Clinica Chimica Acta最新文献

{"title":"Benign prostatic hyperplasia genetic variants in Asians","authors":"Muhammad Mahbubi Sani ,&nbsp;Yudhistira Pradnyan Kloping ,&nbsp;Fakhri Surahmad","doi":"10.1016/j.cca.2024.119986","DOIUrl":"10.1016/j.cca.2024.119986","url":null,"abstract":"<div><div>The global prevalence of benign prostatic hyperplasia (BPH) is increasing annually, with a notably higher incidence in Asian populations. This condition can increase the risk of developing prostate cancer 2- to 12-fold, underscoring the critical need for comprehensive clinical guidelines and appropriate risk stratification testing. This review is the first to address the gap by focusing on genetic screening for risk stratification in Asians, followed by the development of pathophysiology based on the genetic variants identified. For example, the CYP17 gene, which plays a crucial role in testosterone synthesis and BPH progression, includes the <em>CYP17</em> rs743572 C allele, a genetic variant that increases the risk of BPH by 1.58 times in Asians. Identifying such genetic variants can enable the tailoring of therapies to individual genetic profiles. Furthermore, this review provides new insights into the pathophysiology of BPH, suggesting that ethnicity may play a role in its progression, and explores genetic links between BPH and other diseases traditionally considered risk factors for BPH.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2024-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142379160","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":"Exosomal ncRNAs in liquid biopsies for lung cancer","authors":"Md Sadique Hussain ,&nbsp;Gaurav Gupta ,&nbsp;Nehmat Ghaboura ,&nbsp;Ehssan Moglad ,&nbsp;Waleed Hassan Almalki ,&nbsp;Sami I. Alzarea ,&nbsp;Imran Kazmi ,&nbsp;Haider Ali ,&nbsp;Ronan MacLoughlin ,&nbsp;Raimar Loebenberg ,&nbsp;Neal M. Davies ,&nbsp;Sachin Kumar Singh ,&nbsp;Kamal Dua","doi":"10.1016/j.cca.2024.119983","DOIUrl":"10.1016/j.cca.2024.119983","url":null,"abstract":"<div><div>Exosomal non-coding RNAs (ncRNAs) have become essential contributors to advancing and treating lung cancers (LCs). The development of liquid biopsies that utilize exosomal ncRNAs (<em>exo</em>-ncRNAs) offers an encouraging method for diagnosing, predicting, and treating LC. This thorough overview examines the dual function of <em>exo</em>-ncRNAs as both indicators for early diagnosis and avenues for LC treatment. Exosomes are tiny vesicles secreted by various cells, including cancerous cells, enabling connection between cells by delivering ncRNAs. These ncRNAs, which encompass circular RNAs, long ncRNAs, and microRNAs, participate in the modulation of gene expression and cellular functions. In LC, certain <em>exo</em>-ncRNAs are linked to tumour advancement, spread, and treatment resistance, positioning them as promising non-invasive indicators in liquid biopsies. Additionally, targeting these ncRNAs offers potential for innovative treatment approaches, whether by suppressing harmful ncRNAs or reinstating the activity of tumour-suppressing ones. This review emphasizes recent developments in the extraction and analysis of <em>exo</em>-ncRNAs, their practical applications in LC treatment, and the challenges and prospects for translating these discoveries into clinical usage. Through this detailed examination of the current state of the art, we aim to highlight the significant potential of <em>exo</em>-ncRNAs for LC diagnostics and treatments.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2024-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142379162","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":"RVD2 emerges as a serological marker in relation to severity and six-month clinical outcome following acute intracerebral hemorrhage: A prospective cohort study from a single academic institution","authors":"Wenjie Yang ,&nbsp;Tiancheng Lu ,&nbsp;Hao Shan ,&nbsp;Shengdong Zou ,&nbsp;Zejian Ye ,&nbsp;Keyang Zhang ,&nbsp;Qun Lin ,&nbsp;Junxia Dai ,&nbsp;Jianyong Cai ,&nbsp;Wenhua Yu ,&nbsp;Xiaolong Liang ,&nbsp;Lixin Zhang ,&nbsp;Huayong Hong ,&nbsp;Xianjun Wang ,&nbsp;Dingbo Yang","doi":"10.1016/j.cca.2024.119988","DOIUrl":"10.1016/j.cca.2024.119988","url":null,"abstract":"<div><h3>Background</h3><div>Resolvin D2 (RvD2), with an anti-inflammatory activity, harbors a neuroprotective property. Here, serum RvD2 levels were detected with an attempt to explore its prognostic implication in human acute intracerebral hemorrhage (ICH).