Product Manual

Page 3 of 124QuickVue RSV Test
FOR INFORMATIONAL USE ONLY
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FOR INFORMATIONAL USE ONLY
Not to be used for performing assay. Refer to most current package insert accompanying your test kit.
WARNINGS AND PRECAUTIONS
n For in vitro diagnostic use.
n Performance characteristics have not been established for use with adult or
immunocompromised patients.
n Do not use the kit contents beyond the expiration date printed on the outside of
the box.
n Use appropriate precautions in the collection, handling, storage, and disposal of
patient samples and used kit contents.
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Use of Nitrile or Latex gloves is recommended when handling patient samples.
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n Dispose of containers and used contents in accordance with Federal, State and Local
requirements.
n The Test Strip must remain sealed in the protective foil pouch until use.
n The Extraction Reagent contains sodium azide. Sodium azide may react with lead
or copper plumbing to form potentially explosive metal azides. Copious quantities
of water should be used to flush the Extraction Reagent down a sink. If the solution
contacts the skin or eye, flush with copious amounts of water.
n To obtain accurate results, you must follow the Package Insert instructions.
n To obtain accurate results, you must use the proper volume of the Extraction Reagent.
n To avoid erroneous results, you must rotate the swab a minimum of five (5) times as
indicated in the Test Procedure.
n Proper specimen collection, storage, and transport are critical to the performance of
this test.
n Seek specific training or guidance if you are not experienced with specimen collection
and handling procedures.
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n M4-3 and Amies transport media are not compatible with this device. To obtain
optimal results, use the transport media recommended in the Package Insert.
n For proper test performance, use the nasopharyngeal swabs supplied in the kit.
n Individuals with color-impaired vision may not be able to adequately interpret test
results.