BD Veritor System Bedienungsanleitung Seite 3

REAGENTS
The following components are included in the BD Veritor System for Rapid Detection of Group A Strep (GAS) kit:
BD Veritor System
Group A Strep Devices
BD GAS Reagent 1
BD GAS Reagent 2
Individually packaged
swabs, sterile
Positive Control Swab
Negative Control Swab
Materials Required But Not Provided: BD Veritor™ System Reader (Cat. No. 256055) or BD Veritor™ Plus Analyzer
(Cat. No 256066), Timer, Tube Rack for specimen testing
Optional Equipment: BD Veritor™ InfoScan Module (Cat. No. 256068), BD Veritor™ InfoSync Module (Cat. No. 256067),
USB Printer Cable for BD Veritor™ Analyzer (Cat. No. 443907), Epson Printer model TM-T20 II.
Warnings and Precautions:
Gas Reagent 1
Warning
H315 Causes skin irritation.
P280 Wear protective gloves/protective clothing/eye protection/face protection. P264 Wash thoroughly after handling.
P321 Specific treatment (see on this label). P332+P313 If skin irritation occurs: Get medical advice/attention. P302+P352 IF
ON SKIN: Wash with plenty of soap and water. P362+P364 Take off contaminated clothing and wash it before reuse.
P403 Store in a well-ventilated place. P501 Dispose of contents/container in accordance with local/regional/national/
international regulations.
Gas Reagent 2
Warning
H302 Harmful if swallowed. H401 Toxic to aquatic life.
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. Pathogenic microorganisms, including hepatitis viruses, and Human Immunodeficiency Virus may be present in clinical
specimens. 5 "Standard Precautions"
of all specimens and all items contaminated with blood and other body fluids.
4. Dispose of used BD Veritor System test devices as biohazardous waste in accordance with federal, state and
local requirements.
5. 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.
6. Only use the reagents provided with the kit for preparation. Do not mix components from different kit lots.
7. Other than the swabs that are used for specimen collection, kit components should not make contact with the patient.
8. Do not use kit components beyond the expiration date.
9. Do not reuse the device.
10. Do not use the kit if the Positive Control Swab and Negative Control 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, swab specimens must be processed as indicated in the assay procedure section.
13. Specific training or guidance is recommended if operators are not experienced with specimen collection and
handling procedures.
30 devices
Bottle with 4 mL reagent
30 tubes with 200 µL reagent
30 each
1 each
1 each
5-8 and institutional guidelines should be followed in handling, storing and disposing
Foil pouched device containing one reactive strip. Each strip has one test
line of polyclonal antibody specific to Strep A antigen and a positive control
line containing purified Strep A antigen.
Dilute acetic acid solution
Sodium nitrite and EDTA
Swab for throat specimen collection
Strep A Positive Control Swab (purified Strep A antigen) with < 0.1%
sodium azide (preservative)
Strep A Negative Control Swab with < 0.1% sodium azide (preservative)
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