BD Veritor System Handbuch Seite 3

REAGENTS
The following components are included in the BD Veritor System for Rapid Detection of RSV kit:
BD Veritor System RSV Devices
RV Reagent D
Flexible minitip flocked swab
RSV Positive Control Swab
RSV Negative Control 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. The RSV Positive Control Swab and the positive control line on the BD Veritor System for Rapid Detection of RSV device
have been prepared from RSV-infected tissue culture cells which have been inactivated by detergent treatment and
sonication then subsequently tested by bioassay procedures.
4. Pathogenic microorganisms, including hepatitis viruses and Human Immunodeficiency Virus, may be present in clinical
specimens. "Standard Precautions"
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. Other than the flocked swabs that are used for specimen collection, kit components should not come in contact with
the patient.
8. Do not use kit components beyond the expiration date.
9. Do not reuse the BD Veritor System test device.
10. Do not use the kit if the Control RSV Positive Swab and Control RSV Negative Swab do not yield appropriate results.
11. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.
12. To avoid erroneous results, specimens must be processed as indicated in the assay procedure section. The addition of
excess sample may give invalid test results.
13. Proper specimen collection, storage and transport are critical to the performance of this test.
14. Specific training or guidance is recommended if operators are not experienced with specimen collection and
handling procedures.
Storage and Handling: Kits may be stored at 2–30 °C. DO NOT FREEZE. Reagents and devices must be at room
temperature (15–30 °C) when used for testing.
30 devices
30 tubes with 400 μL reagent
30 each
1 each
1 each
6-9 and institutional guidelines should be followed in handling, storing and disposing of
Foil pouched device containing one reactive strip. Each strip
has one test line of monoclonal antibody specific to RSV viral
antigen and murine monoclonal control line antibodies.
Detergent with <0.1% sodium azide (preservative).
Swab for nasopharyngeal collection.
RSV Positive Control Swab, RSV antigen (noninfectious cell
lysate) with <0.1% sodium azide (preservative).
RSV Negative Control Swab, (detergent-treated non-infected
cells) with <0.1% sodium azide (preservative).
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