Annals of Clinical Biochemistry最新文献_第3页

Enhancing laboratory quality through comprehensive risk management and process analysis. 通过全面的风险管理和过程分析提高实验室质量。

IF 1.1 4区医学

Annals of Clinical Biochemistry Pub Date : 2026-07-01 Epub Date: 2026-02-02 DOI: 10.1177/00045632261424771

Shobha C Ramachandra, Venkatesha Madegowda, Manish Kumar Pandey, Akila Prashant, Kusuma K Shivashankar, Swetha N Kempegowda

{"title":"Enhancing laboratory quality through comprehensive risk management and process analysis.","authors":"Shobha C Ramachandra, Venkatesha Madegowda, Manish Kumar Pandey, Akila Prashant, Kusuma K Shivashankar, Swetha N Kempegowda","doi":"10.1177/00045632261424771","DOIUrl":"10.1177/00045632261424771","url":null,"abstract":"BackgroundLaboratory test results are crucial for clinical decisions, but errors at any stage can compromise patient safety. Despite technological advances and quality systems, laboratory processes remain vulnerable, necessitating structured risk assessment. Limited research exists on integrating Failure Mode and Effects Analysis (FMEA) with Sigma metrics. This study addresses these gaps through a comprehensive risk assessment in a NABL-accredited tertiary care hospital laboratory.MethodsA retrospective observational study was conducted over 2.5 years. FMEA was used to identify errors across all phases of the total testing process. Quarterly error rates were calculated, converted to defects per million (DPM), and expressed as Sigma metrics. Risk Priority Numbers (RPN = severity × detectability × frequency) were scored quarterly to prioritize failures. The effect of corrective actions was evaluated by comparing pre- and post-intervention Sigma values.ResultsAcross 10 quarters (five pre- and five post-intervention), 23 error types were identified. The highest RPNs (>20) were observed for haemolyzed samples, clotted samples, and non-intimation of critical values. Haemolyzed samples declined from 0.97% to 0.49% (ARR 0.48%; RR 0.51; 95% CI 0.47-0.55; P < .0001). Clotted samples reduced from 0.24% to 0.06% (ARR 0.18%; RR 0.24; 95% CI 0.20-0.29; P < .0001). Non-intimation of critical values decreased from 2.63% to 2.18% (RR 0.83; 95% CI 0.70-0.99; P = .065).ConclusionIntegrating FMEA with Sigma metrics provides a robust framework for identifying, prioritizing, and reducing laboratory errors. Continuous monitoring and corrective action are essential to sustain improvements in laboratory quality and patient safety.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"345-356"},"PeriodicalIF":1.1,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146103593","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Routine laboratory triage for NT-proBNP elevation may reflect cardiorenal frailty as much as heart failure specificity. NT-proBNP升高的常规实验室分诊可能反映心肾虚弱和心力衰竭的特异性。

IF 1.1 4区医学

Annals of Clinical Biochemistry Pub Date : 2026-07-01 DOI: 10.1177/00045632261466859

Zhanyun Liu

引用次数: 0

Elevated haemoglobin A1c confounds thalassaemia diagnosis by lowering HbA2 levels. 升高的A1c通过降低HbA2水平混淆了地中海贫血的诊断。

IF 1.1 4区医学

Annals of Clinical Biochemistry Pub Date : 2026-07-01 Epub Date: 2025-10-27 DOI: 10.1177/00045632251395562

Jeroen Slaats, Erfan Nur, Harriët Heijboer, Eva Rettenbacher, Rob van Zwieten, Esther Miltenburg, Joyce Reijerse, Nienke Verhaart, Wouter van den Eshof, Bart J Biemond, Henrike M Hamer

