Biochemia medica最新文献_第7页

Application and insights on patient-based real-time quality control: detecting undetected errors in internal quality control through daily antibody positivity rate analysis. 基于患者的实时质量控制的应用与见解：通过每日抗体阳性率分析发现内部质量控制中未被发现的错误。

Biochemia medica Pub Date : 2025-06-15 Epub Date: 2025-04-15 DOI: 10.11613/BM.2025.020801

Chaochao Ma, Qi Zhang, Yingying Hu, Wenyi Ding, Liangyu Xia, Ling Qiu

{"title":"Application and insights on patient-based real-time quality control: detecting undetected errors in internal quality control through daily antibody positivity rate analysis.","authors":"Chaochao Ma, Qi Zhang, Yingying Hu, Wenyi Ding, Liangyu Xia, Ling Qiu","doi":"10.11613/BM.2025.020801","DOIUrl":"10.11613/BM.2025.020801","url":null,"abstract":"Introduction: Traditional internal quality control (IQC) has limitations in detecting systematic errors in clinical laboratories. Patient-Based Real-Time Quality Control (PBRTQC) has emerged as a complementary method, offering new approaches for quality monitoring. Among these, monitoring daily positivity rates provides meaningful insights into laboratory performance.Materials and methods: This study highlights a case in which PBRTQC was implemented to detect and address a reagent batch issue in thyroid peroxidase antibody (TPO-Ab) testing. Over one year (July 2023 to July 2024), daily positivity rates and their fluctuations were retrospectively analyzed and daily positivity rate alarm limits were established for monitoring.Results: A notable increase in the TPO-Ab positivity rate was identified starting in June 2024. For outpatients and inpatients, the positivity rates in June and July 2024 were 46.1% ± 7.8% (N = 9039) and 61.4% ± 12.0% (N = 8735), respectively. For the physical examination population, the positivity rates during the same months were 30.0% ± 11.7% (N = 4754) and 52.5% ± 18.1% (N = 5726), respectively. These rates were significantly higher than the pre-June 2024 average monthly positivity rates of 30.0% ± 2.9% (N = 9070 per month) for patients and 11.0% ± 2.4% (N = 4663 per month) for the physical examination population.Conclusions: PBRTQC, particularly monitoring daily positivity rates, is a valuable tool for early detection of systematic errors. Establishing PBRTQC systems can supplement traditional IQC to improve laboratory test quality.","PeriodicalId":94370,"journal":{"name":"Biochemia medica","volume":"35 2","pages":"020801"},"PeriodicalIF":0.0,"publicationDate":"2025-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12131385/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144228221","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

Impact of fasting duration on LDL cholesterol concentrations estimated by the Friedewald, Martin-Hopkins, and Sampson/NIH equations. 根据Friedewald、Martin-Hopkins和Sampson/NIH方程估算的空腹时间对LDL胆固醇浓度的影响。

Biochemia medica Pub Date : 2025-06-15 Epub Date: 2025-04-15 DOI: 10.11613/BM.2025.020704

Şerif Ercan, Ali Manav

{"title":"Impact of fasting duration on LDL cholesterol concentrations estimated by the Friedewald, Martin-Hopkins, and Sampson/NIH equations.","authors":"Şerif Ercan, Ali Manav","doi":"10.11613/BM.2025.020704","DOIUrl":"10.11613/BM.2025.020704","url":null,"abstract":"Introduction: A paradigm shift is occurring in lipid testing, as fasting is no longer required. We aimed to determine whether low-density lipoprotein cholesterol (LDL-C) concentrations calculated using three different equations, along with the components used in these calculations, vary with different fasting durations in routine clinical practice.Materials and methods: The concentrations of LDL-C were calculated using the Friedewald, Martin-Hopkins, and Sampson/NIH equations, along with the lipid components involved in these equations, depending on time since the last meal in a cohort of 77,300 outpatients at a community hospital. The study population was divided into groups according to fasting durations by 2-hour intervals. A general linear model was applied to identify differences between fasting and nonfasting groups.Results: Regardless of the calculation method, LDL-C concentrations varied with fasting duration for up to 8-10 hours. The greatest absolute mean differences in LDL-C concentrations between fasting and nonfasting states were - 0.32, - 0.30, and - 0.26 mmol/L when using the Friedewald, Sampson/NIH, and Martin-Hopkins equations, respectively. Among the equation components, triglyceride concentrations were the most sensitive to fasting duration, remaining elevated for 4-6 hours after the last meal, while total cholesterol and non-high-density lipoprotein cholesterol (HDL-C) concentrations decreased for up to 8-10 hours postprandially. However, HDL-C concentrations remained relatively stable.Conclusions: The variation in postprandial LDL-C concentrations was observed not to differ between the three calculation methods and reached negligible concentrations after at least 8 hours of fasting. If LDL-C concentrations measured in a nonfasting state are near clinical decision thresholds, subsequent lipid measurement should be performed in a fasting state.","PeriodicalId":94370,"journal":{"name":"Biochemia medica","volume":"35 2","pages":"020704"},"PeriodicalIF":0.0,"publicationDate":"2025-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12131409/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144228234","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

Reply to Christelli et al.: Implementation of new Westgard Rules suggested by the Westgard Advisor software for five immunological parameters. What Six Sigma, quality control, the analytical Sigma-metric, and Westgard Advisor can and cannot do. 回复Christelli等人：实施Westgard Advisor软件建议的五个免疫学参数的新Westgard规则。六西格玛、质量控制、分析西格玛度量和韦斯特加顾问能做什么和不能做什么。

