Correlation of G6PD Activity Across Different Sample Sources, and Different G6PD Testing Platforms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- PATH
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Correlation of capillary and venous blood results using Trinity quantitative G6PD test
研究概览
简要总结
In this study we propose to determine the correlation in glucose-6phosphate dehydrogenase enzyme activity in capillary blood obtained from a finger stick versus a venous blood specimen. As secondary endpoints we will seek to correlate phenotype as determined by quantitative and qualitative G6PD test, genotype as determined by PCR and DNA sequencing with flow cytometry. The secondary endpoints are critical for the design of G6PD diagnostic test evaluation studies.
详细描述
In this study we propose to determine the correlation in glucose-6 phosphate dehydrogenase enzyme activity in capillary blood obtained from a finger stick versus a venous blood specimen. We will also compare results of different G6PD tests with known G6PD genetic profiles. The results of the study will inform design of future G6PD diagnostic development & evaluations. This research will be conducted in MaeSot Thailand, where G6PD deficiency has a high prevalence. Study participants will be recruited into three groups of 50 volunteers per group: 50 G6PD-deficient individuals, 50 G6PD-normal individuals, and 50 G6PD-intermediate individuals. Following a written informed consent, participants will donate about 3 ml of venous blood and about 4 drops of capillary blood (fingerstick). There will be no direct benefit to research participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Previous G6PD test at SMRU clinic
- •Patient willing to participate and sign informed consent form
- •Patient willing to allow donated sample to be used in future research
- •Subjects 18 years of age or older
排除标准
- •patients with severe malaria or other severe illness
- •Patients who received a blood transfusion in the last 3 months
- •Patients who received primaquine in the past 1 month (this is to ensure that previous characterization of phenotype in the healthy subject has not been influenced by a recent hemolytic reaction)
研究组 & 干预措施
G6PD Testing
All subjects receive G6PD test
干预措施: G6PD Test (Other)
结局指标
主要结局
Correlation of capillary and venous blood results using Trinity quantitative G6PD test
时间窗: Six months
Comparison of the performance of the Trinity quantitative test using capillary blood, vs the performance of the same test using venous blood.
次要结局
- Association between flow cytometry-based test and sample genotype(Six months)
- Concordance between a qualitative G6PD test and the spectrophotometric gold standard(Six months)
- Categorical accuracy of qualitative G6PD test against spectrophotometric gold standard(six months)
- Concordance between a flow cytometry-based G6PD test and the spectrophotometric gold standard(six months)
- Categorical accuracy of a flow cytometry-based G6PD test against the spectrophotometric gold standard and genotyping(six months)