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ALL TEST Description Rapid test for the qualitative detection of Streptococcal A antigen in pharyngeal specimens. For professional in vitro diagnostic use only. The Strep A Rapid Test Device (Pharyngeal Sputum) is a rapid lateral flow immunochromatographic assay for the qualitative detection of Strep A carbohydrate antigen in a pharyngeal swab. In this assay, a specific antibody against Strep A carbohydrate antigen is applied to the test line. During the assay, the extracted pharyngeal swab reacts with the Strep A antibody applied to the particles. This mixture migrates to the membrane, where it reacts with the Strep A antibody present, generating a red line in the test line region. The presence of this red line in the test line region indicates a positive result, while its absence indicates a negative result. As a procedural control, a red line will always appear in the control line region if the test has been performed correctly. If no red line appears, the test result is invalid. How to use Sample collection and preparation Collect the specimen using the sterile throat swab provided in the kit. Swabs containing modified Stuart or Amies transport medium may also be used with this product. Wipe the posterior pharynx, tonsils, and other inflamed areas. Avoid contact of the swab with the tongue, cheeks, and teeth. - The test should preferably be performed immediately after sample collection. Samples can be stored in a clean, dry plastic tube at room temperature for up to 8 hours or at 2-8°C for up to 72 hours. - If you wish to perform a culture, gently swirl the swab tip on a Group A Selective Blood Agar (GAS) plate before using the swab with the Streptococcus A Rapid Test Device (Throat Swab). Procedure Bring the test card, reagents, throat swab, and/or controls to room temperature (15-30°C) before testing. 1. Remove the card from the sealed envelope and use it immediately. 2. Holding the Reagent 1 vial upright, add 4 drops (approximately 240 μl) to a sample extraction tube. Reagent 1 is red. Holding the Reagent 2 vial upright, add 4 drops (approximately 160 μl) to the tube. Reagent 2 is colorless. Mix the solution by gently swirling the tube. Adding Reagent 2 to Reagent 1 changes the color of the solution from red to pale yellow. 3. Immediately add the throat swab to the yellow solution in the tube. Swirl the swab in the tube 15 times. Leave the swab in the tube for 1 minute. 4. Then, press the stick into the tube and squeeze the bottom of the tube while removing the stick. Discard the stick. 5. Insert the pipette tip into the top of the test tube. Place the test device on a clean, flat surface. Add 3 drops of solution (approximately 100 μl) to the sample well (S) and start the timer. Wait for the red line(s) to appear. Read the result after 5 minutes. Do not interpret the result after 10 minutes. Interpretation of results POSITIVE:* Two distinct red lines appear. One in the control region (C), the other in the test region (T). A positive result indicates that Streptococcus A was detected in the sample. *NOTE: The intensity of the red color in the test region (T) varies depending on the concentration of Streptococcus A in the sample. Therefore, any shade of red in the test region (T) should be considered a positive result. NEGATIVE: A red line appears in the control region (C). No red or pink line appears in the test region (T). A negative result indicates that Strep A antigen is not present in the specimen or is present below the detectable threshold of the test. The patient specimen should be cultured to confirm the absence of Strep A infection. If clinical symptoms are inconsistent with the results, another specimen should be collected for culture. INVALID: No band appears in the control region (C). The most likely reasons for the control line not appearing are insufficient sample volume or incorrect procedure. Review the procedure and repeat the test with a new card. If the problem persists, discontinue use of the kit and contact your local distributor. warnings - For professional in vitro diagnostic use only. Do not use after the expiry date. - Do not eat, drink or smoke in the area where samples and kits are handled. - Handle all samples as if they were potentially infectious. Observe appropriate precautions against microbiological hazards at all stages of the analysis and follow standard procedures for proper disposal of samples. - When analyzing samples, wear protective clothing: lab coat, disposable gloves, and eye protection. - After use, the test should be disposed of in accordance with local regulations. - Humidity and temperature can negatively affect the results. - Do not use the test if the pouch is damaged. - Reagent 2 contains an acidic solution. If the solution comes into contact with skin or eyes, rinse with plenty of water. Positive and negative controls contain Proclin 300 as a preservative. - Do not change the caps of the reagent bottles. - Do not change the caps of the external control solution vials. limitation 1. The Streptococcus A Rapid Test Device (Pharyngeal Swab) is for in vitro diagnostic use only. The test is for use only for the detection of Streptococcus A antigen in pharyngeal swab. It cannot determine the quantitative value or the percentage increase in the concentration of Streptococcus A antigen. 2. This test only indicates the presence of streptococcal A antigen in the sample, due to viable and non-viable group A streptococcal bacteria. 3. A negative result must be confirmed by culture. A negative result may be due to an inadequate or less than detectable concentration of Strep A antigen in the throat swab. 4. Excessive blood or mucus on the swab may interfere with the test results and cause a false positive result. Avoid contact of the swab with the tongue, cheeks, teeth and any open wounds in the mouth when collecting the samples. 5. As with all diagnostic tests, results should be interpreted in light of the patients overall clinical picture. Conservation Store in the sealed pouch at room temperature or in the refrigerator (2-30°C). The test is stable until the expiration date indicated on the sealed pouch. Keep the test in the sealed pouch until use. Do not freeze. Do not use after the expiration date. Format Materials provided: card, method, sample extraction tubes, reagent 2 (0.027M citric acid), positive control (non-viable Strep A: 0.01% Proclin 300), sterile tips, pipette dispenser, tube rack, reagent 1 (2M NaNO2), negative control (non-viable Strep C: 0.01% Proclin 300). Code IST-502 STREP
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