Asmelash Daniel, Worede Abebaw, Teshome Mulugeta
Department of Clinical Chemistry, School of Biomedical and Laboratory Sciences, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.
Department of Medical Laboratory Sciences, School of Biomedical and Laboratory Sciences, College of Medicine and Health Sciences, University of Gondar, Gondar, Ethiopia.
EJIFCC. 2020 Sep 29;31(3):208-224. eCollection 2020 Sep.
Clinical laboratory testing is a highly complex process involving a different procedure. Laboratory errors may occur at any stage of the test process, but most errors occur during extra-analytical phases. The magnitude of clinical laboratory errors, in particular extra-analytical errors, was inconsistent in different studies.
A systematic review and meta-analysis were conducted based on the Preferred Reporting Items for Systematic Review and Meta-Analysis guidelines. The extracted data were entered into a Microsoft Excel spreadsheet and transferred to STATA version 11 for the analysis. Random effect model was used to estimate pooled prevalence of extra-clinical laboratory errors and I statistic was used to assess heterogeneity between the studies. Funnel plot analysis and Egger weighted regression test were performed to detect the publication bias. Egger weighted regression test with P-value <0.05 was considered to be a statistically significant publication bias.
A total of 1,381 studies were searched, 19 were included in this systematic review and meta-analysis. A total of 621,507 pre-analytical and 51,859 post-analytical outcomes of quality indicators were reported. A total of 145,515 samples were assessed for rejection and 62,513 laboratory requests were evaluated for incompleteness. The pooled prevalence of pre-analytical and post-analytical errors in Africa was 17.5% (95% Cl: 11.55, 23.45) and 10.99% (95% Cl: 5.30, 16.67) respectively. The pooled prevalence of specimen rejection and laboratory request forms incompleteness in Africa was 2.0% (95% Cl: 0.86, 3.14) and 7.55% (95% Cl: 2.30, 12.80) respectively.
The study found high prevalence of pre- and of post-analytical clinical laboratory errors in Africa. In addition, the study showed that the standard completion of the laboratory request forms was poor and there were significant numbers of specimen rejections. Therefore, clinical laboratories should ensure compliance with standard operating procedures, the laboratory information system, the cooperation of the entire staff and the targeted training of sample collectors.
临床实验室检测是一个涉及不同程序的高度复杂过程。实验室误差可能发生在检测过程的任何阶段，但大多数误差发生在分析前阶段。不同研究中临床实验室误差（特别是分析前误差）的严重程度不一致。
根据系统评价和荟萃分析的首选报告项目指南进行系统评价和荟萃分析。将提取的数据录入Microsoft Excel电子表格，并转移到STATA 11版本进行分析。采用随机效应模型估计临床实验室外误差的合并患病率，并使用I统计量评估研究间的异质性。进行漏斗图分析和Egger加权回归检验以检测发表偏倚。P值<0.05的Egger加权回归检验被认为具有统计学意义的发表偏倚。
共检索到1381项研究，19项纳入本系统评价和荟萃分析。共报告了621,507个分析前和51,859个分析后质量指标结果。共评估了145,515个样本的拒收情况，以及62,513个实验室申请的不完整性。非洲分析前和分析后误差的合并患病率分别为17.5%（95%可信区间：11.55，23.45）和10.99%（95%可信区间：5.30，16.67）。非洲样本拒收和实验室申请表不完整的合并患病率分别为2.0%（95%可信区间：0.86，3.14）和7.55%（95%可信区间：2.30，12.80）。
该研究发现非洲分析前和分析后临床实验室误差的患病率较高。此外，研究表明实验室申请表的标准填写情况较差，样本拒收数量较多。因此，临床实验室应确保遵守标准操作程序、实验室信息系统，全体工作人员的合作以及对样本采集人员的针对性培训。
