Comparison of Prenatal Risk Calculation (PRC) with PIA Fetal Database software in first-trimester screening for fetal...

Area of Science:

• Medical diagnostics
• Prenatal screening
• Genetics

Background:

• Fetal aneuploidy poses a significant risk during pregnancy.
• Accurate risk assessment is crucial for appropriate prenatal care.
• New software, Prenatal Risk Calculation (PRC), was introduced in Germany for aneuploidy risk calculation.

Purpose of the Study:

• To evaluate the test performance of the new PRC software.
• To compare PRC's performance against the established PIA Fetal Database (PIA) software.
• To assess the clinical implications of using PRC for first-trimester screening.

Main Methods:

• Retrospective analysis of 2653 singleton pregnancies with known fetal outcomes.
• Risk calculation for fetal aneuploidy using both PIA and PRC software.
• Comparison of sensitivity, false-positive rate, and positive predictive value at defined cut-offs.

Main Results:

• PRC demonstrated lower sensitivity (70.6%) and higher false-positive rates (4.1% at 1:230 cut-off) compared to PIA (76.5% sensitivity, 2.9% false-positive rate).
• Differences in test performance between PRC and PIA were statistically significant (P < 0.0001).
• At a 1:230 cut-off, PRC's positive predictive value was 9.9% versus 14.6% for PIA.

Conclusions:

• The test performance of PRC software was inferior to that of PIA software for detecting fetal aneuploidy.
• PRC's lower sensitivity and higher false-positive rate could lead to a 40% increase in unnecessary invasive procedures.
• Clinical implementation of PRC requires careful consideration due to its suboptimal performance compared to PIA.