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Validation of a PrCr Dipstick Diagnostic Test in Ghana

NCT03510286 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1483

Last updated 2020-08-26

No results posted yet for this study

Summary

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:

* Understand the feasibility of integrating the use of the PrCr test into ANC services in Ghana.
* Explore the potential for improved ANC management of PE/E using the PrCr test in intended ANC settings versus the current standard of care used for proteinuria screening, protein-only determination via a low -cost urine dipstick test.

Conditions

Interventions

DIAGNOSTIC_TEST

Test-it™ PrCr Urinalysis Strips

The LifeAssay Diagnostics prototype PrCr dipstick has been designed to provide the measurement of both protein and creatinine while retaining a very low estimated cost that is comparable to the current protein-only dipsticks at $0.06-0.10 per test. In 2015, an initial laboratory-based validation study of the prototype LAD PrCr test was used on more than 500 characterized urine samples from pregnant women. This validation study demonstrated comparable accuracy for detection of severe proteinuria of the LAD PrCr test to the much more expensive commercial POC test available for PrCr determination, the Siemens Multistix® PRO 10LS. These results were compared to laboratory-based reference standard assays for proteinuria measurement.

Sponsors & Collaborators

  • Kintampo Health Research Centre, Ghana

    collaborator OTHER

  • United States Agency for International Development (USAID)

    collaborator FED

  • PATH

    lead OTHER

Principal Investigators

  • Samuel Newton, PhD · Kintampo Health Research Centre, Ghana

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-09-30
Primary Completion
2020-07-30
Completion
2020-07-30
FDA Device
Yes

Countries

  • Ghana

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03510286 on ClinicalTrials.gov