Alltest rapid professional streptococcal antigen test with throat swab

Product Description

My Benefit offers a professional rapid antigen test for the qualitative determination of Streptococcal A antigen in a throat swab, available in a pack of 20.

Indications

Rapid test for the qualitative determination of Streptococcal A antigen in a throat swab. For professional in vitro diagnostic use only.

The Strep A Rapid Test (throat swab) is a rapid lateral flow immunochromatographic test for the qualitative determination of Streptococcal A carbohydrate antigen in a throat swab. In this test, the specific antibody to Strep A carbohydrate antigen is coated on the test line region. During the test, the extracted throat swab reacts with the antibody to Strep A coated particles. This mixture migrates to the membrane where it reacts with the antibody to Strep A 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.

Instructions for Use

Specimen Collection and Preparation

• Collect the sample using the sterile throat swab provided in the kit. Swabs containing modified Stuart or Amies transport medium can also be used with this product. 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 sample collection. Samples 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.
• If culture is desired, gently rotate the swab tip on a Group A (Gas) selective blood agar plate before using the swab with the Strep A Rapid Test Device (Throat Swab).

Procedure

Bring the device, reagents, throat swab, and/or controls to room temperature (15-30°C) before testing.

1. Remove the device from the sealed pouch and use immediately.
2. Holding the Reagent 1 bottle upright, dispense 4 drops (approximately 240 mcl) into the Reagent 1 device. a specimen extraction tube. Reagent 1 is red. Holding the Reagent 2 bottle upright, add 4 drops (approximately 160 mcl) 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 swab into the tube and squeeze the bottom of the tube while removing the swab. Discard the swab.
5. Insert the dropper tip into the top of the tube. Place the test device on a clean, flat surface. Add 3 drops of solution (approximately 100 mcl) 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.

Warnings

• For professional in vitro diagnostic use only. Do not use after the expiration date.
• 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 at all stages of the analysis and follow standard procedures for proper sample disposal.
• Wear protective clothing during sample analysis: lab coat, disposable gloves, and eye protection.
• After use, the test must be disposed of according to local regulations.
• Humidity and temperature may adversely affect 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 interchange reagent bottle caps.
• Do not interchange external control solution bottle caps.
• An excessive amount of blood or mucus on the swab may interfere with 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 specimen.
• As with all diagnostic tests, results must be interpreted in light of the patient's overall clinical picture.

Storage

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

Kit of 20 tests. Materials provided: test card, method, sample extraction tubes, reagent 2 (0.027M citric acid), positive control (non-viable Strep A: 0.01% Proclin 300), sterile swabs, dropper dispenser, tube holder, reagent 1 (2M Nano2), negative control (non-viable Strep C: 0.01% Proclin 300).