Software for Prenatal Down Syndrome Risk Calculation: A Comparative Study of Six Software Packages
1999; American Association for Clinical Chemistry; Volume: 45; Issue: 8 Linguagem: Inglês
10.1093/clinchem/45.8.1278
ISSN1530-8561
AutoresFrançoise Müller, Philippe Aegerter, Sandrine Ngo, Agnès Fort, Alain Beauchet, P Giraudet, Marc Dommergues,
Tópico(s)Prenatal Screening and Diagnostics
ResumoPrenatal diagnosis of Down syndrome is based on fetal karyotyping, but amniocentesis cannot be performed in all patients because of the risk of fetal loss and the cost. It, therefore, is usually applied only to high-risk (and generally older) patients. Noninvasive assays of maternal serum markers have allowed the extension of screening to mothers of all ages. α-Fetoprotein (AFP), human chorionic gonadotropin (hCG) or free β-hCG, and unconjugated estriol have been prospectively evaluated during the second trimester in large populations (1)(2)(3)(4)(5)(6)(7)(8)(9)(10)(11). Wald et al. (12) proposed an individual risk calculation for Down syndrome, combining maternal age, maternal serum markers, and gestational age, in which amniocentesis was proposed when the risk was above a cutoff leading to a 60% Down syndrome detection rate and a 5% amniocentesis rate. Software is necessary for risk calculation and should be routinely validated. To evaluate the influence of software design on risk calculation, we compared six software packages [Prenatal Interpretive Software (Maciel Inc., distributed in France by Abbott), Prisca (DPC France), DIANASoft (BioChem ImmunoSystemes France), T21 (Chiron), PrenatScreen (CIS bio international), and MultiCalc (Wallac)] in two populations: 529 control patients (ages 18–37 years) selected randomly from 90 000 patients screened in our laboratory, in accordance with the national maternal age structure of pregnant patients in France (Institut National des Statistiques et des Etudes Economiques, 1993), and all 125 Down syndrome-affected pregnancies (patient ages, 20–37 years). AFP (SFRI) and total hCG (13) were expressed in multiples of the median (MoM) for five software packages and in IU/L corresponding to the manufacturer’s MoM for the Abbott package. Gestational age was determined in 99% of cases from ultrasonographic crown-rump length. The cutoff defining the at-risk group was 1 …
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