20 individually packed test cassettes for detection of group A Streptococcus antigens (strep A) in human throat swab specimens
Package contents:
20 test cassettes
20 disposable pipettes
1 bottle Reagent 1 (7.0 mL)
1 bottle Reagent 2 (7.0 mL)
1 bottle Positive Control (1 mL)
20 extraction tube incl. dropper caps
1 reagent holder
1 Lot-specific RFID-card
20 sterile swab
1 package insert
Exclusively for professional users
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The NADAL® Strep A Scan Test is an immunologic rapid test for the qualitative, presumptive detection of group A Streptococcus antigens (strep A) in human throat swab specimens. The test is intended for use as an aid in the diagnosis of strep A infections in patients showing typical symptoms. The qualitative measurement and evaluation of the test result is to be carried out using the nal von minden Colibri point-of-care reader. The test is designed for professional use only.
Beta-haemolytic group A Streptococcus is a major cause of upper respiratory infections such as tonsillitis, pharyngitis and scarlet fever. Early diagnosis and treatment of strep A pharyngitis has been shown to reduce the severity of symptoms and further complications, such as rheumatic fever and glomerulonephritis. Conventional methods for detecting a strep A infection are dependent on the isolation and subsequent identification of the organism, and often require 24 - 48 hours. Recent developments in immunological techniques to detect strep A antigens directly from throat swabs support physicians in diagnosing strep A infections and administering therapy immediately.
The device is not included in the scope of delivery.