open access

Vol 88, No 9 (2017)
Research paper
Published online: 2017-09-29
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Influence of first trimester biochemistry methodology on detection rate in screening for trisomy 21

Bartosz Czuba1, Dariusz Borowski2, Piotr Węgrzyn3, Wojciech Cnota1, Anna Kubaty4, Mirosław Wielgoś2, Krzysztof Sodowski1
DOI: 10.5603/GP.a2017.0090
·
Pubmed: 29057435
·
Ginekol Pol 2017;88(9):492-496.
Affiliations
  1. Teaching Department of Obstetrics and Gynecology in Ruda Slaska, Medical University of Silesia, Ruda Slaska, Poland
  2. 1st Department of Obstetrics and Gynecology, Medical University of Warsaw, Poland
  3. Department of Obstetrics and Perinatology, Medical University of Warsaw, Zwirki i Wigury Str 63a, 02-091 Warsaw, Poland
  4. Department of Obstetrics, Gynecology and Oncology, The Gabiel Narutowicz Hospital,, Krakow, Poland

open access

Vol 88, No 9 (2017)
ORIGINAL PAPERS Obstetrics
Published online: 2017-09-29

Abstract

Objectives: The purpose of the study was to compare detection rates (DR) of FMF-certified and non-certified biochemical tests (BC) in trisomy 21 screening at 11–13 + 6 weeks.

Material and methods: In 2267 singleton pregnancies FMF-certified doctors measured crown to rump length (CRL) and nuchal translucency (NT). Serum samples were tested for free β-hCG and the PAPP-A using 2 analysers (Delfia — Perkin Elmer and Immulite 2000 — DPC), the results were expressed in MoM values and used for computer calculation of the risk for trisomy 21. The cut-off value for the high trisomy 21 risk was 1:300.

Results: Comparison of free β-hCG MoMs by DPC and Delfia demonstrated statistically significant differences in normal, and trisomy 21 fetuses respectively. Similarly, statistically significant differences were noted for PAPP-A MoMs. The above differences in MoMs resulted in altered sensitivity in screening for aneuploidy. The application of the FMF-certified method ensures a markedly higher DR = 74%, compared to non-certified tests (64%), both at 5% FPR. The ROC analysis was performed in order to assess the efficacy of both tests. Results of trisomy 21 BC + NT risk scales using the Delfia and DPC methods are highly significant (p < 0.0001), which means that their discrimination ability is > 90%. The difference between results obtained using the Delfia and DPC methods is AUC = 0.0150 and is statistically significant (Z = 2.4728, p = 0.0134).

Conclusions: The use of FMF-certified first trimester biochemistry analysers improves DR for trisomy 21. The use of non-certified analysers causes reduction of DR and an increase of invasive procedure rate.

Abstract

Objectives: The purpose of the study was to compare detection rates (DR) of FMF-certified and non-certified biochemical tests (BC) in trisomy 21 screening at 11–13 + 6 weeks.

Material and methods: In 2267 singleton pregnancies FMF-certified doctors measured crown to rump length (CRL) and nuchal translucency (NT). Serum samples were tested for free β-hCG and the PAPP-A using 2 analysers (Delfia — Perkin Elmer and Immulite 2000 — DPC), the results were expressed in MoM values and used for computer calculation of the risk for trisomy 21. The cut-off value for the high trisomy 21 risk was 1:300.

Results: Comparison of free β-hCG MoMs by DPC and Delfia demonstrated statistically significant differences in normal, and trisomy 21 fetuses respectively. Similarly, statistically significant differences were noted for PAPP-A MoMs. The above differences in MoMs resulted in altered sensitivity in screening for aneuploidy. The application of the FMF-certified method ensures a markedly higher DR = 74%, compared to non-certified tests (64%), both at 5% FPR. The ROC analysis was performed in order to assess the efficacy of both tests. Results of trisomy 21 BC + NT risk scales using the Delfia and DPC methods are highly significant (p < 0.0001), which means that their discrimination ability is > 90%. The difference between results obtained using the Delfia and DPC methods is AUC = 0.0150 and is statistically significant (Z = 2.4728, p = 0.0134).

Conclusions: The use of FMF-certified first trimester biochemistry analysers improves DR for trisomy 21. The use of non-certified analysers causes reduction of DR and an increase of invasive procedure rate.

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Keywords

screening for chromosomal defects, 11 to 13 + 6 weeks scan, trisomy 21, first trimester biochemistry, PAPP-A, free beta-hCG

About this article
Title

Influence of first trimester biochemistry methodology on detection rate in screening for trisomy 21

Journal

Ginekologia Polska

Issue

Vol 88, No 9 (2017)

Article type

Research paper

Pages

492-496

Published online

2017-09-29

DOI

10.5603/GP.a2017.0090

Pubmed

29057435

Bibliographic record

Ginekol Pol 2017;88(9):492-496.

Keywords

screening for chromosomal defects
11 to 13 + 6 weeks scan
trisomy 21
first trimester biochemistry
PAPP-A
free beta-hCG

Authors

Bartosz Czuba
Dariusz Borowski
Piotr Węgrzyn
Wojciech Cnota
Anna Kubaty
Mirosław Wielgoś
Krzysztof Sodowski

References (10)
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  2. Nicolaides KH. A model for a new pyramid of prenatal care based on the 11 to 13 weeks' assessment. Prenat Diagn. 2011; 31(1): 3–6.
  3. Kagan KO, Cicero S, Staboulidou I, et al. Fetal nasal bone in screening for trisomies 21, 18 and 13 and Turner syndrome at 11-13 weeks of gestation. Ultrasound Obstet Gynecol. 2009; 33(3): 259–264.
  4. Kagan KO, Valencia C, Livanos P, et al. Tricuspid regurgitation in screening for trisomies 21, 18 and 13 and Turner syndrome at 11+0 to 13+6 weeks of gestation. Ultrasound Obstet Gynecol. 2009; 33(1): 18–22.
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  6. Czuba B, Cnota W, Wloch A, et al. Frontomaxillary facial angle measurement in screening for trisomy 18 at 11 + 0 to 13 + 6 weeks of pregnancy: a double-centre study. Biomed Res Int. 2013; 2013: 168302.
  7. Noble PL, Abraha HD, Snijders RJ, et al. Screening for fetal trisomy 21 in the first trimester of pregnancy: maternal serum free beta-hCG and fetal nuchal translucency thickness. Ultrasound Obstet Gynecol. 1995; 6(6): 390–395.
  8. Spencer K, Souter V, Tul N, et al. A screening program for trisomy 21 at 10-14 weeks using fetal nuchal translucency, maternal serum free beta-human chorionic gonadotropin and pregnancy-associated plasma protein-A. Ultrasound Obstet Gynecol. 1999; 13(4): 231–237.
  9. Pietryga M, Borowski D, Czekierdowski A, et al. Polish Gynecological Society Ultrasound Section Guidelines on ultrasound screening in uncomplicated pregnancy. Ginekol Pol. 2012; 83(4): 309–315.
  10. Spencer K. First trimester maternal serum screening for Down's syndrome: an evaluation of the DPC Immulite 2000 free beta-hCG and pregnancy-associated plasma protein-A assays. Ann Clin Biochem. 2005; 42(Pt 1): 30–40.

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