquid as possible from the swab.
• Attach the dropper tip firmly onto the tube.
Step 3: Sample Testing
• Gently squeeze the tube and dispense 3 drops of solution into the sample well. (Note: A false negative or invalid result may occur if less than 3 drops of solution are added to the Sample well.)
Step 4: Testing Result
• The result is valid when read at 10 – 30 minutes. If a POSITIVE result is obtained within 10 minutes, the result should also be considered valid.
Step 5: Guidelines on Test Result Interpretation
Packing Size | 1 Test, 2 tests |
---|---|
Product No | BB0730-1, BB0730-2 |
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