NEW: SuperFlex
SuperFlex™は、出生前スクリーニング向けに開発された、化学発光免疫測定法（CLIA）を採用した全自動化学発光免疫測定用装置です。カートリッジ方式を採用し、24の検体ポジションを備え、最大60テスト/時の処理能力により、検体の連続投入に対応します。また、最短14分（測定項目により異なります。）で最初の測定結果を得ることができます。
妊娠関連バイオマーカー測定をもっと柔軟に
- 必要なタイミングで検体を処理できる柔軟な院内検査運用
- 全自動化によるシンプルなワークフロー
- 検査室やクリニックにおける迅速な結果提供をサポート
1st trimester: Specific marker for preeclampsia - PIGF
In pregnancies that develop preeclampsia, maternal serum placental growth factor (PlGF) levels decrease significantly in the first trimester. This makes it an important biomarker used to predict the onset of preeclampsia. Our high-sensitivity PlGF 1-2-3™ assay is optimized for first trimester screening of preeclampsia and is the only assay which was clinically validated by the ASPRE trial.
The same blood sample can be used for both preeclampsia and aneuploidy screening using the same instrument and markers; no additional blood sample is required.
In pregnancies that develop preeclampsia, maternal serum placental growth factor (PlGF) levels decrease significantly in the first trimester. This makes it an important biomarker used to predict the onset of preeclampsia. Our high-sensitivity PlGF 1-2-3™ assay is optimized for first trimester screening of preeclampsia and is the only assay which was clinically validated by the ASPRE trial.
The same blood sample can be used for both preeclampsia and aneuploidy screening using the same instrument and markers; no additional blood sample is required.
Combined screening model
Based on the evidence from research studies, international guidelines are recommending a combined screening program for preeclampsia at 11-13+6 weeks as the most effective way to identify women at high risk of preeclampsia in the early stages of pregnancy.
Based on the evidence from research studies, international guidelines are recommending a combined screening program for preeclampsia at 11-13+6 weeks as the most effective way to identify women at high risk of preeclampsia in the early stages of pregnancy.
The combined screening program is made up of four simple steps that require short training and minimal additional investment In equipment. Our Lifecycle™ software can generate a unique patient risk profile and report based on these combined screening markers.
- Medical history
- PlGF blood test
- Blood pressure
- Ultrasound (if available}
2nd and 3rd trimester: PIGF as a single marker or sFlt-1/PIGF ratio
Women with signs or symptoms of preeclampsia do not always develop preeclampsia. Angiogenic markers can be used to help identify women with increased risk for developing preeclampsia in the coming days.
Women with signs or symptoms of preeclampsia do not always develop preeclampsia. Angiogenic markers can be used to help identify women with increased risk for developing preeclampsia in the coming days.
After 20 weeks of pregnancy PlGF and sFlt-1 are both predictive and diagnostic for preeclampsia. Determining serum PlGF concentration, used as a single marker, or sFlt-1 and PlGF, used as a ratio, improve the clinical management and decision making (risk stratification) with women showing signs and symptoms of preeclampsia.
PlGF alone and sFlt-1/PlGF ratio have comparable performance for preeclampsia rule-in and rule-out, and both options are equally recommended for clinical use. However, PLGF alone, with concentration-based cut-offs, could provide simpler and more affordable alternative to dual biomarker testing.
Using PlGF has additional advantages. Studies have shown that PlGF is a good marker (decreased serum PlGF level) for identifying pregnancies with placental insufficiency including fetal growth restriction and/or stillbirth.
User configurable laboratory data management
Lifecycle™ software enables monitoring of preeclampsia status with PlGF concentration or the sFlt-1/PlGF ratio. The results can be linked to the patient case in Lifecycle™ software allowing the user to track samples and view all available results in one place. The assay cut-offs for preeclampsia management are user configurable and the software can be tailored to population.
Lifecycle™ software enables monitoring of preeclampsia status with PlGF concentration or the sFlt-1/PlGF ratio. The results can be linked to the patient case in Lifecycle™ software allowing the user to track samples and view all available results in one place. The assay cut-offs for preeclampsia management are user configurable and the software can be tailored to population.
Complete preeclampsia management
Our comprehensive preeclampsia solution spans the entire pregnancy journey. Beginning with first-trimester PlGF screening via our validated PlGF 1-2-3™ assay, risk assessment combines biomarker results with clinical data in our Lifecycle™ software. In later trimesters, PlGF alone or the sFlt-1/PlGF ratio provides reliable assessment for symptomatic women, with PlGF offering additional benefits for detecting placental insufficiency. Throughout pregnancy, our configurable software enables seamless monitoring and result tracking for optimal patient management
Our comprehensive preeclampsia solution spans the entire pregnancy journey. Beginning with first-trimester PlGF screening via our validated PlGF 1-2-3™ assay, risk assessment combines biomarker results with clinical data in our Lifecycle™ software. In later trimesters, PlGF alone or the sFlt-1/PlGF ratio provides reliable assessment for symptomatic women, with PlGF offering additional benefits for detecting placental insufficiency. Throughout pregnancy, our configurable software enables seamless monitoring and result tracking for optimal patient management
Explore our biochemical prenatal & preeclampsia testing applications
Featured resources
References:
Daniel L. Rolnik et al. Aspirin versus Placebo in Pregnancies at High Risk for Preterm Preeclampsia. DOI: 10.1056/NEJMoa1704559, New England J Med June 2017
Wright D et al. Aspirin for Evidence-Based Preeclampsia Prevention trial: influence of compliance on beneficial effect of aspirin in prevention of preterm preeclampsia. Am J Obstet Gynecol. 2017 Sep 6
Poon LC et al., ASPRE trial: effect of aspirin in prevention of preterm preeclampsia in subgroups of women according to their characteristics and
medical and obstetrical history. Am J Obstet Gynecol 2017
Kuklina EV, et al. Hypertensive Disorders and Severe Obstetric Morbidity in the United States. Obstet Gynecol 2009; 113:1299-306
COMPARE study: Performance of commercially available placental growth factor tests in women with suspected preterm preeclampsia, Ultrasound in Obstetric Gynecology
Herraiz et al Update on the Diagnosis and Prognosis of Preeclampsia with the Aid of the sFlt-1/PlGF Ratio in Singleton Pregnancies. Fetal Diagn Ther (2017) PROGNOSIS Hund et al. BMC Pregnancy and Childbirth 2014, 14:324
ISUOG Practice Guidelines: role of ultrasound in screening for and follow-up of preeclampsia, Ultrasound Obstet Gynecol 2018 DOI: 10.1002/uog.20105
Poon L, et al. The International Federation of Gynecology and Obstetrics (FIGO) Initiative on preeclampsia: A Pragmatic Guide for First-Trimester Screening and Prevention. International Journal of Gynegology & Obstetrics. May 2019
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