Clinical biochemistry最新文献

{"title":"Establishing ELISA-derived 99th percentile reference ranges for aCL and anti-β2GPI antibodies in northern Chinese population: Diagnostic value assessed through P-APS/SLE case-control study","authors":"Xiaomin Shi , Zhuoli Zhang , Lanlan Ji , Xiaoning Li","doi":"10.1016/j.clinbiochem.2025.110918","DOIUrl":"10.1016/j.clinbiochem.2025.110918","url":null,"abstract":"","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"137 ","pages":"Article 110918"},"PeriodicalIF":2.5,"publicationDate":"2025-03-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143654741","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Small dense low-density lipoprotein as biomarker in the elderly","authors":"Taina T. Katajamäki ,&nbsp;Marja-Kaisa Koivula ,&nbsp;Marika J. Salminen ,&nbsp;Tero Vahlberg ,&nbsp;Elisa T.M. Heikkilä ,&nbsp;Anna M. Viljanen ,&nbsp;Minna K. Löppönen ,&nbsp;Raimo E. Isoaho ,&nbsp;Sirkka-Liisa Kivelä ,&nbsp;Matti Viitanen ,&nbsp;Jorma Viikari ,&nbsp;Laura Viikari ,&nbsp;Kari J. Pulkki ,&nbsp;Kerttu M. Irjala","doi":"10.1016/j.clinbiochem.2025.110916","DOIUrl":"10.1016/j.clinbiochem.2025.110916","url":null,"abstract":"<div><h3>Objectives</h3><div>Small dense low-density lipoprotein (sdLDL) is atherogenic and associated with atherosclerotic cardiovascular diseases (ASCVD). The aim of this study was to perform the prospective evaluation of sdLDL-c in new ASCVD over 18 years of follow up, and to compare the association of sdLDL-c and conventional lipids and apolipoproteins with ASCVD in the elderly.</div></div><div><h3>Methods</h3><div>This prospective study included a total of 1770 subjects ≥ 64 years of age with an 18-year follow-up period. The determination of sdLDL-c was measured by a homogenous, selective enzymatic method. Levels of total cholesterol (TC), high-density lipoprotein cholesterol (HDL-c) and triglycerides (TG) were determined by enzymatic methods. Apolipoproteins, ApoA1 and ApoB, were analyzed by immunonephelometric methods. Low-density lipoprotein cholesterol (LDL-c) levels were calculated using the Friedewald formula.</div></div><div><h3>Results</h3><div>According to Pearson’s correlation coefficients, sdLDL-c concentration was positively correlated with LDL-c, nonHDL-c, TC and ApoB concentrations. During follow up, sdLDL-c was significantly associated with new ASCVD in men aged 64–76 years in both unadjusted and adjusted Cox regression models. The adjusted hazard ratio (95 % CI) for sdLDL-c was 1.61 (1.13–2.28). No significant associations between sdLDL-c and ASCVD were observed in men aged 77–97 years, nor in women aged 64–79 or 80–100 years.</div></div><div><h3>Conclusions</h3><div>Lipid and apolipoprotein concentrations of the elderly were high compared to the recommended target values. In addition, lipid and apolipoprotein baseline concentrations were not higher in the ASCVD group than in the control group. Our results indicated that sdLDL-c is as good a marker as ApoB and better than LDL-c.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"137 ","pages":"Article 110916"},"PeriodicalIF":2.5,"publicationDate":"2025-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143662297","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating accelerations across multiple routes of a pneumatic tube system to ensure sample integrity for LDH measurement","authors":"Yun Huang ,&nbsp;Christiana Adewale ,&nbsp;Ryanne O’Sullivan ,&nbsp;Donnah Pocius","doi":"10.1016/j.clinbiochem.2025.110917","DOIUrl":"10.1016/j.clinbiochem.2025.110917","url":null,"abstract":"<div><h3>Objectives</h3><div>Lactate dehydrogenase (LDH) concentrations can falsely increase due to the acceleration forces generated in the pneumatic tube system (PTS) during blood sample transport, potentially leading to altered medical decisions. This study evaluated the accelerations and elevated LDH concentrations in 11 routes during PTS transport in an academic hospital.</div></div><div><h3>Methods</h3><div>Three blood samples were collected from each healthy volunteer and transported via hand carrier, PTS carrier, and PTS carrier with an additional foam insert. Five samples were included in the same carrier for every transport. An accelerometer was placed with the samples to record pressure, acceleration and transport time for each PTS route. The samples were then tested for hemoglobin and LDH concentrations on core laboratory chemistry analyzers. Three acceleration parameters were calculated.</div></div><div><h3>Results</h3><div>Transport time across the 11 routes varied widely from 78 to 455 s. Hemoglobin concentrations showed a slight increase during PTS transport, which was associated with a significant increase in LDH concentrations (r 0.716, p &lt; 0.001). On average, LDH increased from 9.5 to 59.2 % during PTS transport. Total accelerations, percentages of acceleration &gt; 5 g, and maximum accelerations ranged from 172.7 to 617.9 g, 3.5 to 14.7 %, and 15.31 to 24.28 g, respectively. When routes were scored based on any of the three parameters exceeding their average, routes with an LDH increase &gt; 15 % had higher scores than those with an LDH increase ≤ 15 %.