Annals of Clinical Biochemistry最新文献

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Phlebotomy technique and its impact on haemolysis in the emergency department. 急诊科放血技术及其对溶血的影响。
IF 1.1 4区 医学
Annals of Clinical Biochemistry Pub Date : 2026-10-13 DOI: 10.1177/00045632261497586
Jonathan Fenn, Ahmed Elgharably, Shivani Mahapatra, Thushi Ashmore, Lauren Starbrook, Rousseau Gama, Tejas Kalaria
{"title":"Phlebotomy technique and its impact on haemolysis in the emergency department.","authors":"Jonathan Fenn, Ahmed Elgharably, Shivani Mahapatra, Thushi Ashmore, Lauren Starbrook, Rousseau Gama, Tejas Kalaria","doi":"10.1177/00045632261497586","DOIUrl":"https://doi.org/10.1177/00045632261497586","url":null,"abstract":"<p><p>BackgroundHaemolysis is a pre-analytical problem that compromises laboratory test accuracy and delays care by necessitating repeat testing. Haemolysis rates in emergency department samples are higher than those in inpatient or outpatient settings. This study evaluated the association between phlebotomy techniques and haemolysis rates in the emergency department.MethodsBlood samples collected in the emergency department with documented phlebotomy technique between November 2023 and September 2024 were audited. Five phlebotomy methods were compared: [1] needle/butterfly to vacutainer (closed system), [2] syringe-needle draw, [3] syringe draw from an intravenous cannula, [4] vacutainer collection from cannula using an adapter, and [5] use of a discard tube for either needle or cannula draws. Haemolysis was defined by an Abbott Alinity H-index ≥1.25 (≈1.25 g/L free haemoglobin), above which potassium results are suppressed by the laboratory.ResultsAmong 586 samples, 42 (7.2%) were haemolysed. Haemolysis rates were 16.7% (2/12) for syringe draw from intravenous cannula, 14.8% (31/209) for vacutainer collection from intravenous cannula using an adapter, 6.3% (1/16) for syringe-needle draw, 2.4% (2/83) for methods using a discard-tube in either needle or cannula collection, and 2.3% (6/266) for needle/butterfly to vacutainer closed phlebotomy method. Haemolysis differed significantly by method (<i>p</i> < 0.0001): draws from cannula using adapter had higher rates than closed phlebotomy (<i>p</i> < 0.0001) and discard-tube draws (<i>p</i> = 0.0017).ConclusionClosed phlebotomy methods, particularly needle or butterfly collection into vacutainer tubes, were associated with the lowest haemolysis rates. Discard-tube samples also had low haemolysis rates, although their effect remains uncertain.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261497586"},"PeriodicalIF":1.1,"publicationDate":"2026-10-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149179012","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
Real-world analytical and diagnostic evaluation of the Abbott i-STAT Alinity point-of-care high-sensitivity troponin I assay in a UK emergency department. 雅培I - stat Alinity护理点高灵敏度肌钙蛋白I测定在英国急诊科的真实世界分析和诊断评估。
IF 1.1 4区 医学
Annals of Clinical Biochemistry Pub Date : 2026-10-08 DOI: 10.1177/00045632261499915
Angela Dawn Burns, Vaishnavi Muthukrishnan, Usmaan Razzaq, Louise Boughen, David Paisley, Andrew Saunders, Faheem Ahmad, Ian M Godber
{"title":"Real-world analytical and diagnostic evaluation of the Abbott i-STAT Alinity point-of-care high-sensitivity troponin I assay in a UK emergency department.","authors":"Angela Dawn Burns, Vaishnavi Muthukrishnan, Usmaan Razzaq, Louise Boughen, David Paisley, Andrew Saunders, Faheem Ahmad, Ian M Godber","doi":"10.1177/00045632261499915","DOIUrl":"10.1177/00045632261499915","url":null,"abstract":"<p><strong>Background: </strong>High-sensitivity cardiac troponin (hs-cTn) testing is central to emergency department assessment of suspected acute coronary syndrome. Point-of-care hs-cTn testing may reduce turnaround time, but local analytical and clinical evaluation is required before implementation.</p><p><strong>Methods: </strong>In a single-centre real-world evaluation, paired whole-blood and plasma samples from patients with suspected acute coronary syndrome were analysed using the Abbott i-STAT Alinity point-of-care hs-cTnI assay and the Alinity laboratory hs-cTnI assay. Imprecision, method comparison, threshold concordance, diagnostic discrimination for adjudicated Type 1 myocardial infarction (MI), and potential effects of haemolysis, icterus, lipaemia and haematocrit were assessed.