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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

229 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-12

Study Completion Date

2020-01-31

Brief Summary

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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

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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

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G6PD Deficiency

Keywords

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G6PD Deficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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G6PD Diagnostic Testing

Participants provided whole blood samples as well as fingerstick capillary blood samples.

At the clinic site lab, study staff conducted the SD Biosensor STANDARD point-of-care G6PD test and the point-of-care HemoCue hemoglobin test on both finger stick blood and whole blood samples.

At the reference laboratory, G6PD activity was measured from whole blood samples using the Pointe Scientific G6PD reference assay and hemoglobin was measured using a hematology analyzer.

Group Type OTHER