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The BD Veritor™ System for Rapid Detection of Respiratory Syncytial Virus (RSV) is a chromatographic immunoassay with an instrumented read for the direct and qualitative detection of RSV fusion protein from nasopharyngeal wash, aspirate and swab in transport media samples from patients suspected of having a viral respiratory infection. This test is intended for in vitro diagnostic use to aid in the diagnosis of RSV infections in infants and pediatric patients under the age of 20 years. Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or for other management decisions. A negative test is presumptive. It is recommended that negative test results be confirmed by viral cell culture or an alternative method, such as a FDA-cleared molecular assay. The test is intended for professional and laboratory use. It is to be used in conjunction with the BD Veritor™ System Reader.

Viral respiratory tract infections are responsible for widespread disease. Respiratory syncytial virus (RSV) is a leading cause of lower respiratory tract infections (LRI) in young children in both the developed and developing worlds. Worldwide, it is estimated that RSV is responsible for greater than 30 million cases of LRI in children under 5 years of age each year.^1,2 RSV has also been implicated in severe respiratory infections in the elderly and immunocompromised.^3,4 RSV has been identified as causing 20% of "influenza-like" illness in people 15-44 years of age and is responsible for greater than 17,000 deaths per year in the United States, almost 80% of which occur in adults over age 65.^5,6

Diagnostic methods for detection of respiratory viruses include viral cell culture, direct fluorescent antibody (DFA), rapid immunoassays, and nucleic acid amplification assays such as the polymerase chain reaction (PCR).^7,8 Each has been demonstrated to have clinical utility for the detection of respiratory viruses including RSV. Rapid immunoassays available for specific viruses such as influenza A/B and RSV allow a quick diagnosis so that patients may be appropriately isolated and treated to prevent the nosocomial spread of infections to fellow patients with compromised cardiac, respiratory or immune functions.⁹ In addition, rapid tests assist with the selection of appropriate antiviral therapy. The most common specimen types collected for RSV testing include nasopharyngeal washes, nasopharyngeal aspirates, nasal swabs and nasopharyngeal swabs.

The BD Veritor System for Rapid Detection of RSV (also referred to as the BD Veritor System and BD Veritor System RSV) is a chromatographic immunoassay to detect RSV fusion protein extracted from various specimens of symptomatic patients.

Quality control requirements and your laboratory's standard Quality Control procedures. Each BD Veritor System RSV device contains both positive and negative internal/procedural controls:

1. The internal positive control validates the immunological integrity of the device, proper reagent function, and assures that the correct test procedure was followed.

2. The membrane area surrounding test lines functions as a background check on the assay device.

These positive and negative internal/procedural controls are evaluated by the BD Veritor System Reader after insertion of the BD Veritor System test device. The BD Veritor System Reader will prompt the operator should a quality issue occur. Failure of the internal/procedural controls will generate an invalid test result.

The following components are included in the BD Veritor System for Rapid Detection of RSV kit:

Materials Required But Not Provided: BD Veritor System Reader (Cat. No. 256055), timer, vortex mixer, transport media (see Specimen Collection and Handling), distilled or deionized water, tube rack for specimen testing.

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 Reader.

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"^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.

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. Do not use kit components beyond the expiration date.

8. Do not reuse the BD Veritor System test device.

9. Do not use the kit if the Control RSV Positive Swab and Control RSV Negative Swab do not yield appropriate results.

10. Wear protective clothing such as laboratory coats, disposable gloves and eye protection when specimens are assayed.

11. 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.

12. Proper specimen collection, storage and transport are critical to the performance of this test.

13. Specific training or guidance is recommended if operators are not experienced with specimen collection and handling procedures.