Clinical Evaluation of the GestAssured® test Kit

D
David Haas, MD

Primary Investigator

Overview

The GestAssured test is a rapid, single use, qualitative, lateral flow chromatography, in vitro diagnostic laboratory test device that detects congophilic proteins that are strongly associated with preeclampsia in urine specimens of pregnant women. The GestAssured test Kit is intended as an aid in diagnosing preeclampsia in pregnant women presenting with signs and symptoms of preeclampsia. The test kit contains the lateral flow test device (Figure 1), a fixed-volume sample applicator (pipette) and is provided with compatible Quality Control (QC) samples (supplied separately). QC samples must be run each day that a patient sample will be tested. The device is intended to be used by or under the supervision of a clinical laboratory licensed to perform CLIA moderate testing, by trained professionals.

Eligibility

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Preeclampsia
  • Age: Between 18 Years - 100 Years
  • Gender: Female

Inclusion Criteria

Pregnant women at > 20 0/7 weeks gestational age based on Estimated Date of Confinement (EDC)


Documented hypertension: a Qualifying Blood Pressure measurement defined as > or = to 140 mm Hg systolic and/or > or = to 90 mm diastolic recorded on site or by a referring healthcare facility within 4 hours of arrival on site. A blood pressure taken outside of a healthcare facility (i.e. at home) does not qualify


Presenting with one or more signs or symptoms of preeclampsia

Updated on 20 Nov 2022. Study ID: 1902765371

Interested in the study?

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