BD Veritor System Bedienungsanleitung Seite 2

Veritor™ System
For Rapid Detection of Group A Strep
CLIA Complexity-WAIVED
For use with throat swab specimens.
For in vitro diagnostic use only.
Rx Only
A Certificate of Waiver is required to perform this test in a CLIA waived setting. To obtain a Certificate of Waiver,
please contact your state health department.
Additional CLIA waiver information is available at the Centers for Medicare and Medicaid website at
www.cms.hhs.gov/CLIA or from your state health department.
Failure to follow the instructions or modification to the test system instructions will result in the test no longer
meeting the requirements for waived classification.
INTENDED USE
The BD Veritor System for Rapid Detection of Group A Strep is a rapid chromatographic immunoassay for the direct and
qualitative detection of Group A Streptococcus antigen from throat swabs of symptomatic patients. It is intended to be used in
conjunction with the BD Veritor System Reader as an aid in the diagnosis of Group A Strep. All negative test results should
be confirmed by bacterial culture because negative results do not preclude Group A Strep infection and should not be used
as the sole basis for treatment.
The BD Veritor System for Rapid Detection of Group A Strep test is intended for use in point-of-care or laboratory settings.
SUMMARY AND EXPLANATION
Streptococcus pyogenes is a gram-positive coccus, which contains the Lancefield group A antigen that can cause serious
infections such as pharyngitis, respiratory infection, impetigo, endocarditis, meningitis, puerperal sepsis, and arthritis. 1 Left
untreated, these infections can lead to serious complications, including rheumatic fever and peritonsillar abscess. 2 Traditional
identification procedures for group A streptococcal infection involve the isolation and identification of viable organisms using
techniques that require 24 to 48 hours or longer. 3
Rapid diagnosis and early antibiotic therapy of group A streptococcal infection appear to be the best means of preventing
The BD Veritor System for Rapid Detection of Group
medical complications and reducing the spread of the disease. 4
A Strep is a digital immunoassay to qualitatively detect the presence of Strep A antigen in throat swab specimens from
symptomatic patients, providing results within 5 minutes. The test utilizes antibodies specific for whole cell Lancefield group A
Streptococcus to selectively detect Strep A antigen.
All BD Veritor System Strep A test devices are interpreted by a BD Veritor System Instrument, either a BD Veritor Reader
or BD Veritor Plus Analyzer (the "Analyzer"). When using an Analyzer, procedures to evaluate test devices depend on
the workflow configuration chosen. In Analyze Now mode, the instrument evaluates assay devices after manual timing of
their development. In Walk Away mode, devices are inserted immediately after application of the specimen, and timing of
assay development and analysis is automated. Additionally, connection of an Analyzer to a printer or IT system is possible if
desired. Additional result documentation capabilities are possible with the integration of a BD Veritor InfoScan ("InfoScan")
or BD Veritor InfoSync ("InfoSync") module. Please refer to the Analyzer Instructions for Use for details on how to implement
these features. InfoSync is not available in all regions.
PRINCIPLES OF THE PROCEDURE
The BD Veritor System for Rapid Detection of Group A Strep is a qualitative, digital immunoassay for the detection of Strep A
antigen in a throat swab. In this test, antibody specific to Strep A antigen is coated on the test line region of the Assay device.
During testing, the processed throat swab specimen reacts with an antibody to Strep A that is conjugated onto detector
particles. The mixture migrates up the membrane and is captured by the line of antibody on the membrane. A positive result
for Strep A is determined by the BD Veritor System Instrument when antigen-conjugate is deposited at the Test "T" position
and the Control "C" position on the BD Veritor System Strep A assay device. The instrument analyzes and corrects for non-
specific binding and detects positives not recognized by the unaided eye to provide an objective digital result.
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