National Institute for Health and Clinical Excellence (NICE)
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NICE draft guidance recommends new tests to help rule-out pregnancy complication and avoid unnecessary hospital admissions

In further draft diagnostics guidance published yesterday following consultation on a previous draft, NICE has recommended the Triage PlGF test (Alere International) and the Elecsys immunoassay sFlt-1/PlGF ratio (Roche Diagnostics), used together with clinical judgement, to help rule-out pre-eclampsia in women between their 20th and 35th week of pregnancy.

Pre-eclampsia is a potentially serious complication of pregnancy caused when the placenta doesn’t develop properly, because of a reduced blood supply . It is characterised by high blood pressure (hypertension) and the presence of protein in the urine (proteinuria). The presence of either hypertension or proteinuria during pregnancy can also indicate a risk of developing pre-eclampsia.

If it’s not treated, there is a risk that the mother can develop potentially life-threatening fits called eclampsia.

Pre-eclampsia can lead to liver, kidney and lung failure, problems with blood clotting and stroke. It is also thought that women who develop pre-eclampsia during pregnancy may have a greater risk of cardiovascular disease later in life. Hypertension and pre-eclampsia can affect the fetus, increasing the risk of its growth slowing or stopping, premature birth, or stillbirth.

The only cure for pre-eclampsia is to deliver the baby; the decision on when to deliver is based on clinical symptoms which indicate risk to the mother or baby, rather than the presence of pre-eclampsia alone.

The Triage PlGF test and the Elecsys immunoassay sFlt-1/PlGF ratio measure levels of placental growth factor (PlGF) in the blood. PlGF is a protein involved in the development of new blood vessels in the placenta. In pre-eclampsia levels of PlGF can be abnormally low. In normal pregnancy, PlGF levels rise and peak at 26 to 30 weeks, so when PlGF levels do not rise during pregnancy this may be an indicator that the placenta is not developing properly.

The Elecsys immunoassay sFlt-1/PlGF ratio also measures soluble FMS-like tyrosine kinase-1 (sFlt-1), a protein which is thought to disable proteins associated with blood vessel formation, such as PlGF. In women who develop pre-eclampsia, the levels of sFlt-1 are thought to be higher than those seen in normal pregnancy.

Mirella Marlow, programme director at NICE, said: “Until now there have been no tests which can be used to confidently rule-out pre-eclampsia. This has meant pregnant women with suspected pre-eclampsia often need increased monitoring or admission to hospital, which can be inconvenient and can cause anxiety.

“The previous draft guidance concluded that there was insufficient evidence to recommend the routine adoption of the Triage PIGF test and the Elecsys immunoassay sFlt-1/PIGF ratio. This was on the basis that the interpretation of positive test results to diagnose (rule-in) pre-eclampsia is more difficult than for ruling it out, and that there was a lack of evidence in this area. Previously, the Committee felt that although PlGF-based tests could be used to safely rule-out pre-eclampsia in women presenting with suspected pre-eclampsia, if a PlGF result was positive for rule-in of pre-eclampsia great emphasis may be placed on this result, rather than clinical assessment. This could result in the unnecessary early delivery of the baby.  

“However, following public consultation, the draft recommendations now provisionally recommend using these tests to rule-out pre-eclampsia.  In making this decision, the Committee emphasised the importance of clarity of laboratory reporting on PlGF-based tests. This should include explaining to clinicians that a positive test result when using PlGF testing to rule-out pre-eclampsia, does not mean that pre-eclampsia should be diagnosed (ruled-in). The Committee concluded that careful laboratory reporting of PlGF-based test results combined with targeted medical education is important and should prevent situations in which results of a test designed to make a rule-out decision start to be used to make a diagnosis.”

The draft diagnostics guidance recommends further research is carried out on using these tests in women with suspected pre-eclampsia to diagnose pre-eclampsia.

Two further tests were considered as part of this assessment. The draft guidance does not recommend the DELFIA Xpress PlGF 1-2-3 test (Perkin Elmer) and BRAHMS sFlt-1 Kryptor / BRAHMS PlGF plus Kryptor PE ratio (Thermo Fisher Scientific) for routine adoption in the NHS. Further evidence to show the clinical effectiveness of these tests including diagnostic accuracy and analytical validity is needed.

For more information call the NICE press office on 0300 323 0142/pressoffice@nice.org.uk or out of hours on 07775 583 813.

Notes to Editors

  1. The draft diagnostics guidance on tests to aid the assessment of suspected pre-eclampsia is available on the NICE website. The closing date for comments on the draft guidance is 11 January 2016.
  2. NICE guideline on antenatal care (2008; CG62) recommends measuring blood pressure and testing urine for proteinuria to screen for pre-eclampsia at each routine antennal visit.
  3. The NICE pathway on pre-eclampsia describes the assessment and treatment of women at risk of pre-eclampsia or with pre-eclampsia. The NICE guideline on hypertension in pregnancy was used to create the pathway (2010; CG107).

About the NICE Diagnostics Assessment Programme 
 

  1. For further information about the NICE diagnostics assessment programme see Developing NICE diagnostic technologies guidance  
  2. Topics to be considered by the Programme are routed through the related Medical Technologies Evaluation Programme. Further information about this can be found at Developing NICE medical technologies guidance

About NICE

The National Institute for Health and Care Excellence (NICE) is the independent body responsible for driving improvement and excellence in the health and social care system. We develop guidance, standards and information on high-quality health and social care. We also advise on ways to promote healthy living and prevent ill health.

Our aim is to help practitioners deliver the best possible care and give people the most effective treatments, which are based on the most up-to-date evidence and provide value for money, in order to reduce inequalities and variation.

Our products and resources are produced for the NHS, local authorities, care providers, charities, and anyone who has a responsibility for commissioning or providing healthcare, public health or social care services.

To find out more about what we do, visit our website:www.nice.org.uk and follow us on Twitter: @NICEComms.

 

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