Effects of calcium dobesilate (CaD) interference on serum creatinine measurements: a national External Quality Assessment (EQA)-based educational survey of drug-laboratory test interactions
-
Tianjiao Zhang
, Honglei Li
and Chuanbao Zhang
Abstract
Objectives
Drug-laboratory test interactions (DLTIs) are one of the major sources of laboratory errors. Calcium dobesilate (CaD) interference on serum creatinine testing is a widespread problem that has long been ignored in China. A national EQA-based survey was launched to investigate the current status of CaD interference on creatinine routine methods used in China and enhance the education of CaD interference in clinical laboratories.
Methods
A descriptive survey was developed to characterize the status quo of Chinese laboratory professionals’ cognition to CaD interference. Four of survey samples which were spiked with/without interference additive were shipped to 175 participant laboratories. The target reference values from a reference measurement procedure were compared against the results from participating laboratories to evaluate the CaD interference on serum creatinine measurements using enzymatic method or Jaffé method.
Results
The lack of knowledge of DLTIs and the barriers to collect information from pharmacological and laboratory data systems had become the main problems on implementing DLTIs education in China. A significant negative influence of CaD on enzymatic method was observed regardless of measurement platforms. Jaffé method was generally free from interaction with CaD but showed poor precision and accuracy at low creatinine concentrations.
Conclusions
More efforts should be made to enhance the education of DLTIs in clinical laboratories in China.
Funding source: China Capital Health Research and Development of Special Project
Award Identifier / Grant number: 2016-2-4017
Research funding: This study was financially supported by the China Capital Health Research and Development of Special Project (2016-2-4017).
Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission.
Competing interests: Authors state no conflict of interest.
Ethical approval: Anonymized left-over sera were collected from patients receiving physical examinations or hospitalized at Peking Union Medical College Hospital (PUMCH, Beijing, China). The study was reviewed and approved by the Ethics Committee of PUMCH.
References
1. Kailajärvi, M, Takala, T, Grönroos, P, Tryding, N, Viikariet, J, Irjala, K, et al.. Reminders of drug effects on laboratory test results. Clin Chem 2000;46:1395–400. https://doi.org/10.1093/clinchem/46.9.1395.Search in Google Scholar
2. Friedman, RB, Young, DS, Beatty, ES. Automated monitoring of drug-test interactions. Clin Pharmacol Ther 1978;24:16–21. https://doi.org/10.1002/cpt197824116.Search in Google Scholar
3. Groves, WE, Gajewski, WH. Use of a clinical laboratory computer to warn of possible drug interference with test results. Comput Programs Biomed 1978;8:275–82. https://doi.org/10.1016/0010-468x(78)90035-1.Search in Google Scholar
4. McNeely, MD. Computerized interpretation of laboratory tests: an overview of systems, basic principles and logic techniques. Clin Biochem 1983;16:141–6. https://doi.org/10.1016/s0009-9120(83)93962-0.Search in Google Scholar
5. AACC effects on clinical laboratory tests: drugs, diseases, herbs & natural products. John Wiley and Sons, Inc. Available from: http://clinfx.wiley.com/aaccweb/aacc/login.Search in Google Scholar
6. Forman, DT, Young, DS. Drug interference in laboratory testing. Ann Clin Lab Sci 1976;6:263–71. https://doi.org/10.1021/bk-1976-0036.ch010.Search in Google Scholar
7. Young, DS. Effects of drugs on clinical laboratory tests. Ann Clin Biochem 1997;34:579–81. https://doi.org/10.1177/000456329703400601.Search in Google Scholar
8. van Balveren, JA, Verboeket-van de Venne, WPHG, Erdem-Eraslan, L, de Graaf, AJ, Loot, AE, Musson, REA, et al.. Impact of interactions between drugs and laboratory test results on diagnostic test interpretation – a systematic review. Clin Chem Lab Med 2018;56:2004–9. https://doi.org/10.1515/cclm-2018-0900.Search in Google Scholar
9. Allain, H, Ramelet, AA, Polard, E, Bentué-Ferrer, D. Safety of calcium dobesilate in chronic venous disease, diabetic retinopathy and haemorrhoids. Drug Saf 2004;27:649–60. https://doi.org/10.2165/00002018-200427090-00003.Search in Google Scholar
