BD Veritor System Bedienungsanleitung Seite 3

All BD Veritor System Flu A+B 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 Flu A+B is a qualitative, digital immunoassay for the detection of influenza
A and B viral antigens in samples processed from respiratory specimens. When specimens are processed and added to the
test device, influenza A or B viral antigens bind to anti-influenza antibodies conjugated to detector particles in the A+B test strip.
The antigen-conjugate complex migrates across the test strip to the reaction area and is captured by the line of antibody on
the membrane. A positive result for influenza A is determined by the BD Veritor System Instrument when antigen-conjugate is
deposited at the Test "A" position and the Control "C" position on the BD Veritor System Flu A+B assay device. A positive result for
influenza B is determined by the BD Veritor System Instrument when antigen-conjugate is deposited at the Test "B" position and
the Control "C" position in the BD Veritor System Flu A+B 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.
REAGENTS
The following components are included in the BD Veritor System for Rapid Detection of Flu A+B kit:
BD Veritor System
Flu A+B Devices
RV Reagent D
Flexible minitip
flocked swab
Control A+/B- Swab
Control B+/A- Swab
Materials Required But Not Provided: BD Veritor™ Plus Analyzer (Cat. No. 256066), Timer, Tube Rack for
specimen testing.
Optional Equipment: BD Veritor™ InfoScan Module (Cat. No. 256068), USB Printer cable for BD Veritor™ Analyzer
(Cat. No. 443907), Epson Printer model TM-T20 II, BD Veritor Plus Connect (contact BD Technical Services for details).
Warnings and Precautions:
Warning
H302 Harmful if swallowed. H402 Harmful to aquatic life. H412 Harmful to aquatic life with long lasting effects.
P273 Avoid release to the environment. P264 Wash thoroughly after handling. P270 Do not eat, drink or smoke when using
this product. P301+P312 IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell. P330 Rinse
mouth. P501 Dispose of contents/container in accordance with local/regional/national/international regulations.
1. For in vitro Diagnostic Use.
2. Test results are not meant to be visually determined. All test results must be determined using the BD Veritor
System Instrument.
3. If infection with a novel influenza A 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. Viral culture should not be
attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.
4. Pathogenic microorganisms, including hepatitis viruses, Human Immunodeficiency Virus and novel influenza viruses,
may be present in clinical specimens. "Standard Precautions"
handling, storing and disposing of all specimens and all items contaminated with blood and other body fluids.
5. Dispose of used BD Veritor System test devices as biohazardous waste in accordance with federal, state and
local requirements.
30 devices Foil pouched device containing one reactive strip. Each strip has two test
lines of monoclonal antibody specific to either influenza A or B viral antigen
and murine monoclonal control line antibodies.
30 tubes with
Detergent with <0.1% sodium azide
400 µL reagent
30 each
Swab for nasopharyngeal or nasal collection
1 each Flu A Positive and Flu B Negative Control Swab, influenza A antigen
(inactive recombinant nucleoprotein) with <0.1% sodium azide
1 each Flu A Negative and Flu B Positive Control Swab, influenza B antigen
(inactive recombinant nucleoprotein) with <0.1% sodium azide
16-19 and institutional guidelines should be followed in
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