Interpretation Of Results; Quality Control - BD Veritor System Handbuch

OPTIONAL TEST PROCEDURE: Testing for RSV and INFLUENZA A+B using a single NP swab. For patients under
the age of 6 years.
Note: The BD Veritor™ System for Rapid Detection of Flu A+B (Cat. No. 256045) is required for this procedure in
addition to the BD Veritor™ System for Rapid Detection of RSV (Cat. No. 256038).
This procedure allows for use of the remaining processed sample from Step 5 above to test additionally for Influenza A+B. When
using this optional test procedure, the sample may be used up to 15 minutes after initial processing.
1. Collect NP swab from the patient and follow Steps 1–5 of the test procedure above as instructed for RSV.
2. Using the sample from Step 5, continue the test procedure using the test device for Flu A+B.
3. Refer to the product insert for BD Veritor System for Rapid Detection of Flu A+B, (Cat. No. 256045) for the test
procedure and full description of the BD Veritor Flu A+B test. Follow the Instrument on-screen prompts to complete
the procedure and obtain test results. Refer to the product insert for the BD Veritor™ System Flu A+B CLIA waived Kit
(Cat. No. 256045) for result interpretation.

INTERPRETATION OF RESULTS:

The BD Veritor System Instrument (purchased separately) must be used for interpretation of all test results. Operators should
not attempt to interpret assay results directly from the test strip contained within the BD Veritor System RSV assay device.
Display
RSV: +
RSV: -
CONTROL INVALID
Invalid Test – If the test is invalid, the BD Veritor System Instrument will display "CONTROL INVALID" and the test or control
must then be repeated. If the "CONTROL INVALID" reading recurs, contact BD Technical Support.
REPORTING OF RESULTS
Positive Test
Positive for the presence of RSV antigen. A positive result may occur in the absence of viable virus.
Negative Test Negative for the presence of RSV antigen. Infection due to RSV cannot be ruled out because the antigen present
in the sample may be below the detection limit of the test. In the U.S., a negative test is presumptive and
it is recommended that these results be confirmed by viral cell culture or an FDA-cleared RSV molecular assay.
Control Invalid Do not report results. Repeat the test.

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 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
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 System Instrument 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:
RSV + and RSV - 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.
Interpretation
Positive Test for RSV (RSV antigen present)
Negative Test for RSV (no RSV antigen detected)
Control line error. Repeat the test.
section 4, to choose or change this configuration.
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