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Strep A Rapid Test Strip - BioStrep A LifeSign (30 Tests)

Strep A Rapid Test Strip - BioStrep A LifeSign (30 Tests)

Item Number: SA-DS
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Product Description
Now CLIA Waived! K Number in CLIA Database is K010582.

Strep A infections originate from group A streptococcal bacterium that can initiate a variety of health problems. Strep A can manifest itself as a mild skin infection or sore throat to severe, life-threatening conditions such as toxic shock syndrome and necrotizing fasciitis, commonly known as flesh eating disease. Nearly everyone is familiar with strep throat, which is the most common form of the disease. Health experts estimate that more than 10 million mild infections (throat and skin) like these occur every year.

Product Description:

  • Group A streptococcus is one of the most significant human pathogens causing acute pharyngitis, tonsillitis, impetigo, and scarlet fever. It is very important to differentiate streptococcal infection from other etiologic agents (e.g., viral, mycoplasma, or chlamydial) so that appropriate therapy may be initiated classical methods for identification requires 8-48 hourís culture time for throat swab specimens or other exudates to produce results showing bacitracin susceptible beta-hemolytic streptococci. Rapid diagnosis and timely treatment of group A streptococcal pharyngitis infections will reduce the severity of symptoms and further complications such as rheumatic fever and glomerulonephritis.
  • Instructions:

    • Just before collecting the throat swab specimen, add 4 drops of Reagent A (yellow) and 4 drops of Reagent B to the extraction tube
    • Collect throat swab specimen using the sterile rayon swabs supplied with this kit
    • Immediately put the swab into the tube
    • Rotate the swab vigorously in the extraction solution to extract specimen thoroughly
    • Let stand for 1-2 minutes
    • Squeeze out as much liquid as possible from the swab by pressing the swab firmly against the side of the tube with two fingers.
    • Take out the Strep A test strip
    • Insert the Strep A test strip into the tube of extracted solution and allow the migration to begin
    • Read the results in 5 minutes, after a distinct colored line has formed in the reading area, but no later than 10 minutes after the test strip has been dipped in the extraction solution
    • All positive results should be confirmed by a laboratory


      Strep A Rapid Test Strip Kit Includes:
      30 Test Strep A Strips
      30 Specimen Extraction Tubes
      30 Collection Throat Swabs
      1 Strep A Rapid Test Strip Procedure Card
      1 Bottle of Extraction Solution A
      1 Bottle of Extraction Solution B
      1 Bottle of Positive Control
      1 Bottle of Negative Control



    Positive (+)††
    Two reddish-purple colored lines, both a Control line (C) and Test line (T) area, indicate that Group A Streptococcal antigen has been detected
    Negative (-)
    Only one colored line in the Control line area, and no distinct colored line in the Test line area indicates that the specimen does not contain detectable levels of Group A Streptococcal antigen and is considered a presumptive negative. The American Academy of Pediatrics recommends that presumptive negative results be confirmed by culture
    A distinct colored line in the Control line (C) area should always appear. The test is invalid if no Control line forms in 5 minutes. When the test shows an invalid result, the test should be considered invalid and should be repeated with a new test strip and a new swab sample.




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