Clinical Evaluation of AS76 with PBS versus light microscopy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Agreement between AS76 with PBS and light microscopy in evaluating white blood cell (WBC), red blood cell (RBC), and platelet (PLT) morphologies. For WBCs: Passing-Bablok regression (slope, intercept, bias) will be used for differential counts. Sensitivity, specificity, and overall agreement will be calculated for detecting WBC abnormalities. For RBCs and PLTs: sensitivity, specificity, and overall agreement for morphological abnormalities.
研究概览
简要总结
The AS76 with PBS device is an automated cell-locating device intended for
1.Quantitative analysis of WBC (Differential count of white blood cell types)
2.Semi-quantitative analysis of RBC (Morphological analysis of red blood cells)
3.Quantitative (Estimation of Platelet count) and Semi-quantitative analysis of platelets (Morphological analysis of Platelets).
Study Objective
The objective of this study is to evaluate the clinical performance of the AS76 with PBS system using peripheral blood smear (hereafter referred to as PBS) and establish equivalence with the reference method, manual review under a light microscope
Study Endpoint
The endpoint of the study is the comparison of operator-classified results of White Blood Cell (WBC) morphologies, Red Blood Cell (RBC) morphologies and Platelet (PLT) morphologies against manual microscopy using multiple statistical measures.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 0.00 Day(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •The study is an “all comers” study that shall include samples from healthy individuals and samples from individuals with various hematological conditions and distributional abnormalities such as anemia, thrombocytopenia, leukopenia, leukocytosis, elevated hematocrit, elevated nucleated red blood cells, leukemia, etc.
- •The abnormal samples shall align with the recommendations of the CLSI H20-A2 standard.
- •Samples from both genders shall be used.
- •Samples from individuals belonging to any race/ethnicity can be used.
排除标准
- •The following sample exclusion criteria shall be applied.
- •Slides that are not prepared adequately shall be excluded from the study. For example – slides that are not smeared well or are stained poorly.
- •Slides that have been prepared from degenerated blood and are considered unsuitable for evaluation by the qualified reviewers after examination under a light microscope (as per the standard procedures of the laboratory).
- •Slides considered unsuitable for evaluation by the qualified reviewers after examination under light microscope (as per the laboratory’s standard procedures).
结局指标
主要结局
Agreement between AS76 with PBS and light microscopy in evaluating white blood cell (WBC), red blood cell (RBC), and platelet (PLT) morphologies. For WBCs: Passing-Bablok regression (slope, intercept, bias) will be used for differential counts. Sensitivity, specificity, and overall agreement will be calculated for detecting WBC abnormalities. For RBCs and PLTs: sensitivity, specificity, and overall agreement for morphological abnormalities.
时间窗: The outcomes will be analyzed 3 months from the date of study initiation.
次要结局
未报告次要终点
研究者
Tathagato Rai Dastidar
Sigtuple Technologies Private Limited