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 range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

Willingness to provide consent

Exclusion criteria

Blood transfusion in the past 90 days by self-report

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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