Kahlmeter G, Dornbusch K, Olsson-Liljequist B
Scand J Infect Dis. 1985;17(1):67-75. doi: 10.3109/00365548509070423.
During 1978-1983 44 Scandinavian laboratories participated in 7 quality surveys of gentamicin serum assays. In each survey 2 test solutions of gentamicin were distributed. In the first 4 surveys very few non-microbiological assays were used while in the 7th survey almost half the laboratories had access to enzyme immunoassay (EMIT). The gentamicin survey mean (SM) concentrations, which did not differ significantly from the intended concentrations, were used as target values. In survey 1, 65% of the results of either of the 2 test solutions were outside the SM +/- 25% and 16% were outside SM +/- 50% ("highly misleading"). In surveys 5 and 7 the corresponding figures were 27 and 5% and 18 and 0%, respectively. The EMIT performed excellently in all surveys. Agar well diffusion assays using Diagnostic Sensitivity Test agar (Oxoid) performed better than other plate diffusion assays. Laboratories participating regularly performed better than others. It is concluded that the survey program, which continues, provides an external facility for unbiased control of commercially available as well as non-commercial assay techniques and that it has been instrumental in the improvement of gentamicin assay standard. It is stressed that the surveys cannot replace internal quality control, best performed by daily measurement and regular statistical evaluation of samples of known potency.
1978年至1983年期间，44个斯堪的纳维亚实验室参与了7次庆大霉素血清检测质量调查。每次调查都分发了2种庆大霉素测试溶液。在前4次调查中，很少使用非微生物检测方法，而在第7次调查中，几乎一半的实验室可以使用酶免疫测定法（EMIT）。庆大霉素调查的平均（SM）浓度与预期浓度无显著差异，用作目标值。在第1次调查中，2种测试溶液中任一种的结果有65%超出SM±25%，16%超出SM±50%（“极具误导性”）。在第5次和第7次调查中，相应的数字分别为27%和5%以及18%和0%。EMIT在所有调查中表现出色。使用诊断敏感性测试琼脂（Oxoid）的琼脂孔扩散测定法比其他平板扩散测定法表现更好。定期参与的实验室表现优于其他实验室。得出的结论是，正在继续进行的调查计划为公正地控制市售和非商业检测技术提供了外部设施，并且在提高庆大霉素检测标准方面发挥了作用。强调这些调查不能取代内部质量控制，内部质量控制最好通过对已知效价样品的每日测量和定期统计评估来进行。
