Biochemia medica最新文献_第3页

Evaluation of the impact of reducing fasting hours on laboratory results in a mediterranean population. 评估地中海人群减少禁食时间对实验室结果的影响。

Biochemia medica Pub Date : 2025-06-15 Epub Date: 2025-04-15 DOI: 10.11613/BM.2025.020703

Gemma Solé-Enrech, Ruth Cano-Corres, Raquel Escribano-Tembleque, Eva Martínez-Sevilla, Núria Busquets-Carmona, Carlos García-Miralles

{"title":"Evaluation of the impact of reducing fasting hours on laboratory results in a mediterranean population.","authors":"Gemma Solé-Enrech, Ruth Cano-Corres, Raquel Escribano-Tembleque, Eva Martínez-Sevilla, Núria Busquets-Carmona, Carlos García-Miralles","doi":"10.11613/BM.2025.020703","DOIUrl":"10.11613/BM.2025.020703","url":null,"abstract":"Introduction: One of the critical points of the preanalytical phase is the patient's adherence to the required fasting duration before undergoing medical analysis. Although many laboratories have already protocols for blood-sample collection that require only a 6-hour fast, clinical guidelines remain unclear on this aspect, and fasting periods of 12 hours are sometimes still recommended. The aim of this study was to evaluate whether there are significant differences between the results obtained in patients' serum samples obtained post-fasting, 4 hours post-meal, and 6 hours post-meal for different predetermined parameters.Materials and methods: 30 volunteers (16 females and 14 males) aged between 23 and 62 years were selected for this study. Each participant underwent an initial analysis after a 10-hour fast (baseline), a second analysis 4 hours after a controlled meal, and a third analysis 6 hours after the meal. The parameters studied correspond to previously selected biochemical, hematological, and coagulation tests. To assess if there are significant differences in the results obtained for each analyte, criteria based on the total allowable error (TEa) and the reference change value (RCV) were used.Results: All parameters evaluated in this study met the criteria based on the RCV at both 4 and 6 hours, although some parameters did not meet TEa criteria.Conclusions: The results obtained in this study demonstrated that a fasting period of 4 or 6 hours is sufficient to obtain reliable results. This could significantly improve the quality of life for patients undergoing analysis without compromising the quality of their results.","PeriodicalId":94370,"journal":{"name":"Biochemia medica","volume":"35 2","pages":"020703"},"PeriodicalIF":0.0,"publicationDate":"2025-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12131384/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144228233","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Interfering heterophile antibodies as the cause of persistently falsely elevated high-sensitivity troponin I on Alinity i: a case report. 干扰性嗜异性抗体引起Alinity上高敏感肌钙蛋白I持续错误升高1例

Biochemia medica Pub Date : 2025-06-15 DOI: 10.11613/BM.2025.021001

Ivana Lapić, Dunja Rogić, Dragana Šegulja, Sandra Jakšić Jurinjak, Željka Vogrinc, Sanja Kačkov, Fran Smaić, Indira Imširović, Lovorka Đerek