{"title":"Elevated haemoglobin A1c confounds thalassaemia diagnosis by lowering HbA2 levels.","authors":"Jeroen Slaats, Erfan Nur, Harriët Heijboer, Eva Rettenbacher, Rob van Zwieten, Esther Miltenburg, Joyce Reijerse, Nienke Verhaart, Wouter van den Eshof, Bart J Biemond, Henrike M Hamer","doi":"10.1177/00045632251395562","DOIUrl":"10.1177/00045632251395562","url":null,"abstract":"Background: Thalassemias are inherited disorders caused by reduced production of structurally normal haemoglobin chains. Haemoglobin A2 (HbA2) constitutes an important parameter in the diagnostic evaluation of thalassaemias. Insight into the factors that modulate HbA2 levels is critical for correct interpretation of laboratory results in cases where thalassaemia is suspected. Methods: A retrospective study was conducted on patients who underwent haemoglobin analysis by high-performance liquid chromatography (HPLC) at Amsterdam UMC. Patients with elevated haemoglobin A1c (HbA1c) levels due to chronic hyperglycaemia were compared with controls, an iron deficiency cohort, and α-thalassemia cohorts. Results: Patients with strongly elevated HbA1c levels (110-180 mmol/mol) showed significantly reduced HbA2 levels compared with controls (2.0% vs. 2.4%, P<0.0001). This reduction in HbA2 fraction was not observed when HbA2 was expressed relative to non-glycated HbA instead of all haemoglobin fractions. Red cell indices (MCH, MCV) and haemoglobin concentrations remained unaffected. The degree of HbA2 reduction in patients with high HbA1c was comparable to that observed in iron deficiency and α-thalassemia. Conclusions: Elevated HbA1c levels due to chronic hyperglycaemia lower measured HbA2 fractions, confounding the diagnostic evaluation of thalassaemias. Laboratories should consider HbA1c status when interpreting HbA2 results in patients with poorly controlled diabetes. Expressing HbA2 relative to non-glycated HbA may improve diagnostic accuracy in such cases.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"357-361"},"PeriodicalIF":1.1,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145375900","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

Improving the PLASMIC score with the use of RDW-SD in the differential diagnosis for thrombotic thrombocytopenic purpura in Chinese patients. 应用RDW-SD提高血浆评分在中国血栓性血小板减少性紫癜患者鉴别诊断中的价值

IF 1.1 4区医学

Annals of Clinical Biochemistry Pub Date : 2026-07-01 Epub Date: 2025-12-15 DOI: 10.1177/00045632251411788

Chi Zhang, Libo Xia, Xuesong Lv, Weixun Sun, Zhigang Xiong, Yang Fei

{"title":"Improving the PLASMIC score with the use of RDW-SD in the differential diagnosis for thrombotic thrombocytopenic purpura in Chinese patients.","authors":"Chi Zhang, Libo Xia, Xuesong Lv, Weixun Sun, Zhigang Xiong, Yang Fei","doi":"10.1177/00045632251411788","DOIUrl":"10.1177/00045632251411788","url":null,"abstract":"BackgroundThis study aimed to identify laboratory parameters that could optimize the PLASMIC score, thereby improving its diagnostic accuracy for thrombotic thrombocytopenic purpura (TTP).MethodsWe performed a retrospective analysis of 136 patients with suspected TTP who had available ADAMTS-13 activity measurements. Patients were stratified into two groups based on ADAMTS-13 activity: a TTP group (n = 49) and a non-TTP group (n = 87). Routine laboratory parameters-including hemoglobin (HGB), red blood cell distribution width-standard deviation (RDW-SD), mean corpuscular volume (MCV), platelet count (PLT), alanine aminotransferase (ALT), aspartate aminotransferase (AST), direct bilirubin (DBIL), indirect bilirubin (IBIL), lactate dehydrogenase (LDH), creatinine (CR), urea (UREA), international normalized ratio (INR), and D-dimer-were compared between groups. Statistically significant parameters were selected as candidate variables to refine the PLASMIC score. The diagnostic performance of the modified model was evaluated using receiver operating characteristic (ROC) curve analysis.ResultsSix parameters-HGB, PLT, ALT, RDW-SD, IBIL, and LDH-demonstrated significant differences between TTP and non-TTP patients. Multivariate logistic regression identified RDW-SD, PLT, and LDH as independent predictors of TTP. Based on these findings, we revised the PLASMIC score by substituting MCV with RDW-SD. The modified model exhibited a higher area under the curve (AUC) (0.907 vs 0.817) while maintaining sensitivity (95.9%) and improving specificity (70.1% vs 65.9%) compared to the original.ConclusionThe modified PLASMIC score model may improve diagnostic accuracy for TTP in similar patient populations, but requires external validation in diverse cohorts to confirm its broader utility.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"327-335"},"PeriodicalIF":1.1,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145761959","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

