Strong negative interference of ethamsylate (Dicynone<sup>®</sup>) in serum creatinine quantification via enzymatic assay using Trinder reaction

Wiewiorka, Ondřej; Dastych, Milan; Čermáková, Z

doi:10.3109/00365513.2013.794300

Cited by 12 publications

(7 citation statements)

References 2 publications

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“…This approach more objectively reflects the presence of interference than those using the alkaline picrate method, as previously compared in the other study. 5 Second, blood concentrations of calcium dobesilate in healthy participants and patients were measured, which would have consolidated our results of dose-dependent deviations in Cr levels. However, certain limitations were still present in our analyses and include a relatively small sample size and a significant age difference between healthy participants and hospitalized patients, which may influence the results.…”

Section: Discussionmentioning

confidence: 54%

Strong Negative Interference by Calcium Dobesilate in Sarcosine Oxidase Assays for Serum Creatinine Involving the Trinder Reaction

et al. 2015

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The vasoprotective drug calcium dobesilate is known to interfere with creatinine (Cr) quantifications in sarcosine oxidase enzymatic (SOE) assays. The aim of this study was to investigate this interference in 8 different commercially available assays and to determine its clinical significance.In in vitro experiments, interference was evaluated at 3 Cr levels. For this, Cr was quantified by SOE assays in pooled serum supplemented with calcium dobesilate at final concentrations of 0, 2, 4, 8, 16, 32, and 64 μg/mL. Percent bias was calculated relative to the drug-free specimen. For in vivo analyses, changes in serum concentrations of Cr, cystatin C (CysC; a renal function marker), and calcium dobesilate were monitored in healthy participants of group I before and after oral calcium dobesilate administration. In addition, variations in interference were also examined among different SOE assays using serum obtained from healthy participants of group II. Lastly, Cr levels from the 10 patients treated with calcium dobesilate were measured using 4 SOE assays and liquid chromatography-isotope dilution tandem mass spectrometry (LC-IDMS/MS) for comparison.Our in vitro analyses indicated that the presence of 8 μg/mL calcium dobesilate resulted in a −4.4% to −36.3% reduction in Cr serum concentration compared to drug-free serum for 8 SOE assays examined. In vivo, Cr values decreased relative to the baseline level with increasing drug concentration, with the lowest Cr levels obtained at 2 or 3 hours after drug administration in participants of group I. The observed Cr concentrations for participants in group II were reduced by −28.5% to −3.1% and −60.5% to −11.6% at 0 and 2 hours after administration related to baseline levels. The Cr values of 10 patients measured by Roche, Beckman, Maker, and Merit Choice SOE assays showed an average deviation of −20.0%, −22.4%, −14.2%, and −29.6%, respectively, compared to values obtained by LC-IDMS/MS.These results revealed a clinically significant negative interference with calcium dobesilate in all sarcosine oxidase-based Cr assays, but the degree of interference varied greatly among the assays examined. Thus, extra care should be taken in evaluating Cr quantification obtained by SOE assays in patients undergoing calcium dobesilate therapy.

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Section: Discussionmentioning

confidence: 54%

Strong Negative Interference by Calcium Dobesilate in Sarcosine Oxidase Assays for Serum Creatinine Involving the Trinder Reaction

et al. 2015

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“…Drug laboratory test interactions (DLTIs) are one of the major sources of laboratory errors, and it is necessary to strengthen the publicity and education of drug interference and enhance the attention of doctors and patients to drug interference on blood tests 16 . In addition to the calcium dobesilate highlighted in this article, there are also ethamsylate, phenolic sulfoethylamine, acetaminophen, ascorbic acid, catecholamine, aspirin, dopamine, analgin, and rifampicin detection inferenced by color development 17‐20 . Trinder's reaction involves not only creatinine but also uric acid (UA), triglyceride (TG), cholesterol (TC), high‐density lipoprotein cholesterol (HDL‐C), low‐density lipoprotein cholesterol (LDL‐C), etc 13,21 .…”

Section: Discussionmentioning

confidence: 99%

“…A number of previous studies have reported on calcium dobesilate's interference with creatinine detection based on the Trinder reaction. 13,[15][16][17] Because this reaction interferes with creatinine quantification, this is very detrimental to the evaluation of renal function, and the detection result is lower than the actual result due to negative interference. 15 This can be interpreted as the patient's kidney function is improving or that the medication is responding, thus leading to a clinical misjudgment.…”

Section: Discussionmentioning

confidence: 99%

A new method for anti‐negative interference of calcium dobesilate in serum creatinine enzymatic analysis

Shen

Chen

Cao

2021

Clinical Laboratory Analysis

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Background Serum creatinine is a widely used biomarker for evaluating renal function. Sarcosine oxidase enzymatic (SOE) analysis is currently the most widely used method for the detection of creatinine. This method was negatively interfered with by calcium dobesilate, causing pseudo‐reduced results. The aim of this study was to explore a new method to alleviate the negative interference of this drug on creatinine detection. Method We formulated eight drug concentrations and 12 creatinine concentrations from serum. The SOE method, the new method, and the Jaffe method were used for detection in five systems. Creatinine biases were analyzed under the conditions with or without the interference of calcium dobesilate, at consistent or inconsistent creatinine concentrations. Creatinine concentrations were also analyzed at three medical decision levels (MDLs). Results Calcium dobesilate had negative interference in creatinine SOE analysis. With the increase in calcium dobesilate concentrations, the negative bias increases. The new BG method showed an anti‐negative interference effect. In the Roche system, the BG method reduced the negative bias from −71.11% to −16.7%. In the Abbott system, bias was reduced from −45.15% to −2.74%. In the Beckman system, the bias was reduced from −65.36% to −7.58%. In the Siemens system, the bias was reduced from −58.62% to −7.58%. In the Mindray system, the bias was reduced from −36.29% to −6.84%. Conclusion The new method alleviated the negative interference of calcium dobesilate in creatinine SOE detection. The negative bias could be reduced from −60% or −70% to less than −20%.

