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AIDING THE CLINICAL MANAGEMENT OF SUSPECTED PRE-ECLAMPSIA
Pre-eclampsia is a complex clinical syndrome that can progress rapidly and unpredictably
Pre-eclampsia is a multisystem hypertensive disorder of pregnancy that affects approximately 3% of all pregnancies.1 Current methods for diagnosing pre-eclampsia and assessing risk include measurement of maternal blood pressure, identifying the presence of protein in the urine and laboratory blood testing to detect maternal organ damage. These methods are generally poor in detecting the onset of pre-eclampsia and in determining a woman’s level of risk for deterioration of pre-eclampsia requiring timely delivery.
Clinical teams have a high degree of suspicion for the disease and a low threshold to admit pregnant women for expectant management and delivery. Current tests make it difficult to accurately identify pre-eclampsia, and assess disease severity, leading to frequent and costly clinical assessments. There is a need for a more sensitive and specific biomarker to aid in differentiating those women who will require timely delivery for pre-eclampsia from the majority of women who will deliver at term.
Only 38% of women had both hypertension and proteinuria before eclampsia2,3
The cause of the preterm pre-eclampsia originates in the placenta4
Placentation occurs from about weeks 6 to 18 of pregnancy and involves remodeling of the uterine spiral arteries, which supply the blood flow to the placenta.
In preterm pre-eclampsia, remodeling of the spiral arteries partially fails, leading to a supply-demand problem as the fetus grows.
Spiral artery remodeling is mediated by angiogenic growth factors: vascular endothelial growth factor (VEGF) and placental growth factor (PlGF).
Maternal circulating PlGF level is abnormally low in women with preterm pre-eclampsia
PlGF is a sensitive and specific marker of failed placentation and its complications, including pre-eclampsia. In women with signs and symptoms of pre-eclampsia occurring after 20 weeks and before 35 weeks’ gestation, PlGF measured at the first presentation is predictive of the development of pre-eclampsia, with the lowest levels found in women at highest risk of an adverse pregnancy outcome.6
Abnormally low levels of maternal circulating PlGF at the first presentation are suggestive of the presence of placental dysfunction and are predictive of the development of pre-eclampsia and its complications.
PlGF measurement may be used in the assessment of women presenting with uncertain or unconfirmed pre-eclampsia after 20 weeks and before 35 weeks’ gestation. For example, when a woman first presents with one or more of the signs & symptoms.
Signs & symptoms
- New hypertension
- Reduced fetal growth
- Upper right quadrant pain
- New proteinuria
- Severe headache
- Changes in vision or sudden weight gain
Introducing Quidel Triage PLGF
The Quidel Triage PLGF Test is a rapid, quantitative fluorescence immunoassay, used with the Quidel Triage Meter. The test is used to measure maternal circulating PlGF in EDTA anticoagulated plasma specimens.
Key features
Highly specific for PlGF isoform-1
Results available in approximately 15 minutes
Measurable range: 12-3,000 pg/mL
Requires 250 μL of EDTA plasma from maternal blood
Runs on the Quidel Triage Meter
Can be used in the laboratory and/or near patient setting
Intended use
The Quidel Triage PLGF Test is used in conjunction with other clinical information as an aid in the diagnosis of preterm pre-eclampsia and as an aid in the prognosis of delivery, in women presenting with signs & symptoms of pre-eclampsia after 20 weeks and prior to 35 weeks of gestation.7
Interpreting test results
Prognosis
Highly Abnormal
Highly abnormal and suggestive of patients with severe placental dysfunction and at increased risk for preterm delivery with pre-eclampsia.
Abnormal
Abnormal and suggestive of patients with placental dysfunction and at increased risk for preterm delivery with pre-eclampsia.
Normal
Normal and suggestive of patients without placental dysfunction and unlikely to progress to delivery with pre-eclampsia within 14 days of the test.
Diagnostic accuracy
A prospective observational cohort study (the PELICAN study), conducted in the United Kingdom and Ireland among 625 women, demonstrated that PlGF measured at first presentation accurately diagnoses pre-eclampsia delivering in 14 days in a sub-group of 287 women presenting with suspected pre-eclampsia after 20 weeks and before 35 weeks’ gestation.8 Sensitivity and specificity of PlGF with a cutoff of 100 pg/mL for a diagnosis of pre-eclampsia delivering within 14 days was 96.1% (73 of 76) and 55.9% (118 of 211), respectively, with an NPV of 97.5% (118 out of 121 women with PlGF ≥100 pg/mL did not have pre-eclampsia needing delivery in 14 days).
