INTENDED USE
The OSOM® Strep A Test is intended for the qualitative detection of Group A
Streptococcal antigen from throat swabs or confirmation of presumptive Group A
Streptococcal colonies recovered from culture.
SUMMARY AND EXPLANATION OF TEST
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 24 to 48
hours or longer(2).
The OSOM Strep A Test detects either viable or nonviable organisms directly
from a throat swab, providing results within 5 minutes, using dual reagent extraction.
- VERY ACCURATE: 96% sensitivity; 98% specificity.
- FAST:
Results in 5 minutes.
- EASY-TO-READ:
Two-color results: blue test line, red control line.
- CONVENIENT:
Compact packaging. Everything you need to run 50 tests.
Kit Includes positive and negative controls. Room temperature storage.
-Quantity: 50 Tests
-FDA 510k & CLIA Waived
-Reimbursement Code/Amount: 87880QW, $12.77-$17.52
-It is always the health care professional to establish the reimbursement amount & this product
is for professional use only.