Placental growth factor (alone or in combination with soluble fms-like tyrosine kinase 1) as an aid to the assessment of women with suspected pre-eclampsia: systematic review and economic analysis

Abstract

growth factor (alone or in combination with soluble fms-like tyrosine kinase 1) as an aid to the assessment of women with suspected pre-eclampsia: systematic review and economic analysis. Health Technol Assess 2016;20(87).Health Technology Assessment is indexed and abstracted in Index Medicus/MEDLINE, Excerpta Medica/EMBASE, Science Citation Index Expanded (SciSearch ® ) and Current Contents ® / Clinical Medicine. This journal is a member of and subscribes to the principles of the Committee on Publication Ethics (COPE) (www.publicationethics.org/). Health Technology Assessment NICE TAR and DAREditorial contact: nihredit@southampton.ac.ukThe full HTA archive is freely available to view online at www.journalslibrary.nihr.ac.uk/hta. Print-on-demand copies can be purchased from the report pages of the NIHR Journals Library website: www.journalslibrary.nihr.ac.uk Criteria for inclusion in the Health Technology Assessment journalReports are published in Health Technology Assessment (HTA) if (1) they have resulted from work for the HTA programme, and (2) they are of a sufficiently high scientific quality as assessed by the reviewers and editors.Reviews in Health Technology Assessment are termed 'systematic' when the account of the search appraisal and synthesis methods (to minimise biases and random errors) would, in theory, permit the replication of the review by others. HTA programmeThe HTA programme, part of the National Institute for Health Research (NIHR), was set up in 1993. It produces high-quality research information on the effectiveness, costs and broader impact of health technologies for those who use, manage and provide care in the NHS. 'Health technologies' are broadly defined as all interventions used to promote health, prevent and treat disease, and improve rehabilitation and long-term care.The journal is indexed in NHS Evidence via its abstracts included in MEDLINE and its Technology Assessment Reports inform National Institute for Health and Care Excellence (NICE) guidance. HTA research is also an important source of evidence for National Screening Committee (NSC) policy decisions.For more information about the HTA programme please visit the website: http://www.nets.nihr.ac.uk/programmes/hta This reportThe research reported in this issue of the journal was commissioned and funded by the HTA programme on behalf of NICE as project number 14/69/05. The protocol was agreed in March 2015. The assessment report began editorial review in September 2015 and was accepted for publication in June 2016. The authors have been wholly responsible for all data collection, analysis and interpretation, and for writing up their work. The HTA editors and publisher have tried to ensure the accuracy of the authors' report and would like to thank the reviewers for their constructive comments on the draft document. However, they do not accept liability for damages or losses arising from material published in this report.This report presents independent research funded by the National Institute for Health Research (NIHR). The ...

Point-of-care diagnostics to improve maternal and neonatal health in low-resource settings

“…Sensitivity and specificity of the Alere Triage PlGF test vary depending on the cutoff value used; between 20 and 34 weeks of gestation, the test has a 96% sensitivity and 56% specificity for pre-eclampsia using a cutoff value of <100 pg/mL and a 63% sensitivity and 90% specificity using a cutoff value of <12 pg/mL. 185 When gestational age is known, a cutoff of <5 th percentile for normal gestational-age dependent range improves test performance with 100% sensitivity and 96% specificity for early onset pre-eclampsia and 77% sensitivity and 95% specificity for all gestational ages. 186 However, with all cutoff values, sensitivity dramatically decreases after week 34 of gestation.…”

“…186 However, with all cutoff values, sensitivity dramatically decreases after week 34 of gestation. 185 …”

“…At a ratio of 23, the test has a 92% sensitivity and 81% specificity, while at a ratio of 85, the test has a 56% sensitivity and 97% specificity. 185 Two additional tests have been developed, the DELFIA Xpress PlGF 1-2-3 test (PerkinElmer), which quantitatively measures PlGF levels in serum samples using a solid-phase, two-site fluoroimmunometric sandwich assay, and the BRAHMS sFlt-1 Kryptor/BRAHMS PlGF plus Kryptor PE ratio test (Thermo Fisher Scientific GmbH) which detects sFLT-1/PlGF ratio with two immunofluorescent sandwich assays. 183,185,187 However, both of the latter tests must be validated in a clinical setting to determine sensitivity and specificity for pre-eclampsia diagnosis.…”

“…183,185,187 However, both of the latter tests must be validated in a clinical setting to determine sensitivity and specificity for pre-eclampsia diagnosis. 185 …”

“…The tests discussed above, including the Triage PlGF (Alere Inc), Elecsys sFlt1/PlGF (Roche Diagnostics Limited), and the DELFIA Xpress PIGF 1-2-3 (PerkinElmer), all have high per-test costs (>$40). 185 Additionally, the clinically relevant detection ranges of PlGF (pg/mL) and sFlt-1 (ng/mL) are currently not detectable by tests appropriate for low resource settings such as LFAs. Recent innovations in developing a paper-based ELISA platform have demonstrated limits of protein detection at 100 pg/mL, 83 which could be applied for detection of these protein targets.…”