BD Veritor System Bedienungsanleitung Seite 112

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.
6. Reagents contain sodium azide, which is harmful if inhaled, swallowed or exposed to skin. Contact with acids produces very
toxic gas. If there is contact with skin, wash immediately with plenty of water. Sodium azide may react with lead and copper
plumbing to form highly explosive metal azides. On disposal, flush with a large volume of water to prevent azide build-up.
7. For optimal results, use the flocked swabs provided with the kit for specimen collection.
8. Other than the flocked swabs that are used for specimen collection, kit components should not make contact with
the patient.
9. Do not use kit components beyond the expiration date.
10. Do not reuse the device.
11. Do not use the kit if the Control A+/B- swab and Control B+/A- swab do not yield appropriate results.
12. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
13. To avoid erroneous results, swab specimens must be processed as indicated in the assay procedure section.
14. Specific training or guidance is recommended if operators are not experienced with specimen collection and
handling procedures.
15. FluMist ® is made from attenuated live flu virus and although the concentration tested (1%) was non-interfering, it is
possible when tested with higher concentrations that an influenza A and/or influenza B false positive may occur.
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
2