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OSOM® Ultra Strep A- Authorized Distributor
A color immunochromatographic assay intended for the qualitative detection of Group A Streptococcus antigen directly from throat swab specimens.
- Read Results in 5 minutes.
- Easy read-
Two-color results:
blue test line, red control line
- Single delivery of reagents, extractions reagents are combined in 1 bottle, No mixing or handling two separate reagent bottles
- Compact packaging. Everything you need to run 25 tests. Kit includes positive and negative controls. Room temperature storage.
- Sensitivity: 96%, Specificity: 96%
- Expiration: 12-18 Months Expiration From Date of Manufacture
Studies have shown that the sensitivity of the
OSOM ® Ultra Strep A Test and the standard
single swab culture method are not statistically different.
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.
KIT CONTENTS AND STORAGE
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.
-Quantity: 25 Tests
-FDA 510k , CLIA Waived
-Reimbursement: 87880QW* ($16.76)
-This product is for professional use only and it is always healthcare provider responsibility to establish reimbursements.
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