OSOM Strep A Test Rapid Test Kit with Throat Swab Sample, 25 Tests Per box

OSOM Strep A Test Rapid Test Kit with Throat Swab Sample, 25 Tests Per box.The OSOM ® Ultra Strep A Test is a color immunochromatographic assay intended for the qualitativedetection of Group A Streptococcal antigen directly from throat swab specimens. For laboratory and professional in vitro diagnostic use only.

Group A Streptococcus is one of the most important causes of acute upper respiratory tract infection. Early diagnosis and treatment of Group A Streptococcal pharyngitis has been shown to reduce the severity of symptoms and further complications such as rheumatic fever and glomerulonephritis (1)  Conventional identification procedures for Group A Streptococcus from throat swabs involve the isolation and subsequent identification of viable pathogens by techniques that require 18 to 24 hours or longer (2) . The OSOM Ultra Strep A Test detects either viable or nonviable organisms directly from a throat swab, providing results within 7 minutes.

PRINCIPLES OF TEST: The OSOM Ultra Strep A Test is a color immunochromatographic assay using Dual Label Technology (DLT)**. DLT uses antibody labeled color particles coated at two separate locations in the test device. DLT allows greater sensitivity than the conventional single label technology without sacrificing specificity. In the test procedure, a throat swab is subjected to a chemical extraction of a carbohydrate antigen unique to Group A Streptococcus. The Test Stick is then placed in the extraction mixture and the mixture migrates along the membrane. If Group A Streptococcus is present in the sample, it will form complexes with the anti-Group A Streptococcus antibody conjugated color particles located at two separate locations on the Test Stick. The complex will then be bound by the anti-Group A Streptococcus capture antibody and a visible blue Test Line will appear to indicate a positive result. A red Control Line will also appear to indicate the test is valid.

• Contents:
  
  • 25 Test Sticks Coated with Rabbit Anti-Group A Streptococcus
  • 25 Test Tubes
  • 25 Sterile Swabs
  • 25 Extraction Reagent Bottles (2 M Sodium Nitrite and One Ampule with 0.3 M Acetic Acid)
  • 1 Positive Control (Nonviable Group A Streptococci, 0.1% Sodium Azide)
  • 1 Negative Control (Nonviable Group C Streptococci, 0.1% Sodium Azide)
  • 1 Workstation
  • 1 Directional Insert

• Note: extra components (swabs, tubes) have been provided for your convenience.
  • Store Test Sticks and reagents tightly capped at 15 ̊ – 30 ̊C (59 ̊ – 86 ̊F).
  • Do not use Test Sticks or reagents after expiration date.
  • Store Extraction Reagent Bottles inside the box. Avoid exposure to light.