摘要
目的探讨化学发光免疫分析系统测定PSA结果的可比性,为该项目推广互认提供依据。方法选择Roche与Abbott Architect作为研究对象,通过比较各台仪器的正常人参考值以及健康人群P50、P95和P97.5来考虑两者是否具有可比性。随后6个月内跟踪6台检测系统的室内质控、进行40份不同浓度新鲜患者血清的比对、结合4年内35个批次的室间质评数据,综合分析两款检测系统在整体上与个体间的可比性和差异情况,并对照澳大利亚室间质评的相关要求来讨论两款检测系统间结果是否可以推广互认。结果两款检测系统具有接近的健康人群参考范围;同款检测系统之间具有较好的一致性;不同款检测系统间则表现出整体一致性优于个体之间的一致性,且随实验室不同而表现出不同的差异率,部分差异超出了相关要求。结论基于稳定的实验室室内质控和规范的校准条件下,两款检测系统在低浓度的结果可以推广互认,不同实验室的同款检测系统也满足推广互认的要求,但不同款的检测系统之间的互认尚存在不确定性,需进一步验证。
Objective To investigate and analyze the comparability of serum prostate - specific antigen measurements between auto- mated chemiluminescence immunoassay systems. It is valuable to provide the basis for the mutual approval between laboratories on results. Methods Six systems from Roche and Abbott Architect in six laboratories were involved in this research. Normal reference ranges of each laboratory were compared to confirm that both two brands of systems are comparable. We measured PSA concentrations in each of 40 serum samples during six months and compared the results using various statistical methods. EQA data from National Center for Clinical Labora- tory were analyzed to show the comparability between analyzer groups. Evaluation standards of Australia were used to measure whether these differences influence the clinical diagnosis. Results Both brands of systems had the similar reference ranges in healthy groups. The differences between the same brands were smaller than the different. The general＇s differences are smaller than the individuals＇. No signif- icant regular of differences between individuals was found in this research. Conclusion The results at lower concentrations can be mutual approved between the two brands of systems based on a stable internal quality control and reliable traceability chains. The same systems in different laboratories also meet the requirements of mutual approval. More researches are required to verify the differences between differ- ent brands of systems.
出处
《医学研究杂志》
2013年第2期159-163,共5页
Journal of Medical Research
