APPLICATION

Equipment and materials not included in the kit

• Test tubes with transport medium.
• Gloves, cotton wool.
• Dispenser (semi-automatic variable volume pipette) for sample introduction with disposable polypropylene tips.
• Timer.
• Fridge freezer.
• Desinfecting solutions approved for use by Sanitary Regulations SP 1.32322-08, except for chlorine containing ones.

Preparation for the Analysis

1. Bring up all materials and samples to room temperature (from +18ºC to +30ºC).
2. Add 8 drops (~0.5 ml) from the vial with extraction buffer to the test tube included in the kit. Place the solution tube vertically in the rack.
3. Using a sterile swab probe, carefully insert the swab portion into the patient's nostril (Figure 1).
   
   
4. Swipe the swab over the back of the nasopharynx and rotate the probe several times.
5. Remove the swab from the nasal cavity.
6. Insert the swab probe into the extraction tube with the extraction solution.
7. Roll the swab probe in a test tube in a circle at least 6 times, pressing it to the bottom and to the walls of the extraction tube (Figure 2).
   
8. Leave the swab in the extraction tube for 1 minute.
9. Squeeze the outside of the tube several times to squeeze out the swab. Remove the swab probe from the test tube.

Note: When using a transport medium, dilution of the samples with the extraction buffer is not required.

1. 1. Remove the test cassette from the sealed foil package (or remove the test strip from the tube), mark and put on a horizontal surface. Immediately close the vial containing the remaining test strips tightly. Do not remove the desiccant from the tube!

When performing the analysis with the test cassette:

1. Put the attachment on the test tube with the extraction solution containing the biological material (see "Preparation for the Analysis"). Make sure the attachment fits tightly against the tube!
   1. Keeping the test tube in an upright position, add 2 drops (~ 80 µl) of the solution into the round hole of the test cassette (marked with “S”).
   2. When using biological material from the test tube with the transport medium, pipette 2 drops (~ 80 µl) of the transport medium into the round hole of the test cassette (marked with the "S").

Note: When using a transport medium, preliminary dilution of the samples with the extraction buffer is not required!

When performing the analysis with the test strip:

1. When using biological material from a test tube with a transport medium, pipette 8 drops (~ 0.5 ml) of the transport medium into the test tube with a nozzle.
2. Holding the test strip in an upright position, immerse it for 5-10 seconds (up to the line marked "???") into a test tube with an extraction solution containing biological material (see "Preparation for the Analysis") or into a test tube with a nozzle containing a transport medium with biological material.
3. Remove the test strip from the tube and place it on a flat, horizontal surface.
4. Start the timer.

Read the analysis results in 15-20 minutes.

Note: Results may not be accurate after 20 minutes.

Note: Do not reuse the test cassette (or test strip). Dispose of the used test cassette (or test strip) according to "Disposal".

Figure 3. Band coloration pattern

Negative:

If the test portion (T) does not have a colored band while the control portion (C) shows a colored band, the result is negative and valid.

Positive:

If two colored bands are observed, the test result is positive and valid.

Invalid:

The test result is invalid if a colored band does not appear on the control portion (C). The sample should be re-analyzed using a new analysis item.