Prediction of delivery within 14 days for pre-eclampsia in women presenting with suspected pre-eclampsia after 20 weeks and before 35 weeks’ gestation for commonly used tests9
| ≥20w <35w GA | % Sens | % Spec | % PPV | % NPV | OR |
|---|---|---|---|---|---|
| PlGF <100 pg/mL | 96.1 | 55.9 | 44.0 | 97.5 | 30.87 |
| Dipstick ≥2+ | 66.7 | 81.0 | 52.6 | 88.4 | 8.50 |
| Uric acid* | 43.6 | 88.0 | 60.0 | 79.1 | 5.66 |
| SBP ≥170 mmHg | 26.7 | 86.3 | 60.0 | 79.1 | 2.22 |
| DBP ≥110 mmHg | 17.3 | 85.8 | 30.2 | 74.5 | 1.27 |
| ALT ≥32 IU/L | 11.3 | 88.7 | 28.6 | 7.14 | 1.00 |
PlGF may be a better predictor of pre-eclampsia requiring delivery within 14 days than other commonly utilised tests.
Test procedure
3 easy steps
1
Add EDTA plasma sample to test device.
2
Insert test device into the Quidel Triage Meter
3
Wait about 15 minutes and read quantitative result
PlGF may help estimate expected time to delivery
For the three discrete risk categories of PlGF Highly Abnormal (<12 pg/mL), PlGF Abnormal (≥12 <100 pg/mL) and PlGF Normal (≥100 pg/mL), there is excellent separation of time to delivery. This is observed in an analysis of all 287 women presenting with suspected pre-eclampsia after 20 weeks and before 35 weeks’ gestation, in the 136 women meeting a final diagnosis of traditional pre-eclampsia and in the sub-groups of 37 women with atypical, 32 with superimposed and 25 with mild pre-eclampsia.9
Potential to improve clinical outcome and resource utilisation
A prospective cluster-randomised stepped-wedge clinical trial (the PARROT trial), conducted in the United Kingdom among 1035 women, demonstrated that PlGF, measured on the Quidel Triage MeterPro, led to a faster diagnosis of pre-eclampsia, less maternal morbidity and better resource targeting with no evidence of a difference in perinatal adverse outcome or gestational age of delivery.10
Importantly, clinical care with PlGF testing did not lead to an increase in premature deliveries or neonatal adverse outcomes, meaning that the improved outcomes for the mothers was not at the cost of a safe outcome for the babies.
Clinical care with PlGF testing may lead to cost-savings through better targeting of out-patient clinic visits and specialist ultrasound examination.11
PlGF revealed to clinicians
PlGF concealed from clinicians
UA-PI = Umbilical Artery Pulsatility Index
Key benefits
Provides pathologically relevant information for use alongside other investigations
Accurately risk stratifies women in their first presentation with suspected pre-eclampsia
Helps reach a faster diagnosis and better resource targeting
Helps appropriately adjust clinical surveillance and, where indicated, plan for preterm delivery
May lead to less maternal morbidity without increasing perinatal adverse outcomes
Product codes
Quidel Triage PLGF Test 98800EU
Quidel Triage PLGF Control 1 98813EU
Quidel Triage PLGF Control 2 98814EU
Quidel Triage MeterPro 55071
References
1 Duley L. The global impact of pre-eclampsia and eclampsia. Semin Perinatol. 2009 Jun;33(3):130-7.
2 Douglas KA, Redman CW. Eclampsia in the United Kingdom. BMJ. 1994 Nov 26;309(6966):1395-400.
3 Knight M; UKOSS. Eclampsia in the United Kingdom 2005. BJOG. 2007 Sep;114(9):1072-8.
4 Redman CWG, Sargent IL. Pre-eclampsia, the Placenta and the Maternal Systemic Inflammatory Response—A Review. Placenta. 2003 Apr;24 Suppl A:S21-7.
5 Redman CW, Sargent IL. Latest advances in understanding preeclampsia. Science. 2005 Jun 10;308(5728):1592-4.
6 Levine RJ, et al. Circulating angiogenic factors and the risk of preeclampsia. N Engl J Med. 2004 Feb 12;350(7):672-83.
7 Quidel Triage P L GF Test Package Insert.
8 Chappell LC, et al. Diagnostic accuracy of placental growth factor in women with suspected preeclampsia: a prospective multicenter study. Circulation. 2013 Nov 5;128(19):2121-31.
9 Supplementary analysis of the PELICAN study. Data on file.
10 Duhig KE, et al; PARROT trial group. Placental growth factor testing to assess women with suspected pre-eclampsia: a multicentre, pragmatic, stepped-wedge cluster-randomised controlled trial. Lancet. 2019 May 4;393(10183):1807-1818.
11 Duhig KE, et al. Placental growth factor testing for suspected pre-eclampsia: a cost-effectiveness analysis. BJOG. 2019 Oct;126(11):1390-1398.
