Description
STREP A TEST is an immunochromatographic test that detects the presence of specific antigens of Streptococcus A thanks to antibodies conjugated with gold and incorporated into the test strip.

How to use
Attention: in case of purchase of multipack, make sure that the sterile swab, sterile tongue depressor, test tube and dropper have not been previously used (this is disposable material and therefore not reusable).
1. Wash hands with warm water and soap, rinse with clean water and dry.
2. Prepare the workstation on a flat, dry and clean surface. Place the empty plastic test tube in one of the workstation holes.
3. Sample collection:
-Open the package containing the tongue depressor, keeping it inside without taking it out and placing it next to you;
-Open the package containing the sterile swab avoiding touching the cotton tip and remove it by grabbing the plastic grip;
-Position yourself in front of the mirror, tilt your head back and open your mouth as widely as possible;
-With one hand grasp the tongue depressor and use it to flatten the tongue down;
-With the other hand, bring the swab to the throat and touch, with the cotton tip, the posterior area of the throat, the one around the tonsils 3 and any red or sore area (soft palate 1, uvula 2). It is recommended to rotate the swab to increase the amount of sample taken. In case of difficulties, ask someone to help you for the withdrawal phase.
4. After collecting the sample, insert the cotton tip of the swab into the plastic test tube provided, which is previously placed on the work station.
5. Open the STREP TEST - R1 vial by unscrewing only the blue cap (leaving the white part tightly screwed), then deposit 4 drops inside the test tube and close the cap.
6. Next, open the STREP A TEST - R2 vial by unscrewing only the green cap (leaving the white part tightly screwed), then deposit 4 drops inside the test tube and close the cap.
ATTENTION: the addition of R2 to R1 leads to the formation of a solution for which the indications described in paragraph 8 and 9 of the “precautions” apply.
7. Holding the pad from the plastic handle, rotate it thoroughly against the walls of the test tube about 10 times to mix the solution. Leave the tampon for an incubation time of 2-5 minutes.
8. After the incubation period, remove the test tube from the work station (with the pad and the extraction liquid still inside) and, using the thumb and forefinger, press the walls of the test tube to squeeze the cotton tip of the swab in order to collect as much liquid as possible inside the tube, By removing the tampon itself.
Dispose of the swab in a waste container according to local regulations and reposition the test tube inside one of the workstation holes.
9. Add the dropper provided to the plastic test tube.
10. Dispend 1 drop in the cassette well.
Note: If the dispensed drop contains air bubbles, please dispense a second drop in the well.
11. Read the results after 5 minutes (some positive results can already be noticeable after 1 minute). Do not read after 10 minutes.

Reading results
Read the result after 5 minutes. Do not read the result after 10 minutes.
POSITIVE RESULT
Two colored lines appear in the reading window at the signs T (Test) and C (Control). The intensity of the T line can be clearer than the C line. This result indicates that the test identified the presence of specific antigens of Streptococcus A within the sample.
It is recommended to consult a doctor.
NEGATIVE RESULT
Only a colored line appears under the sign C (Control).
This result is negative and means that Streptococcus A antigens have not been detected in the pharyngeal sample or are not present in such quantities as to be detected.
RESULT NOT VALID
No lines appear or only a line appears under the sign T (Test) and not under the sign C (Control). In this case it is not possible to interpret the result of the Test which must be considered invalid, it is recommended to carry out a re-test with a new sample.

Warnings
1. Please read these instructions carefully before carrying out the Test. The Test is reliable if the instructions are properly respected (reaction times, the sample collection mode and the extraction instructions indicated).
2. Keep the test away from children.
3. Not suitable for use on children under 2 years of age.
4. Do not use the Test after the expiration date or if the packaging is damaged.
5. Store the test components at temperatures between 4 °C and 30 °C. Do not freeze.
6. Use the individual Test only once.
7. In vitro diagnostic device for individual use.
8. The Test is for external use only. Do not ingest solutions 1 and 2 and other components of the box! If these are ingested, seek advice from your doctor immediately and take the remaining parts of the box with you, along with the instructions for use and packaging.
9. If fluids come into contact with eyes, skin or other mucous membranes, rinse immediately and thoroughly with water and contact a doctor by showing the label of the bottles.
10. After use, dispose of all components according to current local regulations. Liquid waste should not be disposed of in sewers.
11. Open all sealed components (cassette, buffer and tongue depressor) only before running the Test, pay attention to the opening marks.
12. Do not exchange reagent bottle caps.
13. All components of the kit are disposable except for the workstation, which can be reused, the instructions for use and solutions 1 and 2 which must be stored between 4 °C and 30 °C with the relative cap properly closed.

Format
Content:
-Hermetically sealed aluminium envelope containing 1 box of STREP A TEST and 1 sachet of drying;
-Sterile buffer;
-Sterile wood tongue depressor;
-1 workstation;
-1 sheet of instructions for use;
-Empty plastic tube for sampling with dropper;
-1 dropper vial containing the STREP A TEST-R1 solution (R1 test contains 20.7% sodium nitrite;
-1 dropper vial containing the STREP A TEST-R2 solution (R2 test contains 0.55% acetic acid.

Cod. 800060-1AC