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OSOM Ultra 25 Strep A

ProductsOSOM Ultra 25 Strep A
Company Genzyme
Item OSOM Ultra 25 Strep A
Features Performance Characteristics:
  • The OSOM Ultra Strep A was tested by using Rigorous Gold Standard (multiple sample swab culture plus broth enhanced pledget culture) as the Gold Standard.
Test Method:
  • Color immunochromatographic assay using Dual Label Technology (DLT)*. DLT uses antibody labeled color particles coated at two separate locations which allows for greater sensitivity than the conventional single label technology without sacrificing specificity.
Reagents:
  • Single reagent delivery system. Extraction reagents are combined into one device (25 test kit). No mixing or handling two different reagent bottles.
Description 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.
Info Genzyme
Customer Service: (617) 252-7500
Web site: http://www.genzyme.com/

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CRP Calibrator
Drug controls sera available in three levels for the control of accuracy and percision for up to 18 analytes
Human based material available in two levels for thecontrol of percision for up to 10 analytes
Human based assayed sera available in three levels for the control of accuracy and precision for up to 25 analytes
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