To assess potential of automated quantitative blood cell analyzer that combines innovative micro-nano technology and computer vision for blood analysis.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- 1.Assessment of potential of iMOST-L analyzer for the quantitative measurement of blood count (CBC) parameters.
研究概览
简要总结
Aim : To assess potential of automated quantitative blood cell analyzer that combines innovative micro-nano technology and computer vision for blood analysis.
Milestone to be achieved : To assess potential of iMOST-L analyzer for the quantitative measurement of complete blood count (CBC) parameters.
Study Design : 5 ml of blood sample will be collected from all eligible subjects for the study.
Objectives :
-
To assess potential of iMOST-L analyzer for the quantitative measurement of complete blood count (CBC) parameters.
-
To determine accuracy of the device by comparing data obtained from device with data obtained from standard blood testing method.
-
To determine specificity and sensitivity of the iMOST-L analyzer by comparing results obtained from peripheral blood analysis with fingertip blood analysis.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Inclusion criteria:
- •Age: 18-90 years, irrespective of clinical history
- •Subjects who are able to understand and willing to sign the informed consent form (ICF)
- •Subjects who are willing and able to comply with scheduled visit.
排除标准
- •Exclusion criteria:
- •Age less than 18 years.
- •Subject suffering from Immune thrombocytopenic purpura (ITP)
- •Subjects on cytotoxic drugs
- •Verified biohazard samples will be excluded.
结局指标
主要结局
1.Assessment of potential of iMOST-L analyzer for the quantitative measurement of blood count (CBC) parameters.
时间窗: Baseline
2.Accuracy of the device determined by comparing device generated data with standard blood testing method .
时间窗: Baseline
3.Specificity and sensitivity of the iMOST-L analyzer determined by comparing results obtained from peripheral blood and fingertip blood analysis .
时间窗: Baseline
次要结局
未报告次要终点
研究者
Dr Mugdha Ghag
Epigeneres Biotech Pvt.Ltd