BD Veritor System Bedienungsanleitung Seite 121

QUALITY CONTROL
To utilize the Analyzer's QC documentation capability, specimen barcode scanning must be enabled on an
Analyzer equipped with the BD Veritor InfoScan module. Please refer to the Analyzer Instructions for Use,
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
correct test procedure.
2. The membrane area surrounding test lines functions as a background check on the assay device.
The BD Veritor System Instrument evaluates the positive and negative internal/procedural controls after insertion of
each BD Veritor System test device. The BD Veritor Instrument also prompts the operator if a quality issue occurs
during assay analysis. Failure of the internal/procedural controls will generate an invalid test result. NOTE: The
internal controls do not assess proper sample collection technique.
External Positive and Negative Controls:
Flu A positive/B negative and Flu B positive/A negative control swabs are supplied with each kit. These controls provide
additional quality control material to assess that the test reagents and the BD Veritor System Instrument perform as
expected. Prepare kit control swabs and test using the same procedure (either Analyze Now or Walk Away mode) as used
for patient specimen swabs. When using the barcode scanning feature to document QC procedures, scan the barcode on the
control swab packaging when prompted for a Specimen ID.
Your laboratory's standard Quality Control procedures and applicable local, state and/or federal regulations or
accreditation requirements dictate the performance of external quality control procedures.
BD recommends controls be run once for:
• each new kit lot,
• each new operator,
• each new shipment of test kits,
• as required by site quality control procedures and in accordance with local, state and federal regulations or
accreditation requirements.
Control Swab Test Procedure – Preparing the sample
1. Insert the swab all the way into the appropriately labeled RV Reagent D tube and vigorously plunge the swab up and
down in the fluid for a minimum of 15 seconds.
2. Continue processing the swab according to the Test Procedure for Nasal and Nasopharyngeal swabs above
beginning at Step 4 "Remove the swab."
If the kit controls do not perform as expected, do not report patient results. 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 influenza type A and B antigens from nasal swab and
nasopharyngeal swab specimens.
• The BD Veritor System for Rapid Detection of Flu A+B is capable of detecting both viable and non-viable influenza
particles. The BD Veritor System for Rapid Detection of Flu A+B 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 Flu A+B 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 influenza A or influenza B infection, and should be confirmed by viral culture or an FDA-cleared influenza A and B
molecular assay.
• Positive test results do not rule out co-infections with other pathogens.
• Positive test results do not identify specific influenza A virus subtypes.
• Negative test results are not intended to rule in other non-influenza viral or bacterial infections.
• Children tend to shed virus for longer periods of time than adults, which may result in differences in sensitivity between
adults and children.
• 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 influenza activity when disease prevalence is low. False negative
test results are more likely during peak influenza 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, influenza A viruses that have undergone minor
amino acid changes in the target epitope region.
section 4, to choose or change this configuration.
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