Clinical Performance Study of Safety Test ABO Device
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Diagast
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Concordance obtained between blood type information from medical record and patient results obtained by Safety Test ABO.
研究概览
简要总结
The study aims to confirm the performance equivalence of the in vitro diagnostic device Safety Test ABO with the ABTest Card device.
详细描述
According to the regulatory text "Common specifications for certain class D in vitro diagnostic medical devices in accordance with Regulation (EU) 2017/746 of the European Parliament and of the Council" [2], 90% of the results will be derived from the performance study carried out at the DIAGAST laboratory on tube left over and blood bag, and 10% of the results will be derived from the use of the device in a real situation ("at the bedside").
Regulation 2017/746 (IVDR) on IVDMD has been effective since May 2022 with transitional periods. The IVDR replaces the current EU Directive (98/79/EC) to ensure a higher level of health and safety for the making available and putting into service of medical devices on the EU market. As the Safety Test ABO and ABTest Card® are already CE marked under Directive 98/79/EC as List IIA product, this study is part of the device's post-marketing performance monitoring.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years old for the category marked with *.
- •Undergo capillary blood sampling;
- •Belong to one of the clinical category:
- •Patient in need of blood transfusion without any pathology known to have an impact on transfusion act*;
- •Patient in need of blood transfusion suffering from congenital erythrocyte pathology (sickle cell anaemia, beta thalassemia)*
- •Patient in need of blood transfusion suffering from haematology disease (eg. cancer), or undergoing haemodialysis*;
- •Patient with cold agglutinin*;
- •Premature patient with gestational age < 37 weeks of newborn ≤27 days old in need of blood transfusion;
- •Newborn eligible for Guthrie Test;
- •Newborn eligible for glycemic test.
- •Have health care insurance;
- •Have given his/her written consent (or legal representative in case of newborn);
排除标准
- •Pregnant woman;
- •Person deprived of liberty;
- •Unconscious person;
- •Person under guardianship or trusteeship;
- •For neonatal clinical category: age ≥28 days and <18 years old.
结局指标
主要结局
Concordance obtained between blood type information from medical record and patient results obtained by Safety Test ABO.
时间窗: 5 minutes.
Comparison of the "patient" blood type determined from the results of the Safety Test ABO device (A, B, AB, O) with the "patient" blood type in the medical record (A, B, AB, O).
Concordance obtained on patient blood type between Safety Test ABO and ABTest Card® results.
时间窗: 5 minutes.
Comparison of the "patient" blood type determined from the results of the ABTest Card® device (A, B, AB, O) with the "patient" blood type determined from the results of the Safety Test ABO device (A, B, AB, O).
Concordance obtained between blood bag labelling information and blood bag results obtained by Safety Test ABO.
时间窗: 5 minutes.
Comparison of the "donor" blood type determined from the results of the Safety Test ABO device (A, B, AB, O) with the "donor" blood type shown on the blood bag label (A, B, AB, O).
Concordance obtained on blood bag blood type between Safety Test ABO and ABTest Card® results.
时间窗: 5 minutes.
Comparison of the "donor" blood type determined from the results of the ABTest Card® device (A, B, AB, O) with the "donor" blood type determined from the results of the Safety Test ABO device (A, B, AB, O).
Blood compatibility between blood bag and patient for the Safety Test ABO.
时间窗: 5 minutes.
Comparison of the "patient" blood type determined from the results of the Safety Test ABO device (A, B, AB, O) with the "donor" blood type determined from the results of the Safety Test ABO device (A, B, AB, O).
Blood compatibility between blood bag and patient for the ABTest Card®.
时间窗: 5 minutes.
Comparison of the "patient" blood type determined from the results of the ABTest Card® device (A, B, AB, O) with the "donor" blood type determined from the results of the ABTest Card® device (A, B, AB, O).
次要结局
未报告次要终点