NCT04054661

Validation of a Diagnostic Test for Glucose-6-phosphate Dehydrogenase (G6PD) Deficiency in Anti-coagulated Blood

Validation of a Diagnostic Test for Glucose-6-phosphate Dehydrogenase Deficiency: Diagnostic Accuracy and Repeatability in Capillary Samples

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 229 (actual)
• Sponsor: PATH · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The primary objective of the study is to assess the accuracy of the SD Biosensor STANDARD™ point-of-care (POC) G6PD test in measuring G6PD activity and classifying results compared to a reference assay and across repeated measurements in capillary samples.

Detailed description

Cross-sectional diagnostic accuracy study with 250 volunteer participants. The clinic will recruit and consent adult study participants. Clinic staff will draw venous blood and obtain finger stick capillary blood samples. Clinic staff will perform the investigational SD Biosensor STANDARD™ G6PD test for glucose-6-phosphate dehydrogenase (G6PD) deficiency and a HemoCue® hemoglobin test on finger stick capillary blood. An anti-coagulated venous blood sample will be sent to a Clinical Laboratory Improvement Amendments (CLIA) certified lab for G6PD reference testing by the gold standard assays: G6PD measurement by spectrophotometry using the Pointe Scientific G6PD reference assay and hemoglobin measurement by a hematology analyzer. Individuals identified as G6PD deficient or intermediate by the reference test will be notified of their results by the clinic and referred to their physician for follow-up. This study includes a nested repeatability study and a nested sample stability study. In the nested repeatability study up to 20 consented participants will provide 4 additional finger stick samples. Clinic staff will perform the SD Biosensor STANDARD™ G6PD test to assess the repeatability of the test in capillary blood over 8 G6PD and hemoglobin measurements on up to 3 different instruments. In the nested sample stability study up to 8 consented participants will provide an additional venous blood draw sample to be tested at additional time points to document stability of the samples over time when tested by the SD Biosensor STANDARD™ G6PD Test.

Conditions

• G6PD Deficiency

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	SD Biosensor STANDARD G6PD Test	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: 2019-08-12
• Primary completion: 2020-01-31
• Completion: 2020-01-31
• First posted: 2019-08-13
• Last updated: 2021-11-09
• Results posted: 2021-10-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study