1. Introduction and Overview
The OSOM COVID-19 Antigen Home Test is an FDA EUA authorized rapid diagnostic test designed for convenient at-home use. It provides quick results in just 15 minutes, helping you determine your COVID-19 status without leaving your home. This test utilizes the same technology trusted by healthcare professionals and is designed to detect a wide range of COVID-19 variants, including Delta and Omicron.
The test is authorized for non-prescription home use with self-collected anterior nasal swab samples from individuals aged 14 years or older. For children aged 2-13 years, adult collection of the nasal swab sample is required.
Image: A smiling doctor, symbolizing the trusted technology used in the test.
2. Safety Information
- Do not use if the test kit has expired. Always check the expiration date printed on the outer packaging.
- Avoid contact of the extraction liquid with skin and eyes. If contact occurs, rinse thoroughly with water.
- Do not read test results before 15 minutes or after 30 minutes. Reading results outside this window may lead to inaccurate interpretations.
- A negative test result does not rule out COVID-19. Repeat testing is needed to improve test accuracy, especially if symptoms persist.
- If you continue to experience symptoms of COVID-19 despite negative test results, you should follow up with your healthcare provider.
3. What's in the Box
Each OSOM COVID-19 Antigen Home Test kit contains materials for two tests:
- 2 x Individually pouched Test Devices
- 2 x Tubes containing 300 µl of buffer liquid
- 2 x Sterile Nasal Swabs
- 1 x Quick Reference Instructions
- 1 x Tube Holder (integrated into the back of the carton)
Image: Contents of the OSOM COVID-19 Antigen Home Test kit.
4. Setup and Preparation
- Read all of the instructions carefully before performing the test.
- Wash your hands thoroughly with soap and water for at least 30 seconds, or use an alcohol-based hand sanitizer. Ensure your hands are completely dry before starting the test.
- Instruct the individual to gently blow their nose to remove any excess mucus.
- Remove the test device from its foil pouch by tearing along the indexed tear-line. Lay the test device on a clean, flat, level surface (e.g., a table or countertop). Once opened, the test device should be used within 30 minutes.
- Remove the white cap from the collection tube and place the tube into the designated hole on the back of the carton (tube holder).
Image: A woman preparing for the test by blowing her nose.
5. Operating Instructions
- Carefully remove the sterile nasal swab from its packaging. Do not touch the soft tip of the swab or lay it down on any surface.
- Insert the entire soft tip of the swab into the first nostril about 1/2 to 3/4 of an inch. Firmly brush against the entire inner walls of the nostril in a complete circle at least 4 times. Do not insert the swab any farther if you feel resistance.
- Remove the swab and, using the same swab, repeat step 2 in the other nostril.
- Insert the swab into the collection tube containing the buffer liquid. Plunge the swab up and down in the buffer solution for 15 seconds while squeezing the sides of the tube from the outside. Be careful not to spill or splash the contents.
- Remove the swab while squeezing the sides of the tube to extract as much liquid as possible. Discard the used swab safely.
- Firmly cap the collection tube with the attached dropper tip.
- Invert the collection tube and tap the sides of the tube to remove any air bubbles from the dropper tip.
- Hold the dropper tip about 1/4 of an inch vertically above the test device sample well. Slowly squeeze the tube to dispense all liquid (5 drops) into the sample well.
- Set a timer for 15 minutes. Do not handle or move the test device during this time.
Image: Adult-assisted nasal swab collection for children.
Image: Self-collection of nasal swab sample.
Image: Hands preparing the test, illustrating the mixing process.
Official OSOM COVID-19 Antigen Home Test - Explained Video. This video provides a detailed visual guide on how to perform the test steps correctly.
6. Interpreting Results
Read your test results exactly at 15 minutes. Do not interpret results before 15 minutes or after 30 minutes, as this may lead to inaccurate results.
Positive Result:
A positive test result will show two pink or purple colored lines: one on the Control Line (C) and one on the Test Line (T). This indicates that the virus causing COVID-19 was detected in your sample, and it is very likely you have COVID-19 and are contagious.
Negative Result:
A negative test result will show only a single pink or purple colored line on the Control Line (C), with no line appearing on the Test Line (T). This indicates that the virus causing COVID-19 was not detected in your sample.
Invalid Result:
If no Control Line (C) appears at 15 minutes, or if the Control Line (C) appears after 30 minutes, the test is invalid. Even if a Test Line (T) is visible, the test is considered invalid. An invalid result means the test did not work correctly. You should retest with a new kit.
7. Repeat Testing Guidelines
- Individuals with symptoms and initial negative results: Test again after 48 hours.
- Individuals without symptoms and initial negative results: Test again after 48 hours. If the second test is also negative, test a third time after an additional 48 hours.
- If you continue to experience symptoms of COVID-19 despite negative test results, you should follow up with your healthcare provider.
8. Maintenance and Storage
- Store the test kit at room temperature, between 15-30°C (59-86°F).
- Ensure the test kit remains stable until the expiration date marked on the outer packaging. Do not use beyond the stated expiration date.
- Keep the kit in its original packaging to protect components from damage and environmental factors.
Image: Test kits stored in a drawer.
9. Troubleshooting
- Invalid Test Result: If your test yields an invalid result (no Control Line), it indicates an error in the testing process or a faulty kit. Discard the invalid test and retest using a new, unopened kit.
- Difficulty with Swab or Tube: Ensure you follow the instructions precisely, especially regarding the depth of swab insertion and the squeezing technique for the buffer tube. Improper technique can affect sample collection and result accuracy.
- Accuracy Concerns: While the test has high accuracy, factors such as improper storage, failure to follow all instructions, or using an expired kit can impact results. Always ensure optimal conditions for testing.
10. Specifications
- Model Number: 1067-2
- Manufacturer: Sekisui Diagnostics
- Country of Origin: USA
- Results Time: 15 minutes
- Sample Type: Anterior Nasal Swab
- Age Range: Self-collected for individuals 14 years and older; Adult-collected for children 2-13 years old.
11. Warranty and Support
For any questions regarding product performance, troubleshooting beyond this manual, or warranty information, please contact the manufacturer directly:
Sekisui Diagnostics, LLC
Website: sekisuidiagnostics.com
Please refer to the contact information provided on the product packaging for the most up-to-date details.
