Validation of a PrCr Dipstick Diagnostic Test in Ghana

NCT03510286 | Completed FDA Device

• 1 other identifier: 1133673-2
• Study Type: observational
• Target: 1,483
• Locations: 1 country
• Sites: 1

Brief 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

Proteinuria; Preeclampsia

Keywords

proteinuria; preeclampsia; diagnostic; dipstick; protein; urine; creatinine

Outcome Measures

Primary Outcomes (2)

• Accuracy of the PrCr dipstick test compared to a laboratory reference assay (chemistry analyzer measurement of protein and creatinine)

  The results of the PrCr dipstick test will be compared to the results of a laboratory reference assay. Sensitivity and specificity analyses will be conducted at thresholds for normal and proteinuria.

  September 20198-February 2019

• Accuracy of the PrCr dipstick test compared to a protein only dipstick.

  The results of the PrCr dipstick test will be compared to the results of the protein only test. Sensitivity and specificity analyses will be conducted at thresholds for normal and proteinuria.

  September 20198-February 2019

Study Arms (1)

Pregnant women

Pregnant women attending ANC clinics in Techiman Holy Family Hospital and Kintampo North and South districts (all hospitals and clinics inclusive where ANC services are provided) are the primary participant group- primarily women of reproductive age. Pregnant women attending routine ANC will be enrolled. In addition to routine ANC, pregnant women will be tested with the Test-it™ PrCr Urinalysis Strips. Pregnant women are a potentially vulnerable population whose participation in this research is necessary given the target use case for this diagnostic tool: providing reliable and accurate point of care screening of proteinuria in ANC settings. The legal age of consent in Ghana is 18 years and women under the age of 18 will not be recruited for this study.

Diagnostic Test: Test-it™ PrCr Urinalysis Strips

Interventions

Test-it™ PrCr Urinalysis Strips DIAGNOSTIC_TEST

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.

Pregnant women

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women attending ANC clinics in Techiman Holy Family Hospital and Kintampo North and South districts (all hospitals and clinics inclusive where ANC services are provided) are the primary participant group- primarily women of reproductive age. Pregnant women are a potentially vulnerable population whose participation in this research is necessary given the target use case for this diagnostic tool: providing reliable and accurate point of care screening of proteinuria in ANC settings. The legal age of consent in Ghana is 18 years and women under the age of 18 will not be recruited for this study.

You may qualify if:

• Pregnant woman 18 years of age or older (self-report)
• Attending a study site facility for ANC
• ANC visit is within the final 12 weeks of pregnancy (within 12 weeks or less before expected due date)
• Willing to provide written informed consent for study participation

You may not qualify if:

• ANC visit is not within the final 12 weeks of pregnancy
• Unwilling to provide written informed consent for study participation
• Pregnant woman less than 18 years of age

Sponsors & Collaborators

• PATH: lead
• Kintampo Health Research Centre, Ghana: collaborator
• United States Agency for International Development (USAID): collaborator

Study Sites (1)

Kintampo Health Research Center

Kintampo, Ghana

Location

MeSH Terms

Conditions

Proteinuria; Pre-Eclampsia; Disease

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Hypertension, Pregnancy-Induced; Pregnancy Complications; Pathologic Processes

Study Officials

• Samuel Newton, PhD

  Kintampo Health Research Centre, Ghana

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: April 27, 2018
• Study Start: September 30, 2018
• Primary Completion: July 30, 2020
• Study Completion: July 30, 2020
• Last Updated: August 26, 2020

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

GH (1)