J Lab Med Qual Assur.
2004 Jun;26(1):185-192.
Determination of Reference Level for Triple Marker in Korean Population
- Affiliations
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- 1Department of Laboratory Medicine, Sungkyunkwan University, School of Medicine, Samsung Medical Center, Seoul, Korea.
Abstract
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BACKGROUND: The triple marker test with maternal serum during 15~20 weeks gestation is a useful prenatal screening technique. However established reference level is determined for Caucasians and there has not been Korean reference level determined from triple marker results of normal pregnant women without adverse outcome. We intended to determine the Median for triple marker respectively from results which have been done in Samsung Medical Center (SMC), considering the pregnancy outcome in this study.
METHODS
The study population was derived from women undergoing triple marker screening at SMC between January, 2000 and July, 2001. alpha-fetoprotein (AFP) and human chorionic gonadotropin (hCG) were measured by ACS: CentaurTM (Bayer Diagnostics, Chicago, USA) and unconjugated estriol (uE3) was measured by T21 Screening ELISA (Gamma S.A., Liege-Angleur, Belgium). We reviewed the pregnancy outcome, ultrasonographic finding and amniocentesis result in each case.
RESULTS
Eighty two (4.3%) patients of the 1,918 women screened were identified as positive. Two patients with chromosomal abnormalities (trisomy 21) were found in the 64 patients (78%) who underwent chromosomal analysis of amniotic fluid. With reference to total 1,830 cases, we determined the median of AFP, hCG and uE3, categorized by gestational age. Also, we calculated the Multiples of Median (MoM) of each result according to the newly determined median.
CONCLUSIONS
Although triple marker test appears to be an effective method detecting chromosomal abnormalities and neural tube defect (NTD), it is most important to determine the median of our own population for the correct prenatal screening.