Getahun Tigist, Alemu Anberber, Mulugeta Firehiwot, Sileshi Merone, Ayalkebet Abenezer, Habtu Wosene, Geto Zeleke, Girma Fitsum, Challa Feyissa, Wolde Mistire
Ethiopian Public Health Institute, National References Laboratory for Clinical Chemistry, Addis Ababa, Ethiopia.
Department of Medical Laboratory Sciences, Addis Ababa University, Ethiopia.
EJIFCC. 2019 Oct 11;30(3):276-287. eCollection 2019 Oct.
Serum indices (SI) including hemolyzed, lipemic, and icteric samples, affects the accuracy of test result. The aim of this study was to evaluate SI values done by visual inspections and potential false result risks by comparing with actual measurements done by Cobas 6000 Chemistry analyzer at Ethiopian Public Health Institute (EPHI), Addis Ababa, Ethiopia.
An observational, cross-sectional study was conducted from April to May 2017 on samples referred to Clinical Chemistry laboratory of EPHI, Ethiopia. These samples SI values, after visual inspection by three trained observers, was analyzed again on Roche Cobas 6000 analyzer (RCA). The generated data was analyzed by using weighted kappa methods on STAT statistical software version 20.
From a total of 1509 samples, SI values identified by the RCA as hemolysis, icteric, and lipemic were 933 (62%), 74(5%) and 59(4%) respectively. The SI average weighted kappa between RCA and visual inspection were: 0.1870, 0.3421, and 0.1259 for hemolysis, icteric, and lipemic samples, respectively. Combined inter-observers variability among observers for hemolysis, Icterus, and lipemic samples were 0.4758, 0.3258, and 0.3628 respectively. The best agreement among observers was in the case of hemolysis (0 grades), while the lowest agreement was observed in the case of icterus (+3 grades). In addition, test parameters, such as CK-MB (22%), and LDH (20%) were falsely accepted, whereas Cl and Na+ (up to 25%) were falsely rejected tests by observers. On the other hand, results rejected by Cobas SI assessments included CK-MB (22%), LDH (20%), and BIL-D (4%).
Visual inspection of SI showed poorly agreement with automated system. Thus, there is genuine need for more training of Laboratory professionals on identification of SI, and as much as possible SI should be done by automated system to improve quality of test results.
包括溶血、脂血和黄疸样本在内的血清指标（SI）会影响检测结果的准确性。本研究的目的是通过与埃塞俄比亚亚的斯亚贝巴埃塞俄比亚公共卫生研究所（EPHI）的Cobas 6000化学分析仪进行的实际测量结果相比较，评估通过目视检查得出的SI值以及潜在的错误结果风险。
2017年4月至5月，对送往埃塞俄比亚EPHI临床化学实验室的样本进行了一项观察性横断面研究。这些样本经三名经过培训的观察者目视检查后的SI值，再在罗氏Cobas 6000分析仪（RCA）上进行分析。使用STAT统计软件20版中的加权kappa方法对生成的数据进行分析。
在总共1509个样本中，RCA鉴定为溶血、黄疸和脂血的SI值分别为933个（62%）、74个（5%）和59个（4%）。RCA与目视检查之间的SI平均加权kappa分别为：溶血样本0.1870、黄疸样本0.3421、脂血样本0.1259。溶血、黄疸和脂血样本观察者之间的综合观察者间变异性分别为0.4758、0.3258和0.3628。观察者之间一致性最好的是溶血情况（0级），而黄疸情况（+3级）的一致性最低。此外，诸如肌酸激酶同工酶（CK-MB，22%）和乳酸脱氢酶（LDH，20%）等检测参数被观察者错误接受，而氯和钠离子（高达25%）被观察者错误拒绝检测。另一方面，被Cobas SI评估拒绝的结果包括CK-MB（22%）、LDH（20%）和总胆红素（BIL-D，4%）。
SI的目视检查与自动化系统的一致性较差。因此，确实需要对实验室专业人员进行更多关于SI识别的培训，并且应尽可能通过自动化系统进行SI检测，以提高检测结果的质量。
