BD Veritor System Handbuch Seite 2

Veritor™ System
For Rapid Detection of Respiratory Syncytial Virus (RSV)
CLIA Complexity-WAIVED
For use with nasopharyngeal swab specimens.
For in vitro diagnostic use 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 category.
INTENDED USE
The BD Veritor ™ System for Rapid Detection of Respiratory Syncytial Virus (RSV) is a chromatographic immunoassay with
an instrumented read for the direct and qualitative detection of RSV fusion protein from a direct nasopharyngeal swab from
patients suspected of having a viral respiratory infection. This test is intended for in vitro diagnostic use to aid in the diagnosis
of RSV infections in infants and pediatric patients under the age of 6 years. Negative results do not preclude RSV infection
and should not be used as the sole basis for treatment or for other management decisions. A negative test is presumptive. It
is recommended that negative test results be confirmed by viral cell culture or an alternative method, such as a FDA-cleared
molecular assay. The test is intended for professional and laboratory use. It is to be used in conjunction with the BD Veritor
System Instrument.
SUMMARY AND EXPLANATION
Viral respiratory tract infections are responsible for widespread disease. Respiratory syncytial virus is a leading cause
of lower respiratory tract infections (LRI) in young children in both the developed and developing worlds. Worldwide, it is
estimated that RSV is responsible for greater than 30 million cases of LRI in children under 5 years of age each year.
Diagnostic methods for detection of respiratory viruses include viral cell culture, direct fluorescent antibody (DFA), rapid
immunoassays, and nucleic acid amplification assays such as the polymerase chain reaction (PCR).
demonstrated to have clinical utility for the detection of respiratory viruses including RSV. Rapid immunoassays available for
specific viruses such as influenza A/B and RSV allow a quick diagnosis so that patients may be appropriately isolated and
treated to prevent the nosocomial spread of infections to fellow patients with compromised cardiac, respiratory or immune
functions. 5 In addition, rapid tests assist with the selection of appropriate antiviral therapy. The most common specimen types
collected for RSV testing include nasopharyngeal washes, nasopharyngeal aspirates, nasal swabs and nasopharyngeal swabs.
The BD Veritor System for Rapid Detection of RSV (also referred to as the BD Veritor System and BD Veritor System RSV)
is a chromatographic immunoassay to detect RSV fusion protein extracted from nasopharyngeal swab specimens from
symptomatic patients. All BD Veritor System RSV test devices are interpreted by a BD Veritor System Instrument, either a
BD Veritor Reader or BD Veritor Plus Analyzer (the "Analyzer"). When using the BD Veritor Plus Analyzer, workflow steps
depend on the selected operational mode and the Analyzer configuration settings. 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. Connection of the Analyzer
to a printer is possible if desired. Additional result documentation capabilities are possible with the implementation of
the BD Synapsys™ Informatics Solution, and with the addition of the BD Veritor InfoScan module and BD Veritor Plus
Connect. Please refer to the Analyzer Instructions for Use for details on these features and contact BD Technical Support for
more information.
PRINCIPLES OF THE PROCEDURE
The BD Veritor System for Rapid Detection of RSV is a qualitative, digital immunoassay for the detection of RSV fusion protein
in samples processed from nasopharyngeal specimens. When specimens are processed and added to the test device, RSV
antigen binds to anti-RSV antibodies conjugated to detector particles in the RSV test strip. The antigen-conjugate complex
migrates across the test strip to the reaction area and is captured by the line of RSV antibody on the membrane. A positive
result for RSV is determined by the BD Veritor System Instrument (purchased separately) when antigen-conjugate is deposited
at the Test "T" position and the Control "C" position on the BD Veritor System RSV 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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