</div></div><div><h3>Conclusions</h3><div>This study supports using accelerometers to validate and monitor the accelerations of each route generated during PTS blood sample transport and to identify the routes unsuitable for LDH measurement. Further studies are warranted to determine appropriate acceleration parameters and their thresholds to ensure sample integrity.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"137 ","pages":"Article 110917"},"PeriodicalIF":2.5,"publicationDate":"2025-03-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143656369","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Therapeutic drug monitoring of levetiracetam – Is dried blood spot sampling suitable?","authors":"Camilla Linder ,&nbsp;Victoria Barclay ,&nbsp;Mihaela Oana Romanitan ,&nbsp;Stanislav Beniaminov ,&nbsp;Isabella Ekheden","doi":"10.1016/j.clinbiochem.2025.110913","DOIUrl":"10.1016/j.clinbiochem.2025.110913","url":null,"abstract":"<div><h3>Background</h3><div>Therapeutic drug monitoring helps prevent seizures and minimize side effects in epilepsy patients. Phlebotomy is the gold standard for blood collection but can be difficult for children, pregnant women, and patients in remote areas. We previously validated dried blood spot (DBS) sampling for carbamazepine, lamotrigine, levetiracetam (LEV), and valproic acid. Uncertainties in LEV comparisons from the previous validation were further investigated in this study by increasing sample numbers and comparing results using both immunochemistry and LC-MS/MS methods. Additionally, capillary and venous DBS were compared, and the stability of samples during mail transport was assessed.</div></div><div><h3>Aim</h3><div>To compare LEV concentrations in capillary DBS and plasma, and to assess the stability of capillary DBS during transportation.</div></div><div><h3>Method</h3><div>Capillary and venous blood samples were collected from 40 LEV-treated patients. Concentrations were measured using immunochemistry and liquid chromatography tandem mass spectrometry methods. Comparisons between matrices and methods were analyzed with Passing-Bablok regression and Bland-Altman plots.</div></div><div><h3>Results</h3><div>No proportional bias was found in regression analysis and Bland-Altman plots showed no bias between methods. For capillary DBS versus plasma concentrations, 92.1 % of values were within 20 % of the mean. No bias was detected between capillary and venous DBS, with deviations within acceptable limits. Sample stability was maintained during mail transport.</div></div><div><h3>Conclusion</h3><div>The concentrations obtained for LEV in capillary DBS versus plasma showed that therapeutic drug monitoring of LEV can be performed as at-home self-sampling with DBS mailed to the laboratory for analysis.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"137 ","pages":"Article 110913"},"PeriodicalIF":2.5,"publicationDate":"2025-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143639548","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Establishing sustainable quality improvement in the clinical laboratory: Redesign of the total testing process and digital transformation of routine quality assurance activities","authors":"Angela W.S. Fung","doi":"10.1016/j.clinbiochem.2025.110915","DOIUrl":"10.1016/j.clinbiochem.2025.110915","url":null,"abstract":"<div><div>Healthcare services contribute 5 to 10% of global carbon emissions and environmental burden on the planet. Sustainability in health care and laboratory medicine is gaining global momentum emphasizing a holistic approach to reduce carbon footprint, improve the delivery and quality of care, while optimizing operational efficiency and effectiveness. Digital transformation has the potential of achieving these goals simultaneously. Clinical laboratories should assess and mitigate their environmental impact through digital technologies. In this article, opportunities and challenges in establishing sustainable quality improvement in the clinical laboratory will be discussed with a focus on the redesign of the total testing process and digital transformation of routine quality assurance activities.