Annals of Clinical Biochemistry最新文献_第2页

Insulin/C-peptide interpretation in infants with hypoglycaemia of unknown origin. 胰岛素/ c肽在不明原因低血糖婴儿中的解释

IF 1.1 4区医学

Annals of Clinical Biochemistry Pub Date : 2026-09-04 DOI: 10.1177/00045632261489517

Adel A A Ismail, Hilde M Wilkinson-Herbots

{"title":"Insulin/C-peptide interpretation in infants with hypoglycaemia of unknown origin.","authors":"Adel A A Ismail, Hilde M Wilkinson-Herbots","doi":"10.1177/00045632261489517","DOIUrl":"10.1177/00045632261489517","url":null,"abstract":"BackgroundHypoglycaemia is not a disease per se but a manifestation of underlying perturbations of glucose homoeostasis. Among the biochemical tests commonly requested in newborns with confirmed, persistent/recurrent hypoglycaemia of unknown origin is the measurement of insulin and C-peptide in a blood sample(s) taken during the period of hypoglycaemia. Accepting an elevated insulin result with/without raised C-peptide as bona fide could trigger unnecessary investigations and/or diagnostic misapplications.PurposeTo highlight the significance of the \"maternal-foetal-newborn\" associations and the effect of transplacental transfer of two types of harmful IgG autoantibodies which could affect the measurements of insulin/C-peptide and confuse their interpretation. One is maternal insulin-binding autoantibodies (IAAs), a double whammy which can cause hypoglycaemia and distort insulin results due to insulin autoimmune syndrome (IAS also known as Hirata's disease). The other is non-IAA autoantibodies which if present do not cause hypoglycaemia per se but interfere analytically causing fictitious hyperinsulinaemia if measured in infants with hypoglycaemia. IgM is not transferred but could be produced by the foetus and continue after birth. The presence of IgM in newborns' blood in substantial amounts occurs if a congenital infection is encountered in-utero or early neonatal period. IgM also has the potential to interfere in immunoassays causing fictitious results.Results and ConclusionIrrespective of insulin/C-peptide levels, maternal/obstetric history coupled with early tests for antibodies by polyethylene glycol (PEG) followed by confirmatory biochemical tests on both maternal and newborn samples would identify distorted/fictitious hyperinsulinaemia, thus helping appropriate interpretation of insulin/C-peptide results and avoiding diagnostic misapplications.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261489517"},"PeriodicalIF":1.1,"publicationDate":"2026-09-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148890701","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

Reduction in sample recollection number following the implementation of automated pre-analytical interference detection in coagulation testing. 在凝血检测中实施自动分析前干扰检测后样品回收数量的减少。

IF 1.1 4区医学

Annals of Clinical Biochemistry Pub Date : 2026-09-02 DOI: 10.1177/00045632261488734

Vitória Luiza Camargo Milczarski, Iuri Vicente Camargo Morkis, Camila da Silveira Mariot, Gabriel Giron Correa, Carine Ghem

{"title":"Reduction in sample recollection number following the implementation of automated pre-analytical interference detection in coagulation testing.","authors":"Vitória Luiza Camargo Milczarski, Iuri Vicente Camargo Morkis, Camila da Silveira Mariot, Gabriel Giron Correa, Carine Ghem","doi":"10.1177/00045632261488734","DOIUrl":"10.1177/00045632261488734","url":null,"abstract":"BackgroundPre-analytical interferents such as hemolysis, lipemia, and icterus are major sources of error in coagulation testing and frequently lead to sample recollection. Visual inspection, although widely used, is subjective and may fail to identify unsuitable samples. Automated pre-analytical interferent detection using hemolysis, icterus, and lipemia (HIL) indices has been introduced to improve reliability and laboratory efficiency.ObjectiveEvaluate the impact of automated pre-analytical interferent detection on the number of sample recollections due to hemolysis in routine coagulation tests.MethodsA retrospective study compared two 1-year periods in a tertiary hospital laboratory. In 2022, samples were assessed by visual inspection using the STA-R® analyzer, while in 2023 automated inspection was implemented using the ACL Top® 750 system. Recollections due exclusively to hemolysis were analyzed for PT, aPTT, FV, fibrinogen, and D-dimer tests. Statistical analyses included binomial, Wald, and Student's t tests, with p ≤ .005 considered significant.ResultsA significant reduction in recollections was observed after the implementation of automated inspection (0.49% vs 0.35%; p < .001). PT showed a statistically significant decrease in recollections (p = .003), while other tests demonstrated non-significant reductions. Monthly average recollections decreased by 18.9% (p < .001). Annual costs related to recollections were reduced from US$ 638.49 to US$ 399.74, representing savings of US$ 238.75. A significant reduction was also observed in emergency department recollections.ConclusionsAutomated pre-analytical interferent detection significantly reduced hemolysis-related recollections, costs, and subjectivity in coagulation testing, supporting its implementation as a valuable tool to improve laboratory workflow and result reliability.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261488734"},"PeriodicalIF":1.1,"publicationDate":"2026-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148878850","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