{"title":"Interfering heterophile antibodies as the cause of persistently falsely elevated high-sensitivity troponin I on Alinity i: a case report.","authors":"Ivana Lapić, Dunja Rogić, Dragana Šegulja, Sandra Jakšić Jurinjak, Željka Vogrinc, Sanja Kačkov, Fran Smaić, Indira Imširović, Lovorka Đerek","doi":"10.11613/BM.2025.021001","DOIUrl":"10.11613/BM.2025.021001","url":null,"abstract":"Hereby we describe a case of a 59-year-old female patient with persistently elevated high-sensitivity troponin I (hs-TnI) over the course of almost four years measured on Alinity i with the corresponding assay (Abbott Laboratories, Chicago, USA). The patient underwent multiple extensive cardiological evaluations, but none of them suggested acute or chronic cardiac damage. Therefore, interference in measurement was suspected by the attending cardiologist and a detailed, stepwise laboratory investigation was undertaken in the sample with initial hs-TnI result of 2077 ng/L. Serial sample dilutions (1:2,1:5,1:10) did not match the expected, calculated hs-TnI concentrations, yielding both huge positive biases (62, 109 and 139%, respectively) and absolute differences (639, 453 and 290 ng/L, respectively). Precipitation with polyethylene-glycol, pretreatment in heterophilic blocking tubes (HBT) and immunoglobulin G depletion yielded hs-TnI results below the assay's diagnostic cut-off (< 15.6 ng/L). Alternate hs-TnI immunoassays (Siemens Healthineers, Beckman Coulter and Snibe) and measurement with the high-sensitivity troponin T (hs-TnT) assay yielded results below assays' specific cut-off values. This investigation confirmed that results of hs-TnI obtained by the Abbott assay were spuriously elevated. Significant lowering of hs-TnI after HBT pretreatment indicated that heterophile antibodies are the most probable source of interference. Based on this finding, it was entered in the patient's medical record that future determinations of cardiac troponin should be performed with an alternate hs-TnI or hs-TnT assay. This case emphasizes that analytical interferences are usually immunoassay-dependent. Evaluation of laboratory results in the clinical context and close collaboration between laboratory and clinical staff is crucial for their recognition.","PeriodicalId":94370,"journal":{"name":"Biochemia medica","volume":"35 2","pages":"021001"},"PeriodicalIF":0.0,"publicationDate":"2025-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12161512/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144304267","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

National recommendations of the Working group for laboratory diagnostics of autoimmune diseases of the Croatian Society of Medical Biochemistry and Laboratory Medicine: Assessment of antineutrophil cytoplasmic antibodies (ANCA). 克罗地亚医学生物化学和实验室医学学会自身免疫性疾病实验室诊断工作组的国家建议：抗中性粒细胞细胞质抗体的评估。

Biochemia medica Pub Date : 2025-06-15 DOI: 10.11613/BM.2025.020706

Ana Kozmar, Andrea Tešija Kuna, Nada Tomić Sremec, Lovorka Đerek, Vedrana Drvar, Katarina Gugo

{"title":"National recommendations of the Working group for laboratory diagnostics of autoimmune diseases of the Croatian Society of Medical Biochemistry and Laboratory Medicine: Assessment of antineutrophil cytoplasmic antibodies (ANCA).","authors":"Ana Kozmar, Andrea Tešija Kuna, Nada Tomić Sremec, Lovorka Đerek, Vedrana Drvar, Katarina Gugo","doi":"10.11613/BM.2025.020706","DOIUrl":"10.11613/BM.2025.020706","url":null,"abstract":"The family of antineutrophil cytoplasmic antibodies (ANCA) includes autoantibodies targeting proteins within the primary granules of neutrophils and lysosomes of monocytes. So far, proteinase 3 (PR3) and myeloperoxidase (MPO) are considered clinically relevant ANCA specificities. National recommendations for the assessment of ANCA are the outcome of the survey done by the Working group (WG) for laboratory diagnostics of autoimmune diseases of the Croatian Society of Medical Biochemistry and Laboratory Medicine (CSMBLM), where the diversity in the performance of ANCA testing and reporting among the laboratories in Croatia was observed. This document contains recommendations concerning the indications for ANCA testing, preanalytical, analytical and postanalytical issues, including rational algorithm and quality control assurance. The recommendations are based on the International consensus on ANCA testing and reporting as well as other relevant literature in order to help to harmonize ANCA testing. The aim of these recommendations is to improve and harmonize ANCA testing among laboratories in Croatia.","PeriodicalId":94370,"journal":{"name":"Biochemia medica","volume":"35 2","pages":"020706"},"PeriodicalIF":0.0,"publicationDate":"2025-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12161514/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144304268","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Bilirubin - new insights into an old molecule. 胆红素——对一种古老分子的新认识。

Biochemia medica Pub Date : 2025-06-15 Epub Date: 2025-04-15 DOI: 10.11613/BM.2025.020501

Ivana Čepelak, Slavica Dodig, Ivan Pavić

引用次数: 0

Post-exercise creatine kinase variability: a literature review. 运动后肌酸激酶变异性：文献综述。

Biochemia medica Pub Date : 2025-06-15 DOI: 10.11613/BM.2025.020502

Vanja Radišić Biljak, Anja Lazić, Ana Nikler, Damir Pekas, Andrea Saračević, Nebojša Trajković

