Product Manual

Page 4 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.
QuickVue One-Step hCG Urine or Combo
POSITIVE – The appearance of any pink-to-red line next to the letter “T” AND a blue line
next to the letter “C” in the Results Window is a positive result.
NEGATIVE – The appearance of a blue line next to the letter “C” AND NO pink-to-red test
line is a negative result.
INVALID – A blue line next to the letter “C” should always appear. If no blue line appears,
the test result is invalid and the control sample must be repeated.*
RapidVue hCG
POSITIVE – The appearance of any pink-to-red Test Line along with a blue Control Line
is a positive result.
NEGATIVE – The appearance of a blue Control Line only is a negative result.
INVALID – A blue Control Line should always appear. If no blue Control Line appears,
the test is invalid, and the control sample must be retested.*
*An invalid result indicates either the assay was not performed correctly or the reagents
were not working properly. If an invalid result occurs, re-test the control sample using a
new test unit. If the problem persists, please contact Quidel Technical Support.
lImItatIons
The Positive and Negative Controls in the hCG Control Set are qualitative reagents and
are not to be used as quantitative calibrators. They should not be diluted and may be
incompatible for use with other assays.
The hCG Control Set must be used at room temperature 15–30°C (59–86°F). Performance
of the assay at other temperatures may yield invalid results.
expected ValUes
The hCG Control Set will produce examples of the color response to be expected for
negative and positive specimens when tested in the QuickVue+ One-Step hCG Combo,
QuickVue One-Step hCG Urine or Combo, or RapidVue hCG Test. These controls are
calibrated to the W.H.O. 4th International Standard for Chorionic Gonadotropin, Human,
for Bioassay (4th I.S. 75/589).
The failure to obtain a negative result with the Negative Control or a positive result with
the Positive Control indicates that the test was not performed properly or that the test
reagents were not functioning properly.