1 – Program overview

This external quality assessment program evaluates the accuracy of maternal serum marker results for fetal Down’s syndrome. The assessment focuses on the results of the assays in concentration units and MoM, as well as risk classification for the first and second trimesters of pregnancy. Demographic data are provided with each control sample to enable the configuration of fetal Down’s syndrome risk calculation software.

Participating labs can choose to be assessed for all the analytes of this program, or simply a subset of analytes of interest.

2 – Assessment frequency

Number of surveys per year: 4
Number of control samples per survey: 1 or 2
Number of samples per year: 6

3 – List of analytes assessed 

• AFP (kIU/L and MoM)
• Estriol (nmol/L and MoM)
• Total hCG (IU/L and MoM)
• Free beta hCG (IU/L and MoM)
• PAPP-A (mIU/L and MoM)
• Risk for the 1st trimester screening
• Risk for the 2nd trimester screening
• Out-of-time risk*
• 1st trimester risk classification
• 2nd trimester risk classification
• Out-of-time risk classification*

4 – Description of the control samples

Lyophilised human control serum (samples to be resuspended in 1 mL of distilled water).

5 – Demographic data

Each sample is accompanied by demographic data to support the calculation of fetal Down’s syndrome risk.