ABO血型检测卡临床试验要求

Case selection

The total number of clinical cases shall not be less than 3000. Clinical patients shall be used for clinical research, and blood donor samples shall not be included as clinical cases. It should include cases that are easy to interfere with blood type identification, and try to select patients with multiple diseases (such as cancer patients, patients with autoimmune diseases, patients with blood diseases), the elderly, children (different age groups), etc. The distribution of blood groups should be balanced as far as possible. Each ABO blood group should have statistical significance. It is recommended that no less than 50 RhD negative samples be taken.

病例选择

临床总病例数应不少于3000例。应采用临床患者进行临床研究，供血者样本不得作为临床病例纳入。应包括血型鉴定易产生干扰的病例，尽量选择多种疾病患者（如肿瘤患者、自身免疫病患者、血液病患者）、老人、儿童（不同年龄段）等。血型分布尽量均衡，ABO血型每种均应有统计学意义，RhD阴性样本建议不少于50例。

猴痘临床试验，新冠前瞻性临床实验研究（含伦理批文）以及以下检测试剂：梅毒、血糖、PSA、HIV、流感、水痘、尿酸、验孕等常见产品的临床实验研究项目。IVDEAR王小姐