IB10 sphingotest® beta-hCG
IB10 sphingotest® beta-hCG is a rapid point-of-care (POC) immunoassay for the quantitative in vitro determination of human chorionic gonadotropin (hCG) in human lithium-Heparin whole blood and plasma. The assay detects total hCG, measuring both the intact hCG molecule and its free beta subunit. The quantitative measurement of hCG aids in the early detection of pregnancy.
The test is designed for professional use only and may be used on sites where near patient testing is practiced.
Cat. No. IVR-IB54 | beta-hCG (package of 10 discs)
Clinical Significance
hCG is the primary analyte used for pregnancy confirmation and monitoring due to its rapid rise in both blood and urine soon after conception (1). The detection of hCG within 3 - 4 weeks of the last menstrual period is the most reliable indicator for the confirmation of pregnancy. During a normal pregnancy, levels of hCG in the blood vary but are approximately 25 - 50 mIU/mL in the week after conception and rise exponentially doubling every 1.5 - 3 days during the first six weeks (2,3). hCG levels continue to rise through the end of the first trimester, followed by a slow decline as the pregnancy reaches full-term (~ 40 weeks).
Expected Values
Each laboratory should establish its own expected values that represents the population that is to be evaluated at their facility. As a guide, the following ranges were determined. The IB10 sphingotest® beta-hCG Test was used to determine the concentration upper reference limit of hCG in human plasma samples collected from apparently healthy, non-pregnant individuals. The 95th percentile upper reference limit as determined with the samples is 5.42 mIU/mL hCG.
| Reference Group | N | Median (mIU/mL) | 95th percentile (mIU/mL) |
|---|---|---|---|
| Male | 150 | 0.0 | 4.8 |
| Non-preg. female | 248 | 1.6 | 5.8 |
| Female age <50 | 150 | 0.4 | 4.2 |
| Female age >50 | 98 | 3.3 | 7.9 |
| Total | 398 | 0.5 | 5.4 |
Representative hCG ranges during normal pregnancy based on Last Menstrual Period (LMP) are summarized below. Other clinical reference citations may show different values.
| After LMP (weeks) | hCG Range (mIU/mL)2 |
|---|---|
| 4 | 5 - 100 |
| 5 | 200 - 3,000 |
| 6 | 10,000 - 80,000 |
| 7-14 | 90,000 - 500,000 |
| 15-26 | 5,000 - 8,000 |
| 27-40 | 3,000 - 15,000 |
Whole Blood vs. Plasma Comparison
All our assays correlate with r=0.9. For more detailed information please read the IFUs or connect with our sales representatives.
Key Features
| Easy Handling | |
|---|---|
| Sample Type | Lithium-Heparin Whole Blood or Plasma Samples |
| Time to Result | 20 minutes |
| Measuring Range | 4.0 - 400 mIU/mL |
| Limit of Detection | 4.0 mIU/mL |
| No High Dose Hook Effect | up to 700,000 mIU/mL |
| Analyte Stability for IB10 Measurement | 24 hours for whole blood |
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IB10 sphingotest® beta-hCG is a rapid point-of-care (POC) immunoassay for the in vitro quantitative determination of human chorionic gonadotropin.
References
(1) Canfield RE et al. Development of an assay for a biomarker of pregnancy and early fetal loss. Environ Health Perspect. 1987 Oct;74:57-66.
(2) Vaitukaitis JL et al. Gonadotropins and their subunits: basic and clinical studies. Recent Prog Horm Res. 1976;32:289-331.
(3) Wu A. Tietz clinical guide to laboratory tests. 2006. 4th Ed. Philadelphia - Saunders-Elsevier - pp. 252-259