</p><p><strong>Results: </strong>Low-level imprecision was below 10% CV. Concordance at the <5 ng/L rule-out threshold was high (84.1%); all discordant classifications reflected higher POCT values, with no false-negative rule-outs. Both assays showed similar discrimination for adjudicated Type 1 MI and 100% observed sensitivity and negative predictive value at the 5 ng/L threshold, although confidence intervals were wide. POCT specificity was lower than laboratory specificity. Method comparison showed a modest positive POCT bias, and regression analyses did not identify clinically meaningful effects of haemolysis, icterus, lipaemia or haematocrit.</p><p><strong>Conclusion: </strong>The Abbott i-STAT Alinity POCT hs-cTnI assay demonstrated analytical performance and clinical concordance supportive of local implementation, with similar diagnostic discrimination to the Alinity laboratory hs-cTnI assay in a small cohort. Larger prospective studies are needed to confirm clinical safety and workflow impact.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261499915"},"PeriodicalIF":1.1,"publicationDate":"2026-10-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149134886","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
Quality indicator driven sigma scale assessment of extra-analytical phases in clinical chemistry laboratory-Insights from a tertiary care hospital. 质量指标驱动的临床化学实验室分析外相的六西格玛量表评估——来自三级医疗医院的见解。
IF 1.1 4区 医学
Annals of Clinical Biochemistry Pub Date : 2026-10-07 DOI: 10.1177/00045632261499295
Jitender Sharma, Roopali Rajput, Himanshu Sharma, Pradeep K Dabla
{"title":"Quality indicator driven sigma scale assessment of extra-analytical phases in clinical chemistry laboratory-Insights from a tertiary care hospital.","authors":"Jitender Sharma, Roopali Rajput, Himanshu Sharma, Pradeep K Dabla","doi":"10.1177/00045632261499295","DOIUrl":"10.1177/00045632261499295","url":null,"abstract":"<p><p>BackgroundIn recent years, the error rate in the analytical stage of laboratory testing has been drastically reduced due to automation, good-quality reagents, standardized assays, and increased participation of laboratories in proficiency testing programs. Nevertheless, high error rates in extra-analytical phase remain a critical vulnerability impacting diagnostic performance and patient safety.ObjectiveThe present observational study was designed to quantify error rates and evaluate efficiency of extra-analytical processes, using quality indicators on the Sigma metrics.MethodsWe examined extra-analytical errors in 51,072 test requests received in the Clinical Biochemistry Laboratory of GIPMER Delhi, India from March to August 2025. Extra-analytical phase quality standards for sample testing conformed to the IFCC quality indicators. Minitab software was used to calculate Six Sigma from the collected data.ResultsOur investigation revealed that 1572 errors, accounting for about 90% of the total, occurred during extra-analytical phase. Manual entry of test request information in the autoanalyzer during the pre-analytical stage and transcription of test results into patient reports in the post-analytical stage accounts for 35% of all laboratory errors in this study. Pre-analytical errors were chiefly Test transcription (39%) and haemolysis (27%), while post-analytic errors were delay in TAT (43%) and manual result entry errors (41%), expressed as percentage of total pre-analytical and post-analytical errors, respectively. Sigma values for all QIs were acceptable ranging from 4-4.9 for the pre-analytical and 4.2-5 in the post-analytical processes of laboratory testing.ConclusionClinical biochemistry laboratories can significantly improve extra-analytical phase quality using Six Sigma based Quality Indicator framework.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261499295"},"PeriodicalIF":1.1,"publicationDate":"2026-10-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149126259","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