{"title":"Post-exercise creatine kinase variability: a literature review.","authors":"Vanja Radišić Biljak, Anja Lazić, Ana Nikler, Damir Pekas, Andrea Saračević, Nebojša Trajković","doi":"10.11613/BM.2025.020502","DOIUrl":"10.11613/BM.2025.020502","url":null,"abstract":"Creatine kinase (CK) activity has been generally considered as reliable blood marker for assessing muscle function, damage, and repair. However, the greatest challenge in the interpretation of CK activity remains the high variability in CK increase in relation to degrees of muscle cell damage or disturbance. Several known contributors to CK variability have been identified. The most important include the type of training, exercise intensity, gender differences, body composition, intra- and interindividual biological variability, as well as preanalytical and analytical considerations. Creatine kinase variability following different types of exercise reflects the complex interplay between exercise modality, intensity, individual physiology, and recovery strategies. High-intensity exercises, especially those involving eccentric muscle contractions, tend to produce more significant CK responses due to greater muscle fiber disruption. Gender differences in CK variability are pronounced, with men generally exhibiting higher CK activities following exercise compared to women. Creatine kinase variability is also closely linked to body composition, with muscle mass generally leading to higher CK activities post-exercise, while higher body fat may correlate with lower CK responses. Regarding preanalytical and analytical considerations, perhaps the greatest challenge in CK measurement is the limited sample stability, which should always be taken into consideration when analyzing CK activity in stored samples for research or clinical purposes. This review, through exploring all of the above-mentioned sources of CK variability, could facilitate the development of evidence-based practices for preventing overuse injuries, and promoting long-term athlete health and well-being.","PeriodicalId":94370,"journal":{"name":"Biochemia medica","volume":"35 2","pages":"020502"},"PeriodicalIF":0.0,"publicationDate":"2025-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12161516/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144304269","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Use of Hoteling's T² multivariate control chart for effective monitoring of a laboratory test with a 3-level quality control scheme. 利用hotelingt2多变量控制图有效监控实验室测试的三级质量控制方案。

Biochemia medica Pub Date : 2025-06-15 Epub Date: 2025-04-15 DOI: 10.11613/BM.2025.020701

Cristiano Ialongo

{"title":"Use of Hoteling's T2 multivariate control chart for effective monitoring of a laboratory test with a 3-level quality control scheme.","authors":"Cristiano Ialongo","doi":"10.11613/BM.2025.020701","DOIUrl":"10.11613/BM.2025.020701","url":null,"abstract":"Introduction: A control chart based on Hotelling's T2 multivariate statistics was used to monitor the quality of an immunoenzymatic assay for plasma levetiracetam. The chart incorporated a multi-level quality control (MLQC) system with three concentration levels of the analyte and included the analytical performance specification (APS) for therapeutic drug monitoring.Materials and methods: Data were collected from March 1 to August 14, 2024, comprising 84 consecutive triplets of values for the three MLQC levels. The initial 59 triplets were used to estimate the variance-covariance matrix and vector of means (phase I). These estimates were then applied to calculate Hotelling's T2 for the remaining 25 triplets (phase II). The pharmacokinetic model of Fraser was employed to derive the APS for levetiracetam, based on a twice-daily dosing scheme and a median half-life of 8 hours.Results: The three MLQC levels showed significant correlations (r > 0.6) in both control phases. The Hotelling's T2 control chart detected no out-of-specifications states (OC), compared to 12 OC signals from individual Levey-Jennings charts monitoring the MLQC levels separately. The integration of the APS into the Hotelling's T2 chart provided additional insights into the process quality, and in two instances, it aligned with the OC signal from at least one of the Levey-Jennings charts.Conclusions: Hotelling's T2 multivariate chart is effective for internal quality control of laboratory tests. As MLQC data offer correlated information, this approach is advantageous over multiple individual univariate charts as it ensures the correct level of false positive and false negative alarms.","PeriodicalId":94370,"journal":{"name":"Biochemia medica","volume":"35 2","pages":"020701"},"PeriodicalIF":0.0,"publicationDate":"2025-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12131413/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144228236","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

