BD Veritor System Bedienungsanleitung Seite 120

OPTIONAL TEST PROCEDURE: Testing for INFLUENZA A+B and RSV using a single NP swab
Note: The BD Veritor™ System for Rapid Detection of RSV (Cat. No. 256038) is required for this procedure in
addition to the BD Veritor™ System for Rapid Detection of Flu A+B (Cat. No. 256045).
IMPORTANT NOTE: THE SAMPLE TO BE TESTED IN THE RSV KIT MUST BE FROM A PATIENT LESS THAN 6 YEARS
OF AGE AS INDICATED IN THE BD VERITOR RSV POC KIT PACKAGE INSERT. THE PROCESSED SAMPLE SHOULD
BE TESTED WITHIN 15 MINUTES.
This procedure allows for use of the remaining processed sample from Step 5 above to test additionally for RSV. 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 the BD Veritor
System for Rapid Detection of Flu A+B.
2. Using the sample from Step 5, continue the test procedure using the test device for RSV.
3. Refer to the product insert for BD Veritor System for Rapid Detection of RSV, (Cat. No. 256038) for the test
procedure and full description of the BD Veritor RSV test. Follow the Instructions in the insert and the Instrument
on-screen prompts to complete the test procedure and obtain results. Refer to the product insert for the BD Veritor
System RSV Kit (Cat. No. 256038) 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 Flu A+B assay device.
With some specimens, up to four lines may be visible on the test device. The Instrument will appropriately interpret the result.
Display
FLU A: +
FLU B: -
FLU A: -
FLU B: +
FLU A: -
FLU B: -
RESULT INVALID
POSITIVE CONTROL INVALID
NEGATIVE CONTROL INVALID
Invalid Test – If the test is invalid, the BD Veritor System Instrument will display "RESULT INVALID" or "POSITIVE
CONTROL INVALID" or "NEGATIVE CONTROL INVALID" and the test or control must then be repeated. Because true dual
positives are exceptionally rare, the BD Veritor System Instrument reports dual positive influenza A and influenza B results
as "Result Invalid." Specimens generating a "Result Invalid" should be retested. Upon retesting, if the specimen produces
a "Result Invalid" the user may want to consider other methods to determine whether the sample is positive or negative for
influenza virus. If either the POSITIVE or NEGATIVE "CONTROL INVALID" reading recurs, contact BD Technical Support.
REPORTING OF RESULTS
Positive Test
Positive for the presence of influenza A or influenza B antigen. A positive result may occur in the absence of
viable virus.
Negative Test
Negative for the presence of influenza A or influenza B antigen. Infection due to influenza cannot be ruled out
because the antigen present in the sample may be below the detection limit of the test. It is recommended that
these results be confirmed by viral culture or an FDA-cleared influenza A and B molecular assay.
Invalid Test
Test result is inconclusive. Do not report results. Repeat the test.
Interpretation
Positive Test for Flu A (influenza A antigen present)
Positive Test for Flu B (influenza B antigen present)
Negative Test for Flu A and Flu B (no antigen detected)
Result Invalid. Repeat the test.
Test Invalid. Repeat the test.
Test Invalid. Repeat the test.
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