Product Manual

Page 2 of 66QuickVue+ Strep A 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.
The appearance of blue color in the Test Complete Window indicates the completion of
the test. This occurs approximately 5 minutes after the addition of the extracted sample
to the Test Cassette.
REAGENTS AND MATERIALS PROVIDED
 Individually Packaged Test Cassettes (25): Rabbit anti-Strep A antibody and heat-
inactivated Strep A antigen
 Extraction Reagent A (1): 4 M Sodium Nitrite
 Extraction Reagent B (1): 0.2 M Acetic Acid
 Sterile Throat Swabs (25)
 Tubes and Tips (25)
 Positive Control (1): Heat-inactivated Group A Streptococcus, 0.02% sodium azide.
 Negative Control (1): Heat-inactivated Group C Streptococcus, 0.02% sodium azide.
 Package Insert (1)
 Procedure Card (1)
STORAGE AND STABILITY
Store kit at room temperature, 59–86°F (15–30°C). Kit contents are stable until the
expiration date printed on the outer box. Do not freeze.
WARNINGS AND PRECAUTIONS
 For in vitro diagnostic use.
 Do not use kit contents after the expiration date printed on the outside of the kit.
 Use appropriate precautions in the collection, storage, handling and disposal of
patient samples and used kit contents.
 Use of Nitrile or Latex gloves is recommended when handling patient samples.
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 Dispose of containers and unused contents in accordance with Federal, State, and
Local requirements.
 DO NOT interchange caps among reagents.
 The Test Cassette must remain sealed in the foil pouch until just prior to use.
 Reagent A contains 27.6% sodium nitrite and may be harmful if ingested, or absorbed.