BD Veritor System Bedienungsanleitung Seite 2

Veritor™ System
For Rapid Detection of Flu A+B
For use with nasal and nasopharyngeal swab specimens.
CLIA Complexity-WAIVED
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 Flu A+B is a rapid chromatographic immunoassay for the direct and
qualitative detection of influenza A and B viral nucleoprotein antigens from nasal and nasopharyngeal swabs of symptomatic
patients. The BD Veritor System for Rapid Detection of Flu A+B (also referred to as the BD Veritor System and BD Veritor
System Flu A+B) is a differentiated test, such that influenza A viral antigens can be distinguished from influenza B viral
antigens from a single processed sample using a single device. The test is to be used as an aid in the diagnosis of influenza
A and B viral infections. A negative test is presumptive and it is recommended that these results be confirmed by viral
culture or an FDA-cleared influenza A and B molecular assay. Outside the U.S., a negative test is presumptive and it is
recommended that these results be confirmed by viral culture or a molecular assay cleared for diagnostic use in the country
of use. FDA has not cleared this device for use outside of the U.S. Negative test results do not preclude influenza viral
infection and should not be used as the sole basis for treatment or other patient management decisions. The test is not
intended to detect influenza C antigens.
Performance characteristics for influenza A and B were established during January through March of 2011 when influenza
viruses A/2009 H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage were the predominant influenza viruses in
circulation according to the Morbidity and Mortality Weekly Report from the CDC entitled "Update: Influenza Activity—United
States, 2010–2011 Season, and Composition of the 2011–2012 Influenza Vaccine." Performance characteristics may vary
against other emerging influenza viruses.
If infection with a novel influenza virus is suspected based on current clinical and epidemiological screening criteria
recommended by public health authorities, specimens should be collected with appropriate infection control precautions
for novel virulent influenza viruses and sent to the state or local health department for testing. Virus culture should not be
attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
SUMMARY AND EXPLANATION
Influenza illness classically presents with sudden onset of fever, chills, headache, myalgias, and a non-productive cough.
Epidemics of influenza typically occur during winter months with estimated 114,000 hospitalizations
year in the U.S. Influenza viruses can also cause pandemics, during which rates of illness and death from influenza-related
complications can increase dramatically.
Patients who present with suspected influenza may benefit from treatment with an antiviral agent especially if given within the
first 48 hours of onset of illness. It is important to rapidly distinguish influenza A from influenza B in order to allow physicians
a choice in selective antiviral intervention. Moreover, it is important to determine if influenza A or B is causing symptomatic
disease in a particular institution (e.g., nursing home) or community, so that appropriate preventative intervention can be
taken for susceptible individuals. It is therefore important to not only rapidly determine whether influenza is present, but also
which type of influenza virus is present.
Diagnostic tests available for influenza include rapid immunoassay, immunofluorescence assay, polymerase chain reaction
(PCR), serology, and viral culture.
slides using fluorescent-labeled antibodies for observation by fluorescence microscopy.
viral isolation in cell culture, followed by hemadsorption inhibition, immunofluorescence, or neutralization assays to confirm
the presence of the influenza virus.
The BD Veritor System for Rapid Detection of Flu A+B (also referred to as the BD Veritor System and BD Veritor System Flu A+B)
is a chromatographic immunoassay to detect influenza A or B nucleoprotein antigens from respiratory specimens of symptomatic
patients with a time to result of 10 minutes. The speed and simplified workflow of the BD Veritor System for Rapid Detection of
Flu A+B makes it applicable as a "STAT" influenza A and B antigen detection test providing relevant information to assist with the
diagnosis of influenza.
3
4-11 Immunofluorescence assays entail staining of specimens immobilized on microscope
13-15
2
1 and 36,000 deaths
6,12,13 Culture methods employ initial
2 per