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TEST streptococci Description Rapid test for the detection of group A streptococcus in throat infections. How to use Sample collection Use only the reagents and sterile swabs provided in the kit. Collect the sample using the sterile throat swab provided in the kit. 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 specimen collection. Specimens may 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. Swabs containing modified Stuart or Amies transport medium may also be used with this product. If you wish to perform a culture, gently swirl the swab tip on a group A selective blood plate (GAS) before using the swab with the rapid strep test device (throat swab). Testing procedure Bring the test card, reagents, throat swab, and/or controls to room temperature (15-30°C) before testing. Remove the card from the sealed envelope and use it immediately. 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 yellow. 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. Then, press the swab into the tube and squeeze the bottom of the tube as you remove the swab. Discard the swab. Insert the pipette tip into the top of the test tube. Place the test card on a clean, flat surface. Add 3 drops of solution (100 μl) to the sample well (S) and start the timer. Wait for the red band(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) and the other in the test region (T). A positive result indicates that Streptococcus A was detected in the sample. 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 streptococcal 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 streptococcal A infection. If clinical symptoms are inconsistent with the results, another specimen should be cultured. Invalid: No band appears. The most likely reasons for the control band 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 If swallowed: If you feel unwell, call a poison control center or doctor. In case of eye contact: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If irritation persists, consult a doctor. Do not freeze. Do not use after the expiry date. For professional in vitro diagnostic use only. 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 safety glasses. 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 Proclin300 as a preservative. Do not change the caps of the reagent bottles. Do not change the caps of the external control solution vials. The Strep A Rapid Test (Pharyngeal Sputum) is for in vitro diagnostic use only. The test is to be used only for the detection of Strep A antigen in pharyngeal swabs. It cannot determine the quantitative value or percentage increase in Strep A antigen status. This test only indicates the presence of streptococcal A antigen in the sample, due to viable and non-viable group A Streptococcus bacteria. 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. The sterile swabs provided with this test should be used for specimen collection. Other swabs have not been validated for this test. Excessive blood or mucus on the swab may interfere with the test results and may cause a false positive result. Avoid contact of the swab with the tongue, cheeks, teeth, and any oral areas with open wounds when collecting the sample. As with all diagnostic tests, results must be interpreted in light of the patients overall clinical picture. Conservation Store at room temperature or in a refrigerator (2-30°C). Shelf life in intact packaging: 16 months. Format Kit contents: - reagent 1 for Strepto A (2 M sodium nitrite)*; - reagent 2 for Strepto A (citric acid 0.027 M); - book; - sterile swabs; - methodical; - pipette dispenser; - test tubes for sample extraction; - support for test tubes/reagents; - positive control for Strepto A (non-viable Strepto A Proclin 300 0.01%); - negative control for Strepto A (non-viable Strepto C Proclin 300 0.01%). *Keep out of reach of children. Wear gloves and eye and face protection. Code 70773
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Vânzător: Liki24.co.uk
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