Description:

Directions For Use:
The following instructions are the test procedure to complete a single test. If more than one individual will be tested, separate the test components to avoid confusion.

Before starting:

• Scan the QR code on page 1 to download the NAVICA app. Open the app and follow the prompts to complete the test

• Wash or sanitize your hands. Make sure they are dry before starting

Prepare for the test:

• Check the expiration date on the box. Do not use it if the kit is expired

• Ensure the kit is at room temperature for at least 30 minutes prior to use. Open the box and remove 1 each of the components to perform a single test. Do not open individual components until instructed
• Keep buffer bottle upright, twist and pull tab to open the bottle
• Squeeze the liquid from the buffer bottle into the tube. You will need to squeeze at least twice
• Put the Tube into the tube rack before proceeding to the next step

Collect the Nasal Sample:

• Keep fingers away from the swab end

• Open swab protective package at stick end. Take the swab out

• Swab both nostrils. Insert the soft end of the swab straight back into your nostril until resistance is felt (about 2cm). Slowly rotate the swab, gently rubbing it along the insides of your nasal passage at least 5 times. Remove the swab from the nostril
• Insert the swab into the tube. Swirl in the fluid 5 or more times while pushing against the wall of the tube. Pinch the swab tip through the tube to remove any remaining fluid
• Hold the tube firmly with one hand. Lift the swab and locate the break line. Snap the swab handle at the break line. Leave the swab in the tube and discard the stick
• Secure the Blue Cap on the top of the Tube. Return the Tube to the Tube Rack before proceeding to the next step

Perform the test:

• Remove the Test Device from its protective package and place it on a well-lit, flat surface

• Check liquid for bubbles. Wait for any bubbles to disappear as they can lead to inaccurate results. Keep the Tube vertical with the white cap pointed down. Remove the white cap. Do not move the Test Device until the test is finished

• Squeeze 5 drops of liquid from the Tube into the well on the Test Device. Secure white cap back on Tube and wait 15 minutes
• Keep the Test Device flat on the table. After 15 minutes, use the NAVICA app to take a photo of the Test Device and submit your result. The app will automatically submit your result to ICMR and display your test result. Do not read the result earlier than 15 minutes or after 20 minutes

Read the test result:

Invalid Result (test did not work)
Find the result window. If NO Control (C) line is present, the test did not work and is considered Invalid. This may be the result of an incorrect test procedure and the test should be repeated.

Positive Result
Find the result window and look carefully for two lines. Positive Result: If you see two lines, Control (C) line and Test (T) line, this means COVID-19 was detected. If positive, please contact your doctor or local health department immediately and follow local guidelines for self-isolation.

Negative Result
Find the result window and look for a single line in the window. Negative Result: If you see only the Control (C) line is present, this means COVID-19 was not detected. If the rapid antigen test results are negative and symptoms continue, individuals should immediately be tested by RT-PCR per ICMR Advisory. You are also advised to continue following local guidelines for self-isolation and consult your doctor. Ministry of Health & Family Welfare, Government of India (https://www.mohfw.gov.in)

Dispose of the test kit:

• Place swab, tube and test device into the bag

• Seal the bag tightly

• Throw away the bag in the waste bin

Interactions / Warnings: For in vitro diagnostic use only Read instructions prior to performing the test. Follow all instructions to achieve accurate results Do not eat or smoke while handling specimens Wash hands thoroughly before and after the test is completed Clean up spills thoroughly using an appropriate disinfectant Dispose of all specimens, reaction kits and potentially contaminated materials (i.e. Swab, Tube, Test Device) in the bag provided Use only the liquid from the Buffer Bottle provided in the kit. The use of other liquids will lead to inaccurate results Keep the test kit out of reach of children To prevent contamination, only touch the sides of the Test Device and ensure the Swab end only touches the nasal cavity and inside of Tube The provided Swab should be used only for nasal (mid-turbinate) specimen collection Each single Test Device, Swab, Tube, Blue Cap, Buffer Bottle and Bag are single-use. Do not reuse individual components. The Tube Rack is reusable Do not dip the Swab into the buffer or other liquid before inserting the Swab into the nose The provided Buffer Bottle contains <0.1% sodium azide as a preservative which may be toxic if ingested. If you get buffer solution into your eyes rinse for at least 15 minutes under running water. If irritation persists, go to a doctor If you have stored the kit in the refrigerator, store the kit at room temperature (15 to 30°C) for 30 minutes before use Do not use the test kit if the pouch is damaged or the seal is broken Direct swab specimen should be tested immediately after collection