Tonyushkina Ksenia, Nichols James H
Department of Pediatrics, Section of Endocrinology, Baystate Children's Hospital, Tufts University School of Medicine, Springfield, Massachusetts 01199, USA.
J Diabetes Sci Technol. 2009 Jul 1;3(4):971-80. doi: 10.1177/193229680900300446.
Glucose meters are universally utilized in the management of hypoglycemic and hyperglycemic disorders in a variety of healthcare settings. Establishing the accuracy of glucose meters, however, is challenging. Glucose meters can only analyze whole blood, and glucose is unstable in whole blood. Technical accuracy is defined as the closeness of agreement between a test result and the true value of that analyte. Truth for glucose is analysis by isotope dilution mass spectrometry, and frozen serum standards analyzed by this method are available from the National Institute of Standards and Technology. Truth for whole blood has not been established, and cells must be separated from the whole blood matrix before analysis by a method like isotope dilution mass spectrometry. Serum cannot be analyzed by glucose meters, and isotope dilution mass spectrometry is not commonly available in most hospitals and diabetes clinics to evaluate glucose meter accuracy. Consensus standards recommend comparing whole blood analysis on a glucose meter against plasma/serum centrifuged from a capillary specimen and analyzed by a clinical laboratory comparative method. Yet capillary samples may not provide sufficient volume to test by both methods, and venous samples may be used as an alternative when differences between venous and capillary blood are considered. There are thus multiple complexities involved in defining technical accuracy and no clear consensus among standards agencies and professional societies on accuracy criteria. Clinicians, however, are more concerned with clinical agreement of the glucose meter with a serum/plasma laboratory result. Acceptance criteria for clinical agreement vary across the range of glucose concentrations and depend on how the result will be used in screening or management of the patient. A variety of factors can affect glucose meter results, including operator technique, environmental exposure, and patient factors, such as medication, oxygen therapy, anemia, hypotension, and other disease states. This article reviews the challenges involved in obtaining accurate glucose meter results.
血糖仪在各种医疗环境中被广泛用于管理低血糖和高血糖病症。然而，确定血糖仪的准确性具有挑战性。血糖仪只能分析全血，而葡萄糖在全血中不稳定。技术准确性被定义为测试结果与该分析物真实值之间的一致程度。葡萄糖的真值是通过同位素稀释质谱分析法测定的，美国国家标准与技术研究院提供用这种方法分析的冷冻血清标准品。全血的真值尚未确定，在通过同位素稀释质谱分析法等方法进行分析之前，必须将细胞与全血基质分离。血糖仪无法分析血清，而且大多数医院和糖尿病诊所通常没有同位素稀释质谱分析法来评估血糖仪的准确性。共识标准建议将血糖仪上的全血分析结果与从毛细血管标本中离心得到的血浆/血清进行比较，并通过临床实验室比较方法进行分析。然而，毛细血管样本可能无法提供足够的体积来同时用两种方法进行检测，考虑到静脉血和毛细血管血之间的差异时，静脉血样本可以作为替代。因此，在定义技术准确性方面存在多种复杂情况，标准机构和专业协会在准确性标准上没有明确的共识。然而，临床医生更关注血糖仪与血清/血浆实验室结果之间的临床一致性。临床一致性的接受标准因葡萄糖浓度范围而异，并取决于结果将如何用于患者的筛查或管理。多种因素会影响血糖仪的结果，包括操作人员技术、环境暴露以及患者因素，如用药、氧疗、贫血、低血压和其他疾病状态。本文综述了获得准确血糖仪结果所涉及的挑战。
