CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 229 enrolled
Drug / intervention
SD Biosensor STANDARD G6PD Test +2 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04054661
NCT04054661N/ACompleted
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Validation of a Diagnostic Test for Glucose-6-phosphate Dehydrogenase Deficiency: Diagnostic Accuracy and Repeatability in Capillary Samples

PATH·interventional·Posted Aug 13, 2019·Updated Nov 9, 2021

In Brief

A clinical study evaluating SD Biosensor STANDARD G6PD Test, Pointe Scientific Test Kit, and 1 other intervention for G6PD Deficiency. Completed, enrolled 229 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsG6PD Deficiency
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedAug 13, 2019
Enrollment StartAug 12, 2019
Primary CompletionJan 31, 2020
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 6.9 years ago

Interventions

SD Biosensor STANDARD G6PD Testother

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.

Pointe Scientific Test Kitother

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.

HemoCue Systemother

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.