Product Manual

Page 4 of 55QuickVue One-Step hCG Urine 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.
INTERPRETATION OF RESULTS
See Procedure Card for color result interpretation.
Positive:
Any pink-to-red Test Line (T) along with a blue Control Line (C) is a
positive result for the detection of hCG.
Negative:
A blue Control Line (C) and no pink Test Line (T) is a negative result.
Invalid Result:
The test result is invalid if a blue Control Line (C) is not visible at 3
minutes. If this happens, retest using a new sample and a new Test
Cassette or contact Quidel Technical Support.
LIMITATIONS
 The contents of this kit are for use in the qualitative detection of hCG in urine.
 Test results must always be evaluated with other data available to the physician.
 While pregnancy is the most likely reason for the presence of hCG in urine, elevated
hCG concentrations unrelated to pregnancy have been reported in some patients.
2,3
Conditions other than normal pregnancy may be associated with detectable hCG,
including, for example, ectopic pregnancy or molar pregnancy.
4
Patients with
trophoblastic and nontrophoblastic disease may have elevated hCG levels, therefore,
the possibility of hCG secreting neoplasms should be eliminated prior to the diagnosis
of pregnancy.
 hCG may remain detectable for a few days to several weeks after delivery, abortion,
natural termination or hCG injections.
5,6