A UK & Ireland national audit of urine acidification. 英国和爱尔兰尿液酸化的国家审计。

IF 1.1 4区医学

Annals of Clinical Biochemistry Pub Date : 2026-07-01 Epub Date: 2025-12-15 DOI: 10.1177/00045632251411791

Emma Hughes, Louise Ward, Wassif S Wassif

{"title":"A UK & Ireland national audit of urine acidification.","authors":"Emma Hughes, Louise Ward, Wassif S Wassif","doi":"10.1177/00045632251411791","DOIUrl":"10.1177/00045632251411791","url":null,"abstract":"ObjectivesAcidification of urine samples has long been used as a method of preservation to enhance analyte stability. However, there are inherent safety risks to staff and patients when acid preservatives are used. The Association of Laboratory Medicine National Audit Committee sought to assess urine acidification practices in NHS laboratories.MethodAn 11 question survey was sent to all Association of Laboratory Medicine members for completion between 24th January 2023 and 24th February 2023 and data analysis performed using Microsoft Excel. For a variety of analytes, laboratories were asked to detail the type of recommended and accepted collection containers, whether 24 h and/or spot urine samples were accepted, if preservative was added to samples on receipt if not collected with preservative and the storage conditions for unpreserved samples.Results69 laboratories responded. Safety information was provided to users by the majority of laboratories and 88% of laboratories would pH test samples prior to sending them to a referral laboratory if acidification was a prerequisite. Variation was noted in quoted time of sample stability when refrigerated. Laboratories provided answers about specific tests - sodium, potassium, osmolality, calcium, magnesium, phosphate, creatinine, Bence Jones protein, total protein, urate, citrate, oxalate, cysteine, catecholamines, metanephrines, 5-HIAA, VMA/HMMA, copper, amino acids, organics acids and glycosaminoglycans.ConclusionsThere is significant variation in the use of acid as a preservative for urine samples throughout NHS laboratories as well as historical requirements for urine acidification for certain analytes which evidence has indicated is no longer a requirement.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"336-344"},"PeriodicalIF":1.1,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145761915","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

From 'replacement' to 'co-pilot': Reframing artificial intelligence in clinical biochemistry after Stevenson et al. 从“替代”到“副驾驶”：在Stevenson等人之后重新构建临床生物化学中的人工智能。

IF 1.1 4区医学

Annals of Clinical Biochemistry Pub Date : 2026-07-01 Epub Date: 2026-03-14 DOI: 10.1177/00045632261435398

Mulavagili Vijayasimha

引用次数: 0

NT-proBNP and its correlation to left ventricular ejection fraction and heart failure - The DEMONSTRATE database. NT-proBNP及其与左室射血分数和心力衰竭的相关性- demo数据库。

IF 1.1 4区医学

Annals of Clinical Biochemistry Pub Date : 2026-07-01 Epub Date: 2025-11-17 DOI: 10.1177/00045632251403397

Morgan Lundgren, Peter Ridefelt, Maria K Svensson, Emil Hagström, Thomas Cars, Anders Larsson

{"title":"NT-proBNP and its correlation to left ventricular ejection fraction and heart failure - The DEMONSTRATE database.","authors":"Morgan Lundgren, Peter Ridefelt, Maria K Svensson, Emil Hagström, Thomas Cars, Anders Larsson","doi":"10.1177/00045632251403397","DOIUrl":"10.1177/00045632251403397","url":null,"abstract":"BackgroundMeasurement of N-terminal pro-B-type natriuretic peptide (NT-proBNP) and left ventricular ejection fraction (LVEF) are used in diagnosing heart failure (HF). The main aim was to explore the correlation between NT-proBNP and LVEF.MethodsPatient data for 14,962 patients were extracted from medical records and national registries and compiled in the Swedish DEMONSTRATE database. HF phenotype was categorized according to LVEF level: HF with reduced EF (≤40%, HFrEF); HF with mildly reduced EF (41-49%, HFmrEF); HF with preserved EF (≥50%, HFpEF). Spearman's rank was employed for correlation analysis and ROC curves for discrimination and classification.ResultsNT-proBNP correlated negatively with LVEF level (r = -0.40) and positively with age (r = 0.49), creatinine (r = 0.35), and cystatin C (r = 0.53). Individuals with an HF diagnosis were more likely to have higher NT-proBNP levels compared to those without. The association between NT-proBNP and LVEF remained statistically significant (P < .0001) also after adjusting for age and kidney function estimates (r = -0.20). NT-proBNP discriminated well between HFrEF (AUC = 0.80) and HFpEF (AUC = 0.78). In discriminating the presence of an HF diagnosis, NT-proBNP (AUC = 0.81) outperformed LVEF (AUC = 0.75). However, on an individual level the correlation between LVEF and NT-proBNP was modest.ConclusionsNT-proBNP levels increase when LVEF deteriorates but with large inter-individual differences. Further research is needed, but these findings show potential in optimizing the use of LVEF with the aid of sequential analysis of NT-proBNP as a complementary diagnostic and prognostic tool to enhance assessment of cardiac function.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"308-318"},"PeriodicalIF":1.1,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13332166/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145538840","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","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 a point of care prostate-specific antigen blood test on a mobile outreach service. 评价护理点前列腺特异性抗原血液检测在移动外展服务。

