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This evaluation will aim to generate a body of evidence that will determine performance characteristics of the current PrCr dipstick test and the feasibility of its use in target ANC settings. Data will be used to inform further product development and/or support development of an introduction framework, including the process and associated resources needed for incorporation of the PrCr test into future larger-scale demonstration studies as well as to support early product launch.
The objectives of the evaluation are as follows:
Primary objective: Assess the accuracy of the PrCr dipstick test for detection of proteinuria in representative antenatal care settings in Ghana.
Exploratory objectives:
Full description
This cross-sectional diagnostic accuracy evaluation will employ mixed methods to assess the performance of the PrCr dipstick test and to explore the operational feasibility of using this test as an alternative to the current protein-only test. These methods include:
Assess the accuracy of the PrCr test for detection of proteinuria in a representative ANC setting in Ghana.
• Detection of proteinuria using the PrCr dipstick test compared to the current standard of care and laboratory reference assay used for confirming proteinuria. Patient samples will be tested with multiple assays. The PrCr test and a protein-only dipstick (The Mission® Urinalysis Reagent Strips (Urine), will be used at the point of care. Patient samples will be transferred to KHRC laboratory using cold boxes (conditioned at 2oC - 8oC) and will be tested using a laboratory reference assay.
Understand the feasibility of integrating the use of the PrCr test into ANC services.
Explore the potential for improved ANC management of PE/E using the PrCr test in the intended ANC setting.
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1,483 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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