Comparison of three commercially available placental growth factor‐based tests in women with suspected preterm pre‐eclampsia: the COMPARE study

McCarthy, Fergus P.; Gill, Carolyn; Seed, Paul; Bramham, Kate; Chappell, Lucy C; Shennan, Andrew

doi:10.1002/uog.19051

Cited by 41 publications

(38 citation statements)

References 11 publications

(21 reference statements)

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“…We used PlGF testing, rather than the soluble fms-like tyrosine kinase 1/PlGF ratio as used in other studies 20 . Evidence has shown that the commercially available tests compare similarly in their prediction of need for delivery within 14 days; 28 we anticipate that these results would be generalisable in similar settings that use alternative PlGF assays. Other studies have assessed the detection frequency of subsequent pre-eclampsia by use of a combination of maternal factors, including mean arterial pressure, uterine artery pulsatility index, serum PlGF, and serum soluble fms-like tyrosine kinase-1 in unselected populations of women at fixed timepoints (eg, 20 weeks and 36 weeks) 29, 30.…”

Section: Discussionmentioning

confidence: 99%

Placental growth factor testing to assess women with suspected pre-eclampsia: a multicentre, pragmatic, stepped-wedge cluster-randomised controlled trial

et al. 2019

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Summary Background Previous prospective cohort studies have shown that angiogenic factors have a high diagnostic accuracy in women with suspected pre-eclampsia, but we remain uncertain of the effectiveness of these tests in a real-world setting. We therefore aimed to determine whether knowledge of the circulating concentration of placental growth factor (PlGF), an angiogenic factor, integrated with a clinical management algorithm, decreased the time for clinicians to make a diagnosis in women with suspected pre-eclampsia, and whether this approach reduced subsequent maternal or perinatal adverse outcomes. Methods We did a multicentre, pragmatic, stepped-wedge cluster-randomised controlled trial in 11 maternity units in the UK, which were each responsible for 3000–9000 deliveries per year. Women aged 18 years and older who presented with suspected pre-eclampsia between 20 weeks and 0 days of gestation and 36 weeks and 6 days of gestation, with a live, singleton fetus were invited to participate by the clinical research team. Suspected pre-eclampsia was defined as new-onset or worsening of existing hypertension, dipstick proteinuria, epigastric or right upper-quadrant pain, headache with visual disturbances, fetal growth restriction, or abnormal maternal blood tests that were suggestive of disease (such as thrombocytopenia or hepatic or renal dysfunction). Women were approached individually, they consented for study inclusion, and they were asked to give blood samples. We randomly allocated the maternity units, representing the clusters, to blocks. Blocks represented an intervention initiation time, which occurred at equally spaced 6-week intervals throughout the trial. At the start of the trial, all units had usual care (in which PlGF measurements were also taken but were concealed from clinicians and women). At the initiation time of each successive block, a site began to use the intervention (in which the circulating PlGF measurement was revealed and a clinical management algorithm was used). Enrolment of women continued for the duration of the blocks either to concealed PlGF testing, or after implementation, to revealed PlGF testing. The primary outcome was the time from presentation with suspected pre-eclampsia to documented pre-eclampsia in women enrolled in the trial who received a diagnosis of pre-eclampsia by their treating clinicians. This trial is registered with ISRCTN, number 16842031. Findings Between June 13, 2016, and Oct 27, 2017, we enrolled and assessed 1035 women with suspected pre-eclampsia. 12 (1%) women were found to be ineligible. Of the 1023 eligible women, 576 (56%) women were assigned to the intervention (revealed testing) group, and 447 (44%) women were assigned to receive usual care with additional concealed testing (concealed testing group). Three (1%) women in the revealed testing group were lost to follow-up, so 573 (99%) women in this group were included in the analyses. One (<1%) woman in the co...

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Section: Discussionmentioning

confidence: 99%

Placental growth factor testing to assess women with suspected pre-eclampsia: a multicentre, pragmatic, stepped-wedge cluster-randomised controlled trial

et al. 2019

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“…53 So we can conclude that the results of the R&D system, Roche and Thermo Fisher assays are very similar because they are standardized against each other. 54…”

