Finder G6Pd Test Migration to New Finder Instrument Model - Performance Evaluation Protocol
Investigating the Performance of a G6PD Test on a New Instrument
Thomas E. Davis
Primary Investigator
Brief description of study
The purpose of this study is to confirm that the FINDER G6PD Test works the same on a new version of the FINDER instrument. G6PD (glucose-6-phosphate dehydrogenase) is an enzyme that helps red blood cells function properly. When someone doesn’t have enough G6PD, it can lead to hemolytic anemia—a condition where red blood cells break down faster than the body can replace them. Because red blood cells carry oxygen, this can cause symptoms like tiredness, weakness, or shortness of breath.
Detailed description of study
Provide a small amount of blood—up to 6 milliliters (about 1.2 teaspoons) via blood draw. Two tubes will be collected.
- The blood draw will take place at a study collection site. It will only happen once and should take no more than 15 minutes.
- There are no medications, treatments, or experimental procedures involved in this study. This sample collection is for research purposes only.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Healthy
-
Age: 100 years or below
-
Gender: All
Inclusion Criteria:
• Subjects who are willing to donate a blood sample and provide informed consent to be part of the study
Exclusion Criteria:
• Subjects who have received a blood transfusion within the last 30 days
This study investigates the performance of a G6PD test on a new instrument model. G6PD, or glucose-6-phosphate dehydrogenase, is an enzyme that helps red blood cells work properly. Without enough G6PD, red blood cells can break down too quickly, a condition known as hemolytic anemia. This can cause symptoms like tiredness, weakness, or shortness of breath.
Participants will provide a small blood sample, up to 6 milliliters, collected in two tubes. The blood draw will occur once at a study site and should take about 15 minutes. There are no medications or treatments involved, as this is a research-focused sample collection.
- Who can participate: Adults willing to donate a blood sample and provide informed consent can participate. Individuals who have had a blood transfusion in the last 30 days are not eligible.
- Study details: Participants will donate a blood sample by providing up to 6 milliliters via a single blood draw. The process will take about 15 minutes and involves no medications or treatments.
- Study visits: The study requires 1 visit.
