1 (US Patent No. US D560281 (S1); US D5601344 (S1); US ...

External Control Reagents should be tested according to the requirements of the laboratory or those of applicable
local, state or national accrediting agencies.
1. See section on EXTERNAL CONTROL TESTS for instructions on performing these control tests.
2. The reactivity of each new lot and of each new shipment of TRU FLU should be verified on receipt using external
Positive and Negative Control reagents. The number of additional tests performed with the external controls will be
determined by the requirements of local, state or federal regulations or accrediting agencies.
3. The external controls are used to monitor reagent reactivity. Failure of the controls to produce the expected results
can mean that one of the reagents or components is no longer reactive at the time of use, the test was not performed
correctly or that reagents or samples were not added. The kit should not be used if control tests do not produce the
correct results. Repeat the control tests as the first step in determining the root cause of the failure. Contact Meridian
Bioscience Technical Support Services (513-271-3700) for assistance in troubleshooting when control failures are
repeated.
4. Positive and negative reactions are described in the section on INTERPRETATION OF RESULTS. Negative Control
reagent should produce a Control Line without any FLU A or FLU B Test Lines. Flu/RSV Positive Control, since it
contains influenza A and B antigens, is expected to produce PINK-RED bands at the Control FLU A and FLU B
positions. It is a control failure when Flu/RSV Positive Control reagent produces less than the expected three bands.
The Positive and Negative Control reagents manufactured for this assay are prepared in the matrix of the Sample Diluent,
which may not mimic test specimens. If control materials that are identical in composition to test specimens are preferred,
the user can prepare those by diluting known positive and negative specimens in Sample Diluent according to the
SPECIMEN PREPARATION section of this insert. For further information regarding matrix effects refer to The Clinical
Laboratory Standards Institute (CLSI) guideline on matrix effects EP14-A2. 5
LIMITATIONS OF THE PROCEDURE
1. This test does not subtype or differentiate any specific influenza A subtypes or strains. If additional testing is required,
consult with state or local public health departments.
2. The test is qualitative and no quantitative interpretation should be made with respect to the intensity of the positive line
when reporting the result.
3. The test results are to be used in conjunction with information available from the patient’s clinical evaluation and other
diagnostic procedures.
4. Dilution errors may affect test performance. Failure to add sufficient respiratory sample to the Sample Diluent may
result in a falsely negative test result. Failure to add the full amount of Sample Diluent may result in a falsely positive
test. Addition of too much sample may result in an invalid test due to inhibition of sample flow.
5. Children tend to shed virus more abundantly and for longer periods of time than adults. Therefore, specimens from
adults may demonstrate weaker reactions than those of children.
6. Individuals who received nasally administered influenza A vaccine may have positive test results for up to three days
after vaccination.
7. Monoclonal antibodies are used in the production of this assay. Monoclonal antibodies may fail to detect, or detect
with less sensitivity, influenza A viruses that have undergone minor amino acid changes in the epitope antigen.
Alternatively, monoclonal antibodies to large sections of conserved antigens may demonstrate improved sensitivity
over polyclonal antibodies. The exact primary, secondary and/or tertiary structures defined by the monoclonal
antibodies used in this assay have not been identified.
8. Overincubation of tests may lead to false-positive test results. Incubating tests at reduced temperatures or times may
lead to falsely negative results.
9. Dry swab specimens are not as stable as swab specimens in transport medium. Studies performed at Meridian
suggest deterioration occurs more rapidly on metal shafted swabs, than on plastic-shafted swabs.
10. In all immunochromatographic assays, faintly visible or weak test lines are more likely to be falsely positive than are
strongly positive test lines. As with any diagnostic procedure, the result of a TRU FLU test should be used in
conjunction with other tests and the patient’s clinical picture.
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