The impact of demand management on vitamin D testing. 需求管理对维生素D检测的影响。

Biochemia medica Pub Date : 2025-06-15 DOI: 10.11613/BM.2025.020707

Juan José Perales-Afán, Diego Aparicio-Pelaz, Juan José Puente-Lanzarote, Marta Fabre

{"title":"The impact of demand management on vitamin D testing.","authors":"Juan José Perales-Afán, Diego Aparicio-Pelaz, Juan José Puente-Lanzarote, Marta Fabre","doi":"10.11613/BM.2025.020707","DOIUrl":"10.11613/BM.2025.020707","url":null,"abstract":"Introduction: 25-hydroxyvitamin D (25-OH-D) is essential for calcium homeostasis and bone health, with increasing evidence suggesting associations with non-skeletal diseases. However, the lack of consensus on optimal concentrations and laboratory variability has led to clinical uncertainty and excessive testing. This study evaluates the impact of demand management strategies and revised cut-off points on test volumes, unperformed determinations, and cost savings.Material and methods: A retrospective study (January 2015-May 2024) analyzed all 25-OH-D requests. Concentrations of 25-OH-D were measured using electrochemiluminescence assays on a Cobas C8000. An annual trend analysis of 25-OH-D test requests was performed to evaluate changes in demand. In 2018, vitamin D deficiency prevalence was assessed according to three cut-off values (75, 50 and 30 nmol/L). We assessed the impact of demand management rules, implemented in May 2022, to reduce unnecessary testing. The follow-up testing rate was calculated as the proportion of repeat tests within 12 months after determination.Results: There was 25-OH-D testing increased from 10,830 in 2015 to nearly 85,000 in 2023. Demand management strategies led to 12,406 rejections in 2022 (from May onwards), 16,809 in 2023, and 7566 in 2024 (until May), saving €85,600. Follow-up testing rates dropped from ~15% before 2022 to ~5% afterward. Lowering the deficiency threshold from 75 to 50 nmol/L reduced deficiency diagnoses from > 70% to < 50%; at 30 nmol/L, rates could drop to ~10-11%.Conclusions: Demand management strategies effectively reduce unnecessary testing and healthcare costs. Establishing appropriate reference values prevents overestimation of vitamin D deficiency, optimizing clinical and economic outcomes.","PeriodicalId":94370,"journal":{"name":"Biochemia medica","volume":"35 2","pages":"020707"},"PeriodicalIF":0.0,"publicationDate":"2025-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12161517/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144304272","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Routine data analysis for moderate hemolysis interference correction in neuron specific enolase quantification. 神经元特异性烯醇化酶定量中适度溶血干扰校正的常规数据分析。