</div></div><div><h3>Methods</h3><div>In this prospective cohort study, serum RvD2 levels of 301 ICH patients, coupled with 100 heathy individuals, were gauged. All patients were randomly divided to two groups (200 patients in the study group and 101 in the validation group) in a 2:1 ratio. Change of serum RvD2 levels after ICH was investigated, and its correlations with National Institutes of Health Stroke Scale (NIHSS) scores, hematoma volume and poststroke six-month modified Rankin Scale (mRS) scores were determined using multivariate analysis. Its independent association with poor prognosis (mRS scores of 3–6) was uncovered in the study group and its prognostic predictive value was verified in the validation group.</div></div><div><h3>Results</h3><div>The serum levels of RvD2 in patients displayed a notable decline upon admission, as compared to controls. The levels exhibited independent correlations with NIHSS scores, hematoma size and mRS scores. Alternatively, RvD2 levels had independent relation to a poor prognosis after ICH. Within the framework of restricted cubic spline analysis, RvD2 levels were linearly correlated with the likelihood of poor prognosis, even adjusting for NIHSS scores and hematoma size. In the context of receiver operating characteristic (ROC) curve analysis, serum RvD2 dramatically distinguished risk of poor prognosis, with similar predictive ability to NIHSS scores and hematoma volume. By employing subgroup analysis, the relationship between RvD2 levels and poor prognosis was not obviously influenced by other parameters, such as age, sex, hypertension, and more. The integrated model containing serum RvD2, NIHSS scores and hematoma volume was visualized on a nomogram and showed high predictive performance and clinical effectiveness for poor prognosis via multiple evaluation metrics, including the Hosmer-Lemeshow test, ROC curve analysis, calibration curve analysis and decision curve analysis. Clinical usefulness of serum RvD2 was verified in the validation group.</div></div><div><h3>Conclusion</h3><div>Serum RvD2 levels exhibit an immediate decrease post-ICH, which could be able to accurately reflect ICH severity and efficiently prognosticate poor neurological outcomes, signifying that serum RvD2 may represent an encouraging prognostic indicator in ICH.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2024-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142379164","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":"Lipoprotein(a) in atherosclerotic cardiovascular disease and proprotein convertase subtilisin/kexin-type 9 inhibitors","authors":"Ping-an Lian ,&nbsp;Wen-qiang Zhu ,&nbsp;Wei-xin Zhao ,&nbsp;Piao-piao Huang ,&nbsp;Juan-li Ran ,&nbsp;Ya-xin Tang ,&nbsp;Xian-sheng Huang ,&nbsp;Rong Li","doi":"10.1016/j.cca.2024.119982","DOIUrl":"10.1016/j.cca.2024.119982","url":null,"abstract":"<div><div>High plasma lipoprotein(a) (Lp(a)) levels increase the cardiovascular risk in populations with atherosclerotic cardiovascular disease (ASCVD). Apolipoprotein (a) [apo(a)], a unique protein component of Lp(a), plays an important role in the pathogenesis of atherosclerosis. Statins, the primary medication in managing ASCVD, lower low-density lipoprotein cholesterol (LDL-C) but concurrently elevate plasma Lp(a) levels, contributing to an increased residual cardiovascular risk. In turn, proprotein convertase subtilisin/kexin-type 9 (PCSK9) inhibitors, a novel class of LDL-C lowering drugs, effectively reduce plasma Lp(a) levels, which is believed to decrease residual cardiovascular risk. However, the mechanism by which PCSK9 inhibitors reduce Lp(a) levels remains unknown. In addition, there are some clinical limitations of PCSK9 inhibitors. Here, we systematically review the past, present, and prospects of studies pertaining to Lp(a), PCSK9 inhibitors, and ASCVD.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2024-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142375223","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":"Pathogen distribution and infection patterns in pediatric severe pneumonia: A targeted next-generation sequencing study","authors":"Jie Tan ,&nbsp;Yan Chen ,&nbsp;Jia Lu ,&nbsp;Junming Lu ,&nbsp;Guangbing Liu ,&nbsp;Lishai Mo ,&nbsp;Yanhua Feng ,&nbsp;Wenting Tang ,&nbsp;Cuihong Lu ,&nbsp;Xiangjun Lu ,&nbsp;Ruting Chen ,&nbsp;Qiang Huang ,&nbsp;Jielin Chen ,&nbsp;Ya Huang ,&nbsp;Huiping Huang ,&nbsp;Qifei Li ,&nbsp;Chunyun Fu","doi":"10.1016/j.cca.2024.119985","DOIUrl":"10.1016/j.cca.2024.119985","url":null,"abstract":"<div><h3>Objective</h3><div>Severe pneumonia in children represents a significant clinical challenge due to its high incidence and associated mortality. This study aimed to assess the distribution of pathogens and patterns of infection in pediatric patients with severe pneumonia.