CompletedNot Applicable

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

United States250 participantsStarted 2019-05-13

Plain-language 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.

Who can participate

Age range18 Years – 65 Years

SexALL

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Inclusion criteria

✓Willingness to provide consent

Exclusion criteria

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

What they're measuring

Sensitivity of SD Biosensor POC G6PD Test for Identifying G6PD Deficient Individuals

Timeframe: All samples were collected on study day 1

Sensitivity of SD Biosensor POC G6PD Test for Identifying Women With Intermediate G6PD Activity

Timeframe: All samples were collected on study day 1

Specificity of SD Biosensor POC G6PD Test for Identifying G6PD Deficient Individuals

Timeframe: All samples were collected on study day 1

Specificity of SD Biosensor G6PD Test for Identifying Women With Intermediate G6PD Activity

Timeframe: All samples were collected on study day 1

Trial details

NCT IDNCT04010695

SponsorPATH

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-09-19

Results submitted2021-07-30

View on ClinicalTrials.gov More G6PD Deficiency trials