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 (see text box). Further research is recommended on using these tests in women with suspected pre‑eclampsia to rule‑in pre‑eclampsia (see section 6.2).
1.3 The DELFIA Xpress PlGF 1‑2‑3 test and BRAHMS sFlt‑1 Kryptor/BRAHMS PlGF plus Kryptor PE ratio are not recommended for routine adoption in the NHS. Further research by the companies is needed to show the clinical effectiveness of these tests, including diagnostic accuracy and analytical validity.
This guidance only considers using PlGF‑based testing to help diagnose suspected pre‑eclampsia. NICE is aware of ongoing research linking low PlGF levels and high sFlt‑1/PlGF ratios (positive test results) with placental disease, but placental disease is beyond the scope of this guidance. Therefore, the recommendations in this guidance do not consider using PlGF‑based testing for conditions other than suspected pre‑eclampsia and this guidance is not intended to give advice on diagnosing or managing placental disease. If placental disease is suspected, additional clinical surveillance may be needed (see section 5.10).