Toward Introduction of a New Screening Test for Preeclampsia (TINSTEP)

Organization: 
PATH
Organization Location: 
Seattle, Washington

Preeclampsia (PE) is a leading cause of maternal and perinatal death, yet screening and timely treatment for the disease remain a unsolved problems in low-resource settings. A new, potentially breakthrough screening test for PE has been developed and evaluated on a limited scale and is now ready for large-scale evaluation and pre-introduction activities. The assay, based on the biomarker glycosylated fibronectin (GlyFn), predicts PE in the third trimester with sensitivity of 0.97 and specificity of 0.93. Our partner, Diabetomics, is manufacturing its rapid GlyFn strip test per ISO 13485 and expects European CE approval in 2015. PATH will collaborate with Diabetomics and Peter von Dadelszen, University of British Columbia (UBC). We propose to first perform operational evaluations with the GlyFn test in our laboratory and with users in the field, refine training materials, and then implement a prospective-cohort study led by UBC to evaluate the GlyFn test within the Community-Level Interventions for Preeclampsia (CLIP) model in Karnataka, India. Further, we will create a product-introduction strategy with key stakeholders, update the miniPIERS clinical prediction model used by CLIP if appropriate, and share results. GlyFN occurs at higher concentration in blood and is thus easier to detect than competitor biomarkers, yet offers excellent sensitivity and specificity. We believe this test, if successful, represents the best chance to introduce a simple, low-cost test for PE.

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