Clinical Investigation for the Preview® hCG Urine/Serum Combo Pregnancy Test
Clinical Investigation for the Preview® hCG Urine/Serum Combo Pregnancy Test
The objective of this study is to evaluate the agreement of the test device (Preview® hCG
 Urine/Serum Combo Pregnancy Test) with the predicate device, the QuickVue+ hCG Combo Test.
Inclusion Criteria:

 -  Healthy adult women of childbearing age.

 -  Who either request a pregnancy test, or require a pregnancy test for diagnostic
 studies or treatment.

 -  Signed and dated informed consent.

 Exclusion Criteria:

 -  Minors.

 -  Adults who are unable to independently give consent for study.

 -  Known pregnancy (i.e. - patient appears obviously pregnant).

 -  Recent miscarriage or abortion and yet to have 2 complete menstrual cycles before
 study start.

 -  History of ectopic pregnancy, fibroids, congenital uterine anomaly that causes an
 irregular-shaped uterus.

 -  Taken any of the medications of contraceptives containing estrogen in last two weeks.

 -  Hemodynamically unstable.

 -  Moderately to severely ill-appearing or in moderate to severe pain.

 -  Technically not possible to obtain blood or urine from the study subject.