Roberts-Thomson P J, McEvoy R, Gale R, Jovanovich S, Bradley J
Department of Clinical Immunology, Flinders Medical Centre, Bedford Park, South Australia.
Asian Pac J Allergy Immunol. 1993 Jun;11(1):29-37.
A Royal College of Pathologists of Australasia (RCPA) sponsored quality assurance program in clinical immunopathology has, over a 5 year period, demonstrated: enrollment by the majority of immunodiagnostic laboratories in Australia and New Zealand; improved compliance with the program over time eg. increasing numbers returning their replies by the due date; different commercial techniques give different mean values for the same analyte. This appears to be due to the use of different reference materials in each technique; greater utilization of nephelometric techniques in quantitating immunoglobulins, C3, C4, CRP and rheumatoid factor resulting in better accuracy and precision; improvement in the frequency of detecting anticentromere antibody as most laboratories use proliferating cell lines as substrate for anti-nuclear antibody (ANA) detection; improved interlaboratory concordance of ANA titers by the provision of reference standards; improved detection of antibodies to extractable nuclear antigens (counter-immunoelectrophoresis being more sensitive than immunodiffusion); the Farr and radioimmunoassay technique for the demonstration of antibodies to native DNA have greater sensitivity than the Crithidia assay; improvement in accuracy and precision of cell phenotype analysis with the use of whole blood and cell flow cytometric techniques; development of techniques to rank each laboratories performance on a rating scale based on the average number of tests outliers (from the consensus mean) per mailing. However deficiencies in performance are still being observed. These relate to both technical factors causing systematic errors and in the provision of interpretive comments on the laboratory result. Continuing education and participation in quality assurance programs are emphasized to monitor and improve performance over time.
澳大利亚皇家病理学家学会（RCPA）发起的一项临床免疫病理学质量保证计划，在5年期间展现出：澳大利亚和新西兰的大多数免疫诊断实验室都参与其中；随着时间推移，对该计划的依从性有所提高，例如在截止日期前回复的数量增加；不同的商业技术对同一分析物给出不同的均值，这似乎是由于每种技术使用了不同的参考材料；在定量免疫球蛋白、C3、C4、C反应蛋白和类风湿因子时，比浊法技术的使用更加广泛，从而提高了准确性和精密度；随着大多数实验室使用增殖细胞系作为抗核抗体（ANA）检测的底物，着丝粒抗体的检测频率有所提高；通过提供参考标准，提高了ANA滴度的实验室间一致性；可提取核抗原抗体的检测得到改进（对流免疫电泳比免疫扩散更敏感）；用于检测抗天然DNA抗体的Farr法和放射免疫测定技术比克氏锥虫试验更具敏感性；使用全血和细胞流式细胞术技术提高了细胞表型分析的准确性和精密度；开发了根据每次邮寄中异常值（与共识均值相比）的平均测试数量，在评分量表上对每个实验室的表现进行排名的技术。然而，仍观察到性能方面的不足。这些不足既涉及导致系统误差的技术因素，也涉及对实验室结果提供解释性评论方面的问题。强调持续教育和参与质量保证计划，以便随着时间的推移监测和提高性能。