Biochemia medica Pub Date : 2025-06-15 DOI: 10.11613/BM.2025.020401

Sten Westgard, Hassan Bayat

引用次数: 0

Telomere length and oxidative stress in small cell lung cancer patients: changes through chemotherapy cycles compared to healthy controls. 小细胞肺癌患者端粒长度和氧化应激：通过化疗周期与健康对照的变化

Biochemia medica Pub Date : 2025-06-15 Epub Date: 2025-04-15 DOI: 10.11613/BM.2025.020705

Azra Guzonjić, Dragana Jovanović, Ivana Simić, Vesna Ćeriman Krstić, Natalija Samardzić, Barbara Ostanek, Janja Marc, Miron Sopić, Jelena Kotur Stevuljević

{"title":"Telomere length and oxidative stress in small cell lung cancer patients: changes through chemotherapy cycles compared to healthy controls.","authors":"Azra Guzonjić, Dragana Jovanović, Ivana Simić, Vesna Ćeriman Krstić, Natalija Samardzić, Barbara Ostanek, Janja Marc, Miron Sopić, Jelena Kotur Stevuljević","doi":"10.11613/BM.2025.020705","DOIUrl":"10.11613/BM.2025.020705","url":null,"abstract":"Introduction: Small cell lung cancer (SCLC) is an aggressive malignant disease with poor survival outcomes. The aim of this study was to investigate leukocyte telomere length (LTL) and redox status parameters during chemotherapy and evaluate their prognostic potential based on the hypothesis that shorter LTL and oxidative stress burden correlate with poorer survival.Materials and methods: This longitudinal study included 60 SCLC patients and 73 healthy controls. Leukocyte telomere length was measured by quantitative PCR (qPCR) method, while redox status parameters (MDA - malondialdehyde, IMA - ischemia-modified albumin, PON1 - paraoxonase 1, redox index) were determined by spectrophotometric methods before, after two and after four cycles of chemotherapy.Results: All measured parameters showed significant differences between patients and controls, except the oxy-score (P < 0.001). Significant differences in IMA, PON1 and redox index were observed between SCLC patient groups at different time points (P < 0.001). Significant differences in IMA and PON1 were observed between SCLC survival groups, with higher values found in survivors after two chemotherapy cycles (P < 0.001). Redox index was the highest in the pre-chemo group (P = 0.019). Among patients who died, PON1 activity differed significantly between those who died within 2 months and after 4 months (P = 0.028). Kaplan-Meier analysis showed that LTL and PON1 were significant predictors of survival, with values below the 25th percentile associated with a higher risk of death.Conclusions: Leukocyte telomere length and PON1 are potential prognostic biomarkers for SCLC survival, suggesting their potential use in non-invasive biomarker panels for improved patient stratification.","PeriodicalId":94370,"journal":{"name":"Biochemia medica","volume":"35 2","pages":"020705"},"PeriodicalIF":0.0,"publicationDate":"2025-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12131383/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144228235","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

Cumulative IgG reagent carryover detected in carryover evaluation of urinary total protein testing using AU5800 biochemistry analyzer. AU5800生化分析仪检测尿总蛋白携带评价中的累积IgG试剂携带。

Biochemia medica Pub Date : 2025-06-15 Epub Date: 2025-04-15 DOI: 10.11613/BM.2025.020702

Jialu Li, Guoxiang Bao

{"title":"Cumulative IgG reagent carryover detected in carryover evaluation of urinary total protein testing using AU5800 biochemistry analyzer.","authors":"Jialu Li, Guoxiang Bao","doi":"10.11613/BM.2025.020702","DOIUrl":"10.11613/BM.2025.020702","url":null,"abstract":"Introduction: Accurate measurement of urinary total protein (UTP) is crucial for diagnosing renal and systemic diseases. This study aims to comprehensively evaluate potential carryover scenarios in UTP testing using AU5800 biochemistry analyzer and to identify factors influencing assay accuracy.Materials and methods: High-concentration quality control materials and pure water was used to evaluate specific sample probe carryover. Additionally, 24-hour mixed urine samples from patients were used to evaluate specific carryover from the reagent probe, mixbars, and cuvettes. For cumulative sample carryover evaluation, pure water was used as reagent and mixed serum as sample for continuous testing. During the process, 24-hour urine samples were interspersed, and UTP concentrations were measured at 0, 10, 20, and 30 minutes. Cumulative reagent carryover was evaluated by testing pure water sequentially with eight reagents sharing the same analytical unit and inner cuvettes as UTP, with UTP concentrations of 24-hour urine samples recorded at 0, 10, 20, and 30 minutes.Results: Specific carryover from the sample probe, reagent probe, mixbars, and cuvettes was not detected during carryover evaluation of UTP testing. However, a significant cumulative reagent carryover of Immunoglobulin G (IgG) reagent was observed, while no cumulative sample carryover was identified.Conclusions: The full range of possible carryover scenarios in UTP testing was evaluated using AU5800 biochemistry analyzer. Our data provide valuable references for evaluating carryover in laboratories, ensuring the accuracy and reliability of laboratory results.","PeriodicalId":94370,"journal":{"name":"Biochemia medica","volume":"35 2","pages":"020702"},"PeriodicalIF":0.0,"publicationDate":"2025-06-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12131410/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144228232","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

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

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

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