HIV感染的实验室检测质量控制

Quality Control for HIV Laboratory Testing

目的探讨人类免疫缺陷病毒(HIV)检测的质量控制方法。方法参考美国临床实验室标准化研究院(CLSI)M53-P指南及EP23-A指南的相关内容,利用风险管理原理,结合临床实验室实际情况,建立实验室特异的HIV质量控制计划(QCP)。结果风险管理的核心为风险评估,其基本过程包括风险因素识别、根本原因分析、风险估计和风险评价。特定工具失效模式与影响分析(FMEA)可用于HIV检测过程的风险评估,并明确降低风险的控制措施,综合这些控制措施得到QCP。实施QCP后,建立监控系统监测其有效性。结论 HIV感染的正确诊断对于限制HIV的传播及适当的临床治疗是至关重要的,利用风险管理的实验室质量控制有助于降低HIV感染检测的风险,为临床提供有效可靠的诊疗依据。

Objective To discuss the quality control for HIV testing. Methods Referred to Clinical and Laboratory Standards Institute document M53-P and EPg3-P,then employed the principle of risk management. Based on the clinical practice to develop a specific quality control plan（QCP） for HIV testing. Results Risk assessment, key of the risk man- agement, included hazard identification, root cause analysis, risk estimation and risk evaluation. Tools like failure mode and effects analysis （FMEA） could be used to identify the risk in each step of HIV testing and propose controls for risk mitigation. All the controls were put together to formulate the QCP. Once implemented, the laboratory should establish a surveillance system for monitoring the effectiveness of QCP. Conclusion Corrective diagnosis of HIV infection is very im- portant to limit the spread of infection and to identify individuals who may benefit from earlier initiation of antiviral thera- py. Developing a specific and appropriate quality control plan for HIM testing with the principle of risk management can re- duce the risk of the testing and provide an accurate and valid result for the diagnosis.