NCT04010695

Validation of Diagnostics to Identify Glucose-6-phosphate Dehydrogenase Activity in the US

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 250 (actual)
• Sponsor: PATH · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The primary objective of this study is to assess the accuracy of the SD Biosensor STANDARD G6PD Analyzer in measuring G6PD activity when used by trained health care workers.

Detailed description

This is a cross-sectional diagnostic accuracy study with up to 250 participants with a goal of obtaining 20 deficient and 20 intermediate samples. The clinic will recruit and consent study participants. Clinic staff will draw 3 whole blood samples and obtain finger stick capillary blood. G6PD activity is reported in terms of grams of hemoglobin (Hb), hence the hemoglobin concentration must be measured. Clinic staff will perform the investigational Standard Diagnostics (SD) Biosensor point-of-care (POC) test for glucose-6-phosphate dehydrogenase (G6PD) deficiency and a HemoCue® hemoglobin test on finger stick capillary blood and on the venous blood samples. Another venous blood sample will be sent to a clinical laboratory improvement amendments (CLIA)-certified laboratory for reference testing by the gold standard assays: * G6PD measurement by spectrophotometry using the Pointe Scientific G6PD reference assay * hemoglobin measurement by a hematology analyzer Individuals identified as G6PD deficient with the reference test will be notified of their results by the clinic and referred to their physician for follow-up.

Conditions

• G6PD Deficiency

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	SD Biosensor G6PD Analyzer	The SD Biosensor G6PD Analyzer is designed to measure the quantitative determination of total hemoglobin concentration and G6PD enzymatic activity in fresh human whole blood specimens based on reflectometry assays in a point-of-care setting. The test is intended to aid in the identification of people with G6PD deficiency. The test is currently not licensed for use in the US and is considered an investigational product.
DIAGNOSTIC_TEST	Pointe Scientific Test Kit	The Pointe Scientific test kit will serve as the reference assay to assess G6PD activity. Its intended use is for the quantitative, kinetic determination of G6PD in blood at 340 nm.
DIAGNOSTIC_TEST	HemoCue System	The HemoCue hemoglobin (Hb) 201+ system is designed for quantitative point-of-care whole blood hemoglobin determination in primary care using a specially designed analyzer, the HemoCue Hb 201+ Analyzer, and specially designed microcuvettes, the HemoCue Hb 201+Microcuvettes.

Timeline

• Start date: 2019-05-13
• Primary completion: 2019-09-19
• Completion: 2019-09-19
• First posted: 2019-07-08
• Last updated: 2022-05-10
• Results posted: 2021-08-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study