Chan Michael H M, Ng K F, Szeto C C, Lit Lydia C W, Chow K M, Leung C B, Suen Michael W M, Li Phillip K T, Lam Christopher W K
Department of Chemical Pathology, The Chinese University of Hong Kong, Prince of Wales Hospital, Shatin, Hong Kong, China.
Ann Clin Biochem. 2004 Nov;41(Pt 6):482-4. doi: 10.1258/0004563042466776.
Roche Diagnostics has issued new c-fas calibrators for its automated systems. These produce creatinine values that are more comparable with those obtained by high-performance liquid chromatography. However, this results in an underestimation of measured creatinine at concentrations below 155 micromol/L and an overestimation at concentrations above this value.
Serum and urine creatinine concentrations were prospectively determined on samples from 60 patients using the new (compensated) and old (uncompensated) c-fas calibrators, and Passing-Bablok regression analysis was performed. The regression equations thus determined were then used retrospectively to determine the compensated creatinine results (i.e. those results that would have been obtained using the new calibrator) in those serum and urine samples analysed in the previous year using the old uncompensated c-fas calibrator. The compensated creatinine results were then used to estimate the glomerular filtration rate (GFR) by calculating creatinine clearance. This was done by using the formula: UV/Pt, in which U represents the urinary creatinine concentration (micromol/L), V the urinary collection volume (mL), P the serum creatinine concentration (micromol/L) and t the urinary collection time (min). It was also calculated using the abbreviated Modification of Diet in Renal Disease study group (MDRD) formula.
The creatinine clearance as determined using either the UV/Pt calculation or the MDRD formula overestimated GFR by approximately 30% and approximately 50%, respectively, in normal individuals with a serum creatinine concentration below 155 micromol/L. However, in patients with mild to moderate renal failure (serum creatinine from 155 to 500 micromol/L), changes in creatinine clearances determined by the two procedures were minimal.
When laboratories introduce this new, compensated calibrator into practice, it may be appropriate to discuss its potential impact with clinical staff who monitor patients using creatinine clearance.
罗氏诊断公司已为其自动化系统发布了新的c-fas校准品。这些校准品产生的肌酐值与通过高效液相色谱法获得的值更具可比性。然而,这导致在浓度低于155微摩尔/升时测量的肌酐被低估,而在高于此值的浓度时被高估。
前瞻性地使用新的(补偿性)和旧的(未补偿)c-fas校准品测定60例患者样本中的血清和尿肌酐浓度,并进行Passing-Bablok回归分析。然后使用由此确定的回归方程回顾性地确定在前一年使用旧的未补偿c-fas校准品分析的那些血清和尿液样本中的补偿肌酐结果(即使用新校准品本应获得的结果)。然后通过计算肌酐清除率,使用补偿肌酐结果来估计肾小球滤过率(GFR)。这是通过使用公式:UV/Pt来完成的,其中U代表尿肌酐浓度(微摩尔/升),V代表尿液收集体积(毫升),P代表血清肌酐浓度(微摩尔/升),t代表尿液收集时间(分钟)。也使用简化的肾脏病饮食改良研究组(MDRD)公式进行计算。
在血清肌酐浓度低于155微摩尔/升的正常个体中,使用UV/Pt计算或MDRD公式确定的肌酐清除率分别高估GFR约30%和约50%。然而,在轻度至中度肾衰竭患者(血清肌酐为155至500微摩尔/升)中,两种方法确定的肌酐清除率变化最小。
当实验室将这种新的补偿校准品引入实践时,与使用肌酐清除率监测患者的临床工作人员讨论其潜在影响可能是合适的。