Abstract

To evaluate individual PAPP-A and β-hCG median MoM values as a possible audit for the quality of CRL measurement, using data from a national first trimester screening database. Calculation of operator specific PAPP-A and β-hCG MoM values from a national database including all women undergoing first trimester screening and risk calculation in Denmark in the period 2008–2010. All scans were performed by an FMF-certified operator, with a unique ID number. We restricted our analysis to singleton pregnancies where the gestational age at the time of blood sample was between 10 + 0 and 13 + 6 weeks: in 2008, 28664; in 2009, 27230; in 2010, 26230. Data were collected prospectively in the local Astraia database and automatically sent to the national database. Existing models were used to produce MoM values for PAPP-A and β-hCG specific to gestational age, maternal weight, ethnicity, smoking status, mode of conception and laboratory analyzer. For each operator, biases in PAPP-A and β-hCG MoM values were transformed into a bias in CRL measurement. The method was validated using simulated data with known CRL bias. Of those operators performing 10 or more scans, 98% showed CRL bias within ± 5 mm. 70% were within ± 2 mm. These accounted for 99.7% and 77.8%, resp., of all scans. Precision of the CRL measurement appears to increase with increasing number of scans, indicating a learning curve for CRL measurement. However, some very experienced operators showed biases indicating a systematic measurement error. These data indicate that operator-specific median PAPP-A and β-hCG MoM-values are a promising candidate as an audit parameter for CRL measurements in first trimester risk assessment. We have developed a graphical tool that could be incorporated into fetal medicine risk calculation software.

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