Wilson Siobhan, Earle Hannah, Bohn Mary Kathryn, Hall Alexandra, Adeli Khosrow
CALIPER Program, Department of Pediatric Laboratory Medicine, The Hospital for Sick Children, Toronto, ON, Canada.
Department of Laboratory Medicine & Pathobiology, Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
J Appl Lab Med. 2022 Mar 2;7(2):582-588. doi: 10.1093/jalm/jfab155.
Glucose testing at the point-of-care (POC) is routinely used in the diagnosis, prognosis, and monitoring of diabetic states and other clinical conditions. Accurate reference intervals (RIs) are essential in appropriate clinical decision-making. In this study, RIs were established for random glucose (whole blood) in the Canadian Laboratory Initiative on Pediatric Reference (CALIPER) cohort using 2 POC instruments: the Nova Biomedical StatStrip (handheld glucometer) and Radiometer ABL90 FLEX Plus (benchtop instrument). An analytical comparison was also completed between the 2 POC systems and a laboratory-based analyzer (Ortho Vitros 5600).
Approximately 400 healthy children and adolescents (birth to 18 years) were recruited with informed consent from community schools or clinics providing care to metabolically stable/healthy children. Random venous samples were collected and run sequentially on the Nova Biomedical StatStrip (whole blood), Radiometer ABL90 FLEX Plus (whole blood), and Ortho Vitros 5600 (serum). RIs and method comparisons between analytical platforms were completed according to CLSI guidelines.
Significantly different glucose concentrations were observed in infancy, requiring age-specific partitioning (0-<1 month, 1-<6 months, 6 months-<19 years) on all platforms. Excellent concordance was observed between POC platforms (Pearson r > 0.90), with a small negative bias. Good comparability was observed between POC and laboratory-based platforms (Pearson r > 0.80).
This study established comprehensive pediatric RIs for random glucose (whole blood) on modern POC systems in the CALIPER cohort for the first time. Results demonstrate excellent concordance in glucose values between POC systems and good comparability with a laboratory-based analyzer. These data will assist in more accurate clinical decision-making in pediatric healthcare institutions.
即时检测（POC）血糖检测常用于糖尿病状态及其他临床病症的诊断、预后评估和监测。准确的参考区间（RIs）对于恰当的临床决策至关重要。在本研究中，使用两种POC仪器，即诺瓦生物医学StatStrip（手持式血糖仪）和雷度ABL90 FLEX Plus（台式仪器），在加拿大儿科参考实验室倡议（CALIPER）队列中建立了随机血糖（全血）的参考区间。还对这两种POC系统与基于实验室的分析仪（奥森多Vitros 5600）进行了分析比较。
从为代谢稳定/健康儿童提供护理的社区学校或诊所，在获得知情同意的情况下招募了约400名健康儿童和青少年（出生至18岁）。采集随机静脉样本，并依次在诺瓦生物医学StatStrip（全血）、雷度ABL90 FLEX Plus（全血）和奥森多Vitros 5600（血清）上进行检测。根据临床和实验室标准协会（CLSI）指南完成了分析平台之间的参考区间和方法比较。
在所有平台上，婴儿期观察到显著不同的血糖浓度，需要按年龄进行划分（0至<1个月、1至<6个月、6个月至<19岁）。POC平台之间观察到极好的一致性（皮尔逊r>0.90），存在小的负偏差。POC平台与基于实验室的平台之间观察到良好的可比性（皮尔逊r>0.80）。
本研究首次在CALIPER队列中的现代POC系统上建立了全面的儿科随机血糖（全血）参考区间。结果表明POC系统之间血糖值具有极好的一致性，与基于实验室的分析仪具有良好的可比性。这些数据将有助于儿科医疗机构做出更准确的临床决策。