Biochemia medica Pub Date : 2025-06-15 DOI: 10.11613/BM.2025.020802

Leyre Ruiz, Tomás Munoz, Alvaro González, Estibaliz Alegre

{"title":"Routine data analysis for moderate hemolysis interference correction in neuron specific enolase quantification.","authors":"Leyre Ruiz, Tomás Munoz, Alvaro González, Estibaliz Alegre","doi":"10.11613/BM.2025.020802","DOIUrl":"10.11613/BM.2025.020802","url":null,"abstract":"Introduction: Serum neuron specific enolase (NSE) is used as neuroendocrine tumor and central nervous system damage marker. It is present in variable concentrations in erythrocytes and hemolysis interferes in serum NSE quantification. Our aim was to develop a correction formula for moderate hemolysis, based on repeated patient samples instead of artificial sample doping with hemolysates.Materials and methods: We searched in laboratory informatics system for patients with sample pairs obtained within 24 h, for NSE quantification. We registered NSE and hemolytic index (NSE1 and HI1) from the first moderate hemolyzed sample (HI: 15-80), and from the second non-hemolyzed sample obtained afterwards (NSE2 and HI2). In a development cohort (N = 41), we obtained the formula NSEcalc = NSE1 - (0.354 x (HI1 - HI2)) - 0.162, which was later used in the validation cohort (N = 26) to calculate NSE corrected concentrations (NSEcalc).Results: Concentrations of NSE2 differed from NSE1 (P = < 0.001) but not from NSEcalc (P = 0.291). In 84% samples, NSE1 had a relative bias from NSE that exceeded the 14% limit of total error allowable, with a median relative bias of 22.5%. Meanwhile, the bias between NSE2 concentrations and NSEcalc was - 0.4 µg/L (95% confidence interval = - 3.8 to 4.5), the relative bias was 8.3% and only 23% of samples exceeded the 14% limit. Formula usefulness was limited to moderate hemolytic samples.Conclusions: In summary, with this innovative approach, the NSEcalc bias is low enough to have clinical significance, so re-drawings of blood samples might be avoided. This approach also opens the possibility to correct the estimation of other magnitude concentrations affected by in vitro hemolysis.","PeriodicalId":94370,"journal":{"name":"Biochemia medica","volume":"35 2","pages":"020802"},"PeriodicalIF":0.0,"publicationDate":"2025-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12161513/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144304271","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Strategic use of Big Data: implementing reference intervals for serum folate and serum cobalamin. 策略性使用大数据：实施血清叶酸和血清钴胺素的参考区间。

Biochemia medica Pub Date : 2025-02-15 DOI: 10.11613/BM.2025.010705

Alicia Madurga, Ariadna Arbiol-Roca, Maria Rosa Navarro-Badal, Anna Cortes-Bosch de Basea, Dolors Dot-Bach

{"title":"Strategic use of Big Data: implementing reference intervals for serum folate and serum cobalamin.","authors":"Alicia Madurga, Ariadna Arbiol-Roca, Maria Rosa Navarro-Badal, Anna Cortes-Bosch de Basea, Dolors Dot-Bach","doi":"10.11613/BM.2025.010705","DOIUrl":"10.11613/BM.2025.010705","url":null,"abstract":"Introduction: Defining trustworthy reference intervals (RIs) for serum folate (FOL) or serum cobalamin (VITB12) is a difficult task. The purpose of this study is to use an indirect approach from the laboratory information's system to indirectly generate RIs for FOL and VITB12.Materials and methods: A retrospective observational study was performed at a tertiary-care laboratory's hospital during 12 months. All FOL and VITB12 tests were measured using a Cobas8000 e801 system (Roche Diagnostics, Mannheim, Germany). The RIs were calculated using a non-parametric approach. The RIs established in the present study were verified by calculating the fraction of RIs that fell outside the new RIs, in two validation cohorts sampled using the direct and indirect method.Results: A total of 19,214 (FOL) and 27,420 (VITB12) results were obtained. The RIs were 4.5 nmol/L (90% confidence intervals (CI) 4.4-4.6) to 38.4 nmol/L (CI 38.3-38.5) for FOL and 140 pmol/L (CI 139-141) to 659 pmol/L (CI 657-660) for VITB12. The verification included 8,798 FOL results and 7,365 VITB12 results. For both magnitudes was acceptable since only 0.1% of FOL and 0.02% of VITB12 results fell outside the RIs. Finally, the RIs were verified using a direct method with twenty individuals. For FOL 20/20 cases and 19/20 of VITB12 cases fell within the estimated RIs.Conclusions: In summary, the use of an indirect data approach has enabled us to calculate RIs for FOL and VITB12. The RIs obtained in our study are lower than those proposed by the manufacturer for both FOL and VITB12.","PeriodicalId":94370,"journal":{"name":"Biochemia medica","volume":"35 1","pages":"010705"},"PeriodicalIF":0.0,"publicationDate":"2025-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11838714/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143461557","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Understanding green discoloration in serum and citrate plasma samples: a case report. 了解血清和柠檬酸盐血浆样品中的绿色变色：一个病例报告。

Biochemia medica Pub Date : 2025-02-15 Epub Date: 2024-12-15 DOI: 10.11613/BM.2025.011001

Iva Friščić, Sonja Perkov, Mirjana Mariana Kardum Paro

引用次数: 0