Clinical evaluation of a point-of-care spectrophotometric test for detecting G6PD deficiency
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- PATH
- 入组人数
- 1,030
- 试验地点
- 2
- 主要终点
- Estimates of diagnostic performance (positive percent agreement, negative percent agreement, positive predictive value (PPV), and negative predictive value (NPV) of the Wondfo G6PD/Hb test classification of G6PD status compared to the reference assay in venous blood.
研究概览
简要总结
This is a cross-sectional diagnostic accuracystudy with 1,000 participants and 30 health worker participants. Febrile patients will be recruited from outpatientdepartments (OPDs) of Netaji Subhash Chandra Bose (NSCB) MedicalCollege and Govt. Seth Govind Das (Victoria) District Hospital situated in the urban setting under the supervision ofstaff from the National Institute of Researchin Tribal Health (NIRTH). The health worker participants will include trainedintended users of Glucose-6-PhosphateDehydrogenase (G6PD) tests. Finger-stick blood samples will be taken to perform a standard commercialmalaria RDT to identify Plasmodium falciparum and questionnaire.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 8.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Diagnostic accuracy study -Individuals attending the health care facility -Age greater than equal to 8 years -Body temperature greater than equal 37.5â°C (axillary) or with a history of fever in the last 48 hours (self-report).
- •Willing to provide written informed consent/ written assent Usability assessment study -18 years of age or older -Considered an intended user of point-of-care G6PD deficiency test -Study staff member responsible for operation and use of the POC tests -Willing and able to provide informed consent and comply with study requirements.
排除标准
- •Diagnostic accuracy participants.
- •Considered by the on-duty doctor to be too sick to undergo recruitment.
- •Less than 8 years of age.
- •Unwilling to provide informed consent.
- •Received a blood transfusion in the past three months.
- •Children who have a LAR to provide consent other than Parents.
- •Previously participated in the same study Usability study.
结局指标
主要结局
Estimates of diagnostic performance (positive percent agreement, negative percent agreement, positive predictive value (PPV), and negative predictive value (NPV) of the Wondfo G6PD/Hb test classification of G6PD status compared to the reference assay in venous blood.
时间窗: Outcome assessments will be done at the completion of study enrollments.
Overall percentage agreement between the Wondfo G6PD/Hb test and the reference hemoglobin assay for the classification of anemia status in capillary and venous whole blood specimens.
时间窗: Outcome assessments will be done at the completion of study enrollments.
次要结局
- Diagnostic performance (positive percent agreement, negative percent agreement, PPV, & NPV) of the SD Biosensor STANDARD G6PD test classification of G6PD status compared to the reference assay.(Diagnostic performance (positive percent agreement, negative percent agreement, PPV, & NPV) of the SD Biosensor STANDARD G6PD test classification of anemia status compared to hemoglobin reference assay.)