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Strep A Rapid Test CE Marking


Product Number: RAPG-STRA-001


Pack size

20 tests

Product Description

The Biopanda Strep A Rapid Test qualitatively detects Strep A antigens in throat swab samples. This is a rapid test to aid in the diagnosis of Group A Streptococcal infections.

Test Attributes

  • Throat swab samples may be used for testing
  • Results available in only 5 minutes
  • Easy to use
  • Results can be read visually
  • No need for an analyser
  • Cost effective method for assisting in the diagnosis of Strep A infections

Test Procedure

  1. Ensure specimen and test reagents are brought to room temperature before testing.
  2. Add 4 drops of extraction reagent 1 (red in colour)  and 4 drops of extraction reagent 2 (colourless)  to an extraction tube (See illustration 1).
  3. Mix the solution gently by swirling the extraction tube. The colour will change from red to yellow.
  4. Immediately place the swab into the Extraction Tube. Rotate the swab vigorously 15 times and leave inside the tube for 1 minute. 
  5. Remove the swab while squeezing the swab head against the inner wall of the Extraction Tube as you remove it to expel as much liquid as possible (See illustration 3). Discard the swab in accordance with your biohazard waste disposal protocol.
  6. Place the extraction tube tip on top of the tube. (See illustration 4).
  7. Remove the test cassette from the sealed pouch and place the test cassette on a clean and level surface. (Use as soon as possible).
  8. Add three drops of the solution from the extraction tube (approx. 100 μl) to the sample well and then start the timer. Read the result at 5 minutes. Results read after 10 minutes are considered invalid.

Principle

The Biopanda Strep A Rapid Test is a qualitative, sandwich lateral flow immunoassay for the detection of Strep A carbohydrate antigen in a throat swab. Strep A carbohydrate antigen present in the extracted throat swab sample reacts with the antibodies to Strep A that are pre-coupled onto particles. The antigen, antibody, and/or antigen-antibody complex migrate up the membrane and react with the antibodies pre-coated on the membrane in the test line and control regions of the cassette. The presence of a coloured line in the test line region indicates a positive result. To serve as a procedural control, a coloured line will always appear in the control region to show the test has been performed properly.

Performance Characteristics

  • Relative sensitivity: 95.1%,
  • Relative specificity: 97.8%
  • Accuracy: 97.1%

Storage Conditions

Store the kit between 2-30°C and ensure the kits are not frozen or stored in direct sunlight. The test is valid until the expiration date printed on the foil wrapping. 




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