Machine learning for the identification of mild to moderate EDTA contamination of serum samples. 机器学习用于鉴定轻度至中度EDTA污染的血清样本。

IF 1.1 4区医学

Annals of Clinical Biochemistry Pub Date : 2026-09-02 DOI: 10.1177/00045632261488751

Christopher-John L Farrell, Julie Sherfan, Tony Badrick

{"title":"Machine learning for the identification of mild to moderate EDTA contamination of serum samples.","authors":"Christopher-John L Farrell, Julie Sherfan, Tony Badrick","doi":"10.1177/00045632261488751","DOIUrl":"10.1177/00045632261488751","url":null,"abstract":"BackgroundK2EDTA contamination of serum samples is a preanalytical error that poses a risk to patient safety. Contamination is most frequently mild to moderate, which standard detection procedures often miss. We examined whether machine learning models could improve the detection of K2EDTA contamination.MethodsArtificial neural network, decision tree (both simple and complex), extreme gradient boosting, k-nearest neighbours, logistic regression, naïve Bayes, random forest, and support vector machine models were developed. Models were trained using extracted patient results for electrolytes, urea, creatinine, albumin-adjusted calcium, magnesium, and phosphate, with K2EDTA contamination errors simulated in silico. Model performance was evaluated on 300 real-world samples, half of which were intentionally contaminated with mild to moderate amounts of K2EDTA. Model performance was compared with that of limit checks, multi-analyte rules and two novel parameters, the potassium/calcium ratio and the potassium/magnesium ratio.ResultsAll nine machine learning models identified K2EDTA contamination more accurately than standard approaches (p-values <0.05). Seven models performed similarly, with accuracies of 91.3-93.3%, sensitivities of 88.0-90.0%, specificities of 94.7-96.7%, and area under the receiver operating characteristic curve (AUROC) of 0.9727-0.9787. The simple decision tree and naïve Bayes models performed slightly worse. The potassium/calcium ratio was the most effective of the standard approaches, with an accuracy of 79.7%, sensitivity of 68.7%, specificity of 90.7%, and AUROC of 0.9233.ConclusionsUsing machine learning models would enable better detection of mild to moderate K2EDTA serum contamination and improve patient safety. For laboratories unable to implement machine learning models, the best alternative is the potassium/calcium ratio.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261488751"},"PeriodicalIF":1.1,"publicationDate":"2026-09-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148878808","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

Evaluating diagnostic accuracy and analytical performance of HELIOS in detecting autoimmune disorders using external proficiency data as a tool: A three-year analysis. 外部熟练度测试的3年回顾，评估HELIOS检测自身免疫性疾病的分析性能和诊断准确性。

IF 1.1 4区医学

Annals of Clinical Biochemistry Pub Date : 2026-09-01 DOI: 10.1177/00045632261488247

Nayab Zehra, Asif Loya, Hiba Asif, Mudassar Hussain, Hina Maqbool, Umer Nisar

{"title":"Evaluating diagnostic accuracy and analytical performance of HELIOS in detecting autoimmune disorders using external proficiency data as a tool: A three-year analysis.","authors":"Nayab Zehra, Asif Loya, Hiba Asif, Mudassar Hussain, Hina Maqbool, Umer Nisar","doi":"10.1177/00045632261488247","DOIUrl":"10.1177/00045632261488247","url":null,"abstract":"ObjectiveTo assess the analytical performance and diagnostic accuracy of an automated analyzer HELIOS in external proficiency testing for diagnosing autoimmune disorders based on antinuclear antibody (ANA) images and titer values.MethodsTotal 09 CAP shipments over the period of 03 years were included in our study, comprising 05 samples in each shipment making a total of 45 samples. All samples were analyzed on HELIOS by the technique of Indirect Immunofluorescence (IFA) having built-in library for ANA image comparison and end-point titer estimation.ResultsThe data showed that there was 100% agreement with the positivity and negativity of the PT samples in detecting autoimmune disorders; however, for ANA pattern agreement, it was an average of 90.3% compared to peer mean. The most frequent ANA pattern in all 3 years was nuclear homogenous (40%) followed by nuclear speckled (32%). However, for end-point titer, there is a marked difference of mutual agreement with the PT peer group showing the lowest harmony of 35.3% in 2022 which was reported with titer of 5120; however, peer group reported titer was ≤640. Thus, the analyzer has a limitation in evaluating end-point titer and it should always be critically evaluated by the pathologist before final approval.Conclusion HELIOS has an acceptable performance in detecting autoimmune disorders and ANA pattern identification; however, for end-point titer, there were many variations for which manual dilutions should be done in routine for accurate analysis of results.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261488247"},"PeriodicalIF":1.1,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148862850","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

