Product Manual

Page 1 of 60QuickVue One-Step hCG Combo test
FOR INFORMATIONAL USE ONLY
FOR INFORMATIONAL USE ONLY
Not to be used for performing assay. Refer to most current package insert accompanying your test kit.
INTENDED USE
The QuickVue One-Step hCG Combo test is a one-step immunoassay intended for the
qualitative detection of human Chorionic Gonadotropin (hCG) in serum or urine for the
early detection of pregnancy. The test is intended for use by healthcare professionals.
SUMMARY AND EXPLANATION
Human Chorionic Gonadotropin is a hormone produced by the placenta shortly after
implantation. Since hCG is present in the serum and urine of pregnant women, it is an
excellent marker for confirming pregnancy.
PRINCIPLE OF THE TEST
The QuickVue test uses a monoclonal antibody specific to the beta subunit of hCG in a
single-step technology to accurately detect hCG.
Serum or urine is added to the Sample Well on the Test Cassette. If hCG is present in
the specimen at a level of 25 mIU/mL or greater, a pink-to-red Test (T) Line will appear
along with a blue procedural Control (C) Line in the Result Window. If hCG is present at
very low levels, or not present in the specimen, only a blue procedural Control Line will
appear in the Result Window.
REAGENTS AND MATERIALS SUPPLIED
50 individually wrapped Test Cassettes
Test Strip contains murine monoclonal anti-hCG antibody
50 disposable pipettes
1 Package Insert
1 Procedure Card
CLIA Complexity: Waived-Urine / Moderate - Serum

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