Abstract：
OBJECTIVE: Blood glucose meters are commonly used at the bedside, but most of the meters used in Hung Vuong Hospital (Ho Chi Minh City, Vietnam) are built for self-monitoring and might not be suitable for determining glucose levels in patients. In this study, we aimed to validate the performance of six frequently used meters in our hospital using the Clinical & Laboratory Standards Institute (CLSI) standard, and investigate the hematocrit impact on the accuracy of these meters.
METHODS: A total of 135 pregnant women who underwent a 75-g oral glucose tolerance test consented to participate in the study at Hung Vuong Hospital. Whole blood glucose levels were measured in duplicate using meters, and hematocrit levels were measured using an Alinity h-series analyzer. Within 5 min, plasma glucose levels were measured twice in a row using the Cobas c502 reference analyzer. For accuracy and precision, the hematocrit effect was assed using CLSI POCT12-A3.
RESULTS: Out of six evaluated meters, three meters qualified. For CLSI criterion at glucose concentration of 5.55 mmol/L, Accu-Chek Inform II, Accu-Chek Performa and OneTouch VerioVue achieved 97.31%, 98.08% and 99.62%, respectively. For CLSI criterion at 4.17 mmol/L, these three achieved 100%. Accu-Chek Inform II and Accu-Chek Performa showed an inverse correlation between glucose level and hematocrit with slopes of -0.500 (95% confidence interval -0.678 to -0.322) and -0.396 (95% confidence interval -0.569 to -0.224), whereas OneTouch VerioVue was not affected by hematocrit, with a slope of 0.207 (95% confidence interval -0.026 to 0.440).
CONCLUSIONS: Blood glucose meters\' measurements can be affected by hematocrit, and might provide readings not within an acceptable bias. Medical organizations need to verify or validate before using on patients.
METHODS: A total of 135 pregnant women who underwent a 75-g oral glucose tolerance test consented to participate in the study at Hung Vuong Hospital. Whole blood glucose levels were measured in duplicate using meters, and hematocrit levels were measured using an Alinity h-series analyzer. Within 5 min, plasma glucose levels were measured twice in a row using the Cobas c502 reference analyzer. For accuracy and precision, the hematocrit effect was assed using CLSI POCT12-A3.
RESULTS: Out of six evaluated meters, three meters qualified. For CLSI criterion at glucose concentration of 5.55 mmol/L, Accu-Chek Inform II, Accu-Chek Performa and OneTouch VerioVue achieved 97.31%, 98.08% and 99.62%, respectively. For CLSI criterion at 4.17 mmol/L, these three achieved 100%. Accu-Chek Inform II and Accu-Chek Performa showed an inverse correlation between glucose level and hematocrit with slopes of -0.500 (95% confidence interval -0.678 to -0.322) and -0.396 (95% confidence interval -0.569 to -0.224), whereas OneTouch VerioVue was not affected by hematocrit, with a slope of 0.207 (95% confidence interval -0.026 to 0.440).
CONCLUSIONS: Blood glucose meters\' measurements can be affected by hematocrit, and might provide readings not within an acceptable bias. Medical organizations need to verify or validate before using on patients.
摘要：
目的：血糖仪通常用于床边，但洪武医院(胡志明市，越南）是为自我监测而建造的，可能不适合确定患者的血糖水平。在这项研究中,我们的目的是使用临床和实验室标准研究所（CLSI）标准来验证我们医院六个常用仪表的性能，并研究血细胞比容对这些仪表准确性的影响。
方法：共有135名接受75克口服葡萄糖耐量试验的孕妇同意参加洪富荣医院的研究。用米测量全血葡萄糖水平一式两份，和血细胞比容水平使用Alinityh系列分析仪测量。5分钟内,使用Cobasc502参考分析仪连续两次测量血浆葡萄糖水平.为了准确和精确，使用CLSIPOCT12-A3评估血细胞比容效应。
结果：在六个评估仪表中，三米合格。对于葡萄糖浓度为5.55mmol/L的CLSI标准，Accu-ChekInformII,Accu-ChekPerforma和OneTouchVerioVue实现了97.31%，98.08%和99.62%,分别。对于4.17mmol/L的CLSI标准，这三者达到了100%。Accu-ChekInformII和Accu-ChekPerforma显示葡萄糖水平与血细胞比容之间呈负相关，斜率为-0.500（95％置信区间-0.678至-0.322）和-0.396（95％置信区间-0.569至-0.224），而OneTouchVerioVue不受血细胞比容的影响，斜率为0.207（95%置信区间-0.026至0.440）。
结论：血糖仪的测量值会受到血细胞比容的影响，并可能提供不在可接受偏差范围内的读数。医疗机构需要在患者使用之前进行验证或验证。
方法：共有135名接受75克口服葡萄糖耐量试验的孕妇同意参加洪富荣医院的研究。用米测量全血葡萄糖水平一式两份，和血细胞比容水平使用Alinityh系列分析仪测量。5分钟内,使用Cobasc502参考分析仪连续两次测量血浆葡萄糖水平.为了准确和精确，使用CLSIPOCT12-A3评估血细胞比容效应。
结果：在六个评估仪表中，三米合格。对于葡萄糖浓度为5.55mmol/L的CLSI标准，Accu-ChekInformII,Accu-ChekPerforma和OneTouchVerioVue实现了97.31%，98.08%和99.62%,分别。对于4.17mmol/L的CLSI标准，这三者达到了100%。Accu-ChekInformII和Accu-ChekPerforma显示葡萄糖水平与血细胞比容之间呈负相关，斜率为-0.500（95％置信区间-0.678至-0.322）和-0.396（95％置信区间-0.569至-0.224），而OneTouchVerioVue不受血细胞比容的影响，斜率为0.207（95%置信区间-0.026至0.440）。
结论：血糖仪的测量值会受到血细胞比容的影响，并可能提供不在可接受偏差范围内的读数。医疗机构需要在患者使用之前进行验证或验证。