</div></div><div><h3>Methods</h3><div>This study included 110 pediatric patients diagnosed with severe pneumonia, who were admitted to Guangxi Maternal and Child Health Hospital between July 2021 and November 2023. Pathogen-targeted next-generation sequencing (tNGS) was employed to identify respiratory pathogens in these cases.</div></div><div><h3>Results</h3><div>Pathogens were detected in 109 out of 110 cases, yielding a positive detection rate of 99.09%. Among these cases, 25 (22.72%) involved single-pathogen infections, while 84 (76.36%) were characterized by mixed infections. The infection pattern in children with severe pneumonia was relatively common with bacterial-viral coinfection (28.2%, 31/110). A total of 39 pathogens were identified from the 110 children with severe pneumonia, with the top three pathogens being <em>Mycoplasma pneumoniae</em> (30.91%, 34/110), Human Respiratory Syncytial Virus Type A (26.36%, 29/110), and Human Herpesvirus (18.18%, 20/110). Notably, 38.2% (13/34) of the cases were found to have macrolide-resistant <em>Mycoplasma pneumoniae</em> (MRMP). Additionally, 40% (44/110) of the children required admission to the intensive care unit (ICU).</div></div><div><h3>Conclusion</h3><div>The application of tNGS demonstrates significant utility in the detection of pathogens in pediatric patients with severe pneumonia. The predominant pathogens identified in this study are <em>Mycoplasma pneumoniae</em>, Human Respiratory Syncytial Virus, and Human Herpesvirus. Furthermore, mixed infections involving multiple pathogens were observed in 76.36% of the cases, and a substantial proportion (40%) of these patients necessitated intensive care.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2024-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142371131","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":"Comparative accuracy of CA-153 and KL-6 as diagnostic and prognostic biomarkers for interstitial lung disease","authors":"Chih-Wei Tseng ,&nbsp;Kao-Lun Wang ,&nbsp;Chung-Yi Li","doi":"10.1016/j.cca.2024.119980","DOIUrl":"10.1016/j.cca.2024.119980","url":null,"abstract":"<div><h3>Backgrounds</h3><div>To discern the potential of KL-6 and CA-153 as diagnostic tools for interstitial lung disease (ILD), understand their relationship with GAP (Gender, Age, and Physiology) stage, and analyze their predictive capacities alongside CT features. This research aims to enhance ILD detection and management in autoimmune patients, emphasizing the diagnostic utility of these biomarkers.</div></div><div><h3>Methods</h3><div>From Mar 2017 to Mar 2024, 398 patients from Taichung Veterans General Hospital’s Division of Allergy, Immunology, and Rheumatology with autoimmune diseases were prospectively enrolled. ILD diagnoses were confirmed using High-Resolution Computed Tomography (HRCT) or lung biopsy and characterized by radiologists. GAP scores were calculated for IPF prognosis. 583 serum samples were collected and tested for KL-6, CA-153, CA-199, and CA-125 using specific assays. Statistical analyses compared patients, assessed variables, determined missingness, and predicted ILD, with tools like ROC analysis and logistic regressions. Analyses were performed with IBM SPSS and MedCalc.</div></div><div><h3>Results</h3><div>ILD patients were older, predominantly male, and had more smokers compared to non-ILD. Both KL-6 and CA-153 were higher in ILD and showed a significant, but non-interchangeable correlation. Age, BMI, smoking, and biomarker levels influenced ILD odds, with KL-6 and CA-153 being the strongest predictors. HRCT imaging highlighted these markers’ roles, especially in detecting specific features. Both markers also strongly associated with GAP stages. Stratified analyses emphasized KL-6′s significance in predicting ILD across both AD and non-AD groups. Complete data sensitivity analysis reinforced KL-6 and CA-153 as key ILD predictors.</div></div><div><h3>Conclusions</h3><div>This research emphasizes CA-153 as a feasible, cost-effective alternative to KL-6 in diagnosing and monitoring ILD. Both CA-153 and KL-6 levels were notably elevated in ILD patients, displaying a strong correlation, especially at CA-153 levels of ≤100 U/ml. They both also have significant associations with CT characteristics and GAP stages. The study reinforces the potential of CA-153, particularly in settings where KL-6 testing might be inaccessible or expensive.