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CD4+ T细胞检测实验室改进项目影响评估

Assessment of the impact of a CD4+ T-cell testing laboratory improvement program.

作者信息

Rosner E, Siragusa M, Schalla W, Cross D, Cohn R, Hearn T

机构信息

Public Health Practice Program Office, Centers for Disease Control and Prevention, Atlanta, GA 30341, USA.

出版信息

Arch Pathol Lab Med. 1998 Jun;122(6):512-9.

PMID:9625418
Abstract

OBJECTIVE

To evaluate the effectiveness of the Centers for Disease Control and Prevention's CD4+ T-cell laboratory testing improvement program and the influence of other laboratory improvement programs on CD4+ T-cell testing practices.

DESIGN

Surveys asking for practice changes and factors that influenced the changes, a survey of clinicians' perceptions of laboratory quality in CD4 testing, and analysis of data from the Model Performance Evaluation Program.

INTERVENTIONS

Centers for Disease Control and Prevention interventions included a series of 3-day workshops on flow cytometry, CD4+ T-cell testing guidelines published in the Morbidity and Mortality Weekly Report, the Clinical Laboratory Improvement Amendments of 1988, and the Model Performance Evaluation Program.

PARTICIPANTS

All known laboratories in the United States that perform clinical CD4+ T-cell testing, workshop participants, and a sample of clinicians that treat patients infected with the human immunodeficiency virus.

MAIN OUTCOME MEASURES

Changes in practices, factors most influential in effecting change, and performance on samples mailed to laboratories by the Model Performance Evaluation Program; knowledge before and after presentation of material in workshops; and practicing clinicians' observations of any effects of changes in laboratory practices.

RESULTS

Many existing laboratories changed practices as a result of both governmental and nongovernmental CD4+ T-cell testing improvement programs. Sources of influence varied with each testing practice. Perceptions that test results were more reproducible seemed to offset presumed increases in the time and cost of testing. Clinicians who had ordered CD4+ T-cell testing for more than 10 years noted some improvements in results reported.

CONCLUSIONS

As new complex testing methodologies are introduced into clinical and public health laboratories, the users seem to seek guidance in appropriate application of preanalytic, analytic, and postanalytic phases of the testing process. Testing improvement programs from a variety of sources were credited with changing practices and should continue to provide this guidance.

摘要

目的

评估疾病控制与预防中心的CD4+T细胞实验室检测改进计划的有效性,以及其他实验室改进计划对CD4+T细胞检测实践的影响。

设计

询问实践变化及影响变化因素的调查、临床医生对CD4检测实验室质量看法的调查,以及对模型性能评估计划数据的分析。

干预措施

疾病控制与预防中心的干预措施包括一系列为期3天的流式细胞术研讨会、《发病率与死亡率周报》发布的CD4+T细胞检测指南、1988年《临床实验室改进修正案》以及模型性能评估计划。

参与者

美国所有已知的进行临床CD4+T细胞检测的实验室、研讨会参与者,以及治疗人类免疫缺陷病毒感染患者的临床医生样本。

主要观察指标

实践变化、影响变化的最主要因素、模型性能评估计划邮寄给实验室的样本的检测性能;研讨会材料展示前后的知识;以及临床医生对实验室实践变化的任何影响的观察。

结果

许多现有实验室因政府和非政府的CD4+T细胞检测改进计划而改变了实践。影响来源因每种检测实践而异。检测结果更具可重复性的认知似乎抵消了检测时间和成本可能增加的影响。订购CD4+T细胞检测超过10年的临床医生指出报告的结果有一些改善。

结论

随着新的复杂检测方法被引入临床和公共卫生实验室,用户似乎在检测过程的分析前、分析中和分析后阶段的适当应用方面寻求指导。来自各种来源的检测改进计划被认为改变了实践,应继续提供这种指导。

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