Evaluation of a Diagnostic to Identify G6PD Deficiency in Brazil
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,754
- 试验地点
- 2
- 主要终点
- Specificity of SD Biosensor STANDARD G6PD Test for Identifying Women With Intermediate G6PD Activity
研究概览
简要总结
Th objectives of this study are:
- To determine the performance of G6PD tests in detecting G6PD activity and hemoglobin (Hb) compared to a reference assay
- To assess the comprehension of the G6PD test packaging and labelling among intended users
- To assess the usability of G6PD test result outputs among intended users
详细描述
This is a cross-sectional diagnostic accuracy study that includes both participants and health worker participants.
The participant population will be recruited at clinics and through a household survey using an enriched sample of a population with known G6PD status, established through previous epidemiological studies. Clinic staff will take capillary blood samples and conduct two point of care (POC) tests: 1) HemoCue® hemoglobin test, and 2) the investigational Standard Diagnostics (SD) Biosensor STANDARD POC test for glucose-6-phosphate dehydrogenase (G6PD) deficiency. Venous blood will be collected and transferred to a laboratory where reference assays will be performed on venous samples using the Pointe Scientific G6PD Analyzer and hemoglobin tests.
The health worker participants will include trained intended users of the G6PD tests. Trained health workers will be surveyed to assess product usability through a questionnaire to assess label and packing comprehension as well as results interpretation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provides malaria case management at study facility or study site
- •Considered an intended user of quantitative POC G6PD tests
- •Trained and proficient in the use of the POC G6PD test
- •Willing to provide informed consent
排除标准
- •Does not provide malaria case management at study facility or study site
- •Not considered an intended user of quantitative POC G6PD tests
- •Not trained or not proficient in the use of the POC G6PD test
- •Unwilling to provide informed consent
结局指标
主要结局
Specificity of SD Biosensor STANDARD G6PD Test for Identifying Women With Intermediate G6PD Activity
时间窗: All samples were collected on study day 1
To investigate the performance of the SD Biosensor STANDARD G6PD test to distinguish females with intermediate G6PD activity from females with normal activity, the specificity was determined at a G6PD activity threshold of 70%. A true negative for intermediate G6PD activity in females was defined as G6PD activity \> 70% of normal in circulating venous blood as determined by the Pointe Scientific test. Specificity is the percentage of participants who tested negative for G6PD deficiency on the reference test who were identified as negative using the test assay, calculated as: Number of participants who were both test and true negative / (Number of participants who were test and true negative + Number of participants who were test positive but true negative \[ie false positive\]) \* 100%. Specificity of the SD Biosensor STANDARD G6PD test was calculated from both venous and capillary blood samples.
Specificity of SD Biosensor STANDARD G6PD Test for Identifying G6PD Deficient Individuals
时间窗: All samples were collected on study day 1
For the purposes of this study, an individual was considered G6PD deficient if they tested positive by the Pointe Scientific assay. A true negative was defined as \> 30% of normal G6PD activity in circulating venous blood as determined by the Pointe Scientific test. Specificity is the percentage of participants who tested negative for G6PD deficiency on the reference test who were identified as negative using the test assay, calculated as: Number of participants who were both test and true negative / (Number of participants who were test and true negative + Number of participants who were test positive but true negative \[ie false positive\]) \* 100%. Specificity of the SD Biosensor STANDARD G6PD test was calculated from both venous and capillary blood samples.
Sensitivity of SD Biosensor STANDARD G6PD Test for Identifying Women With Intermediate G6PD Activity
时间窗: All samples were collected on study day 1
To investigate the performance of the SD Biosensor STANDARD G6PD test to distinguish females with intermediate G6PD activity from females with normal activity, assay sensitivity was determined at a G6PD activity threshold of 70%. A true positive for intermediate G6PD activity in females was defined as G6PD activity between 30 and 70% of normal in circulating venous blood as determined by the Pointe Scientific test. Sensitivity of the SD Biosensor STANDARD G6PD test is the percentage of women who tested positive for intermediate G6PD activity on the reference test who were identified by the test assay as positive, calculated as: Number of women who were both test and true positive / (Number of women who were test and true positive + Number of women who were test negative but true positive \[ie false negative\]) \* 100%. Sensitivity of the SD Biosensor STANDARD G6PD test for identifying females with intermediate G6PD activity was calculated from both venous and capillary blood samples.
Sensitivity of SD Biosensor STANDARD G6PD Test for Identifying G6PD Deficient Individuals
时间窗: All samples were collected on study day 1
For the purposes of this study, an individual was considered G6PD deficient if they tested positive in the Pointe Scientific assay. A true positive was defined as a participant with ≤ 30% of normal G6PD activity in circulating venous blood determined by the Pointe Scientific test. Diagnostic sensitivity of the SD Biosensor STANDARD G6PD test is defined as the percentage of participants who tested positive for G6PD deficiency on the reference test who were identified by the test assay as positive, calculated as: Number of participants who were both test and true positive / (Number of participants who were test and true positive + Number of participants who were test negative but true positive \[ie false negative\]) \* 100%. Sensitivity of the SD Biosensor STANDARD G6PD test was calculated from both venous and capillary blood samples.
次要结局
- Accuracy Between the SD Biosensor STANDARD G6PD Test Measure of Hemoglobin and the Hemoglobin Measured in a Complete Blood Count(All samples were collected on study day 1)
- Accuracy Between the SD Biosensor STANDARD G6PD Test Assay and the Pointe Scientific Test Kit(All samples were collected on study day 1)
- Median G6PD Values Measured by the SD Biosensor STANDARD G6PD Test for Venous and Capillary Blood Samples(All samples were collected on study day 1)
- Accuracy Between the SD Biosensor STANDARD G6PD Test Measure of Hemoglobin and the Reference HemoCue Hemoglobin Test(All samples were collected on study day 1)
- Number of Participants Who Met Acceptance Criteria for Label Comprehension(Day 1)
- Number of Participants Who Met Acceptance Criteria for Accurate Results Interpretation(Day 1)