10. Guder, WG, Hoffmann, GE, Hubbuch, A, Poppe, WA, Siedel, J, Price, CP. Multicentre evaluation of an enzymatic method for creatinine determination using a sensitive colour reagent. J Clin Chem Clin Biochem 1986;24:889–902. https://doi.org/10.1515/cclm.1986.24.11.889.Search in Google Scholar
11. Andreev, E, Koopman, M, Arisz, L. A rise in plasma creatinine that is not a sign of renal failure: which drugs can be responsible? J Intern Med 1999;246:247–52. https://doi.org/10.1046/j.1365-2796.1999.00515.x.Search in Google Scholar
12. Perrone, RD, Madias, NE, Levey, AS. Serum creatinine as an index of renal function: new insights into old concepts. Clin Chem 1992;38:1933–53. https://doi.org/10.1093/clinchem/38.10.1933.Search in Google Scholar
13. Guo, X, Hou, L, Cheng, X, Zhang, T, Yu, S, Fang, H, et al.. Strong negative interference by calcium dobesilate in sarcosine oxidase assays for serum creatinine involving the Trinder reaction. Medicine (Baltimore) 2015;94:e905. https://doi.org/10.1097/MD.0000000000000905.Search in Google Scholar
14. Zhang, CB, Chen, ZY, Ma, R, Zhang, T, Zhao, H, Xie, JH, et al.. Evaluation of matrix effects of reference materials in serum creatinine measurements. Chin J Lab Med 2009;32:515–20. https://doi.org/10.3760/cma.j.issn.1009-9158.2009.05.008.Search in Google Scholar
15. Stokes, P, O’Connor, G. Development of a liquid chromatography-mass spectrometry method for the high-accuracy determination of creatinine in serum. J Chromatogr B Analyt Technol Biomed Life Sci 2003;794:125–36. https://doi.org/10.1016/s1570-0232(03)00424-0.Search in Google Scholar
16. Miller, WG, Myers, GL, Ashwood, ER, Killeen, AA, Wang, E, Thienpont, LM, et al.. Creatinine measurement: state of the art in accuracy and interlaboratory harmonization. Arch Pathol Lab Med 2005;129:297–304. https://doi.org/10.1043/1543-2165(2005)129<297:CMSOTA>2.0.CO;2.10.5858/2005-129-297-CMSOTASearch in Google Scholar PubMed
17. Drion, I, Cobbaert, C, Groenier, KH, Weykamp, C, Bilo, HF, Wetzels, JF, et al.. Clinical evaluation of analytical variations in serum creatinine measurements: why laboratories should abandon Jaffe techniques. BMC Nephrol 2012;13:133. https://doi.org/10.1186/1471-2369-13-133.Search in Google Scholar
18. Piéroni, L, Delanaye, P, Boutten, A, Bargnoux, AS, Rozet, E, Delatour, V, et al.. A multicentric evaluation of IDMS-traceable creatinine enzymatic assays. Clin Chim Acta 2011;412:2070–5. https://doi.org/10.1016/j.cca.2011.07.012.Search in Google Scholar
19. Greenberg, N, Roberts, WL, Bachmann, LM, Wright, EC, Dalton, RN, Zakowski, JJ, et al.. Specificity characteristics of 7 commercial creatinine measurement procedures by enzymatic and Jaffe method principles. Clin Chem 2012;58:391–401. https://doi.org/10.1373/clinchem.2011.172288.Search in Google Scholar
20. van Balveren, JA, Verboeket-van de Venne, WPHG, Erdem-Eraslan, L, de Graaf, AJ, Zakowski, JJ, Musson, REA, et al.. Diagnostic error as a result of drug-laboratory test interactions. Diagnosis (Berl) 2019;6:69–71. https://doi.org/10.1515/dx-2018-0098.Search in Google Scholar
21. Guo, X, Hou, L, Yin, Y, Wu, J, Zhao, F, Xia, L, et al.. Negative interferences by calcium dobesilate in the detection of five serum analytes involving Trinder reaction-based assays. PLoS One 2018;13:e0192440. https://doi.org/10.1371/journal.pone.0192440.Search in Google Scholar
22. Jassam, N, Weykamp, C, Thomas, A, Secchiero, S, Sciacovelli, L, Plebani, M, et al.. Post-standardization of routine creatinine assays: are they suit-able for clinical applications. Ann Clin Biochem 2017;54:386–94. https://doi.org/10.1177/0004563216664541.Search in Google Scholar
23. Benakis, A, Glasson, B, Bouvier, CA, Ritschard, J, Krahenbuhl, B, Jung, A, et al.. Metabolism and pharmacokinetics of calcium dobesilate in humans. Thérapie 1974;29:211–9. PMID: 4849166.Search in Google Scholar
24. Zhou, Y, Qi, C, Li, S, Shao, X, Mou, S, Ni, Z. Diabetic nephropathy can be treated with calcium dobesilate by alleviating the chronic inflammatory state and improving endothelial cell function. Cell Physiol Biochem 2018;51:1119–33. https://doi.org/10.1159/000495491.Search in Google Scholar
Supplementary Material
The online version of this article offers supplementary material (https://doi.org/10.1515/cclm-2020-0424).
© 2020 Walter de Gruyter GmbH, Berlin/Boston
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- The emerging role of cell senescence in atherosclerosis
- Mini Review
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