Product Manual

Page 1 of 60QuickVue+ One-Step hCG Combo 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.
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 normally produced by the placenta. Since
hCG is present in the serum and urine of pregnant women, it is an excellent marker for
confirming pregnancy.
The QuickVue+ One-Step hCG Combo test is a lateral-flow test using a monoclonal
antibody specific to the beta subunit of hCG to accurately detect hCG as early as 2 or 3
days before the expected menses.
PRINCIPLE OF THE TEST
To perform the test, a serum or urine sample is collected and added to the Reaction Unit.
If the sample contains hCG, a pink vertical line forms in the Read Result Window. This
pink vertical line, together with the pre-printed blue horizontal line, form a plus sign (+)
to indicate a positive result. If hCG is not present in the sample, the Read Result Window
shows only the pre-printed blue horizontal line, forming a minus sign (–) to indicate a
negative result.
As the sample continues to move through the test, a bar in the Control Window
becomes blue. Blue color in the Control Window indicates that the test is functionally
active and is also evidence that the test has been performed correctly.
CLIA Complexity: Waived-Urine / Moderate - Serum