Rapid throat strep a test - streptococcus a antigen detection 10 tests

Product Description

This product is a rapid throat test for the detection of Group A Streptococcus antigen in throat swabs.

Indications

Rapid test for the detection of Group A Streptococcus in throat infections.

Composition

Active ingredients

• Reagent 1 for Strepto A (Sodium Nitrite 2M)
• Reagent 2 for Strepto A (Citric Acid 0.027M)
• 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%)

Directions for Use and Dosage

Specimen Collection

• Use only the sterile reagents and swabs provided in the kit.
• Collect the sample with the sterile throat swab provided in the kit. Swab 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. 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. This product is Swabs containing modified Stuart or Amies transport medium may also be used.
• If a culture is desired, gently rotate the swab tip on a blood plate selective for group A (Gas) before using the swab with the Streptococcal Rapid Test Device (Throat Swab).

Test Procedure

• Bring the test device, reagents, throat swab, and/or controls to room temperature (15-30°C) before testing.
• Remove the test device from the sealed pouch and use it immediately.
• Holding the Reagent 1 bottle upright, dispense 4 drops (approximately 240 mcl) into a specimen extraction tube. Reagent 1 is red. Holding the Reagent 2 bottle upright, add 4 drops (approximately 160 mcl) to the test 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 while removing the swab. Discard the swab.
• Insert the dropper tip into the top of the tube. Place the test device on a clean, flat surface. Add 3 drops of solution (100 mcl) 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 Streptococcal A has been 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 sample. present below the detectable threshold of the test. The patient sample must be cultured to confirm the absence of Strep A infection. If clinical symptoms are inconsistent with the results, collect another sample for culture.
• Invalid: No control 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 device. 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.
• If in eyes: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If irritation persists, consult a physician.
• Do not freeze. Do not use after the expiration date.
• For professional in vitro diagnostic use only.
• Do not eat, drink, or smoke in the area where specimens and kits are handled.
• Handle all specimens as if potentially infectious. Observe appropriate precautions against microbiological hazards throughout the test procedure and follow standard procedures for proper specimen disposal.
• Wear protective clothing during specimen analysis: lab coat, disposable gloves, and eye protection.
• Humidity and temperature may adversely affect results.
• Do not use the test if the pouch is damaged. Damaged.
• Reagent 2 contains an acidic solution. If the solution comes into contact with skin or eyes, rinse with copious amounts of water.
• Positive and negative controls contain Proclin300 as a preservative.
• Do not interchange reagent bottle caps.
• Do not interchange external control solution bottle caps.
• The Strpt A Rapid Test Device (Throat Swab) is for in vitro diagnostic use only. The test should be used to detect Streptococcal A antigen in throat swab only. It cannot determine the quantitative value or the specificity of the test. The percentage increase in Strep A antigen status.
• This test indicates only the presence of Strep A antigen in the specimen due to Group A Streptococcus bacteria, whether viable or non-viable.
• A negative result must be confirmed by culture. A negative result may be due to an inadequate concentration of Strep A antigen in the throat swab or one that is below the detectable level of the test.
• The sterile swabs provided with this test should be used for specimen collection. Other swabs have not been validated for this test.
• An excessive amount of blood or mucus on the swab may indicate a potential cause. interfere with the test results and cause a false-positive result. Avoid contact of the swab with the tongue, cheeks, and teeth, and any oral areas where open wounds are present at the time of specimen collection.
• As with all diagnostic tests, results must be interpreted in light of the patient's overall clinical picture.

*Keep out of reach of children. Wear gloves and protective clothing for eyes and face.

Storage

Store at room temperature or refrigerator (2-30°C).

Shelf life: 12 months. Shelf life: 16 months.

Format

Kit contents:

• Reagent 1 for Strepto A (2 M sodium nitrite)*;
• Reagent 2 for Strepto A (0.027 M citric acid);
• Card;
• Sterile swabs;
• Method sheet;
• Dropper;
• Sample extraction tubes;
• Tube/reagent holder;
• 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%).