Unit: 1 Box (50 Tests)
Regulatory Status: CLIA Waived (Urine) / Moderately Complex (Serum) / Professional Use Only
Contents: (50) Test Strip, (50) Disposable Pipette, (1) Package Insert, (1) Procedure Card
Determinations: Qualitative Human Chorionic Gonadotropin (hCG)
Storage Requirements: 59° – 86° F
Sample Volume: 3 Drops (Urine or Serum)
Processing Time: 3 Minutes (Urine), 5 Minutes (Serum)
The QuickVue One-Step Pregnancy (hCG) Combo Test is a fast, easy-to-use, on-site immunoassay that offers a qualitative detection of human Chorionic Gonadotropin (hCG) in urine or serum in 5 minutes or less. The presence of hCG, nicknamed “the pregnancy hormone,” is detectable within days of fertilization, making it an excellent diagnostic marker for confirming pregnancy in its earliest stages.
The QuickVue One-Step hCG Combo Test Includes:
50 Individually packaged Test Cassettes
50 Disposable Pipettes
1 Package Insert
1 Procedure Card
- High Sensitivity – Able to detect low hCG levels (25mIU/mL) as early as 2 to 3 days before expected menses.
- Easy to Use – One-step Process
- Fast & Convenient – Urine Sample Results in 3 minutes; Serum Sample Results in 5 minutes
- Accurate – 99% Sensitivity, 99% Specificity
- Long Shelf Life – 18 months from date of manufacture
- No special storage or shipping required – Stable at Room Temperature (59-86 degrees F)
- CLIA Waived – Urine Only
About the Human Chorionic Gonadotropin Hormone (hCG)
Human Chorionic Gonadotropin (hCG) is a glycopeptide hormone produced by the syncytiotrophoblasts in the developing placenta and is vital to maintaining pregnancy. Human Chorionic Gonadotropin is measured in milli-international units per milliliter (mIU/mL). Non-pregnant females that have not yet experienced menopause normally maintain very low levels of hCG (<5.0 mIU/mL), therefore an hCG reading of 5.0 mIU/mL or less is considered negative for pregnancy. However, if the egg is fertilized and implantation occurs, syncytiotrophoblasts will first penetrate the uterine wall, rupturing maternal capillaries with the purpose of creating an interface between maternal blood and embryonic extracellular fluid. Then by the 9th day after fertilization, the syncytiotrophoblasts begin producing the hCG hormone. The hCG hormone is responsible for many essential functions during pregnancy including promoting uterine angiogenesis and vasculgenesis, preventing menstrual bleeding and rejection of the fetoplacental tissue, preventing degeneration of the corpus luteum (an important temporary maternal endocrine cell group), and the facilitation of umbilical cord growth and development. hCB levels typically double every 48 to 72 hours, reaching peak levels between the 8th and 11th weeks of pregnancy. Some pregnancy tests, such as the QuickVue hCG Combo Test, can detect hCG levels as low as 25 mIU/mL, confirming pregnancy with 99% accuracy as early as 2 to 3 days before expected mensus.