Strep B Rapid Test

The Biopanda Strep B Rapid Test qualitatively detects Group B Streptococcus (GBS) antigens in samples taken from vaginal or rectal swabs of pregnant women, or general swabs from newborns. This is a rapid test to aid in the diagnosis of Strep B infections.

Strep B Rapid Test Cassette

Product Number: RAPG-STRB-002

Pack size

20 tests

Test Procedure

  1. Ensure all test reagents and swab samples have reached room temperature (15-25°C) before use.
  2. Remove the test cassette from the sealed foil pouch and use it as soon as possible. Best results will be obtained if the test is performed immediately after opening the foil pouch.
  3. Hold the Extraction Reagent 1 bottle vertically and add 4 full drops (approximately 240 μl) of Extraction Reagent 1 to an extraction tube. Extraction Reagent 1 is red in colour. Hold the Extraction Reagent 2 bottle vertically and add 4 full drops (approximately 160 μl) to the tube. Extraction Reagent 2 is colourless. Mix the solution by gently swirling the extraction tube. The addition of Extraction Reagent 2 to Extraction Reagent 1 changes the colour of the solution from red to yellow.
  4. Immediately add the swab into the extraction tube, agitate the swab vigorously 15 times, leave the swab in the extraction test tube for 2 minutes.
  5. Press the swab against the side of the tube and squeeze the tube while removing the swab so that most of the liquid stays in the tube. Discard the swab.
  6. Fit the dropper tip on top of the extraction tube. Place the test cassette on a clean and level surface.
  7. Add 3 full drops of the extracted solution (approx. 150μl) to the specimen well of the test cassette, then start the timer. Avoid trapping air bubbles in the specimen well. Wait for the colour to appear. Read the result at 10 minutes. Results read after 20 minutes are considered invalid.

Principle

The Biopanda Strep B Rapid Test detects Group B Streptococcus antigens through visual interpretation of colour development on the internal strip. Anti-Strep B antibodies are immobilized on the test region of the membrane. During testing, the specimen reacts with polyclonal anti-Strep B antibodies conjugated to coloured particles and pre-coated onto the sample pad of the test. The mixture then migrates through the membrane by capillary action, and interacts with reagents on the membrane. If there is sufficient Strep B antigen in the specimen, a coloured band will form at the test region of the membrane. The presence of this coloured band indicates a positive result, while its absence indicates a negative result. The appearance of a coloured band at the control region serves as a procedural control, indicating that proper volume of specimen has been added and membrane wicking has occurred.

Performance Characteristics

  • Relative sensitivity: 95.2%,
  • Relative specificity: 97.8%
  • Accuracy: 97.2%

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. 


Strep B Rapid Test Strip

Product Number: RAPG-STRB-001

Pack size

50 test strips

Test Procedure

  1. Ensure all test reagents and swab samples have reached room temperature (15-25°C) before use.
  2. Hold the Extraction Reagent 1 bottle vertically and add 4 full drops (approximately 240 μl) of Extraction Reagent 1 to an extraction tube. Extraction Reagent 1 is red in colour. Hold the Extraction Reagent 2 bottle vertically and add 4 full drops (approximately 160 μl) to the tube. Extraction Reagent 2 is colourless. Mix the solution by gently swirling the extraction tube. The addition of Extraction Reagent 2 to Extraction Reagent 1 changes the colour of the solution from red to yellow.
  3. Immediately add the swab into the extraction tube, agitate the swab vigorously 15 times, leave the swab in the extraction test tube for 2 minutes.
  4. Press the swab against the side of the tube and squeeze the tube while removing the swab so that most of the liquid stays in the tube. Discard the swab.
  5. Remove the test strip from the sealed pouch and place the test strip inside the tube of solution and start the timer.
  6. Read the result at 10 minutes. Results read after 20 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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