Accuracy of the novel automated VIDAS TBI (GFAP, UCH-L1) assay for ruling out acute intracranial traumatic lesions in patients under 65 years of age with mild traumatic brain injury in an Emergency Department: An exploratory study. 新型自动VIDAS TBI (GFAP, ch - l1)检测在急诊科排除65岁以下轻度外伤性脑损伤患者急性颅内外伤性病变的准确性:一项探索性研究。
IF 1.1 4区 医学
Annals of Clinical Biochemistry Pub Date : 2026-10-01 DOI: 10.1177/00045632261497264
Eva Pérez Fernández, Esther Montoro Jorquera, Leandro Noblia, Alberto Fernández Reina, Joaquín Valle Alonso, Francisco Manuel Gómez Morales, Juan Manuel Sánchez Gil, Mercedes González Morales, Luis García de Guadiana-Romualdo
{"title":"Accuracy of the novel automated VIDAS TBI (GFAP, UCH-L1) assay for ruling out acute intracranial traumatic lesions in patients under 65 years of age with mild traumatic brain injury in an Emergency Department: An exploratory study.","authors":"Eva Pérez Fernández, Esther Montoro Jorquera, Leandro Noblia, Alberto Fernández Reina, Joaquín Valle Alonso, Francisco Manuel Gómez Morales, Juan Manuel Sánchez Gil, Mercedes González Morales, Luis García de Guadiana-Romualdo","doi":"10.1177/00045632261497264","DOIUrl":"10.1177/00045632261497264","url":null,"abstract":"<p><p>BackgroundCombination of glial fibrillary acidic protein (GFAP) and ubiquitin C-terminal hydrolase-L1 (UCH-L1) is useful to exclude intracranial injury after mild traumatic brain injury (mTBI). We evaluated the diagnostic performance of the novel regulatory-approved VIDAS<sup>®</sup> TBI assay for this purpose.MethodPatients under 65 years of age presenting to the Emergency Department with TBI, Glasgow Coma score 13-15, completed head computed tomography (CT) scan and blood collected within 12 hours of injury were included. UCH-L1/GFAP levels were analysed using prespecified cutoffs and combined into a single result and evaluated against CT findings.Results78 enrolled participants were analysed. Intracranial injury was detected in 4 patients. VIDAS<sup>®</sup> TBI test achieved a sensitivity and negative predictive value of 100%.ConclusionThe VIDAS TBI assay showed potential as a rule-out test in this exploratory cohort; however, estimates were based on only four CT-positive cases and require confirmation in larger prospective studies.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261497264"},"PeriodicalIF":1.1,"publicationDate":"2026-10-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149102985","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
Developing a new LDLc regressor machine learning model to predict LDLc levels and comparing with conventional LDLc formula: our experience from clinical laboratory dataset. 开发一种新的LDLc回归机器学习模型来预测LDLc水平,并与传统的LDLc公式进行比较:我们从临床实验室数据集的经验。
IF 1.1 4区 医学
Annals of Clinical Biochemistry Pub Date : 2026-09-30 DOI: 10.1177/00045632261497288
Suchitra Kumari, Saurav Nayak
{"title":"Developing a new LDLc regressor machine learning model to predict LDLc levels and comparing with conventional LDLc formula: our experience from clinical laboratory dataset.","authors":"Suchitra Kumari, Saurav Nayak","doi":"10.1177/00045632261497288","DOIUrl":"10.1177/00045632261497288","url":null,"abstract":"<p><p>BackgroundThe treatment goals of cardiovascular diseases are focused primarily on LDLc. ML-based LDLc estimation methods offer a superior, reliable alternative to traditional formulas. This study aims to evaluate the performance of ML-based LDLc estimation models and compare their accuracy to direct LDLc and conventionally used formulas.MethodsML models based on Elastic Net-Based Formula, Elastic Net based Formula With Simplified Coefficient, Random Forest (RDF), eXtreme Gradient Boost, Multiple Layer Perceptron Regressor (MLP) were developed based on 61,444 patient datapoints, that is, 36,866-internal dataset and 24,578-external dataset. The performance of model evaluated in data subsets based on Total Cholesterol and TG levels. These subsets were evaluated, that is, adjusted R<sup>2</sup>, MSE, RMSE, Mean Absolute Error, % Bias along with evaluation matrix score (EMS)-based ranking and Subset-Integrated EMS (SI-EMS).ResultsBased on the EMS and SI-EMS, MLP model was depicted to be the best model for overall dataset as well as all subsets. Bland-Altman plot showed all ML models Highly Reliable based on Bias and Trend (r). Among the formulas, Martin's is only Highly Reliable. Classification Validation Score (CVS) depicted better performance of ML models than their counterparts, except when classifying Very High LDL. MLP was in top five methods with equivalent CVS to top models.ConclusionBased on the SI-EMS, ML models and formula were evaluated, the MLP neural network performed the best to estimate LDLc levels, and the web application constructed by utilising best model could be a potential aid to clinicians and laboratories in estimating LDL values closer to the actual measurement.