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The Programme aims to assess the performance of organisations utilising biochemical markers to aid in the diagnosis of pre-eclampsia in pregnancy. The NICE guideline on hypertension in pregnancy defines pre eclampsia as new hypertension with significant proteinuria after 20 weeks’ gestation. Biochemical Markers for pre-eclampsia include, Placental growth factor, (PlGF) used on its own, or as a ratio to Soluble fms-like tyrosine kinase-1 (sFlt-1 or sVEGFR-1) i.e sFlt-1 / PIGF ratio.
1.1 The Triage PlGF test and the Elecsys immunoassay sFlt 1/PlGF ratio, used with standard clinical assessment and subsequent clinical follow-up, are recommended to help rule out pre eclampsia in women presenting with suspected pre eclampsia between 20 weeks and 34 weeks plus 6 days of gestation.
When pre eclampsia is not ruled out using a PlGF based test result, the result should not be used to diagnose (rule in) pre eclampsia (see text box).
1.2 The Triage PlGF test and the Elecsys immunoassay sFlt 1/PlGF ratio, used with standard clinical assessment and subsequent clinical follow-up, show promise in helping to diagnose (rule in) pre eclampsia in women presenting with suspected pre eclampsia between 20 weeks and 34 weeks plus 6 days of gestation. However, there is currently insufficient evidence to recommend their routine adoption for diagnosing pre eclampsia in the NHS. Further research is recommended on using these tests in women with suspected pre eclampsia to rule in pre eclampsia.135
The programme aim is to cover the clinically relevant range, i.e. PlGF < 12 pg/ml to ≥100 pg/ml and sFlt 1/PlGF ratio of < 33 to > 110. However, the analytical measuring range will also be assessed where appropriate. The programme is suitable for both Laboratory and POCT applications.
Three liquid human serum samples are distributed monthly, with a minimum of 36 samples distributed over the year covering a wide clinically relevant range. The samples consist of endogenous samples from patients along with a panel of linearly related samples produced from donations from healthy volunteers spiked with PlGF and sFlt-1. They are distributed on a number of occasions over that period which allows for the assessment of the organisation’s and method’s performance, including linearity, bias, within and between batch imprecision.
Post – analytical interpretation of pre-eclampsia risk outcome is also assessed.
|Analyte||Approx. Range Covered|
|sFlt-1||60 - 10,000||pg/mL|
|PIGF||<12 - 900||pg/mL|
|sFlt-1/PlGF Ratio||0 - 700|
|Pre-Eclampsia Risk||Qualitative Interpretation:
Unlikely / Elevated Risk / Very high Risk