8086100(01) 2012-09 Veritor™ System For Rapid Detection of Respiratory Syncytial Virus (RSV) Laboratory kit configured for testing liquid nasopharyngeal wash, aspirate and swab in transport media samples.
Veritor™ System For Rapid Detection of Respiratory Syncytial Virus (RSV) Laboratory kit configured for testing liquid nasopharyngeal wash, aspirate and swab in transport media samples. For in vitro diagnostic use only.
4. 5. 6. 7. 8. 9. 10. 11. 12. 13. Pathogenic microorganisms, including hepatitis viruses and Human Immunodeficiency Virus, may be present in clinical specimens. “Standard Precautions”10-13 and institutional guidelines should be followed in handling, storing and disposing of all specimens and all items contaminated with blood and other body fluids. Dispose of used BD Veritor System test devices as biohazardous waste in accordance with federal, state and local requirements.
. Process the specimen or control as directed below: a. For NP washes, aspirates and swab specimens in transport media: 1. Vortex or thoroughly mix specimen. Do not centrifuge. 2. Remove and discard the cap from the RV Reagent C tube corresponding to the sample to be tested. 3. Using the transfer pipette, transfer 300 µL of specimen into the RV Reagent C tube. Discard pipette after use. = = = = = = b. = For Kit Swab Controls: 1.
8. After adding the sample, allow the test to run for 10 minutes before inserting into the reader. RSV T 9. When the test is ready, insert the BD Veritor System RSV device into the BD Veritor System Reader. (The BD Veritor System Reader should be powered-on prior to use and will indicate when it is ready for insertion of the BD Veritor System device.) Follow the reader on-screen prompts to complete the procedure and obtain the test result.
The BD Veritor System for Rapid Detection of RSV is capable of detecting both viable and non-viable RSV particles. The BD Veritor System for Rapid Detection of RSV performance depends on antigen load and may not correlate with other diagnostic methods performed on the same specimen. Results from the BD Veritor System for Rapid Detection of RSV test should be correlated with the clinical history, epidemiological data and other data available to the clinician evaluating the patient.
Reproducibility The reproducibility of the BD Veritor System for Rapid Detection of RSV test was evaluated at three clinical laboratory sites. The reproducibility panel was composed of 12 simulated RSV samples. These included moderate positive samples, low positive samples (near the assay limit of detection), high negative samples (i.e., containing very low concentrations of virus) and negative samples. The panel was tested by two operators at each site for five consecutive days.
Interfering Substances Various substances were evaluated with the BD Veritor System for Rapid Detection of RSV test. These substances included whole blood (2%) and various medications. No interference was noted with this assay for any of the substances at the concentrations tested.
10. Clinical and Laboratory Standards Institute. 2005. Approved Guideline M29-A3. Protection of laboratory workers from occupationally acquired infections, 3rd ed., CLSI, Wayne, PA. 11. Garner, J. S. 1996. Hospital Infection Control Practices Advisory Committee, U. S. Department of Health and Human Services, Center for Disease Control and Prevention. Guideline for isolation precautions in hospitals. Infect. Control Hospital Epidemiol. 17:53-80. 12. U.S. Department of Health and Human Services. 2007.
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