Product Manual

Page 2 of 55QuickVue One-Step hCG Urine 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.
MATERIALS REQUIRED BUT NOT PROVIDED
 Watch or clock that measures minutes
 Specimen collection containers
MATERIALS RECOMMENDED BUT NOT PROVIDED
 External hCG controls traceable to WHO Standard (4th IS 75/589).
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.
 To obtain accurate results, you must follow the Package Insert instructions.
KIT STORAGE AND STABILITY
Store kit at room temperature 59–86°F (15–30°C), out of direct sunlight. Kit contents
are stable until the expiration date printed on the outer box carton.
SPECIMEN COLLECTION AND STORAGE
Collect urine specimens in clean containers. First morning specimens generally contain
the highest concentrations of hCG and are recommended for early detection of pregnancy.
However, any urine specimen is suitable for testing.
Specimens may be kept at room temperature for 8 hours or refrigerated at 36–46°F
(2–8°C) for up to 72 hours. Samples may be frozen once at -20°C or below. If frozen,
mix after thawing. Do not refreeze.