Maternal serum median levels of alpha-foetoprotein, human chorionic gonadotropin & unconjugated estriol in second trimester in pregnant women from north-west India.

Background & objectives: Triple test as prenatal screening procedure does not form a part of routine health care of pregnant women in India. Hence, median values of triple test biomarkers are lacking for Indian population. This study was undertaken to establish population-specific medians for biomarkers viz. alpha-foetoprotien (AFP), human chorionic gonadotropin (hCGβ), and unconjugated estriol (uE3) for detection of Down’s syndrome, Edward’s syndrome and neural tube defects (NTDs) in pregnant women in north-west India. Methods: Serum biomarker values were derived from 5420 pregnant women between 15-20 wk of gestation who were enrolled for triple test investigations at Department of Gynecology and Obstetrics, Government Medical College and Hospital, Chandigarh, India, between January, 2007 to December, 2009. Median values were calculated for rounded weeks using database comprising pregnancies with normal outcomes only. Simple statistical analysis and log-linear regression were used for median estimation of the biomarker values. Results: The levels of the three biomarkers were found to be ranging from 1.38 to 187.00 IU/ml for AFP, 1.06 to 315 ng/ml for hCGβ, and 0.25 to 28.5 nmol/l for uE3. The age of women ranged from 18 to 47 yr and mean weight was 57.9 ± 9.8 kg. Data revealed that AFP, hCGβ and uE3 medians in our study population were not significantly different from those reported from other countries or when compared ethnically. Interpretation & conclusion: The population-specific median values for the three biomarkers (AFP, hCGβ, uE3) may be used as reference values during prenatal screening in Indian pregnant women.

Determination of Reference Level for Triple Marker in Korean Population / 임상검사와정도관리

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.

An Evaluation of Prenatal Triple Marker Screening / 대한진단검사의학회지

BACKGROUND: Maternal serum triple marker screening has become standard in prenatal care to help identify women at risk for neural tube defects (NTDs), trisomy 21 (Down syndrome) and trisomy 18 (Edwards' syndrome). This study was undertaken to evaluate the results of maternal serum triplemarker screening performed in pregnant women visiting Chung-Ang University Hospital and to assess the effectiveness of prenatal triple-marker screening. METHODS: Alpha-fetoprotein (AFP), human chorionic gonadotropin (hCG) and unconjugated estriol (uE3) were measured by radioimmunoassay (Amerlex-M 2nd Trimester Kit, Ortho Clinical Diagnostics, Amersham, Aylesbury, UK) in 506 pregnant women visiting Chung-Ang University Hospital. Women at risk for NTDs, trisomy 21 and trisomy 18 were identified using the computer program (HIT Program). Amniocentesis with chromosome analysis was performed in women who had positive screening results. RESULTS: Positive screening results were found in 41 (8.1%) women among 506 pregnant women who had undergone prenatal triple-marker screening between 14 and 22 weeks of gestation. Of these 41 women, 39 (7.7%) had a positive screening results for Down syndrome and 2 (0.4%) for NTDs. Thirty-two women with positive screening results for Down syndrome chose amniocentesis for chromosomal analysis, of which the results showed normal in 28 (87.5%), inv(9) in 3 (9.4%) and 48, XXY, +18 in 1 (3.1%). Although all but one of the fetuses with normal karyotypes and inv(9) were born with normal phenotypes, one pregnancy with 48, XXY, +18 was terminated due to fetal death in-utero. One of 2 pregnancies affected with NTDs was correctly identified, showing meningocele, abdominal wall defect and scoliosis. CONCLUSIONS: Our data confirm chromosome abnormalities or congenital anomalies in about 5% of the pregnancies with positive triple-marker screening results, suggesting an effective prenatal screening test. It has been found that the presence of inv(9) in fetuses might be accompanied by false-positive results for Down syndrome.