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261497288"},"PeriodicalIF":1.1,"publicationDate":"2026-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149079494","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
Analytical performance of a single epitope meta-sandwich total 25-hydroxyvitamin D immunoassay and establishment of reference intervals in a Chinese population. 单表位夹层总25-羟基维生素D免疫分析法的分析性能及参考区间的建立。
IF 1.1 4区 医学
Annals of Clinical Biochemistry Pub Date : 2026-09-30 DOI: 10.1177/00045632261497590
Xiaochun Dai, Chun Xia, Fang Zhang, Xinci Huang, Jun Ye, Dapeng Wan, Ji Zeng
{"title":"Analytical performance of a single epitope meta-sandwich total 25-hydroxyvitamin D immunoassay and establishment of reference intervals in a Chinese population.","authors":"Xiaochun Dai, Chun Xia, Fang Zhang, Xinci Huang, Jun Ye, Dapeng Wan, Ji Zeng","doi":"10.1177/00045632261497590","DOIUrl":"10.1177/00045632261497590","url":null,"abstract":"<p><p>BackgroundThe concentration of 25-hydroxyvitamin D [25-(OH)D] is used to evaluate vitamin D status. Persistent discrepancies between chemiluminescent immunoassays (CLIAs) and liquid chromatography-tandem mass spectrometry (LC-MS/MS) continue to challenge clinical laboratories. To investigate the single epitope meta-sandwich (SEMS) immunoassay from Mindray, we assessed the analytical performance of the VD-T II assay and established reference intervals.MethodsWe evaluated detection limits, precision, linearity, and cross-reactivity following the American Clinical and Laboratory Standards Institute (CLSI) protocols. A total of 118 selected serum samples were measured using the Mindray VD-T II assay (CLIA), and the results were compared with those obtained by LC-MS/MS and three other automated 25-(OH)D assays (Roche, Abbott, Snibe). Additionally, season-stratified 95% reference intervals for adults and age-specific 95% reference intervals for children were established using the VD-T II assay based on samples from 1402 healthy individuals.ResultsThe limits of blank (LoB), detection (LoD), and quantitation (LoQ) all met the claimed specifications. Within-run and within-laboratory precision coefficients of variation (%CV) for the VD-T II assay ranged from 1.64% to 2.36% and from 3.08% to 6.32%, respectively. Good linearity was observed over the linear range of 3.00-150.00 ng/mL. Cross-reactivity with analogs was acceptable. The correlation coefficient between VD-T II and LC-MS/MS was 0.963, the highest among the assays tested. In adults, the 95% reference intervals were 7.86-48.56 ng/mL in summer and 6.28-43.34 ng/mL in winter. In children, the 95% reference intervals were 3.76-43.34 ng/mL for those <1 year old, 6.56-50.47 ng/mL for those 1-13 years old, and 4.66-29.22 ng/mL for those 14-18 years old.ConclusionsThe Mindray VD-T II assay demonstrates robust analytical performance and good agreement with LC-MS/MS, supporting its use as a suitable method for routine total 25-(OH)D testing.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261497590"},"PeriodicalIF":1.1,"publicationDate":"2026-09-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149103036","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
Strengthening pre-analytic management of biotin interference in clinical immunoassays. 加强临床免疫分析中生物素干扰的分析前管理。
IF 1.1 4区 医学
Annals of Clinical Biochemistry Pub Date : 2026-09-24 DOI: 10.1177/00045632261492534
Arisha Hussain
{"title":"Strengthening pre-analytic management of biotin interference in clinical immunoassays.","authors":"Arisha Hussain","doi":"10.1177/00045632261492534","DOIUrl":"https://doi.org/10.1177/00045632261492534","url":null,"abstract":"","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261492534"},"PeriodicalIF":1.1,"publicationDate":"2026-09-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149036076","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
