Berhan Ayenew, Almaw Andargachew, Damtie Shewaneh, Solomon Yenealem, Legese Biruk, Getie Birhanu, Erkihun Mulat
Department of Medical Laboratory Science, College of Health Sciences, Debre Tabor University, Debre Tabor, Ethiopia.
Heliyon. 2024 May 22;10(11):e31736. doi: 10.1016/j.heliyon.2024.e31736. eCollection 2024 Jun 15.
The preanalytical phase encompasses the time between the clinician's test order to the sample being ready for analysis. Of all errors during the laboratory diagnostic process,70 % appeared in the pre-analytical phase. In clinical laboratories, it is crucial to ensure proper specimen collection and handling, which is essential to guarantee quality assessment, monitoring process standardization, improving performance, and ensuring patient safety. Despite this importance, no study has been conducted in the study area to investigate the rate and reasons for human immunodeficiency virus viral load sample rejection.
To determine the rate of human immunodeficiency virus viral load sample rejection (number of preanalytical errors) documented during the preanalytical phase and articulate possible causes for specimen rejection.
A retrospective study was conducted at Debre Tabor Comprehensive Specialized Hospital from January 1st to January 31, 2023. During the study period, 5950 samples were extracted from the human immunodeficiency virus viral load laboratory sample tracking log books, which were sent to the hospital for viral load testing between August 2021 to November 2022. The collected data were cleaned and entered into EPI data version 4.6 before transferred it to STATA version 14.0 for analysis. Descriptive statistics such as frequencies, percentages, and cross-tabulations were used to summarize the findings.
The study found that improper sample handling was common during the preanalytical phase. According to the current study, 3.6 % of the sample was rejected at pre analytical stage. The most common reasons for specimen rejection were using inappropriate containers (64.0 %) uncentrifuged specimens (20.4 %); hemolyzed specimens (7.0 %); insufficient specimen volume (6.2 %); clotted specimens (1.9 %); and specimen labeling problems (0.5 %).
This study found that the most common preanalytical error was using an inappropriate sample collection container, followed by uncentrifuged samples, Therefore, it is recommended that mentorship programs be developed to educate staff on the preanalytical phase of laboratory testing, specifically on sample collection, storage, and transportation for HIV viral load testing. Additionally, the quality management system of laboratory processes should be strengthened to ensure accuracy and minimize errors.
分析前阶段涵盖从临床医生下达检验医嘱到样本准备好进行分析的时间段。在实验室诊断过程中的所有误差中,70%出现在分析前阶段。在临床实验室中,确保正确的标本采集和处理至关重要,这对于保证质量评估、监测过程标准化、提高性能以及确保患者安全必不可少。尽管这一点很重要,但在该研究领域尚未开展研究来调查人类免疫缺陷病毒病毒载量样本拒收的发生率及原因。
确定分析前阶段记录的人类免疫缺陷病毒病毒载量样本拒收率(分析前误差数量),并阐明样本拒收的可能原因。
于2023年1月1日至1月31日在德布雷塔博尔综合专科医院进行了一项回顾性研究。在研究期间,从人类免疫缺陷病毒病毒载量实验室样本追踪日志中提取了5950份样本,这些样本于2021年8月至2022年11月期间被送往该医院进行病毒载量检测。收集到的数据在被转移到STATA 14.0版本进行分析之前,先进行清理并录入EPI数据4.6版本。使用频率、百分比和交叉表等描述性统计方法来总结研究结果。
研究发现,在分析前阶段,样本处理不当的情况很常见。根据当前研究,3.6%的样本在分析前阶段被拒收。样本拒收的最常见原因是使用了不合适的容器(64.0%)、未离心的标本(20.4%);溶血标本(7.0%);标本量不足(6.2%);凝血标本(1.9%);以及标本标签问题(0.5%)。
本研究发现,最常见的分析前误差是使用了不合适的样本采集容器,其次是未离心的样本。因此,建议制定指导计划,对工作人员进行实验室检测分析前阶段的培训,特别是关于人类免疫缺陷病毒病毒载量检测的样本采集、储存和运输方面的培训。此外,应加强实验室流程的质量管理体系,以确保准确性并尽量减少误差。