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2024-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142364616","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":"“Urinary tract infection: Conventional testing to developing Technologies”","authors":"Kavi Bharathi Ramaiah ,&nbsp;Indhu Suresh ,&nbsp;Noel Nesakumar ,&nbsp;N. Sai Subramanian ,&nbsp;John Bosco Balaguru Rayappan","doi":"10.1016/j.cca.2024.119979","DOIUrl":"10.1016/j.cca.2024.119979","url":null,"abstract":"<div><div>Urinary tract infections (UTIs) present an escalating global health concern, precipitating increased hospitalizations and antibiotic utilization, thereby fostering the emergence of antimicrobial resistance. Current diagnostic modalities exhibit protracted timelines and substantial financial burdens, necessitating specialized infrastructures. Addressing these impediments mandates the development of a precise diagnostic paradigm to expedite identification and augment antibiotic stewardship. The application of biosensors, recognized for their transformative efficacy, emerges as a promising resolution. Recent strides in biosensor technologies have introduced pioneering methodologies, yielding pertinent biosensors and integrated systems with significant implications for point-of-care applications. This review delves into historical perspectives, furnishing a comprehensive delineation of advancements in UTI diagnostics, disease etiology, and biomarkers, underscoring the potential merits of these innovations for optimizing patient care.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2024-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142342715","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":"Exchangeable serum copper: Adult and pediatric reference intervals and in vitro stability in a nordic cohort","authors":"Silje Hovden Christensen ,&nbsp;Frederik Teicher Kirk ,&nbsp;Tua Gyldenholm ,&nbsp;Emilie Munk ,&nbsp;Britta Eilersen Hjerrild ,&nbsp;Helene Kvistgaard ,&nbsp;Lene Damm Christensen ,&nbsp;Thomas Damgaard Sandahl ,&nbsp;Anders Abildgaard","doi":"10.1016/j.cca.2024.119978","DOIUrl":"10.1016/j.cca.2024.119978","url":null,"abstract":"<div><div>Wilson disease (WD) is a rare genetic disorder characterized by copper overload, primarily affecting the liver and brain, and the organ damage is believed to be caused by non-ceruloplasmin-bound copper (NCC). Accurate and early diagnosis is important for prognosis. Recently, a method for the measurement of NCC, exchangeable serum copper (CuEXC), was developed and shown to be a promising marker of WD, especially as the fraction of total copper, relative exchangeable copper (REC). This study aimed to validate the CuEXC extraction method and establish reference intervals for CuEXC and REC, as well as to examine short- and long-term stability of CuEXC in serum samples.</div><div>The adult reference interval for CuEXC was 0.61–1.62 µmol/L and for REC 3.0–9.7 % based on 120 blood donors. Based on 88 children, the reference intervals for CuEXC was 0.45–1.16 µmol/L. The intervals for REC were 1.8–5.8 % for children &lt;10 years and 2.3–8.5 % for children ≥10 years. Regarding stability, CuEXC increased following a logarithmic scale in uncentrifuged serum and exceeded the permissible difference of 10 % after 4 h. With long-term freezing at −20 °C, CuEXC was stable for 1.7 months.</div><div>In conclusion, reference intervals for CuEXC and REC were established and confirmed to be substantially lower in children. Accurate reference intervals are important to ensure timely diagnosis of WD. Finally, our findings on stability have important implications and highlight the need for standardization of the pre-analytical handling of CuEXC samples in order to obtain comparable results within and between laboratories both for clinical and research use.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2024-09-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142322386","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":"A combined model of six serum microRNAs as diagnostic markers for hepatocellular carcinoma","authors":"Bingqiang Zhang ,&nbsp;Boyang Zhu ,&nbsp;Junmei Yu ,&nbsp;He Liu ,&nbsp;Yang Zhou ,&nbsp;Guolong Sun ,&nbsp;Yongchao Ma ,&nbsp;Yansong Luan ,&nbsp;Mengmeng Chen","doi":"10.1016/j.cca.2024.119977","DOIUrl":"10.1016/j.cca.2024.119977","url":null,"abstract":"<div><h3>Background</h3><div>Hepatocellular carcinoma (HCC) is associated with high morbidity and mortality, and its poor prognosis is mainly due to the lack of an effective means of early diagnosis. This study aimed to identify a group of serum microRNAs (miRNAs) as potential biomarkers for the diagnosis of HCC.</div></div><div><h3>Methods</h3><div>We collected 190 HCC cases, 109 benign lesions of the liver, 40 cases of non-HCC tumors, and 130 healthy controls. The 469 participants were divided into training and validation sets. A literature search revealed 12 miRNAs closely associated with HCC. In the training set, significantly differentially expressed miRNAs (DEmiRNAs) were screened using real-time quantitative PCR, and a diagnostic model of HCC was constructed using logistic regression analysis. An independent validation was performed using a validation set. The identified DE miRNAs were subjected to target gene prediction and functional analyses.