- Nasal swab specimens may be self-collected by the patient if the collection procedure is instructed and observed by a healthcare professional.
- Process the collected specimen immediately after collection.
- Use only the swab provided in the INDICAIDTM COVID-19 Rapid Antigen Test Kit.
- Wear appropriate personal protective equipment and gloves when collecting and handling patient samples and when running the test.
- Inspect all test reagents and materials for damage prior to use. Do not use any test components that show evidence of damage.
Remove the Swab and Test Device from their packaging. Place the Test Device on a horizontal (flat) surface for running the test.
Insert the entire collection tip of the swab provided (usually 1⁄2 to 3⁄4 of an inch, or 1 to 1.5 cm) inside the nostril.
Firmly sample the nasal wall by rotating the swab in a circular path against the nasal wall at least 4 times. Take approximately 15 seconds to collect the specimen. Be sure to collect any nasal drainage that may be present on the swab.
Repeat in the other nostril using the same swab.
The Buffer Solution Vial cap is composed of two parts (purple and white). Remove the entire cap. Stir the swab into the Buffer Solution, ensuring that the swab head is fully submerged by tilting the vial.
Twist the swab back and forth 20 times in the Buffer Solution. Roll the swab head against the inner wall of the vial to release the liquid from the swab, then discard the swab.
Close the entire vial cap tightly. Immediately proceed to the Test Procedures to process the sample.
Test Procedure for Patient Swabs
- Perform the following Test Procedures immediately after the specimen has been collected in the Buffer Solution Vial.
- The Test Device should be placed on a horizontal (flat) surface when running the test. Do not perform testing with the Test Device in any other orientation.
01 Remove the purple top half of the cap to expose the dropper tip.
02 Hold the vial vertically above the sample well (S). Slowly squeeze and apply 3 drops of the Buffer Solution into the sample well (S) of the Test Device.
03 Read the test line (T) and control line (C) results promptly at 20 minutes, and not earlier to ensure proper test performance.
Results after 25 minutes should not be used.
- Test results are interpreted visually, without the aid of instruments.
The presence of both the red-colored control line (C) and red-colored test line (T) indicates the presence of SARS-CoV-2 antigen. The result suggests current SARS-CoV-2 infection. Samples with low levels of antigen may produce a faint test line. Any visible test line is considered positive.
The presence of the red-colored control line (C) and no visible test line (T) indicates a negative result. No SARS-CoV-2 antigen was detected.
If the red-colored control line (C) is not visible, DO NOT interpret the test result. The result is invalid regardless of the appearance of the test line. Collect a new nasal swab sample and repeat the assay with a new INDICAIDTM COVID-19 Rapid Antigen Test.
External Quality Control Test Procedure
Please refer to the complete INDICAIDTM COVID-19 Antigen Quality Controls Instructions For Use.
01 Remove a new Swab and Test Device from their packaging. Place the Test Device on a horizontal (flat) surface for running the test.
02 Hold a new INDICAIDTM COVID-19 Antigen Positive Control Vial vertically and open the cap.
03 Dip the new Swab into the Positive Control Vial, making sure that the Swab head is fully submerged in the solution. Roll the Swab head around in the solution to ensure the swab is wetted. Remove the Swab from the Vial.
04 Test the Swab immediately performing the same steps as described in section “Test Procedure for Patient Swabs” above.