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MEDICAL ASSISTANCE TEST Streptococcus A SELF-DIAGNOSTIC Description Self-test for the detection of group A beta-hemolytic streptococcal bacteria from a throat swab. How to use 1) Wash your hands with warm water and soap, rinse with clean water and dry. 2) Insert the empty plastic test tube into the hole on the back of the packaging. 3) Sample collection: - open the packaging 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 grabbing the plastic handle; - stand in front of the mirror, tilt your head back and open your mouth as wide as possible; - with one hand, grab the tongue depressor and use it to flatten the tongue downward; - 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 are having difficulty, ask someone to help you collect the sample. 4) After collecting the sample, insert the cotton tip of the swab into the plastic tube provided, previously placed in the corresponding hole in the box. 5) Open the STREPT A TEST - R1 bottle 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 put 4 drops inside the test tube and close the cap. CAUTION: Adding R2 to R1 results in the formation of a solution for which the instructions in points 8 and 9 of the precautions apply. 7) Holding the swab by the plastic handle, roll it gently around the sides of the tube approximately 10 times to mix the solution. Leave the swab in the tube for 2-5 minutes to incubate. 8) After the incubation period is complete, remove the tube from the opening in the packaging (with the swab and extraction fluid still inside) and, using your thumb and forefinger, press the edges of the tube to squeeze the cotton tip of the swab, collecting as much fluid as possible inside the tube. Remove the swab. Dispose of the swab in a waste container according to local regulations and replace the tube in the holder opening on the back of the test package. 9) Add the provided pipette to the plastic test tube. 10) Apply one drop to the well of the cassette. Note: If the released drop contains air bubbles, please release 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 corresponding to the T (Test) and C (Control) marks appear in the reading window. The intensity of the T line may be less than that of the C line. Therefore, the test should be considered positive regardless of the intensity of the T 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 A single colored line appears under the C (Control) mark. This result indicates that streptococcal A antigens were not detected in the throat swab 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, the test result cannot be interpreted and should be considered invalid. It is recommended to perform a new test with a fresh sample. warnings - Read the instructions for use carefully before performing the test. The test is reliable if the instructions are strictly followed. - Keep out of reach of children. - Do not use the test after the expiration date or if the packaging is damaged. - Follow the procedure exactly, respecting the indicated amounts of blood and diluent. - Use the test and lancet only once. - The test is for external use only. Do not swallow. - In vitro diagnostic device for individual use. - Not recommended for use by people taking blood-thinning medications (anticoagulants) or by people with hemophilia 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. Shelf life in intact packaging: 24 months. Format Package containing: - 1 test cassette; - 1 desiccant sachet; - 1 sterile swab; - 1 sterile wooden tongue depressor; - 1 pipette bottle with R2 solution (green cap); - 1 empty tube for pipette sampling; - user manual. Code MM-STREP-A
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