Korean J Lab Med.  2007 Feb;27(1):28-33. 10.3343/kjlm.2007.27.1.28.

Prenatal Serum Marker Screening in Korea: Survey Results

• Kim S
• Kim YH
• Min WK

• KMID: 1121656
• DOI: http://doi.org/10.3343/kjlm.2007.27.1.28

Abstract

BACKGROUND: Maternal serum triple marker screening has been covered by the medical insurance system in Korea since December 2004. The number of tests is on the increase, but an external quality control program and a basic survey have not been established yet. The aim of this study was to port the survey of prenatal screening tests. METHODS: Three different quality control specimens were prepared using the sera obtained from 100 women who were in the 15th to 20th week of pregnancy and visited Asan Medical Center during May 2005. We assumed that the three specimens belonged to the first day of 15 weeks, third day of 16 weeks, and second day of 19 weeks, respectively, and sent them to 10 laboratories. Nine laboratories replied to the survey. We analyzed concentrations, multiples of medians (MoMs), and risk estimates. RESULTS: The coefficients of variance of MoM were 32.1-32.6% for alpha-fetoprotein, 15.3-19.8% for unconjugated estriol, 6.3-12.5% for human chorionic gonadotropin, and 12.9-18.2% for inhibin-A. In Down syndrome risk estimation for specimen-2, six of the eight laboratories that used the triple test reported the screen positive, but two laboratories reported negative. Three of five laboratories using the quadruple test reported the screen positive, and two laboratories reported negative. In case of neural tube defect, all laboratories except one reported all specimens the screen negative. In case of Edward syndrome, all laboratories reported all specimens the screen negative. CONCLUSIONS: Since MoMs and risk estimates showed a wide variation among the participating laboratories in this survey, an external quality control and the standardization of the variables seemed warranted.

Keyword

Prenatal screening test; Survey; MoM

MeSH Terms

Biological Markers/*blood
Female
Humans
Korea
Pregnancy
Prenatal Diagnosis/*standards

Reference

References

1. Wald NJ, Cuckle HS, Densem JW, Nanchahal K, Royston P, Chard T, et al. Maternal serum screening for Down's syndrome in early pregnancy. BMJ. 1988; 297:883–7.

2. Canick JA, MacRae AR. Second trimester serum markers. Semin Perinatol. 2005; 29:203–8.

3. Van Lith JM, Pratt JJ, Beekhuis JR, Mantingh A. Second-trimester maternal serum immunoreactive inhibin as a marker for fetal Down's syndrome. Prenat Diagn. 1992; 12:801–6.

4. Screening for Down syndrome. Guide to clinical preventive services: report of the US Preventive Services Task Force. Baltimore: Williams & Wilkins;1996. p. 449–65.

5. Lance J-MR. CETS 99–4 RE. Issue concerning prenatal screening and diagnosis of Down syndrome Quebec: The Minister of Research. Science and Technology of Quebec. 2001.

6. Palomaki GE, Knight GJ, Holman MS, Haddow JE. Maternal serum alpha-fetoprotein screening for fetal Down syndrome in the United States: results of a survey. Am J Obstet Gynecol. 1990; 162:317–21.

7. D'Alton M, Cleary-Goldman J. First and second trimester evaluation of risk for fetal aneuploidy: the secondary outcomes of the FASTER Trial. Semin Perinatol. 2005; 29:240–6.

8. Wald NJ, Rodeck C, Hackshaw AK, Rudnicka A. SURUSS in perspective. Semin Perinatol. 2005; 29:225–35.

9. Wald NJ, Kennard A, Hackshaw A, McGuire A. Antenatal screening for Down's syndrome. J Med Screen. 1997; 4:181–246.

10. FBR/CAP Maternal screening FP-A. College of American Pathologists. 2006.

11. Mizejewski GJ. Fetal defect marker proficiency test mailout 9/13/04. http://www.wadsworth.org/labcert/clep/PT/fedm/fedm904critique.pdf. (Updated on October. 2004.

12. Mizejewski GJ. Fetal defect marker proficiency test mailout September 13. http://www.wadsworth.org/labcert/clep/PT/fedm/fedm-905critique.pdf. (Updated on October. 2005.

13. Mizejewski GJ. Fetal defect marker proficiency test mailout January 24. http://www.wadsworth.org/labcert/clep/PT/fedm/fedm106-critique.pdf. (Updated on March. 2006.

14. Serdar MA, Tutuncu L, Olgun A, Hasimi A, Ozgurtas T, Erbil MK. The effects of analytical factors on second trimester risk estimations. Int J Gynaecol Obstet. 2006; 93:28–32.

15. Reynolds T, Ellis A, Jones R. Down's syndrome risk estimates demonstrate considerable heterogeneity despite homogeneity of input. Ann Clin Biochem. 2004; 41:464–8.

16. Wald NJ, Hackshaw AK, George LM. Assay precision of serum alpha fetoprotein in antenatal screening for neural tube defects and Down's syndrome. J Med Screen. 2000; 7:74–7.

17. Knight GJ, Palomaki GE, Neveux LM, Fodor KK, Haddow JE. hCG and the free beta-subunit as screening tests for Down syndrome. Prenat Diagn. 1998; 18:235–45.