Evaluating the Clinical Performance and Usability of Novel Malaria Rapid Diagnostic Tests (RDTs) for the Detection of Plasmodium Malaria Infections in Brazil
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,030
- 试验地点
- 2
- 主要终点
- Diagnostic accuracy of NxTek™ Malaria Pf Plus for the detection of P. falciparum infections
研究概览
简要总结
Prospective cross-sectional diagnostic accuracy study with 1,000 patient participants and 30 lay provider/health care worker participants. The patient participant population will be recruited at clinics. At the point of care, study staff will collect capillary blood samples and conduct malaria microscopy (both the standard of care and study specific research-grade microscopy) and two index tests: the NxTek™ Malaria P.f plus Rapid Diagnostic Test (RDT) and the NxTek™ Malaria P.f/P.v RDT. Venous blood will be collected and transferred to the laboratory where the reference PCR assay and three comparator RDTs will be run. The index RDTs will also be repeated in the laboratory. All clinical management of study participants will follow the standard of care for malaria diagnosis in Brazil and will be based on the standard microscopy result. Confirmatory testing may also be conducted, such as typing and sequencing of Plasmodium genes and antigens of interest, including but not limited to HRP2, HRP3, and pLDH as well as the human inflammatory response marker CRP.
The lay provider/health worker participants will include intended users of the index tests. They will be surveyed to assess index test usability through a questionnaire to assess label and packaging comprehension as well as results interpretation.
详细描述
Primary Objectives
1.1 To assess the sensitivity, specificity and, when applicable, positive and negative predicting values (PPV and NPV) [altogether referred to hereafter as "diagnostic accuracy"] of NxTek™ Malaria Pf Plus in intended use settings for detecting P. falciparum infections in capillary whole blood samples collected prospectively from patients with symptoms suggestive of malaria.
1.2 To assess the diagnostic accuracy of NxTek™ Malaria Pf/Pv Plus in intended use settings for detecting P. falciparum and P. vivax infections in capillary whole blood samples collected prospectively from patients with symptoms suggestive of malaria.
Secondary Objectives
2.1 To assess the diagnostic accuracy of the study comparator tests in intended use settings for detecting P. falciparum and P. vivax infections in venous whole blood samples collected prospectively from patients with symptoms suggestive of malaria.
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
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Diagnostic accuracy of NxTek™ Malaria Pf Plus for the detection of P. falciparum infections
时间窗: 5 months
1.1 Estimates of diagnostic accuracy characteristics with 95% confidence intervals (sensitivity, specificity, NPV, PPV) of NxTek™ Malaria Pf Plus for the detection of P. falciparum infections in patients with symptoms suggestive of malaria.
Diagnostic accuracy of of NxTek™ Malaria Pf/Pv Plus for the detection of P. falciparum and P.vivax infections
时间窗: 5 months
1.2 Estimates of diagnostic accuracy characteristics with 95% confidence intervals (sensitivity, specificity, NPV, PPV) of NxTek™ Malaria Pf/Pv Plus for the detection of P. falciparum and P.vivax infections in patients with symptoms suggestive of malaria.
次要结局
- Usability: label comprehension(1 week)
- Diagnostic accuracy of the index tests for the detection of P. falciparum infections with HRP2 and/or HRP3 deletions(5 months)
- Diagnostic accuracy of comparator tests for the detection of P. falciparum and, when relevant, P.vivax infections(5 months)
- Frequency of P. falciparum infections containing HRP2 and/or HRP3 mutations.(5 months)
- Usability: results interpretation(1 week)