IF 1.1 4区医学

Annals of Clinical Biochemistry Pub Date : 2026-07-01 Epub Date: 2025-11-05 DOI: 10.1177/00045632251398445

Masood Moghul, Helen Berry, Freeda Millet, Amina Tran, Fiona Mutch, Elizabeth Westaway, Fionnuala Croft, Robyn Shea, Netty Kinsella, Patrick Kierkegaard, Declan Cahill, Nicholas David James

{"title":"Evaluation of a point of care prostate-specific antigen blood test on a mobile outreach service.","authors":"Masood Moghul, Helen Berry, Freeda Millet, Amina Tran, Fiona Mutch, Elizabeth Westaway, Fionnuala Croft, Robyn Shea, Netty Kinsella, Patrick Kierkegaard, Declan Cahill, Nicholas David James","doi":"10.1177/00045632251398445","DOIUrl":"10.1177/00045632251398445","url":null,"abstract":"BackgroundPoint of care (POC) tests may improve accessibility and reduce costs of blood tests including in prostate cancer. The Man Van project was a pilot designed to address health inequalities that affect prostate cancer with novel community-based targeting of high-risk groups on a mobile clinical unit.MethodsThe i-CHROMA-II™ POC machine is a quantitative assay for the measurement of total prostate specific antigen (PSA) from capillary blood using fluorescence immunoassay technology. Laboratory based Serum PSA testing was compared with capillary blood POC testing using the i-CHROMA-II™ to determine its accuracy and impact on clinical decision making on the Man Van.Results28 men participated. The median age was 53 years (range 45-74). One POC test result was invalid. Nine POCT samples gave a result of <0.5 μg/L and were not included in the analysis. Of the remaining results (N = 18) the median PSA was 1.97 μg/L (range 0.54-31.22 μg/L). Using Lin's Concordance Correlation Coefficient of Absolute Agreement gave a value of 0.392 (N = 17). A Bland-Altman plot showed a mean difference of 0.377 μg/L.ConclusionsWe report the first testing of PSA using the i-Chroma-II™ machine, and the first real-world mobile testing using any POC PSA test. Our study did not show correlation between the laboratory and i-Chroma-II™, although it did replicate the positive bias seen in previous studies. Further testing and refinement of POC tests may help to achieve the goal to developing reliable POC PSA tests.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"301-307"},"PeriodicalIF":1.1,"publicationDate":"2026-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145443683","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

引用次数: 0

From interpretable NT-proBNP prediction to equitable laboratory stewardship. 从可解释的NT-proBNP预测到公平的实验室管理。

IF 1.1 4区医学

Annals of Clinical Biochemistry Pub Date : 2026-07-01 DOI: 10.1177/00045632261466858

Rajesh Prasad Jayaswal, Shailendra Thapliyal, Rama Kumari Badyal, Rahul Kumar Ranawat, Kundan Kumar Chaubey

引用次数: 0

PCSK9 in critical illness - It's not all about lipids. 危重疾病中的PCSK9——这并不全与脂质有关。

IF 1.1 4区医学

Annals of Clinical Biochemistry Pub Date : 2026-07-01 Epub Date: 2025-10-27 DOI: 10.1177/00045632251395579

Emma Crossley, Jonathan A Silversides, Cecilia M O'Kane, Paul K Hamilton

引用次数: 0