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Recalibration of cystatin C using standardized material in Siemens nephelometers.
Pediatric Nephrology ( IF 3 ) Pub Date : 2019-11-03 , DOI: 10.1007/s00467-019-04389-2
George J Schwartz 1 , Christopher Cox 2 , Jesse C Seegmiller 3 , Paula S Maier 1 , Donna DiManno 1 , Sue L Furth 4 , Bradley A Warady 5 , Alvaro Munoz 2
Affiliation  

BACKGROUND Cystatin C is a key GFR biomarker. Recently, Siemens recalibrated the assay based on certified reference material ERM-DA471/IFCC. The NIH-funded longitudinal chronic kidney disease in children (CKiD) study has > 3000 cystatin C measurements based on a pre-IFCC calibrator provided by Siemens. Since cystatin C values for CKiD are now standardized to IFCC certified reference material, it is important to relate the IFCC-calibrated results to the previous values so that there are no discontinuous results. METHODS We diluted cystatin C ERM-DA471/IFCC (5.48 mg/L) into buffer and compared results with predicted ones. We then updated the cystatin C application on our BN II nephelometer to provide results based on pre-IFCC and IFCC calibrations of CKiD specimens simultaneously. We assayed 51 previously analyzed sera and 62 fresh additional specimens. RESULTS The predicted concentrations from the IFCC standard were consistently 17% higher than the measured values using the pre-IFCC calibration (y = 1.1686x). Similarly, the re-run and fresh sample concentrations were 17% higher via the IFCC calibration than by the pre-IFCC calibration (y = 1.168x). There was very high reliability in the measurements using the previous calibration for re-run specimens (0.99) and for 33 pristine specimens using IFCC calibration (0.99). CONCLUSIONS We confirm the recalibration proposed by Siemens. To convert pre-IFCC results to IFCC-calibrated concentrations, the value is multiplied by 1.17. Conversely, one divides IFCC-calibrated results by 1.17 to estimate GFR via previously published pre-IFCC CKiD eGFR equations. For older adolescents, cystatin C has already been standardized and can be directly applied to the CKD-EPI equations.

中文翻译:

使用西门子浊度计中的标准化材料对半胱氨酸蛋白酶抑制剂C进行重新校准。

背景胱抑素C是关键的GFR生物标志物。最近,西门子根据认证的参考材料ERM-DA471 / IFCC重新校准了该测定法。美国国家卫生研究院(NIH)资助的儿童纵向慢性肾脏病(CKiD)研究基于西门子提供的IFCC预先校准器进行了3000多次胱抑素C测量。由于CKiD的半胱氨酸蛋白酶抑制剂C值现在已根据IFCC认证的参考材料进行了标准化,因此将IFCC校准的结果与以前的值联系起来很重要,这样就不会出现不连续的结果。方法我们将半胱氨酸蛋白酶抑制剂C ERM-DA471 / IFCC(5.48 mg / L)稀释至缓冲液中,并将结果与​​预测值进行比较。然后,我们在BN II浊度计上更新了胱抑素C的应用,以同时基于CKiD标本的IFCC前和IFCC校准提供结果。我们分析了51个先前分析的血清和62个新鲜的其他标本。结果IFCC标准的预测浓度始终比使用IFCC之前的标定值(y = 1.1686x)高17%。同样,通过IFCC校准,重新运行和新鲜样品的浓度比IFCC之前的校准高(y = 1.168x)17%。对于重新运行的样品,使用先前的校准(0.99),使用IFCC校准的33个原始样品(0.99),测量具有很高的可靠性。结论我们确认了西门子提议的重新校准。要将IFCC之前的结果转换为IFCC校准浓度,请将该值乘以1.17。相反,人们可以将IFCC校准结果除以1.17,从而通过先前发布的IFCC CKiD eGFR预先方程式估算GFR。对于年龄较大的青少年,
更新日期:2020-01-04
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