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"137 ","pages":"Article 110915"},"PeriodicalIF":2.5,"publicationDate":"2025-03-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143639544","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The case of a bloody mess – Bictegravir/emtricitabine/tenofovir alafenamide induced colitis","authors":"Meshach Asare-Werehene ,&nbsp;Mary Kathryn Bohn ,&nbsp;Allison Ming-Freckleton ,&nbsp;Rajeevan Selvaratnam","doi":"10.1016/j.clinbiochem.2025.110910","DOIUrl":"10.1016/j.clinbiochem.2025.110910","url":null,"abstract":"<div><h3>Background</h3><div>Fecal calprotectin is a marker used to differentiate inflammatory bowel disease versus irritable bowel syndrome and is relevant in the diagnosis of ulcerative colitis and Crohn’s disease. Markedly elevated calprotectin from stool samples provides evidence of colonic inflammation to support the diagnosis of pancolitis. This report is the first to demonstrate the clinical significance of fecal calprotectin in supporting the diagnosis of pancolitis induced by the anti-viral drug, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide).</div></div><div><h3>Case report</h3><div>A 62-year-old male on Biktarvy for his HIV diagnosis was admitted to internal medicine with abdominal pain, bloody diarrhea and pancolitis. His white blood cell count was 15.8 (4.0–11.0x10⁹/L), neutrophil count was 9.7 (2.0–7.5 × 10⁹/L), monocyte count was 1.2 (0.2–0.8 × 10⁹/L), granulocyte count was 1.5 (≤0.1 × 10⁹/L) and hemoglobin was 163 (140–180 g/L). The patient had a C-reactive protein of 229 (≤11.0 mg/L). Serology and blood culture were negative for microbial testing and abdomino-pelvic computed tomography findings were unremarkable. A bloody stool collected had a fecal calprotectin level of 1,159 (&lt;50 µg/g).</div></div><div><h3>Conclusions</h3><div>This case highlights how anti-retroviral therapies such as Biktarvy may elicit medication-induced gastrointestinal symptoms, which may underlie the cause of bloody diarrhea and pancolitis, and consequently a grossly elevated fecal calprotectin.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"137 ","pages":"Article 110910"},"PeriodicalIF":2.5,"publicationDate":"2025-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143633922","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The pitfalls and significance of using ratios and calculated parameters in laboratory medicine","authors":"Loralie J. Langman ,&nbsp;Christine LH Snozek ,&nbsp;Andre Mattman","doi":"10.1016/j.clinbiochem.2025.110914","DOIUrl":"10.1016/j.clinbiochem.2025.110914","url":null,"abstract":"","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"137 ","pages":"Article 110914"},"PeriodicalIF":2.5,"publicationDate":"2025-03-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143633928","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Assessment of accuracy, clinical validity, and analytical linearity in point-of-care glucose monitoring devices for diabetes mellitus: A systematic review and meta-analysis","authors":"Michael Pius Ukpe ,&nbsp;Anastecia Chinasa Ezeanuka","doi":"10.1016/j.clinbiochem.2025.110911","DOIUrl":"10.1016/j.clinbiochem.2025.110911","url":null,"abstract":"<div><div>Point-of-care technology (POCT) is utilized in diabetes management due to its fast turnaround time. However, the accuracy and reliability of its results are of concern. This review aims to evaluate the (i) accuracy, (ii) clinical validity and (iii) linearity of POCT for blood glucose concentration following ISO 15197. The study was conducted following the PRISMA framework. Searches with the search term “point of care test” OR “POCT” AND “Accuracy” AND “glucose” were made on Scopus, PubMed, DOAJ, and Cochrane Library. Quality assessments were performed using the QUADAS-2 tool. Proportion and Coefficient <em>meta</em>-analyses were used. Recent studies (2019–2023) evaluating the accuracy of POC devices in blood glucose estimation were included. 4918 participants and 56 POC brands were identified from the 30 included studies. The pooled percentage of POCT results within ±15 mg/dL (±0.83 mmol/L) for glucose concentrations &lt;100 mg/dL (&lt;5.6 mmol/L) was 98.83 % (95 % CI: 96.52–99.92) for professional use and 87.70 % (95 % CI: 62.65–99.65) for home-use glucometers. For glucose concentrations ≥100 mg/dL (≥5.6 mmol/L), the pooled percentages were 98.59 % (95 % CI: 95.90–99.88) and 88.79 % (95 % CI: 67.35–99.44), respectively. Measurements in zones A and B of the consensus error grid analysis were 98.06 % (95 % CI: 94.59–99.80) for professional-use and 98.70 % (95 % CI: 95.85–99.95) for home-use glucometers. The pooled correlation coefficient for professional-use glucometers was 0.988 (95 % CI: 0.980–0.993) while home-use was 0.930 (95 % CI: 0.869–0.963). While professional-use glucometers met ISO 15197 accuracy criteria but not clinical validity standards, home-use devices failed to meet both accuracy and clinical validity criteria. Professional-use glucometers demonstrated superior accuracy compared to home-use glucometers. Based on the variability in analytical performance of POC devices, it is recommended that proper care be taken when selecting POCT devices for optimal use in diabetic management.