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

PATH

Status: Completed

Conditions: G6PD Deficiency

Treatments: Diagnostic Test: HemoCue System; Diagnostic Test: SD Biosensor G6PD Analyzer; Diagnostic Test: Pointe Scientific Test Kit

Study type: Interventional

Funder types: Other

Identifiers

NCT04010695

G6PD Validation Seattle

Details and patient eligibility

About

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.

Full 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.

Enrollment: 250 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

-Willingness to provide consent

Exclusion criteria

-Blood transfusion in the past 90 days by self-report

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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250 participants in 1 patient group

G6PD Diagnostic Testing

Other group

Description:

Participants provided whole blood samples as well as fingerstick capillary blood samples. At the clinic site lab, study staff conducted the SD Biosensor point-of-care G6PD test and the point-of-care HemoCue Hb 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.

Treatment:

Diagnostic Test: SD Biosensor G6PD Analyzer

Diagnostic Test: Pointe Scientific Test Kit

Diagnostic Test: HemoCue System