Product Manual

Page 3 of 6hCG Control Set
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.
test procedUre
The hCG Control Set is to be used in accordance with the directions accompanying the
QuickVue+ One-Step hCG Combo, QuickVue One-Step hCG Urine or Combo, or RapidVue
hCG Test kits. When following these directions, the hCG Control Set is to be used in the
same manner as a patient sample.
1. Gently mix the hCG Controls by shaking the vials prior to use.
Important – The quantity of drops required to perform the control assay
differs between the QuickVue+ One-Step hCG Combo, QuickVue One-Step
hCG Urine or Combo, and RapidVue hCG tests. Please read carefully.
2. Add four (4) drops (approximately 160 µL) of either the Positive or Negative Control
to the QuickVue+ One-Step hCG Combo Reaction Unit’s “Add Sample” well.
Add three (3) drops (approximately 120 µL) of either the Positive or Negative Control
to the QuickVue One-Step hCG Urine or Combo test cassette sample well.
Apply two (2) drops (approximately 80 µL) of either the Positive or Negative Control
to the “dip” end of the RapidVue hCG test strip, below the orange line.
3. Read test results at the designated read time specified in the package insert.
InterpretatIon of resUlts
Refer to the QuickVue+ One-Step hCG Combo, QuickVue One-Step hCG Urine or
Combo, or RapidVue hCG Test package insert.
QuickVue+ One-Step hCG Combo
POSITIVE – The appearance of any vertical pink-to-purple Test Line intersecting the
pre-printed horizontal blue line in the Read Result Window, along with a blue procedural
Control Line in the Control Window, is a positive result.
NEGATIVE – The appearance of the pre-printed horizontal blue line only in the Read
Result Window, along with the blue procedural Control Line in the Control Window,
is a negative result.
INVALID – A blue procedural Control Line should always appear. If no procedural Control
Line appears, the test result is invalid and the control sample must be retested.*