Section: Discussionmentioning

confidence: 99%

Role of sFlt-1 and PlGF in the screening of small-for-gestational age neonates during pregnancy: A systematic review

et al. 2019

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Background Fetal growth restriction, i.e. the restriction of genetically predetermined growth potential due to placental dysfunction, is a major cause of neonatal morbidity and mortality. The consequences of inadequate fetal growth can be life-long, but the risks can be reduced substantially if the condition is identified prenatally. Currently, screening strategies are based on ultrasound detection of a small-for-gestational age fetus and do not take into account the underlying vascular pathology in the placenta. Measurement of maternal circulating angiogenic biomarkers placental growth factor, sFlt-1 (soluble FMS-like tyrosine kinase-1) are increasingly used in studies on fetal growth restriction as they reflect the pathophysiological process in the placenta. However, interpretation of the role of angiogenic biomarkers in prediction of fetal growth restriction is hampered by the varying design, population, timing, assay technique and cut-off values used in these studies. Methods We conducted a systematic-review in PubMed (MEDLINE), EMBASE (Ovid) and Cochrane to explore the predictive performance of maternal concentrations of placental growth factor, sFlt-1 and their ratio for fetal growth restriction and small-for-gestational age, at different gestational ages, and describe the longitudinal changes in biomarker concentrations and optimal discriminatory cut-off values. Results We included 26 studies with 2514 cases with small-for-gestational age, 27 cases of fetal growth restriction, 582 cases mixed small-for-gestational age/fetal growth restriction and 29,374 reference. The largest mean differences for the two biomarkers and their ratio were found after 26 weeks of gestational age and not in the first trimester. The ROC-AUC varied between 0.60 and 0.89 with sensitivity and specificity matching the different cut-off values or a preset false-positive rate of 10%. Conclusions Most of the studies did not make a distinction between small-for-gestational age and fetal growth restriction, and therefore the small-for-gestational age group consists of fetuses with growth restriction and fetuses that are constitutionally normal. The biomarkers can be a valuable screening tool for small-for-gestational age pregnancies, but unfortunately, there is not yet a clear cut-off value to use for screening. More research is needed to see if these biomarkers are sufficiently able to differentiate growth restriction on their own and how these biomarkers in combination with other relevant clinical and ultrasound parameters can be used in clinical routine diagnostics.

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“…In the COMPARE study, 23 equivalent clinical thresholds for PlGF rule‐out differed by 50% and the DELFIA Xpress PlGF 1‐2‐3 has a rule‐out threshold of 150 pg/ml, whereas the rule‐out threshold for the Triage PlGF test is 100 pg/ml. This illustrates that they are not identical assays, nor are they interchangeable clinically.…”

Section: Comparison Of Triage Plgf Test and Elecsys Sflt‐1/plgf Ratiomentioning

confidence: 99%

“…The two PlGF‐based tests recommended by the National Institute for Health and Care Excellence have been subject to direct comparison 23–25 . McCarthy and colleagues (2019) compared the Triage PlGF test, Elecsys sFlt‐1/PlGF ratio and the DELFIA Xpress PlGF 1‐2‐3 tests in 305 women, 62 of whom developed early‐onset pre‐eclampsia 23 . They found that the AUC were nearly identical for the Elecsys sFlt‐1/PlGF ratio and the Triage PlGF test, with that for the DELFIA Xpress PlGF 1‐2‐3 test being very similar.…”

Section: Comparison Of Triage Plgf Test and Elecsys Sflt‐1/plgf Ratiomentioning

confidence: 99%

Placental growth factor in suspected preterm pre‐eclampsia: a review of the evidence and practicalities of implementation

Hurrell

Beardmore-Gray

Duhig

et al. 2020

BJOG

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Despite extensive research, the pathophysiology and prevention of pre‐eclampsia remain elusive, diagnosis is challenging, and pre‐eclampsia remains associated with adverse maternal and perinatal outcomes. Angiogenic biomarkers, including placental growth factor (PlGF) and soluble fms‐like tyrosine kinase 1 (sFlt‐1), have been identified as valuable biomarkers for preterm pre‐eclampsia, accelerating diagnosis and reducing maternal adverse outcomes by risk stratification, with enhanced surveillance for high‐risk women. PlGF‐based testing is increasingly being implemented in clinical practice in several countries. This review provides healthcare providers with an understanding of the evidence for PlGF‐based testing and describes the practicalities and challenges to implementation. Tweetable abstract Placental growth factor in pre‐eclampsia: evidence and implementation of testing.

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Comparison of three commercially available placental growth factor‐based tests in women with suspected preterm pre‐eclampsia: the COMPARE study

Abstract: Objective

Cited by 41 publications

References 11 publications

Placental growth factor testing to assess women with suspected pre-eclampsia: a multicentre, pragmatic, stepped-wedge cluster-randomised controlled trial

Placental growth factor testing to assess women with suspected pre-eclampsia: a multicentre, pragmatic, stepped-wedge cluster-randomised controlled trial

Role of sFlt-1 and PlGF in the screening of small-for-gestational age neonates during pregnancy: A systematic review

Placental growth factor in suspected preterm pre‐eclampsia: a review of the evidence and practicalities of implementation

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