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The BD Veritor™ System for Rapid Detection of Flu A+B is a rapid chromatographic immunoassay for the direct and qualitative detection of influenza A and B viral nucleoprotein antigens from nasal and nasopharyngeal swabs of symptomatic patients. The BD Veritor System for Rapid Detection of Flu A+B (also referred to as the BD Veritor System and BD Veritor System Flu A+B) is a differentiated test, such that influenza A viral antigens can be distinguished from influenza B viral antigens from a single processed sample using a single device. The test is to be used as an aid in the diagnosis of influenza A and B viral infections. A negative test is presumptive and it is recommended that these results be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay. Negative test results do not preclude influenza viral infection and should not be used as the sole basis for treatment or other patient management decisions. The test is not intended to detect influenza C antigens.

Performance characteristics for influenza A and B were established during January through March of 2011 when influenza viruses A/2009 H1N1, A/H3N2, B/Victoria lineage, and B/Yamagata lineage were the predominant influenza viruses in circulation according to the Morbidity and Mortality Weekly Report from the CDC entitled "Update: Influenza Activity - United States, 2010-2011 Season, and Composition of the 2011-2012 Influenza Vaccine." Performance characteristics may vary against other emerging influenza viruses.

If infection with a novel influenza 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. Virus culture should not be attempted in these cases unless a BSL 3+ facility is available to receive and culture specimens.

Influenza illness classically presents with sudden onset of fever, chills, headache, myalgias, and a non-productive cough. Epidemics of influenza typically occur during winter months with estimated 114,000 hospitalizations¹ and 36,000 deaths² per year in the U.S. Influenza viruses can also cause pandemics, during which rates of illness and death from influenza-related complications can increase dramatically.

Patients who present with suspected influenza may benefit from treatment with an antiviral agent especially if given within the first 48 hours of onset of illness. It is important to rapidly distinguish influenza A from influenza B in order to allow physicians a choice in selective antiviral intervention. Moreover, it is important to determine if influenza A or B is causing symptomatic disease in a particular institution (e.g., nursing home) or community, so that appropriate preventative intervention can be taken for susceptible individuals. It is therefore important to not only rapidly determine whether influenza is present, but also which type of influenza virus is present.³

Diagnostic tests available for influenza include rapid immunoassay, immunofluorescence assay, polymerase chain reaction (PCR), serology, and viral culture.^4-11 Immunofluorescence assays entail staining of specimens immobilized on microscope slides using fluorescent-labeled antibodies for observation by fluorescence microscopy.^6,12,13 Culture methods employ initial viral isolation in cell culture, followed by hemadsorption inhibition, immunofluorescence, or neutralization assays to confirm the presence of the influenza virus.^13-15

The BD Veritor System for Rapid Detection of Flu A+B is a chromatographic immunoassay to detect influenza A or B nucleoprotein antigens from respiratory specimens of symptomatic patients with a time to result of 10 minutes. The speed and simplified workflow of the BD Veritor System for Rapid Detection of Flu A+B makes it applicable as a "STAT" influenza A and B antigen detection test providing relevant information to assist with the diagnosis of influenza.

Each BD Veritor System Flu A+B 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 Flu A+B kit:

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. 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"^16-19 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. 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.