INDICAID COVID-19 Rapid Antigen Test Instructions

 INDICAID COVID-19 Rapid Antigen Test

INTENDED USE

INDICAID® COVID-19 Rapid Antigen Test is an in vitro diagnostic test for determining the presence of SARS-CoV-2 antigen in direct nasal swab samples or nasopharyngeal swab sample.

PRINCIPLE

During COVID-19 infection, the virus SARS-CoV-2 is found in the upper respiratory tract. SARS-CoV-2 antigens are substances of the virus that serve as markers for disease exposure.

CONTAINED IN THIS BOX

HOW TO USE

• Remove the test device and swab from their packaging.

• Tilt your head back. Gently insert the swab about 1 inch into one of your nostrils. Rub the swab against the wall of one of your nostrils at least 5 times in a large circular path. Repeat with your other nostril.

• The buffer solution vial cap is composed of two parts. Remove the entire cap. Stir the swab into the buffer solution by twisting the swab back and forth 20 times. Slightly tilt the vial to ensure the swab tip is fully submerged in the solution

• Close the entire vial cap tightly. Immediately perform Steps 5-7.

• Remove the top half of the vial cap to expose the dropper tip.

• Hold the vial vertically. Squeeze and drip 3 drops of the solution into the circular opening of the test device.

• Leave for 20 minutes and read the results. Do not read after 25 minutes. Refer to the “Interpreting Your Results” section below.

• Watch the how-to-use video by scanning the QR code

INTERPRETING YOUR RESULTS

IMPORTANT

• For in vitro diagnostic use
• User should not make any decision of medical relevance without first consulting their health care provider
• All components in this test kit should remain sealed until ready for use
• The test must be performed between 15-30°C
• All components in this test kit are for one-time use only. Do not reuse
• Store at 2-30°C. Do not freeze. Avoid direct sunlight
• Do not swallow or inhale
• Avoid contact with your eyes. If contact occurs, flush with water immediately and seek medical help
• Do not use the test kit after the expiration date
• Samples with low levels of antigen may give a faint test line. Any visible pink/purple-colored line is positive, do not compare the color intensity of each indicator line to another
• If you have questions about your results, please contact Customer Service at +852-3700-8888 or cs@indicaid.com

LIMITATIONS

• The test is designed for using a direct nasal swab sample or a nasopharyngeal swab sample.
• Negative results do not rule out COVID-19 infection, especially if you have been in contact with the virus. A follow-up PCR test should be considered to rule out infection
• Positive results may be due to current infection with non-SARS-CoV-2 coronavirus strains
• Results from antigen testing should not be used as the sole basis to diagnose or exclude COVID-19 infection

FREQUENTLY ASKED QUESTIONS (FAQs)

• I ACCIDENTALLY SPILLED THE TEST SOLUTION. IS IT HARMFUL?
  If the test solution has been spilled, flush abundantly with water upon disposal. Avoid having the test solution come into contact with your eyes, skin, and mouth. If contact occurs with the eyes, flush with water immediately and seek medical help. If contact occurs with your skin, wash the area with soap and rinse with water. Do not ingest or inhale the test solution. If accidental ingestion occurs, please seek medical help immediately.

• HOW DEEP SHOULD I INSERT THE SWAB INTO MY NOSTRILS?
  Inserting the swab 1 inch into the nostril should be deep enough to collect samples for this test. Once you feel a slight resistance, proceed to gently collect your sample. Check the swab after collection to ensure the tip is covered in nasal secretion.

• WHAT DO I DO WITH THE TEST KIT AFTER READING THE RESULTS?
  After completing the test and recording your results, carefully wrap all product components and dispose of them into the garbage just like any other household trash. Wash your hands thoroughly with soap and water after handling the components.

• HOW ACCURATE IS THE TEST?
  In the first study using retrospective nasopharyngeal swab specimens, the INDICAID® COVID-19 Rapid Antigen Test has been clinically validated to achieve a high detection accuracy, reaching a relative detection specificity of >99% and a relative detection sensitivity of 96% for nasopharyngeal swab sample (Table A). In the second study using prospective nasal and retrospective nasopharyngeal swab specimens, the relative detection specificity and sensitivity reach >95% and 91% respectively (Table B).

About the INDICAID® Mobile APP

The INDICAID® Mobile APP is a digital health pass that can interpret and record test results when used with the INDICAID® COVID-19 Rapid Antigen Test. It also provides users with clear step-by-step instructions throughout the process to ensure effective testing and accurate results.

User Instructions

1. Download the mobile APP
2. Create your account
3. Select start self-test
4. Scan the QR code on the test device packaging
5. Follow the instructions to complete the test
6. Scan the test results after 20 minutes
7. Check your result QR code and test record.

MANUFACTURER
PHASE Scientific International Limited 32 & 33/F, Gravity, 29 Hing Yip Street, Kwun Tong, Kowloon, Hong Kong

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