</div></div><div><h3>Results</h3><div>Compared to the controls, the levels of miR-21, miR-221, miR-801, and miR-1246 significantly decreased in HCC (<em>P</em> &lt; 0.05), while the levels of miR-26a and miR-122 significantly increased (<em>P</em> &lt; 0.05). A diagnostic model based on the six DE miRNAs was successfully constructed, with AUC values of 0.953 for the training set and 0.952 for the verification set. Finally, 100 target genes of the DE miRNAs were predicted and were significantly enriched in the B cell receptor, neurotrophin, ferroptosis, and EGFR tyrosine kinase inhibitor resistance signaling pathways.</div></div><div><h3>Conclusions</h3><div>The constructed diagnostic model based on six DE miRNA combinations has important clinical value for the early diagnosis of HCC.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2024-09-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142342716","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":"Beyond the basics: Sigma scores in laboratory medicine with variable total allowable errors (TEa)","authors":"Dharmveer Yadav,&nbsp;Mohini Rathore,&nbsp;Mithu Banerjee,&nbsp;Sojit Tomo,&nbsp;Praveen Sharma","doi":"10.1016/j.cca.2024.119971","DOIUrl":"10.1016/j.cca.2024.119971","url":null,"abstract":"&lt;div&gt;&lt;h3&gt;Background&lt;/h3&gt;&lt;div&gt;To diagnose diseases, track the effectiveness of treatments and make well-informed clinical decisions, doctors rely on results from laboratories. Accurate and precise results minimize the necessity for additional testing, saving time and money while enhancing patient satisfaction.. Internal quality control and an external quality assurance scheme(EQAS) are metrics used to evaluate a clinical laboratory’s performance. One of the numerous quality indicators that can be used to gauge the amount of errors is sigma metrics. To calculate the sigma scores bias%, CV%, and Total Error Allowable (TEa) are needed. Total Error allowable(TEa) is a crucial benchmark that establishes allowed limits on the degree of deviation from the target value for a certain analyte. Nevertheless, a proper consensus for establishing a TEa goal has not been reached and the impact of this limiting factor in standard laboratory practice and sigma calculation has not been sufficiently established. Choosing the right Total Error allowable(TEa) goal is one of the greatest challenges when employing sigma metrics as depending on the source, several measurands of TEa values may exhibit alteration.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Material and methods&lt;/h3&gt;&lt;div&gt;Our study aims to determine the sigma scores of 20 routine chemistry parameters using six different TEa sources: Clinical Laboratory Improvement Amendment (CLIA 88′), CLIA(Clinical Laboratory Improvement Amendment) 24, BDV (Biological Variation Desirable), RCPA(Royal College of Pathologists of Australasia&lt;strong&gt;),&lt;/strong&gt; RiliBak(Guideline of the German Medical Association for Quality Assurance of Laboratory Medical Examinations), and EMC/Spain(Measurement and Control Scheme) over a 12-month period using the bias percent from the External Quality Assessment Scheme (EQAS) and coefficient of variation (CV) from the Internal Quality Control (IQC). Detection system was automated, multi-channel, selective analyzer, the Beckman Coulter AU680 which works on the principle of spectrophotometry. To compute the Sigma metrics, formula used was Sigma = (TEa – Bias%) / CV%. By comparing the sigma values from the different TEa sources, TEa variance on the evaluation of the sigma metric was ascertained after which an internal quality control plan and QGI(Quality Goal Index) for underperforming parameters were devised.&lt;/div&gt;&lt;/div&gt;&lt;div&gt;&lt;h3&gt;Results&lt;/h3&gt;&lt;div&gt;The study discovered that the sigma values of common chemical parameters varied significantly based on the TEa sources used. Maximum parameters in the above three-sigma zone were TBil, HDL, CK, ALP, amylase and uric acid in CLIA’88 while RCPA and Biological variation were determined to be the most severe, with the highest performing parameters falling below three sigma zones. Rilibaek was the most liberal, with only sodium in the lower three sigma zones along with CLIA’88. The findings indicate that there is the substantial influence of various Total Error Allowable (TEa) sourc","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":null,"pages":null},"PeriodicalIF":3.2,"publicationDate":"2024-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142326724","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}