BOSON Rapid SARS-CoV-2 Antigen Test Card - Home Test

Product Overview

The BOSON Rapid SARS-CoV-2 Antigen Test Card is a rapid, qualitative test for the detection of SARS-CoV-2 antigens in anterior nasal swab specimens. It is intended for home use and is authorized for Emergency Use Authorization (EUA) only.

Results are available in 15 minutes.

This test is for individuals aged 2 years and older. For ages 2-13, an adult must collect and perform the test.

Important Note: This test does not determine past COVID-19 infection or immunity.

Kit Contents

Each kit typically contains:

• SARS-CoV-2 Antigen Test Card
• Sterilized Swab
• Extraction Buffer Tube
• Tube Holder
• Quick Reference Instructions

Items necessary but not provided: Timer.

Storage and Stability

Store the kit at 2-30°C (36-86°F) and protect from direct sunlight. Do not freeze. Use before the expiration date indicated on the packaging.

Test Procedure

1. Preparation: Wash hands thoroughly with soap and water or use hand sanitizer. Ensure the kit is at room temperature. Check the expiration date on the test cassette pouch.
2. Buffer Tube Setup: Remove the seal from the buffer tube, being careful not to spill the liquid. Place the tube in the tube holder.
3. Swab Collection: Peel open the swab packaging and gently remove the swab, avoiding touching the soft tip. Insert the absorbent tip into one nostril, no more than 12 to 3.5 inches deep.
4. Swabbing: Slowly rotate the swab 5 times in a circular motion, pressing against the nostril wall for a total of 15 seconds. Do not just spin the swab.
5. Second Nostril: Gently remove the swab and repeat the swabbing process in the other nostril using the same swab.
6. Sample Preparation: Place the swab into the buffer tube. Rotate the swab 5 times, pressing against the tube to extract as much liquid as possible.
7. Buffer Tube Capping: Pinch the buffer tube with your fingers and remove the swab. Press the cap onto the buffer tube until it is secure.
8. Test Cassette: Open the pouch and remove the test cassette. Place it on a flat, level surface.
9. Add Sample: Invert the buffer tube and add exactly 3 drops of the extracted sample into the sample well (S) of the test cassette. Do not add sample to the rectangular results window.
10. Wait for Results: Set a timer for 15 minutes.

Read and Interpret the Results

WARNING: Do not read the result before 15 minutes or after 30 minutes, as this may lead to inaccurate results.

The result window shows a Control line (C) and a Test line (T).

• Negative Result: Only the Control line (C) is visible. This indicates that SARS-CoV-2 antigens were not detected. If you have symptoms and test negative, repeat testing is recommended. Test again in 48 hours if you have symptoms on the first day. If you do not have symptoms, test again after 48 hours, and if still negative, test a third time after another 48 hours.
• Positive Result: Both the Control line (C) and the Test line (T) are visible. This indicates that SARS-CoV-2 antigens were detected, and it is very likely you have COVID-19. Self-isolate and contact a healthcare provider.
• Invalid Result: The Control line (C) is not visible. The test is invalid. Repeat the test with a new swab and test device.

Serial Testing Recommendations

To improve test accuracy, serial testing is recommended:

• Symptomatic Individuals: If you have symptoms and test negative, test again after 48 hours. If the second test is also negative, a third test after another 48 hours is recommended.
• Asymptomatic Individuals: If you do not have symptoms and test negative, test again after 48 hours. If the second test is also negative, a third test after another 48 hours is recommended.

You may need to purchase additional tests to perform serial testing.

Limitations

• Antigen tests have lower sensitivity than molecular tests, meaning there is a higher chance of false negative results, especially with low viral loads.
• All negative results are presumptive. Confirmation with a molecular assay may be necessary, especially if symptoms persist.
• Incorrect results may occur if the specimen is not collected or handled properly.
• The test has not been validated for use by individuals with impaired vision or color vision.
• Performance may vary depending on circulating variants of SARS-CoV-2.

Warnings, Precautions, and Safety Information

• Read all instructions before use.
• Keep out of reach of children and pets.
• Do not use past the expiration date.
• Do not reuse test components.
• Do not touch the swab tip.
• Use the test card within 30 minutes of opening the pouch.
• Avoid contact with skin, eyes, and mouth. Do not ingest components. The buffer solution contains chemicals; flush with water if contact occurs. Seek medical advice if irritation persists.
• Wear a face mask when collecting specimens from others.
• For use under FDA Emergency Use Authorization (EUA) only.

Manufacturer Information

Xiamen Boson Biotech Co., Ltd.
90-94 Tianfeng Road, Jimei North Industrial Park
Xiamen, Fujian, 361021, P.R. China.
Tel: +1-800-689-7794
Email: support@bosoncovt.com
Website: www.bosoncovt.com

Frequently Asked Questions

What are the risks and benefits?

Risks: Possible discomfort during sample collection; possible incorrect test results.

Benefits: Results aid healthcare providers in making informed care decisions; may help limit the spread of COVID-19.

Antigen vs. Molecular Test?

Molecular tests detect viral genetic material; antigen tests detect viral proteins. Antigen tests are less sensitive and have a higher chance of false negatives.

How accurate is this test?

Accuracy is improved with serial (repeat) testing. Refer to performance data in the Healthcare Provider Instructions for Use (IFU) available at www.bosoncovt.com.

What if I have a positive result?

It is very likely you have COVID-19. Self-isolate and contact a healthcare provider.

What if I have a negative result?

A negative result is presumptive. If symptomatic, repeat testing is recommended due to lower sensitivity. If asymptomatic, serial testing is recommended.

What does an invalid result mean?

The test could not determine the result. Repeat the test with a new kit.

Index of Symbols

Model Information

Available models include:

• REF 1N40C5-1-US (1 Test)
• REF 1N40C5-2-US (2 Tests)
• REF 1N40C5-4-US (4 Tests)
• REF 1N40C5-5-US (5 Tests)
• REF 1N40C5-8-US (8 Tests)
• REF 1N40C5-10-US (10 Tests)
• REF 1N40C5-20-US (20 Tests)
• REF 1N40C5-40-US (40 Tests)

Regulatory Information

For use under the Food and Drug Administration's Emergency Use Authorization (EUA). This product has not been FDA cleared or approved. It has been authorized for the detection of SARS-CoV-2 proteins only.

For the most up-to-date information on COVID-19, visit www.cdc.gov/COVID19.

For information on EUAs, visit https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization.