Product Sheet - Beckman Coulter

REPRODUCTIVE
ACCESS TOTAL βhCG (5th IS)
Standardized to the WHO 5th International Standard for Chorionic Gonadotropin
MOVING YOUR LAB FORWARD
WITH EXCEPTIONAL REPRODUCTIVE
HEALTH MANAGEMENT
INTRODUCTION
Human Chorionic Gonadotropin (hCG) is a protein hormone that is produced by the placenta and is most
commonly measured for the confirmation of pregnancy. In addition, physicians run hCG tests on nearly
all women of childbearing age who present to the Emergency Department and require a treatment which
could potentially be harmful to a fetus.
In normal pregnancies, hCG can usually be detected after implantation, seven to nine days after conception
(or 22-24 days after the last menstrual period in a normal 28-day cycle).1 hCG concentrations double
approximately every one and a half to three days for the first six weeks and then continue to rise until the
end of the first trimester, gradually falling to a lower level for the remainder of the pregnancy.2
Healthy, non-pregnant individuals typically have low (< 5 mIU/mL) to undetectable hCG levels; however, the
production of hCG can rise to detectable levels in peri- and post-menopausal women.3,4
HOW ACCESS TOTAL βhCG (5th IS) MOVES THE LAB FORWARD
Access Total βhCG (5th IS) is the first βhCG assay standardized to the highly purified WHO
5th International Standard for Chorionic Gonadotropin. This new assay delivers:
› Efficient and cost-effective results through a broad dynamic range with automatic on-board
dilution capability up to 270,000 mIU/mL, reducing the need for manual sample dilution.5
› Confidence in patient results due to no discernible hook effect up to 1,000,000 mIU/mL.
› Flexibility in sample handling through assay compatibility with serum or lithium heparin plasma.
LAB FORWARD
ACCESS TOTAL βhCG (5th IS)
EXPECTED VALUES
Total βhCG concentrations were measured in human serum collected from apparently healthy non-pregnant females using the Total βhCG
(5th IS) assay (Table 1). Total βhCG concentrations measured in 100% of the samples were determined to be ≤ 11.6 mIU/mL (IU/L).
Table 1. Expected ranges: non-pregnant females.
Reference
(Non-Pregnant Females)
N
Median
(mIU/mL)
Range
(mIU/mL)
95th Percentile
(mIU/mL), [95% CI]
≥ 18 and < 40 years
132
0
0 – 0.6
0.3 [0.2 – 0.4]
≥ 40 years
141
0
0 – 3.1
1.5 [1.1 – 2.9]
Post-menopausal*
134
2.8
0.1 – 11.6
7.7 [6.4 – 10.4]
*Post-menopausal status confirmed using circulating FSH and estradiol levels.
CHARACTERISTICS
ORDERING INFORMATION
Sample Type/Size
Serum or plasma (lithium heparin) / 25 μL
Reagent Kit (2 x 50 tests)
A85264
Time to First Result
~18 min.
Calibrators (1 set, 6 x 4.0 mL)
B11754
Limit of Blank (LoB)
≤ 0.5 mIU/mL
Limit of Detection (LoD)
≤ 0.5 mIU/mL
Limit of Quantitation (LoQ) ≤ 0.6 mIU/mL
Approximate
Calibrator Levels
0, 6, 35, 195, 620 & 1350 mIU/mL
Reportable Range
0.6-1350 mIU/mL
Open Pack Stability
28 days
Calibration Stability
28 days
Precision≤ 10.0% CV @ concentrations > 3.9mIU/mL
SD ≤ 0.39 mIU/mL @ concentrations ≤ 3.9 mIU/mL
Calibration Traceability
WHO 5th International Standard5
LAB FORWARD
References
1.Sturgeon CM, McAllister EJ. Analysis of hCG: clinical applications and
assay requirements. Ann Clin Biochem 1998; 35:460-491.
2.Vaitukaitis JL. Recent progress in hormone research 1976; 32: 289.
3. Gronowski AM, et al. Use of serum FSH to identify perimenopausal
women with pituitary hCG. Clin Chem 2008; 54(4):652‐656.
4. Tietz NW. Textbook of clinical chemistry and molecular diagnostics.
4th ed. 2006;364, 2261.
5. 5th WHO IS Chorionic Gonadotropin (NIBSC Code 07/364)
Instructions for Use, Available http://www.nibsc.ac.uk/products/
biological_reference_materials/product_catalogue/detail_page.
aspx?catid=07/364.
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DS-14678B B2013-14147
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