Professional IVD Manufacturer

 

Strep A Rapid Test---Dipstick or Cassette


Streptococcus pyogenes is non-motile gram-positive cocci, which contains the Lancefield group A antigen that can cause serious infections such as tonsillitis, pharyngitis, scarlet fever.respiratory infection, impetigo, endocarditis, meningitis, puerperal sepsis, and arthritis. Left untreated, these infections can lead to serious  complications, including rheumatic fever and peritonsillar abscess. Traditional identification procedures for Group A Streptococci infection involve the isolation and identification of viable organisms using techniques that require 24 to 48 hours or longer.The Strep A Rapid Test is a rapid test to qualitatively detect the presence of Strep A antigen in throat swab specimens, providing results within 10 minutes. The test utilizes antibodies specific for whole cell Lancefield Group A Streptococcus to selectively detect Strep A antigen in a throat swab specimen.
  • Easy to use
  • Easy to interpret results 
  • Rapid - results in approximately 5 minutes
  • In-built controls to monitor:
    • Antibody functionality - indicated by presence of the Positive On Board Control
    • Non-specific binding - indicated by presence of the Negative On Board Control
  • Highly sensitive and specific
Test Procedure:
1 Remove the test strip from the sealed foil pouch and use it as soon as possible.
2 Hold the Reagent A bottle vertically and add 4 full drops (approximately 240 ul) to an extraction test tube. Hold the Reagent B bottle vertically and add 4 full drops (approximately 160ul) of Reagent B. Mix the solution by gently swirling the extraction test tube.

High performance:
--High Sensitivity: 97.6%

--High Specificity: 99.3%

--Reliable results		 3 Immediately add the throat swab into the extraction test tube of yellow solution. Agitate the swab by rotating it at least 10 times. Leave the swab in the extraction test tube for 1 minute. Then express the liquid from the swab head by rolling the swab against the inside of the tube and squeezing the tube as the swab is withdrawn.  Discard the swab.
AN1009C   Strep A Rapid Test Cassette
AN1009S   Strep A Dipstick		 4 With arrows pointing toward the specimen, immerse the test strip vertically into the extracted specimen solution and then start the timer. If the procedure is followed correctly, the extraction solution should not pass the arrow on the test strip when the strip is immersed. See the illustration below.
5 Leave the strip in the extraction tube and wait for the red line(s) to appear.  Read the result at 5 minutes.