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临床实验室CD34 +细胞计数检测现状与改进措施分析

Current status of CD34 +cell enumeration assay in clinical laboratories and its improvement

摘要目的:调查临床实验室开展CD34 +细胞计数的检测现状,分析存在的问题,为制定质量改进方案提供依据。 方法:以参加CD34 +细胞计数全国室间质量评价活动的101家实验室为调查对象,通过问卷调查和质评物检测,收集相关检测方法学信息及质评物检测结果。参考国内外指南文件确定CD34 +细胞计数的质量控制要求,对调查实验室的遵循情况进行分析。分组统计质评物检测结果,并与美国病理家学会(CAP)质评数据进行比较。 结果:共收到97家实验室回报的调查问卷信息,99家实验室回报的质评物检测结果。问卷调查数据显示实验室对设门方案、移液方式和获取细胞数等关键质量控制要求的遵循比率较高,分别为92.8%、83.9%和82.5%;而对采用全血质控品开展室内质量控制、溶血素的选择、处理样品是否洗涤、是否报告绝对计数以及仪器的质量控制等要求的遵循比率较低,分别为5.2%、28.9%、39.2%、46.4%和55.7%。质评物检测结果显示,国内实验室CD34 +相对计数的变异系数与CAP质评数据相近,但绝对计数的变异系数大于CAP质评数据。 结论:临床实验室对部分质量控制要求的遵从性较差,绝对计数结果的实验室间差异较大,建议实验室加强CD34 +细胞计数质量控制相关培训,特别是绝对计数方法和技术要求的培训。

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abstractsObjective:To investigate the current status and problems of CD34 + cell enumeration in clinical laboratories and provide suggestions for the development of quality improvement programs. Methods:A total of 101 laboratories participating in the national external quality assessment program of CD34 +cell enumeration were surveyed. Questionnaires and quality assessment materials were distributed to collect information on assay methodology and testing results. Quality control requirements for CD34 +cell enumeration were determined according to the international guidelines, and the compliance of the surveyed laboratories was analyzed. Testing results were analyzed in groups and compared with the College of American Pathologists (CAP) quality assessment data. Results:A total of 97 laboratories returned the questionnaires and 99 laboratories returned the results of quality assessment materials. The questionnaire data showed high compliance rates of quality control requirements such as gating protocols, pipetting methods, and the number of cells acquired (92.8%, 83.9%, and 82.5% respectively). However, these laboratories had relatively low compliance rates such as the use of whole blood quality control materials for internal quality control, selection of erythrocyte lysing reagents, sample processing method, whether to report absolute count results, and quality control of equipment (5.2 %, 28.9%, 39.2%, 46.4%, and 55.7%, respectively). Testing results demonstrated that the coefficient of variation ( CV) of percent counts was similar to the CAP quality assessment data, but the CV of absolute counts was greater than the CAP quality assessment data. Conclusions:Clinical laboratories have poor compliance with some quality control requirements and the variability of absolute count results between different laboratories is not satisfactory. Therefore, it is recommended that clinical laboratories should strengthen the training related to the quality control of CD34 +cell enumeration, especially the absolute counting.

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中华医学杂志

中华医学杂志

2021年101卷37期

2999-3005页

MEDLINEISTICPKUCSCDCA

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