Nissinen A, Strandén P, Myllys R, Takkinen J, Björkman Y, Leinikki P, Siitonen A
Microbiology Laboratory, Central Hospital of Central Finland, Jyväskylä, Finland.
Eur J Clin Microbiol Infect Dis. 2009 Jan;28(1):17-20. doi: 10.1007/s10096-008-0580-9. Epub 2008 Jul 5.
The purpose of this study was to evaluate the overall performance of rapid antigen detection (RAD) in group A streptococcus (GAS) in Finland by using the results of external quality assurance (EQA) samples. We also compared the performance of laboratory professionals to that of nursing professionals. Around 22,800 EQA results among a total of 383 laboratories and physician's offices were analysed. Vocational data on the personnel who carried out the tests were available for 10,088 EQA samples, 7,428 of which were tested by laboratory technicians and 2,531 by nursing staff. The best overall performance was found with GAS-negative samples: 99% of the reports were correct. In contrast, the overall performance was only 76% when the samples were weakly positive for GAS antigen. The laboratory technicians performed statistically significantly better than the nursing staff, with both strongly positive (correct results 98.9% vs. 95.1%, respectively; p<0.001) and weakly positive (79.3% vs. 65.3%, respectively; p<0.001) samples. With negative samples, no difference in performance between the laboratory and nursing staff was found (99.5% vs. 99.0%, respectively). The professional skills of the person performing the RAD test for GAS have a major impact on the sensitivity of the test. Based on the results of this study, we suggest that EQA-like artificial specimens could be used as a tool to improve and validate the quality of RAD testing in individual testing sites.
本研究的目的是通过使用外部质量保证（EQA）样本的结果来评估芬兰A组链球菌（GAS）快速抗原检测（RAD）的整体性能。我们还比较了实验室专业人员和护理专业人员的检测性能。分析了总共383个实验室和医生办公室的约22,800份EQA结果。有10,088份EQA样本可获取进行检测人员的职业数据，其中7,428份由实验室技术人员检测，2,531份由护理人员检测。GAS阴性样本的整体性能最佳：99%的报告正确。相比之下，当样本GAS抗原弱阳性时，整体性能仅为76%。实验室技术人员的表现在统计学上显著优于护理人员，无论是强阳性样本（正确结果分别为98.9%和95.1%；p<0.001）还是弱阳性样本（分别为79.3%和65.3%；p<0.001）。对于阴性样本，未发现实验室人员和护理人员在性能上有差异（分别为99.5%和99.0%）。进行GAS的RAD检测人员的专业技能对检测的敏感性有重大影响。基于本研究结果，我们建议类似EQA的人工标本可作为一种工具，用于提高和验证各个检测点RAD检测的质量。
