Chan Pak Cheung R, Rozmanc Mary, Seiden-Long Isolde, Kwan Jason
Department of Clinical Pathology, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada M4N 3M5.
Clin Biochem. 2009 Jul;42(10-11):1104-12. doi: 10.1016/j.clinbiochem.2009.03.023. Epub 2009 Apr 5.
To evaluate the performance of the StatStrip glucose meter from Nova Biomedical for use in complex tertiary care facilities.
Performance evaluation was conducted in 6 clinical locations involving nurse end-users. Imprecision (CV)<5% was considered acceptable. Ten substances were examined for potential analytical interferences at two levels and 3 glucose concentrations. Inaccuracy was determined by 386 paired glucose differences between glucose meter and laboratory reference analyses. Acceptability was based on CSLI/ISO15197 criteria. Potential clinical impact was classified under a 5-level severity scheme.
Imprecision varied from CV 2.4 to 4.9%. Significant interference was observed only for free hemoglobin at 10 g/L. 97% of paired glucose meter-laboratory differences met CSLI/ISO15197 criteria. All discrepant results had low severity scores.
The StatStrip glucose meter demonstrated acceptable imprecision and inaccuracy, and was relatively free from common interferences. It should be a good candidate for general use in complex tertiary care facilities.
评估新生物医学公司的StatStrip血糖仪在复杂三级医疗机构中的性能。
在6个涉及护士终端用户的临床地点进行性能评估。不精密度（CV）<5%被认为是可接受的。对10种物质在两个水平和3种葡萄糖浓度下进行潜在分析干扰检查。通过血糖仪与实验室参考分析之间的386对葡萄糖差异确定不准确性。可接受性基于CSLI/ISO15197标准。潜在临床影响根据5级严重程度方案进行分类。
不精密度的CV范围为2.4%至4.9%。仅在游离血红蛋白浓度为10 g/L时观察到显著干扰。97%的血糖仪与实验室配对差异符合CSLI/ISO15197标准。所有差异结果的严重程度得分都很低。
StatStrip血糖仪表现出可接受的不精密度和不准确性，并且相对不受常见干扰。它应该是在复杂三级医疗机构中普遍使用的良好候选产品。
