Inoue Akitoshi, Nitta Norihisa, Ohta Shinichi, Imoto Katsuji, Yamasaki Michio, Ikeda Mitsuru, Murata Kiyoshi
Department of Radiology, Shiga University of Medical Science, Seta-Tsukinowa-cho, Otsu, Shiga 520-2192, Japan.
Department of Radiology, Kohka Public Hospital, Koka, Shiga 528-0074, Japan.
Exp Ther Med. 2017 Jun;13(6):3503-3508. doi: 10.3892/etm.2017.4389. Epub 2017 Apr 26.
The current study assessed the accuracy of the StatSensor-i (STA) point-of-care creatinine analyzer prior to and following adjustment (offset correction) by linear regression scatter plots produced by the reference samples from patients and volunteers for detecting high risk of contrast-induced nephropathy in patients with an estimated glomerular filtration rate <45 ml/min/1.73 m. Blood samples were obtained from 233 consecutive outpatients scheduled for contrast-enhanced CT studies. Of the 233 patients, 123 patient samples were evaluated prior to adjustment and the other 110 following adjustment. Serum creatinine levels and estimated glomerular filtration rate were measured using the analyzer and compared with the values returned by laboratory tests. Analysis was with the paired t-test, the Pearson correlation coefficient and Bland-Altman plotting. The sensitivity, specificity, positive and negative predictive values (PPV, NPV), and accuracy for detecting patients with an estimated glomerular filtration rate <45 ml/min/1.73 m were subsequently calculated. Mean serum creatinine levels measured with the analyzer were significantly higher than those returned by laboratory tests before (P<0.0001) and after adjustment (P<0.01). Following adjustment, the difference in serum creatinine values obtained with the STA analyzer and by laboratory methods did not exceed 0.3 mg/dl. Prior to adjustment, 9.7% of the samples were overdiagnosed as having an estimated glomerular filtration rate of <45 ml/min/1.73 m; following adjustment, the overdiagnosis rate was 2.7%. The sensitivity, specificity, PPV, NPV and accuracy were 100, 89, 50, 100 and 90.2% before and 100, 96.3, 33.3, 100 and 96.4% after adjustment, respectively. With the adjusted point-of-care creatinine analyzer, estimated glomerular filtration rate may be reliably evaluated in the radiology suite.
本研究通过对患者和志愿者的参考样本生成的线性回归散点图,评估了StatSensor-i(STA)即时检测肌酐分析仪在调整(偏移校正)前后,对估算肾小球滤过率<45 ml/min/1.73 m²的患者检测对比剂肾病高风险的准确性。从233名连续安排进行增强CT检查的门诊患者中采集血样。在这233名患者中,123份患者样本在调整前进行评估,另外110份在调整后评估。使用该分析仪测量血清肌酐水平和估算肾小球滤过率,并与实验室检测结果进行比较。采用配对t检验、Pearson相关系数和Bland-Altman绘图进行分析。随后计算检测估算肾小球滤过率<45 ml/min/1.73 m²患者的敏感性、特异性、阳性和阴性预测值(PPV、NPV)以及准确性。分析仪测量的平均血清肌酐水平在调整前(P<0.0001)和调整后(P<0.01)均显著高于实验室检测结果。调整后,STA分析仪与实验室方法获得的血清肌酐值差异不超过0.3 mg/dl。调整前,9.7%的样本被过度诊断为估算肾小球滤过率<45 ml/min/1.73 m²;调整后,过度诊断率为2.7%。调整前敏感性、特异性、PPV、NPV和准确性分别为100%、89%、50%、100%和90.2%,调整后分别为100%、96.3%、33.3%、100%和96.4%。使用经调整的即时检测肌酐分析仪,可在放射科可靠地评估估算肾小球滤过率。