Saliva-based COVID-19 DNA Aptamer Test: Formative Usability and Internal Validation Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Patient subjective elements
研究概览
简要总结
This study aims to conduct formative usability and internal validation of the COVID-19 rapid diagnostic test tool based on DNA aptamers, involving 200 patients to assess aspects of experimental setup, testing center, testing kit configuration, designing algorithms or workflows for clinical trials, and also assess initial accuracy by validating with the patient's PCR test results.
详细描述
RT-PCR has several limitations that need to be considered in its role as a COVID-19 diagnostic modality, especially in areas with limited health infrastructure. Potential diagnostic tests are needed that are capable of detecting results that are fast to read, can be carried out in service locations with limited infrastructure, and have high accuracy. The DNA Aptamers-based diagnostic test has the potential to meet these criteria, as it allows the detection of infection quickly and without invasive procedures, where the examination is only on a person's saliva.
The development of diagnostic tools must be well planned including the usability and internal validation of the tools to be studied before they can be used in clinical trial settings or diagnostic accuracy tests by involving patients in health services. This study aims to conduct formative usability and internal validation of the DNA aptamer-based COVID-19 rapid diagnostic test, involving 200 patients and also laboratory personnel to assess aspects of experimental setup, testing center, testing kit configuration, designing algorithms or workflows for testing in clinical trials, and also assess early indications of instrument accuracy by validating with the patient's PCR test data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessors are blinded to the PCR test result
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18-59 years old
- •Undertaking PCR swab test for screening, or
- •In-patients undertaking PCR swab test
排除标准
- •Unable to produce saliva
- •Refusing to participate
结局指标
主要结局
Patient subjective elements
时间窗: 1 month
Aspects of the workflow liked/not liked by the patient during saliva collection
Technician Subjective elements
时间窗: 1 month
Aspects of the workflow liked/not liked by the technicians
Time-To-Result (TTR)
时间窗: 1 month
Instrument readout, from loading the cuvette in the spectrophotometer, up to recording the test as Positive / Negative
Hands-On-Time (HOT)
时间窗: 1 month
Total time (seconds) spent by the Operator(s) to process one test
Testing Centre First-Time-Hit percentage (FTH)
时间窗: 1 month
The FTH percentage measures proportion of test kits that will be correctly processed with no single mistake, from the opening of the test kit to recording the test result.
次要结局
- Specificity(1 month)
- Negative Predictive Value(1 month)
- Positive Predictive Value(1 month)
- Sensitivity(1 month)