Department of Laboratory Medicine, Children's Hospital Boston, Boston, MA, USA.
Pediatr Diabetes. 2011 Nov;12(7):649-55. doi: 10.1111/j.1399-5448.2011.00768.x. Epub 2011 Mar 29.
Diagnosis and management of diabetic ketoacidosis (DKA) often rely on the measurement of urine ketones along with blood glucose, anion gap, and pH. These values, however, do not reliably reflect the severity of ketoacidosis. The Abbott Precision Xceed Pro® meter is an FDA-approved device that quantitatively measures β-hydroxybutyrate (BOH) in whole blood. This study was undertaken to determine whether the ketone meter meets the analytical criteria to aid DKA diagnosis and management in the hospital.
54 heparinized venous whole blood BOH concentrations from 27 diabetic patients were measured by the Abbott meter, and compared with the plasma BOH concentrations measured with Stanbio reagent (reference method). Measurements were done in the hospital central laboratory.
Of the 54 pairs of specimens analyzed, 17 pairs displayed a difference of >15% between the two methods. Nearly all discrepant points occurred when BOH >5 mmol/L (reference method). Linearity evaluation revealed that the meter is not linear from 0.0 to 8.0 mmol/L, contrary to the claim by the manufacturer. Further, we identified acetoacetate, a metabolite commonly present in DKA patients, as a potential interfering substance for the meter BOH measurement.
BOH measurements by the Abbott meter up to 3 mmol/L correlate well with the reference method, but become discrepant above that point. While this characteristic may be useful in the diagnosis of DKA, it may not allow clinicians to serially follow the response to therapy in hospitalized DKA patients with BOH values greater than 5 mmol/L (reference method).
糖尿病酮症酸中毒（DKA）的诊断和管理通常依赖于尿酮体与血糖、阴离子间隙和 pH 值的测量。然而，这些值并不能可靠地反映酮症酸中毒的严重程度。雅培 Precision Xceed Pro® meter 是一种经过 FDA 批准的设备，可定量测量全血中的 β-羟丁酸（BOH）。本研究旨在确定该酮体计是否符合分析标准，以帮助在医院诊断和管理 DKA。
对 27 例糖尿病患者的 54 份肝素化静脉全血 BOH 浓度进行了 Abbott meter 测量，并与 Stanbio 试剂（参考方法）测量的血浆 BOH 浓度进行了比较。测量在医院中心实验室进行。
在分析的 54 对标本中，有 17 对两种方法的差异>15%。几乎所有的差异点都发生在 BOH >5 mmol/L（参考方法）时。线性评估显示，该计在 0.0 至 8.0 mmol/L 范围内不是线性的，这与制造商的说法相反。此外，我们发现乙酰乙酸盐，一种常见于 DKA 患者的代谢物，是该计 BOH 测量的潜在干扰物质。
Abbott meter 测量的 BOH 在 3 mmol/L 以下与参考方法相关性良好，但超过该点则会出现差异。虽然这一特性在 DKA 的诊断中可能有用，但它可能不允许临床医生在 BOH 值大于 5 mmol/L（参考方法）的住院 DKA 患者中连续监测治疗反应。
