Self-diagnostic strep test munus medical detection of group a beta-hemolytic strep bacteria from throat swab

TEST
STREPTOCOCCUS A

SELF-DIAGNOSTIC

Description
Self-test for the detection of group A beta-haemolytic streptococcus bacteria from throat swab.

How to use
1) Wash your hands with warm water and soap, rinse with clean water and dry.
2) Place the empty plastic tube into the hole on the back of the package.
3) Sample collection:
- open the package containing the tongue depressor, keeping it inside without removing it, and place it next to you;
- open the package containing the sterile swab, avoiding touching the cotton tip, and remove it by grasping the plastic handle;
- stand in front of the mirror, tilt your head back and open your mouth as wide as possible;
- with one hand, grasp the tongue depressor and use it to flatten the tongue downwards;
- With your other hand, bring the swab to your throat and touch the back of your throat, around your tonsils, and any red or sore areas (soft palate, uvula) with the cotton tip. It is recommended to rotate the swab to increase the amount of sample collected. If you have difficulty, ask someone to help you with the collection phase.
4) After collecting the sample, insert the cotton tip of the swab into the plastic tube provided, previously placed in the appropriate hole in the box.
5) Open the STREPT A TEST - R1 vial by unscrewing only the blue cap (leaving the white part tightly screwed on), then place 4 drops inside the test tube and close the cap.
6) Next, open the STREPT A _R2 bottle by unscrewing only the green cap (leaving the white part tightly screwed on), then place 4 drops inside the test tube and close the cap.
WARNING: adding R2 to R1 leads to the formation of a solution for which the indications described in points 8 and 9 of the "precautions" apply.
7) Holding the swab by the plastic handle, rotate it thoroughly against the walls of the tube about 10 times to mix the solution. Leave the swab there for an incubation time of 2-5 minutes.
8) Once the incubation period is over, remove the tube from the hole in the package (with the swab and extraction fluid still inside) and, using your thumb and forefinger, press the walls of the tube to squeeze the cotton tip of the swab to collect as much fluid as possible inside the tube, removing the swab itself. Dispose of the swab in a waste container according to local regulations and replace the tube inside the support hole on the back of the test package.
9) Add the dropper provided to the plastic test tube.
10) Dispense 1 drop into the cassette well.
Note: If the dispensed drop contains air bubbles, please dispense a second drop into the well.
11) Read results after 5 minutes (some positive results may be evident after 1 minute). Do not read after 10 minutes.
INTERPRETATION OF RESULTS
READ THE RESULT AFTER 5 MINUTES.
POSITIVE RESULT
Two colored lines appear in the reading window at the T (Test) and C (Control) marks. The intensity of the T line may be lower than the C line. The test should therefore be considered positive regardless of the intensity of the T test line. This result indicates that the test has detected the presence of specific Streptococcus A antigens in the sample. It is recommended to consult a physician.
NEGATIVE RESULT
Only one colored line appears under the C (Control) mark. This result indicates that Strep A antigens were not detected in the throat specimen or were not present in sufficient quantities to be detected.
INVALID RESULT
No lines appear or only one line appears under the T (Test) mark and not under the C (Control) mark. In this case it is not possible to interpret the Test result which must be considered invalid, it is recommended to perform a new test with a new sample.

Warnings
- Read the instructions for use carefully before performing the test. The test is reliable if the instructions are carefully followed.
- Keep out of reach of children.
- Do not use the test after the expiration date or if the package is damaged.
- Follow the procedure exactly, respecting the indicated quantities of blood and diluent.
- Use the test and the lancet only once.
- The test is for external use only. Do not ingest.
- In vitro diagnostic device for individual use.
- Not recommended for use by people taking medicines that thin the blood (anticoagulants) or people who have haemophilia problems.
- After use, dispose of all components in accordance with local regulations, ask your pharmacist for advice.

Conservation
Store at temperatures between 4°C and 30°C.
Validity with intact packaging: 24 months.

Format
Package containing:
- 1 test cassette;
- 1 desiccant sachet;
- 1 sterile swab;
- 1 sterile wooden tongue depressor;
- 1 dropper bottle with R2 solution (green cap);
- 1 empty sampling tube with dropper;
- user manual.

Code MM-STREP-A