1 – Program overview

Assessment of accuracy – quantitative methods.

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 serums (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 Trisomy 21 risk.