OcuSense TearLab™ 渗透压仪的可重复性和再现性。
Reproducibility and repeatability of the OcuSense TearLab™ osmometer.
机构信息
Ophthalmic Research Group, School of Life and Health Sciences, Aston University, Birmingham, B4 7ET, UK.
出版信息
Graefes Arch Clin Exp Ophthalmol. 2012 Aug;250(8):1201-5. doi: 10.1007/s00417-012-1961-4. Epub 2012 Feb 21.
BACKGROUND
Some studies report that increased tear osmolarity is a reliable indicator of dry eye syndrome (DES). The OcuSense TearLab™ osmometer requires less than a 100-nl sample of tears and provides an instant quantitative result. Our aim was to clinically evaluate this instrument in terms of its reproducibility and repeatability.
METHODS
Twenty-nine participants who ranged in age from 19 to 49 years (mean ± SD: 23.3 ± 5.5 years) were recruited. Osmolarity readings were collected by two operators, in two sessions separated by 1 or 2 weeks in order to assess test reproducibility and repeatability.
RESULTS
The coefficient of reproducibility was 39 mOsms/l; the coefficient of repeatability was 33 mOsms/l.
CONCLUSIONS
Our mean coefficient of variation over four readings for 29 subjects is 2.9%, which compares well with that reported by the manufacturer. Our results inform practitioners about the level of change over time that can be considered clinically relevant for healthy subjects. This value is 33mOsms/l; any change smaller than this could be attributed to measurement noise.
背景
一些研究报告表明，泪液渗透压升高是干眼症（DES）的可靠指标。OcuSense TearLab™渗透压计只需不到 100nl 的泪液样本，即可提供即时定量结果。我们的目的是评估该仪器在重复性和再现性方面的临床性能。
方法
共招募了 29 名年龄在 19 至 49 岁之间（平均±标准差：23.3±5.5 岁）的参与者。由两名操作人员在 1 至 2 周的时间间隔内进行两次测试，以评估测试的可重复性和再现性。
结果
重复性系数为 39mOsms/l；再现性系数为 33mOsms/l。
结论
我们对 29 名受试者的四次读数的平均变异系数为 2.9%，与制造商报告的数据相当。我们的结果为临床医生提供了有关健康受试者随时间变化的可被认为具有临床相关性的变化水平的信息。该值为 33mOsms/l；任何小于该值的变化都可能归因于测量噪声。
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