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"137 ","pages":"Article 110911"},"PeriodicalIF":2.5,"publicationDate":"2025-03-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143609573","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Rising illicit drug Adulterants: Xylazine and levamisole","authors":"Pedro E.M. Amaral ,&nbsp;Samuel O. Beane ,&nbsp;Angie Albarouki ,&nbsp;Michael J. Tan ,&nbsp;Megan J. Schoenberger ,&nbsp;Yuan Yao ,&nbsp;Li Liu ,&nbsp;Sacha N. Uljon ,&nbsp;Yusheng Zhu ,&nbsp;Donald C Hall Jr ,&nbsp;Yinghua Qiu","doi":"10.1016/j.clinbiochem.2025.110912","DOIUrl":"10.1016/j.clinbiochem.2025.110912","url":null,"abstract":"<div><div>The increasing prevalence of xylazine and levamisole as adulterants in illicit drugs presents significant challenges for medical professionals. This review aims to provide an overview of the mechanisms of action, prevalence of adulteration, and detection methods for xylazine and levamisole. Clinical implications associated with xylazine and levamisole-contaminated drugs are also discussed. It provides a comprehensive examination of methodologies for analyzing these emerging contaminants, shedding light on the challenges faced by toxicology laboratories in accurately identifying and quantifying these substances. Various analytical techniques, including but not limited to GC–MS, HPLC-MS, and HPLC-MS/MS, are explored in detail, with a focus on their strengths and limitations. This serves as a valuable resource for clinicians seeking to navigate the complexities of analyzing xylazine and levamisole in illicit drug samples. It also contributes to the existing knowledge on illicit drug adulteration by xylazine and levamisole, providing insights that can inform public health interventions, law enforcement efforts, and treatment strategies aimed at mitigating the risks associated with contaminated substances.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"137 ","pages":"Article 110912"},"PeriodicalIF":2.5,"publicationDate":"2025-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143623680","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Phosphatidylethanol clearance after packed red blood cell transfusion","authors":"Olivia C Iverson ,&nbsp;Karlie A Smith ,&nbsp;Pragya Sharma ,&nbsp;Matthew R Buras ,&nbsp;Jaxon K Quillen ,&nbsp;Dominic L Showkeir ,&nbsp;Kathy N Alegria ,&nbsp;Loralie J Langman ,&nbsp;Paul J Jannetto ,&nbsp;Theresa N Kinard ,&nbsp;Christine LH Snozek","doi":"10.1016/j.clinbiochem.2025.110909","DOIUrl":"10.1016/j.clinbiochem.2025.110909","url":null,"abstract":"<div><h3>Objectives</h3><div>Phosphatidylethanol (PEth) is a long-term marker of alcohol consumption used clinically for evaluating abstinence in patients including transplant candidates. Packed red blood cell (pRBC) transfusion can introduce exogenous PEth to recipients, complicating interpretation. This study evaluated the kinetics and duration of PEth 16:0/18:1 positivity post-transfusion.</div></div><div><h3>Design &amp; methods</h3><div>This study evaluated liver transplant recipients (n = 76) who received ≥ 1 pRBC during transplantation surgery. PEth 16:0/18:1 concentrations were monitored up to 2 weeks post-transfusion to determine clearance kinetics.</div></div><div><h3>Results</h3><div>Post-transfusion PEth was ≥ 10 ng/mL (range 10.0 – 79.7 ng/mL [0.014–0.113 µmol/L]) in 37 (48.7 %) recipients. Approximately 24 h after transfusion, pRBC-derived PEth decreased by a mean of 19 %, consistent with pRBC turnover post-transfusion. After 24–36 h, the apparent half-life of PEth was 6.6 d but was highly variable (SD 3.6 d). Correction for hemoglobin or hematocrit improved variability, with mean half-life estimated at 4.9 d (SD 1.6 d) and 4.6 d (SD 1.4 d), respectively. Time to clearance of PEth &lt; 10 ng/mL ([&lt;0.014 µmol/L]) ranged from &lt; 1 d to &gt; 19 d; 15 (40.5 %) pRBC recipients cleared PEth within 5 d post-transfusion. Using the consensus cutoff for PEth interpretation, only 10 had PEth &gt; 20 ng/mL (&gt;0.028 µmol/L) at 5 d and all had 14 d values &lt; 20 ng/mL (&lt;0.028 µmol/L).</div></div><div><h3>Conclusions</h3><div>These findings suggest that PEth positivity after pRBC transfusion might be more common than previously recognized, and that higher decision-making thresholds (e.g., 20 ng/mL [&lt;0.028 µmol/L]) are appropriate. Post-transfusion kinetics are not identical to clearance of endogenously-produced PEth after alcohol consumption (half-life 5–8 d), likely due to both patient and pRBC characteristics. Transplant care teams should recognize the risk for pRBC transfusion to impact PEth concentrations in recipients, and interpret PEth cautiously for 2–3 weeks after transfusion.</div></div>","PeriodicalId":10172,"journal":{"name":"Clinical biochemistry","volume":"137 ","pages":"Article 110909"},"PeriodicalIF":2.5,"publicationDate":"2025-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143579297","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}