The qualitative detection of human chorionic gonadotropin (hCG) in urine to aid in the early detection of pregnancy.

For sites with Sysmex UN-2000 automated urinalysis analyzers (CEN,UND,MCY), urine pregnancy testing should not be added on to a poured off urine sample that has had a urinalysis performed due to observed false positive reporting from reagent carryover.

Screw cap plastic container (non sterile)

A first morning urine specimen is preferred since it generally contains the highest concentration of hCG, however, urine specimens collected at any time of day may be used.

Transfer urine to a Urine aliquot transport vial/tube - 10mL (AHL)

Urine aliquot transport vial/tube - 10mL (AHL)

Refrigerated (preferred) - 48 hours

Ambient - 24 hours

Frozen (OK)

• Improper label (unlabeled or mislabeled)
• Delay in transport

Immunoassay (IA)

Negative

Human chorionic gonadotropin (hCG) is a glycoprotein hormone produced by the developing placenta shortly after fertilization. In normal pregnancy, hCG can be detected in both urine and serum as early as 7 to 10 days after conception. hCG levels continue to rise very rapidly, frequently exceeding 100 mIU/mL by the first missed menstrual period, and peaking in the 100,000-200,000 mIU/mL range about 10-12 weeks into pregnancy. The appearance of hCG in both the urine and the serum soon after conception, and its subsequent rapid rise in concentration during early gestational growth, make it an excellent marker for the early detection of pregnancy.