Performance Characteristics - BD Veritor System Handbuch

BD recommends controls be run once for:
• each new kit lot,
• each new operator,
• each new shipment of test kits,
• as required by internal quality control procedures and in accordance with local, state and federal regulations or
accreditation requirements.
Test Procedure For Kit Swab Controls:
1. Remove and discard the cap from the RV Reagent D tube corresponding to the sample to be tested.
2. Insert the control swab into the tube and vigorously plunge the swab up and down in the fluid for a minimum of 15 seconds.
3. Remove the swab while squeezing the sides of the tube to extract the liquid from the swab.
4. Continue processing the swab according to the Test Procedure for Nasopharyngeal Swabs above, beginning at Step 5.
If the kit controls do not perform as expected, do not test patient specimens. Contact BD Technical Services at
1.800.638.8663.
LIMITATIONS OF THE PROCEDURE
• Failure to follow the Test Procedure may adversely affect test performance and/or invalidate the test result.
• The contents of this kit are to be used for the qualitative detection of RSV antigens from nasopharyngeal swabs.
• 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.
• A false-negative test result may occur if the level of viral antigen in a sample is below the detection limit of the test or if
the sample was collected or transported improperly; therefore, a negative test result does not eliminate the possibility of
RSV infection, and should be confirmed by viral cell culture or in the U.S., an FDA-cleared RSV molecular assay.
• Positive test results do not rule out co-infections with other pathogens.
• Negative test results are not intended to rule in other non-RSV viral or bacterial infections.
• Positive and negative predictive values are highly dependent on prevalence rates. Positive test results are more likely
to represent false positive results during periods of little/no RSV activity when disease prevalence is low. False negative
test results are more likely during peak RSV activity when prevalence of disease is high.
• This device has been evaluated for use with human specimen material only.
• Monoclonal antibodies may fail to detect, or detect with less sensitivity, RSV viruses that have undergone minor amino
acid changes in the target epitope region.
• The performance of this test has not been evaluated for use in patients without signs and symptoms of respiratory infection.
• The validity of the BD Veritor System for Rapid Detection of RSV test has not been proven for identification/confirmation
of tissue culture isolates and should not be used in this capacity.
• Therapeutic anti-RSV monoclonal antibodies may interfere with the BD Veritor System for Rapid Detection of RSV.
• Performance characteristics have not been established for use with patients older than 5 years of age or for
immunocompromised patients.
EXPECTED VALUES
The rate of positivity observed in RSV testing will vary depending on the method of specimen collection, handling/transport
system employed, detection method utilized, time of year, age of the patient, geographic location and most importantly, local
disease prevalence. In the 2012/2013 clinical trial the overall prevalence of RSV as determined by viral cell culture positive
specimens was 25.6% (range of 7.7 to 65.2%). Overall prevalence of RSV as determined by PCR positive specimens tested
was 34.2% (range of 15.4 to 69.6%).

PERFORMANCE CHARACTERISTICS

Clinical Performance
Performance characteristics for the BD Veritor System for Rapid Detection of RSV test were established in a prospective
multi-center clinical study conducted at eight Point of Care (POC) U.S. testing sites during the 2012–2013 respiratory season.
The performance of the BD Veritor RSV test was compared to a commercially available PCR method as well as viral culture.
A total of 540 specimens were enrolled in the clinical trial. A total of 523 specimens had evaluable results for all three testing
methods: PCR, viral cell culture and BD Veritor RSV. The study population was 42.6% females and 57.4% males. The table
below shows age distribution of the study population.
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