Follin S L, Mueller B A, Scott M K, Carfagna M A, Kraus M A
Department of Pharmacy, St Joseph Hospital, Denver, CO 80218-1191, USA.
Am J Kidney Dis. 1996 Jan;27(1):67-74. doi: 10.1016/s0272-6386(96)90032-3.
Fluorescence polarization immunoassay (FPIA) is the most widely used clinical vancomycin assay in the United States. Questions exist regarding the accuracy of this polyclonal assay in patients with end-stage renal disease (ESRD). While several studies have reported discrepancies in vancomycin serum concentrations determined by FPIA compared with other vancomycin assays, no study has investigated the accuracy of vancomycin serum concentrations determined by FPIA in patients with ESRD undergoing maintenance hemodialysis. Therefore, we compared the assay performance of FPIA and enzyme multiplied immunoassay technique (EMIT) in six subjects with ESRD receiving high-efficiency hemodialysis. Subjects underwent 6 consecutive weeks of hemodialysis treatment with a cellulose acetate dialyzer (CA210) and received 1 g vancomycin intravenously once weekly during the last hour of dialysis. Vancomycin serum concentrations were determined by both EMIT and FPIA methodologies. From the serum concentration results of both assays, vancomycin dosing recommendations were calculated to achieve a desired steady-state peak concentration of 35 mg/L and trough concentration of 10 mg/L. Overall, vancomycin serum concentrations reported by FPIA were significantly higher than those reported by EMIT. The mean difference between assays in the peak serum concentrations at weeks 1, 4, and 6 was 7.5, 11.5, and 11.2 mg/L, respectively. The mean difference in trough serum concentrations at weeks 1, 4, and 6 was 4.2, 6.2, and 5.2 mg/L, respectively. The FPIA overestimation of the EMIT values (calculated as FPIA-EMIT) varied widely among study subjects with a range of 0.0 mg/L to 27.0 mg/L for peak serum concentrations and 0.0 mg/L to 12.8 mg/L for trough serum concentrations. The mean doses calculated based on FPIA results were significantly lower than the EMIT-derived doses. No significant difference was observed in the calculated dosing intervals. These results demonstrate that FPIA significantly overestimates vancomycin serum concentrations compared with EMIT in patients with ESRD undergoing high-efficiency hemodialysis. The overestimation by FPIA may result in significantly different vancomycin dosing recommendations, leading to underdosing and the potential for therapeutic failures. Due to the unpredictability of the overestimation by FPIA, we were unable to formulate vancomycin dosing guidelines for institutions that use FPIA. Therefore, we recommend that the EMIT vancomycin assay be used in patients with ESRD to ensure appropriate dosing.
荧光偏振免疫分析法（FPIA）是美国使用最广泛的临床万古霉素检测方法。对于终末期肾病（ESRD）患者中这种多克隆检测方法的准确性存在疑问。虽然有几项研究报告了FPIA测定的万古霉素血清浓度与其他万古霉素检测方法相比存在差异，但尚无研究调查FPIA测定的万古霉素血清浓度在接受维持性血液透析的ESRD患者中的准确性。因此，我们比较了FPIA和酶放大免疫分析技术（EMIT）在6例接受高效血液透析的ESRD患者中的检测性能。受试者使用醋酸纤维素透析器（CA210）连续进行6周的血液透析治疗，并在透析的最后一小时每周静脉注射1g万古霉素。通过EMIT和FPIA方法测定万古霉素血清浓度。根据两种检测方法的血清浓度结果，计算万古霉素给药建议，以达到预期的稳态峰浓度35mg/L和谷浓度10mg/L。总体而言，FPIA报告的万古霉素血清浓度显著高于EMIT报告的浓度。第1、4和6周时，两种检测方法的血清峰浓度平均差异分别为7.5、11.5和11.2mg/L。第1、4和6周时，血清谷浓度的平均差异分别为4.2、6.2和5.2mg/L。FPIA对EMIT值的高估（计算为FPIA - EMIT）在研究对象中差异很大，血清峰浓度范围为0.0mg/L至27.0mg/L，血清谷浓度范围为0.0mg/L至12.8mg/L。根据FPIA结果计算的平均剂量显著低于基于EMIT得出的剂量。在计算的给药间隔方面未观察到显著差异。这些结果表明，在接受高效血液透析的ESRD患者中，与EMIT相比，FPIA显著高估了万古霉素血清浓度。FPIA的高估可能导致显著不同的万古霉素给药建议，导致剂量不足和治疗失败的可能性。由于FPIA高估的不可预测性，我们无法为使用FPIA的机构制定万古霉素给药指南。因此，我们建议在ESRD患者中使用EMIT万古霉素检测方法以确保适当给药。