CSF Kappa Free Light Chain: An enhancement to Oligoclonal Bands? A Tertiary Centre Cohort. 脑脊液Kappa游离轻链:寡克隆带的增强?高等教育中心队列。
IF 1.1 4区 医学
Annals of Clinical Biochemistry Pub Date : 2026-09-15 DOI: 10.1177/00045632261492540
Nicholas Alexei Eric Armfield, Sally Hanton, Nicola Williams, Katherine Birch, Robert Tate, Edward Jackson, Carrie Chadwick
{"title":"CSF Kappa Free Light Chain: An enhancement to Oligoclonal Bands? A Tertiary Centre Cohort.","authors":"Nicholas Alexei Eric Armfield, Sally Hanton, Nicola Williams, Katherine Birch, Robert Tate, Edward Jackson, Carrie Chadwick","doi":"10.1177/00045632261492540","DOIUrl":"https://doi.org/10.1177/00045632261492540","url":null,"abstract":"<p><p>Background Measurement of kappa free light chains (κFLC) in cerebrospinal fluid (CSF) has been demonstrated as a quantitative biomarker for neuroinflammation. CSF κFLC may be displayed in several forms, often using a peripheral κFLC measurement as a denominator to highlight intrathecal rather than systemic inflammation. This study seeks to contextualise CSF κFLC as an alternative to oligoclonal band (OCB) analysis. Methods Patient samples were separated into 2 distinct cohorts by clinical diagnosis and OCB result. κFLC, IgG, albumin and OCB were analysed for paired CSF and serum samples (n=104); CSF cell counts were also performed. Quotient calculations for κFLC were performed and hyperbolic reference curves drawn. Results Comparison of κFLC and OCB results showed that samples with 2 or more unmatched OCB gave significantly different CSF κFLC determinations in all κFLC result formats (p <0.001) compared with other OCB cohorts. CSF κFLC also correlated with ≥1 unmatched OCB. All multiple sclerosis (MS) patients gave significantly different κFLC determinations in all κFLC result formats (p <0.001) between MS and non-MS cohorts. Using a κFLC index cut-off ≥16 gave PPV and NPV of 85% and 94% for MS. Conclusions CSF κFLC has been incorporated into the 2024 revision of the McDonald Criteria. This study supports CSF κFLC as a quantitative, non-specific biomarker for MS. Advantages of κFLC in a laboratory repertoire include simple analysis available on common analytical platforms. We recommend that CSF κFLC should be used in conjunction with OCB for samples without a clear positive or negative result.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261492540"},"PeriodicalIF":1.1,"publicationDate":"2026-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148966001","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
Comparability of Total Bilirubin methods for neonatal samples across 6 NHS trusts within North West England. 总胆红素方法的新生儿样本跨越6 NHS信托在英格兰西北部的可比性。
IF 1.1 4区 医学
Annals of Clinical Biochemistry Pub Date : 2026-09-15 DOI: 10.1177/00045632261492544
Francesca Ryan-Beswick, Caitlin Kyle, Laura Parke, Lesley Tetlow, Steven John McCann, Sharman Harris, Suzanne Armitage, Mandy Pickersgill, Faustina Owusu, Jonathan Scargill
{"title":"Comparability of Total Bilirubin methods for neonatal samples across 6 NHS trusts within North West England.","authors":"Francesca Ryan-Beswick, Caitlin Kyle, Laura Parke, Lesley Tetlow, Steven John McCann, Sharman Harris, Suzanne Armitage, Mandy Pickersgill, Faustina Owusu, Jonathan Scargill","doi":"10.1177/00045632261492544","DOIUrl":"10.1177/00045632261492544","url":null,"abstract":"<p><strong>Background: </strong>The National Institute for Health and Care Excellence (NICE) guideline: management of neonatal jaundice [CG98] outlines total bilirubin (TBil) thresholds for the treatment of neonatal jaundice. Despite wide analytical variation in TBil, evidenced on external quality assessment schemes, the thresholds are based on a single Roche diazo assay. Adoption of these thresholds may result in inappropriate treatment decisions depending on the analytical methodology. This study assesses TBil method bias using pooled neonatal (<29 days) samples, prompted by incidents within Greater Manchester where differences in neonatal TBil measurements obtained due to transfer of care across sites caused clinical confusion.