RightSign COVID-19 Antigen Rapid Test (Nasal Swab) Self Test

1. Introduction

This user manual provides comprehensive instructions for the proper use of the RightSign COVID-19 Antigen Rapid Test (Nasal Swab) Self Test. This test is designed for unsupervised testing in the home to detect SARS-CoV-2 nucleocapsid protein antigen in nasal swab specimens. Please read this manual thoroughly before performing the test to ensure accurate results and safe operation.

The RightSign COVID-19 Antigen Rapid Test provides results in approximately 15 minutes. A negative test result does not exclude infection with COVID-19, and positive results or symptomatic persons require immediate confirmatory testing using a polymerase chain reaction (PCR) test.

2. Safety Information

• The test can only be performed one time. Do not reuse any components of the test kit.
• Testing must be performed by an adult only or under adult supervision.
• Do not ingest any components of the kit.
• Avoid contact of the buffer solution with skin or eyes. In case of contact, flush with plenty of water.
• Keep out of reach of children.
• Store the test kit between 2-30°C (35.6-86°F). Do not freeze.
• Do not use the test kit beyond its expiration date.
• Dispose of all used test components in the provided disposal bag according to local regulations for biohazardous waste.

3. Package Contents

Each RightSign COVID-19 Antigen Rapid Test (Nasal Swab) Self Test kit contains the following components:

• 5 x Test Cassettes (individually sealed)
• 5 x Extraction Buffer Tubes with Dropper Tips
• 5 x Sterile Nasal Swabs
• 5 x Disposal Bags
• 1 x Instructions for Use (this manual)
• 1 x Quick Reference Guide

Image: Contents of the RightSign COVID-19 Antigen Rapid Test kit, showing the individually packaged test cassette, buffer tube, sterile nasal swab, and accompanying instructions.

4. Operating Instructions

Follow these steps carefully to perform the RightSign COVID-19 Antigen Rapid Test:

4.1. Preparation

1. Wash your hands thoroughly with soap and water for at least 20 seconds. Dry them completely.
2. Ensure the test kit components are at room temperature (15-30°C or 59-86°F) before use.
3. Open the sealed foil pouch of the test cassette just before use and place it on a clean, flat surface. Use the test cassette within one hour of opening.
4. Open the pre-filled buffer tube and insert it into the hole on the kit box or a suitable holder to keep it upright.
5. Tear the aluminum foil from the pre-filled buffer tube.

4.2. Specimen Collection (Nasal Swab)

Before collecting the nasal swab, blow your nose to clear any excess mucus.

1. Carefully open the sterile nasal swab package. Avoid touching the soft tip of the swab.
2. Insert the entire absorbent tip of the nasal swab (typically 3/5 to 1 inch or 1.5 to 2.5 cm) into one nostril.
3. Firmly sample the nasal wall by rotating the swab in a circular path against the nasal wall at least 5 times for approximately 15 seconds. This ensures sufficient specimen collection.
4. Using the same swab, repeat the process for the other nostril.

4.3. Test Procedure

1. Immediately after collection, place the swab specimen into the pre-filled buffer tube.
2. Rotate the swab vigorously for approximately 10 seconds while pressing the head against the inside of the pre-filled buffer vial.
3. Remove the swab while squeezing the swab head against the inside of the pre-filled buffer vial to remove as much liquid as possible from the swab. Dispose of the swab in the provided disposal bag.
4. Fit the dropper tip securely onto the pre-filled buffer vial.
5. Hold the dropper vertically and transfer 3 drops of the sample solution into the specimen well (S) of the test cassette. Start a timer immediately.

Image: Quick Reference Guide illustrating the step-by-step process for performing the RightSign COVID-19 Antigen Rapid Test, from sample collection to result interpretation.

5. Interpretation of Results

Read the result at 10 minutes. Do not interpret the result after 20 minutes, as this may lead to inaccurate readings.

• Positive Result:

  Two colored lines appear. One colored line appears in the control region (C) and another colored line appears in the test region (T). Any faint line in the test region (T) should be considered positive. A positive result indicates the presence of SARS-CoV-2 antigen. You should immediately seek confirmatory PCR testing and follow local health guidelines.

• Negative Result:

  One colored line appears in the control region (C). No colored line appears in the test region (T). A negative result indicates that SARS-CoV-2 antigen was not detected. However, a negative result does not rule out COVID-19 infection. Continue to follow all applicable rules regarding social distancing and protective measures. If symptoms persist, consider retesting or seeking medical advice.

• Invalid Result:

  No colored line appears in the control region (C). This indicates that the test is invalid, regardless of whether a line appears in the test region (T). An invalid result may be due to incorrect test procedure or a faulty test kit. You should discard the test and repeat the procedure with a new test kit.

6. Maintenance and Storage

• Store the test kit in its original sealed pouch at room temperature, between 2-30°C (35.6-86°F).
• Do not store the test kit in direct sunlight or in areas with high humidity.
• Ensure the test kit is used before the expiration date printed on the packaging.
• After use, place all used test components (swab, buffer tube, test cassette) into the provided disposal bag. Seal the bag and dispose of it according to local regulations for medical waste. Do not dispose of in regular household trash.

7. Troubleshooting

• Invalid Result (No Control Line): If no line appears in the control region (C), the test is invalid. This could be due to insufficient sample volume, incorrect procedure, or a damaged test kit. Discard the test and repeat with a new kit, carefully following all instructions.
• No Lines Appear: If neither the control line nor the test line appears, the test is invalid. Repeat the test with a new kit.
• Faint Lines: Even a very faint line in the test region (T) indicates a positive result.
• Symptoms Persist Despite Negative Result: If you experience COVID-19 symptoms but receive a negative test result, it is recommended to retest after 24-48 hours or seek medical advice and confirmatory PCR testing.
• Test Kit Damaged: Do not use a test kit if the packaging is damaged or if any components are missing or appear compromised. Contact your supplier for a replacement.

8. Specifications

9. Warranty Information

Specific warranty information for the RightSign COVID-19 Antigen Rapid Test is not provided in the product details. For any warranty-related inquiries, please contact the retailer or the manufacturer directly using the contact information available on their official website or product packaging.

10. Support and Contact

For technical support, questions regarding test results, or any other inquiries, please contact the point of purchase or the manufacturer:

Manufacturer: Hangzhou Biotest Biotech Co. Ltd.

Please refer to the product packaging or the manufacturer's official website for the most current contact details and support resources.

11. Important Notes

• Negative test results do not exclude infection with COVID-19. Face masks, social distancing, and good hygiene practices must be maintained.
• Positive test results or symptomatic persons require immediate confirmatory testing using a polymerase chain reaction (PCR) test.
• This test is for in vitro diagnostic use only.