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“…For the remaining samples, the observed differences may be partially attributable to systemic differences between different reagents or other unknown interference factors in the serum samples. A number of substances may interfere with creatinine quanti cation using enzymatic assays [24][25][26][27][28][29]. For some patients with large deviating Cr-R and Cr-C assay results who did not have detectable serum CaD, we evaluated the patient's medical records and compared the creatinine levels with those determined by the reference method and identi ed ten cases where this discrepancy may have been caused by the presence of etamsylate.…”

Section: Discussionmentioning

confidence: 99%

“…For some patients with large deviating Cr-R and Cr-C assay results who did not have detectable serum CaD, we evaluated the patient's medical records and compared the creatinine levels with those determined by the reference method and identi ed ten cases where this discrepancy may have been caused by the presence of etamsylate. Etamsylate is known to interfere with enzymatic creatinine assays [28][29]. The Cr-R assay also solved the problem of interference by etamsylate, and generally gave more accurate serum creatinine results in these cases.…”

Section: Discussionmentioning

confidence: 99%

Multicentre Evaluation of a Newly Developed Anti-Calcium Dobesilate-Enzymatic Creatinine Assay Based on Real-World Data in China

Guo¹,

Hou²,

Lu³

et al. 2020

Preprint

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BackgroundPreviously, we reported that calcium dobesilate (CaD), a vasoprotective agent mainly used for diabetic retinopathy, negatively interferes with enzymatic creatinine assays. Anewly developed enzymatic creatinine assay, the “Cr-R assay”, is commercially available and claims to have no interference from CaD. This study aimed to verify the performance of the Cr-R assay on clinical samples and to investigate the degree of CaD interference in a multicentre, real-world study.MethodsThe precision and accuracy ofthe Cr-R assay was evaluated in 23 hospitals in different regions of China. Interference was then calculated both in vitro and in clinical samples. Samples with potential interference were screened based on the different creatinine results between Cr-R and the creatinine assays commonly used in each participating hospital (Cr-C). Interference was confirmed by determining serum CaD concentration by directly using ultra-performance liquid chromatography (UPLC) methodand by assessing the “true” creatinine levels using the standard isotope dilution mass spectrometry (ID-MS/MS) method. ResultsTheprecision and bias and anti-interference ability of Cr-R assay on most platforms fulfilled the specification criteria. In the clinical setting, 67,469 samples were tested in 23 centres, and CaD concentration was measured in 818 samples, of which 257 contained CaD, accounting for 0.38% of the total and 31% of screened patients. In these 257 cases, the median CaD concentration was 11.356 (range, 1.350–121.519; IQR, 7.162–21.175) μg/mL. Creatinine levels measured using Cr-C assay were up to 35.1% (95%CI, 37.9–32.4 %; P < 0.001) lower than the “real” creatinine levels using the ID-MS/MSmethod. For Cr-R reagent, the average bias from the reference method was -6.2% (95%CI, -7.9–4.6%; P < 0.001), ranging from -17.9% to 7.1%.ConclusionsMulticentre tests confirmed that the precision, bias, and anti-CaD ability of the Cr-R assay met clinical needs. The prevalence of CaD interference should be considered when performing clinical enzymatic creatinine measurements.Other manufacturers should improve the anti-interference performance of creatinine reagents.

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Strong negative interference of ethamsylate (Dicynone^®) in serum creatinine quantification via enzymatic assay using Trinder reaction

Cited by 12 publications

References 2 publications

Strong Negative Interference by Calcium Dobesilate in Sarcosine Oxidase Assays for Serum Creatinine Involving the Trinder Reaction

Strong Negative Interference by Calcium Dobesilate in Sarcosine Oxidase Assays for Serum Creatinine Involving the Trinder Reaction

A new method for anti‐negative interference of calcium dobesilate in serum creatinine enzymatic analysis

Multicentre Evaluation of a Newly Developed Anti-Calcium Dobesilate-Enzymatic Creatinine Assay Based on Real-World Data in China

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Strong negative interference of ethamsylate (Dicynone®) in serum creatinine quantification via enzymatic assay using Trinder reaction

Cited by 12 publications

References 2 publications

Strong Negative Interference by Calcium Dobesilate in Sarcosine Oxidase Assays for Serum Creatinine Involving the Trinder Reaction

Strong Negative Interference by Calcium Dobesilate in Sarcosine Oxidase Assays for Serum Creatinine Involving the Trinder Reaction

A new method for anti‐negative interference of calcium dobesilate in serum creatinine enzymatic analysis

Multicentre Evaluation of a Newly Developed Anti-Calcium Dobesilate-Enzymatic Creatinine Assay Based on Real-World Data in China

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Strong negative interference of ethamsylate (Dicynone^®) in serum creatinine quantification via enzymatic assay using Trinder reaction