</p><p><strong>Methods: </strong>Seventeen serum and 9 plasma neonatal pools were analysed in duplicate on 6 platforms: Roche Cobas 701, Roche Pro, Abbott Alinity, Beckman Coulter AU5800, Siemens Atellica and Siemens XPT , utilising 5 diazo and 2 vanadate oxidation methodologies. Measurement biases compared to Roche Cobas were assessed.</p><p><strong>Results: </strong>Siemens Atellica and XPT vanadate oxidation methods exhibited significant positive bias: 17.4% [95% CI: 15.0-19.8%] and 17.0% [95% CI: 15.0-19.0%], respectively. All diazo methods were within desirable bias limits (+/-8%) as defined by the European Federation of Clinical Chemistry and Laboratory Medicine analytical performance specifications. Bias for Siemens vanadate oxidation and Beckman Coulter diazo methods exhibited matrix variation.</p><p><strong>Conclusions: </strong>Use of Siemens TBil vanadate oxidation method may lead to over treatment of neonatal jaundice when using NICE [CG98] thresholds. Laboratory professionals should evaluate the appropriateness of their TBil methodology in collaboration with their neonatal teams to minimise risks of overtreatment.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261492544"},"PeriodicalIF":1.1,"publicationDate":"2026-09-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148966342","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
Clinical significance of inter-assay discrepancies in serum CA19-9 values: A comparison between CLIA and ECLIA. 血清CA19-9值测定间差异及回归校正的临床意义:CLIA与ECLIA的比较
IF 1.1 4区 医学
Annals of Clinical Biochemistry Pub Date : 2026-09-10 DOI: 10.1177/00045632261491148
Ling Zhang, Yuichiro Uchida, Midori Saito, Hayato Ichikawa, Kunpei Hada, Masato Hoshi, Takeshi Takahara, Hiroyasu Ito, Koichi Suda
{"title":"Clinical significance of inter-assay discrepancies in serum CA19-9 values: A comparison between CLIA and ECLIA.","authors":"Ling Zhang, Yuichiro Uchida, Midori Saito, Hayato Ichikawa, Kunpei Hada, Masato Hoshi, Takeshi Takahara, Hiroyasu Ito, Koichi Suda","doi":"10.1177/00045632261491148","DOIUrl":"10.1177/00045632261491148","url":null,"abstract":"<p><p>BackgroundSerum carbohydrate antigen 19-9 (CA19-9) is widely used in the management of pancreatic diseases, but results often vary across immunoassay platforms. This study sought to describe how the values obtained by chemiluminescent immunoassay (CLIA) and electrochemiluminescent immunoassay (ECLIA) differ, to assess whether discrepancies vary across concentration ranges, and to identify clinical factors potentially contributing to this variability.MethodsWe examined 1,760 paired samples measured simultaneously by CLIA (Abbott Alinity i) and ECLIA (Roche Cobas e801) during a transition period. To assess agreement between assays, correlation analysis, Passing-Bablok regression, and Bland-Altman analysis were performed on log<sub>10</sub>-transformed data.Subgroup comparisons were made by CA19-9 concentration, disease category, and hepatobiliary enzyme status. Multivariable regression was used to explore independent factors associated with the magnitude of inter-assay differences.ResultsCorrelation between CLIA and ECLIA was strong (r = 0.94, ρ = 0.89) although a concentration-dependent bias was observed with CLIA yielding higher values at higher concentrations, whereas ECLIA tended to yield higher values at lower concentrations. Discrepancies were greater in pancreatic cancer samples in those with elevated ALP or γ-GT, and at higher concentrations (CLIA ≥ 1000 U/mL). Older age, female sex, pancreatic cancer, and elevated hepatobiliary enzymes were independently associated with larger assay differences (adjusted R<sup>2</sup> = 0.13).ConclusionsDespite good overall agreement, the two methods showed variability that could affect clinical interpretation, especially in low or high concentration ranges. When assay changes are unavoidable, using method-specific reference ranges or confirming results near decision thresholds may help ensure consistent interpretation.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261491148"},"PeriodicalIF":1.1,"publicationDate":"2026-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148918256","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}
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