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诊断实验室与研究实验室之间基础淋巴细胞表型结果的比较。

Comparison of basic lymphocyte phenotype results between a diagnostic and a research laboratory.

作者信息

Aziz Najib, LaBelle Erik, Jamieson Beth D, Mimiaga Matthew J, Detels Roger

机构信息

Department of Epidemiology, Fielding School of Public Health, University of California, Los Angeles, CA, US.

Department of Medicine, David Geffen School of Medicine, University of California, Los Angeles, CA, US.

出版信息

Lab Med. 2025 May 9;56(3):271-278. doi: 10.1093/labmed/lmae091.

Abstract

OBJECTIVE

Lymphocyte phenotyping is a valuable tool for monitoring the effects of antiretroviral therapy on individuals living with HIV-1. A switch study was conducted to compare T-cell subset quantification performed by a research laboratory and a diagnostic, laboratory to understand the impact on the retrospective and prospective results of a long-term study.

METHODS

Using FACSCanto II Flow Cytometers, EDTA anticoagulated peripheral blood from 73 males enrolled in the Multicenter AIDS Cohort Study/Women Interagency HIV Combined Cohort Study was analyzed by both a research (laboratory 1) and a diagnostics laboratory (laboratory 2) for quantification of cluster of differentiation (CD)3, CD4, and CD8 T-cells. There were 47 males living with and 26 living without HIV-1.

RESULTS

Bland-Altman (B-A) analysis was applied to assess the agreement between laboratory 1 and laboratory 2 results. There were 69 out of 73 CD3, 71 out of 73CD4, and 72 out of 73 CD8 T-cell results that fell within acceptable B-A limits of agreement. The mean differences between the 2 laboratories were -1.000, -0.945, and +0.685(%), respectively.

CONCLUSION

The strong agreement between results from laboratory 1 and laboratory 2 for CD3, CD4, and CD8 T-cell percentage suggests that the difference between laboratories using the same instrumentation and methodology will have a minimal effect on long-term study results.

摘要

目的

淋巴细胞表型分析是监测抗逆转录病毒疗法对HIV-1感染者疗效的一项重要工具。开展了一项转换研究,以比较一个研究实验室和一个诊断实验室进行的T细胞亚群定量分析,从而了解其对一项长期研究的回顾性和前瞻性结果的影响。

方法

使用FACSCanto II流式细胞仪,由一个研究实验室(实验室1)和一个诊断实验室(实验室2)对参与多中心艾滋病队列研究/女性机构间HIV联合队列研究的73名男性的乙二胺四乙酸(EDTA)抗凝外周血进行分析,以定量分化簇(CD)3、CD4和CD8 T细胞。其中47名男性感染了HIV-1,26名未感染。

结果

采用布兰德-奥特曼(B-A)分析评估实验室1和实验室2结果之间的一致性。73个CD3结果中有69个、73个CD4结果中有71个、73个CD8 T细胞结果中有72个落在可接受的B-A一致性界限内。两个实验室之间的平均差异分别为-1.000%、-0.945%和+0.685%。

结论

实验室1和实验室2在CD3、CD4和CD8 T细胞百分比结果上的高度一致性表明,使用相同仪器和方法的不同实验室之间的差异对长期研究结果的影响极小。

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