TEST
STREPTOCOCCO

AUTODIAGNOST

Description
Self-test for detection of beta-emolytic group A streptococcus by pharyngeal buffer.

Mode of use
1) Wash hands with hot water and soap, rinse with clean water and dry.
2) Place the blank plastic tube in the hole on the back of the package.
3) Sample collection:
- open the box containing the lower tongue by keeping it inside it without parade and placing it next to it;
- open the box containing the sterile pad avoiding touching the cotton tip and removing it by grasping the plastic handle;
- place in front of the mirror, tilt the head backwards and open the mouth as widely as possible;
- with a hand grasp the lower tongue and use it to flatten the tongue down;
- With the other hand, approach the swab to the throat and touch, with the cotton tip, the back of the throat, that around the tonsils and any reddened or sore area (soft side, ugola). It is recommended to rotate the pad to increase the amount of sample taken. In case of difficulty, ask someone for help in the withdrawal phase.
4) After collecting the sample, insert the cotton tip of the pad into the supplied plastic tube, previously placed in the special hole in the box.
5) Open the STREPT A TEST - R1 bottle by unscrewing only the blue cap (leaving the white part strictly screwed), then deposit 4 drops inside the tube and close the cap.
6) Next, open the STREPT A _R2 bottle by unscrewing only the green cap (leaving the white part strictly screwed), then deposit 4 drops inside the tube and close the cap.
WARNING: the addition of R2 to R1 leads to the formation of a solution for which the indications described in point 8 and 9 of the "precautions".
7) Holding the swab from the plastic handle, let it rotate thoroughly against the walls of the tube for about 10 times to mix the solution. Leave the tampon for a 2-5 minute incubation time.
8) Finished the incubation period, remove the tube from the hole on the package (with the pad and the extraction liquid still inside) and, using the thumb and index, press the walls of the tube to squeeze the cotton tip of the tampon in order to collect as much liquid as possible within the tube, removing the pad itself. dispose of the buffer in a waste container according to local provisions and reposition the tube inside the support hole placed on the back of the test box.
9) Add to the plastic tube the dropper provided.
10) Dispense 1 drop in the box well.
Note: If the dispensed drop contains air bubbles, please dispense a second drop in the well.
11) Read results after 5 minutes (some positive results can already be obvious after 1 minute). Don't read after 10 minutes.
INTERPRETATION OF RESULTS
I'LL READ THE STATEMENT AFTER FIVE MINUTES.
POSITIVE RESULTS
Two colored lines appear in the reading window at T (Test) and C (Control). The intensity of the T line can be lower than the C line. The test must therefore be considered as positive regardless of the intensity of the test band T. This result indicates that the test identified the presence of specific antigens of Streptococco A within the sample. It is recommended to consult a doctor.
NEGATIVE RESULTS
Only a coloured line appears under the sign C (Control). This result indicates that the antigens of Streptococco A were not detected in the pharyngeal sample or are not present in quantities such as to be detected.
NATIONAL RESULTS
Lines do not appear or appear only a line under sign T (Test) and not under sign C (Control). In this case it is not possible to interpret the result of the Test that must be considered invalid, it is recommended to carry out a new test with a new sample.

Warnings
- Carefully read the instructions for use before testing. The test is reliable if the instructions are carefully respected.
- Keep away from the reach of children.
- Do not use the test after the expiry date or if the packaging is damaged.
- Follow exactly the procedure respecting the indicated quantities of blood and diluent.
- Use the test and the tip only once.
- The test is only for external use. Don't swallow.
- In vitro diagnostic device for individual use.
- Not recommended to use people taking medicines that make blood more fluid (anti-agulants) or people who have hemophilia problems.
- After use dispose of all the components according to current local standards, ask for advice to the pharmacist.

Conservation
Store at temperature between 4°C and 30°C.
Validity of whole packaging: 24 months.

Format
Packaging:
- 1 test box;
- 1 drying bag;
- 1 sterile swab;
- 1 lower tongue in sterile wood;
- 1 dropper bottle with R2 solution (green plug);
- 1 empty sample tube with dropper;
- user manual.

Cod. MM-STREP-A