From Flinders University International Centre for Point-of-Care Testing, Flinders University, Adelaide, South Australia, Australia (Regnier, M. Shephard, A. Shephard).
Royal College of Pathologists of Australasia Quality Assurance Programs, St Leonards, New South Wales, Australia (Graham, DeLeon, A. Shepherd).
Arch Pathol Lab Med. 2020 Oct 1;144(10):1199-1203. doi: 10.5858/arpa.2020-0106-OA.
CONTEXT.—: The burden of chronic kidney disease in Indigenous Australians is 7.3 times higher than that of non-Indigenous Australians. If chronic kidney disease is detected early and managed, deterioration in kidney function can be reduced. Urine albumin to creatinine ratio is a key marker of early renal damage.
OBJECTIVE.—: To report on 16 years of analytic quality of urine albumin to creatinine ratio testing on Siemens DCA devices enrolled in the national Quality Assurance for Aboriginal and Torres Strait Islander Medical Services point-of-care testing program.
DESIGN.—: Quality Assurance for Aboriginal and Torres Strait Islander Medical Services participants are required to test 2 quality assurance samples each month across two 6-monthly testing cycles per year. Participants also test 2 quality control samples monthly.
RESULTS.—: The percentage of urine albumin, creatinine, and albumin to creatinine ratio results for quality assurance point-of-care testing that were within assigned allowable limits of performance averaged 96.9%, 95.9%, and 97.5%, respectively. The percentage acceptable quality control results for urine albumin and creatinine averaged 93.5% and 86.8%. The median imprecision for urine albumin, creatinine, and albumin to creatinine ratio quality assurance testing averaged 5.5%, 4.1%, and 3.3%, respectively, and the median within-site imprecision for quality control testing averaged 5.4%, 4.3%, and 5.7%, respectively, for the low sample and 4.0%, 4.1%, and 4.5%, respectively, for the high sample.
CONCLUSIONS.—: For 16 years the DCA system has proven to be reliable and robust and operators at Aboriginal medical services have demonstrated they are able to conduct point-of-care testing for urine albumin to creatinine ratio that consistently meets analytic performance standards.
澳大利亚原住民慢性肾病的负担是非原住民的 7.3 倍。如果早期发现并管理慢性肾病，可以减少肾功能的恶化。尿白蛋白与肌酐比值是早期肾损伤的关键标志物。
报告西门子 DCA 设备在全国原住民和托雷斯海峡岛民医疗服务点护理测试计划中的尿液白蛋白与肌酐比值检测 16 年的分析质量。
原住民和托雷斯海峡岛民医疗服务参与者每年需要在两个 6 个月的测试周期中每月测试 2 个质量保证样本。参与者还每月测试 2 个质量控制样本。
尿液白蛋白、肌酐和白蛋白与肌酐比值的质量保证点护理测试结果在可接受的性能范围内的百分比分别平均为 96.9%、95.9%和 97.5%。尿液白蛋白和肌酐的可接受质量控制结果的百分比分别平均为 93.5%和 86.8%。尿液白蛋白、肌酐和白蛋白与肌酐比值质量保证测试的中位数不精密度分别平均为 5.5%、4.1%和 3.3%，而质量控制测试的中位数内站点不精密度分别平均为 5.4%、4.3%和 5.7%（低样本）和 4.0%、4.1%和 4.5%（高样本）。
16 年来，DCA 系统已被证明是可靠和强大的，原住民医疗服务的操作人员已经证明，他们能够进行尿液白蛋白与肌酐比值的即时护理测试，并且始终符合分析性能标准。
