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临床试验/NCT05983536
NCT05983536尚未招募不适用

The Evaluation of Anti-interference Ability and Clinical Specificity of HIV Ag +Ab Assay Kit (Sysmex)

Qianfoshan Hospital0 个研究点目标入组 1,200 人开始时间: 2023年9月20日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
1,200
主要终点
The HIV Ab/Ag results

研究概览

简要总结

To evaluate the anti-interference and specificity of HIV Ag +Ab Assay Kit (Sysmex) for the detection of HIV antigens and antibodies.

详细描述

First,HIV Ag +Ab Assay Kit (Sysmex)Assay Kit (Sysmex) was used to detect HIV antigens and antibodies in the serum of patients with tumor and blood diseases, and then confirmed by using the gold standard for HIV diagnosis,human immunodeficiency virus (HIV type 1+2) antibody assay kit (immunoimprinting). The specificity of HIV Ag +Ab Assay Kit (Sysmex) for HIV assay in patients with tumor and hematological diseases was calculated.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of tumor Disease or blood disease
  • Blood samples must meet the test requirements

排除标准

  • 未提供

结局指标

主要结局

The HIV Ab/Ag results

时间窗: through study completion, an average of 1.5 year

The HIV Ab/Ag results generated using HIV Ag +Ab Assay Kit (Sysmex) and the gold standard method for HIV test. The results will be recoreded seperately.

次要结局

未报告次要终点

研究者

发起方
Qianfoshan Hospital
申办方类型
Other
责任方
Sponsor

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