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

The conjugate bead is first rehydrated in the Conjugate Tube with Sample Diluent, prior to the addition of patient specimen.
The contents are mixed before the Test Strip is added. As the test is incubated at 20-25 C, influenza A or influenza B
antigens, if present in the diluted sample, bind to the corresponding monoclonal antibody-colloidal gold conjugate as the
sample moves up the Test Strip. The influenza A capture monoclonal antibody is bound to the Test Strip at the test-FLU A
position of the device. When it binds the antigen-influenza A antibody-colloidal gold complex, it yields a visible pink-red line.
Similarly, the influenza B capture monoclonal antibody bound to the assay membrane at the test-FLU B position will result in
a pink-red line when it captures antigen-influenza B antibody-colloidal gold complexes. When no antigen is present, no
complexes are formed and no pink-red line will appear at either the test FLU A or the test FLU B position of the Test Strip.
An internal control line helps determine whether adequate flow has occurred through the Test Strip during a test run. A
visible pink-red line at the Control position of the Test Strip should be present each time a specimen or control is tested. If
no pink-red control line is seen, the test is considered invalid.
REAGENTS/MATERIALS PROVIDED
The maximum number of tests obtained from this test kit is listed on the outer box.
1. Test Strip: A test strip attached to a plastic holder enclosed in a foil pouch with desiccant. The test strip carries
monoclonal anti-influenza A and anti-influenza B capture antibodies* for the test lines. The holder is used to stopper
the Conjugate Tube. The paddle portion of the holder indicates where test and control lines should appear. Store the
pouch at 2-25 C when not in use.
2. Conjugate Tube: A capped plastic tube containing a conjugate bead. The tube is enclosed in a foil pouch. The
conjugate consists of gold-conjugated anti-influenza A and anti-influenza B which serve as the detector antibodies.*
Store the foil pouch at 2-25 C when not in use. Do not store in the freezer. Do not remove the cap before use.
3. Sample Diluent/Negative Control: A buffered protein solution provided in a plastic vial. Sodium azide (0.094%)
added as a preservative. Use as supplied. Store at 2-25 C when not in use.
4. Plastic transfer pipettes with 100, 200 and 300 µL volume marks (see diagram below).
5. TRU FLU Conjugate Tube labels (to differentiate TRU FLU Conjugate Tubes from Conjugate Tubes of other assays).
*The influenza strains used to produce the monoclonal antibodies incorporated into Test Strips and Conjugate were A/Texas,
A/H1N1, B/Singapore and B/Beijing/184/93.
MATERIALS NOT PROVIDED
1. Disposable latex gloves (Handle respiratory samples as if they are potentially infectious.)
2. Vortex for suspending the specimen in Sample Diluent (optional)
3. Interval timer
4. Medical waste container
5. Marking pen
6. Meridian Bioscience Flu/RSV Positive Control (Catalogue number 751110): Inactivated RSV, influenza A (strain
A/Texas/1/77) and influenza B (strain B/Hong Kong/5/72) viruses in a buffered solution containing sodium azide
(0.094%) as a preservative. The viruses were inactivated by merthiolate treatment and tested and shown to be
noninfectious by viral culture. The reagent is supplied ready for use. Store at 2-8 C when not in use. (This adjunct
External Control is sold separately.)
PRECAUTIONS
1. For in vitro diagnostic use.
2. Do not use kit or components beyond the expiration date.
3. Test Strips and Conjugate Tubes are packaged in foil pouches that exclude moisture during storage. Inspect each foil
pouch before opening. Do not use Test Strips or Conjugate Tubes in pouches that have holes in the foil, or where the
pouch has not been completely sealed. Do not use Test Strips where the desiccant indicator has changed from blue to
pink. The change in the desiccant color indicates the contents have been exposed to moisture. False-negative
reactions may result if test components and reagents are improperly stored.
4. Do not use the Sample Diluent if it is discolored or turbid. Discoloration or turbidity may be a sign of microbial
contamination.
5. Directions should be read and followed carefully or falsely positive or falsely negative results may occur.
6. The Positive Control reagent vial should be held vertically when dispensing drops to ensure consistent drop size and
delivery.
7. Some patient specimens contain infectious agents; therefore all patient specimens should be handled and discarded
as if they are biologically hazardous.
8. All respiratory samples must be mixed thoroughly before testing, regardless of consistency, to ensure a representative
sample prior to testing.
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