Optimization of HBsAg retesting process: An improvement in laboratory management system based on health economics. 乙肝表面抗原复检流程优化：基于卫生经济学的实验室管理制度改进。

IF 1.1 4区医学

Annals of Clinical Biochemistry Pub Date : 2026-09-01 DOI: 10.1177/00045632261488246

Jingrou Chen, Yang Wang, Lejian Dong, Huimin Fang, Xiaoyu Zhu, Hongxu Xu

{"title":"Optimization of HBsAg retesting process: An improvement in laboratory management system based on health economics.","authors":"Jingrou Chen, Yang Wang, Lejian Dong, Huimin Fang, Xiaoyu Zhu, Hongxu Xu","doi":"10.1177/00045632261488246","DOIUrl":"10.1177/00045632261488246","url":null,"abstract":"ObjectiveTo optimize the retesting process for hepatitis B screening, reduce false positives in samples with weak positive signals, and improve the laboratory management system, ensuring no missed cases and eliminating resource waste.Methods131 HBsAg-positive samples with initial signal to cut-off (S/CO) values ranging from 0.05 to 10 were divided into 5 intervals. After high-speed centrifugation, the samples were retested for HBsAg, and the initial and retest results were compared. By evaluating the repeatability and accuracy of the HBsAg results in different intervals, the \"gray zone\" of the HBsAg screening test was identified, and a laboratory optimization process plan was established. The new plan was piloted in parallel with the old plan to assess the reliability of the new plan.ResultsIn the interval of initial cut-off (S/CO) values [0.05∼0.2], the difference rate between the initial test group and retest group was the highest (40%), and there was a significant difference in the qualitative results (p < .01). In the interval (1, 2], although there was no significant difference in the qualitative results before and after the retest (p = .47), there were two samples with qualitative differences in the two groups. Under the new plan, the missed detection rate was reduced to 0, and it had excellent clinical application effects.ConclusionOn the premise of ensuring 0 missed detection, fully considering the economic benefits and the rational allocation of resources, the hepatitis B screening \"gray zone\" is set to [0.05, 2]. For \"gray zone\" specimens, the retesting process must be implemented.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261488246"},"PeriodicalIF":1.1,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148862804","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

Reference intervals for serum cystatin C in Brazilian children aged 5-11 years: A short report. 巴西5-11岁儿童血清胱抑素c参考间隔：一份简短报告。

IF 1.1 4区医学

Annals of Clinical Biochemistry Pub Date : 2026-09-01 Epub Date: 2025-11-17 DOI: 10.1177/00045632251403403

N F Jacobi, Acm Ciceri, L E de Oliveira, Iso Tioda, M Kaefer, S A de Oliveira, L B Pasqualoto, B G Rossato, R N Moresco, C Paniz, José Antonio Mainardi de Carvalho

{"title":"Reference intervals for serum cystatin C in Brazilian children aged 5-11 years: A short report.","authors":"N F Jacobi, Acm Ciceri, L E de Oliveira, Iso Tioda, M Kaefer, S A de Oliveira, L B Pasqualoto, B G Rossato, R N Moresco, C Paniz, José Antonio Mainardi de Carvalho","doi":"10.1177/00045632251403403","DOIUrl":"10.1177/00045632251403403","url":null,"abstract":"BackgroundCystatin C (CysC) is a biomarker used to assess kidney function. Produced by all nucleated cells, it is freely filtered by the glomeruli, and its serum levels increase rapidly following kidney injury. Establishing reference intervals (RIs) is fundamental for the clinical application of CysC, as these parameters vary with geographic region and ethnic origin. This study aimed to determine RIs for CysC in healthy children aged 5-11 years from public schools in Santa Maria, southern Brazil.MethodsWe enrolled 134 healthy children (aged 5-11 years, both sexes). Cystatin C levels were measured via immunoturbidimetry, and RIs were defined by the 2.5th and 97.5th percentiles.ResultsThe RI for serum CysC was 0.59 to 1.10 mg/L. Sex-specific analysis revealed CysC RIs of 0.53-1.10 mg/L for females and 0.61-1.10 mg/L for males.ConclusionsThese findings provide valuable insights for paediatric clinical decision-making in a previously unstudied population and underscore the need for further research to validate and refine the clinical applications of CysC in paediatrics.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"445-447"},"PeriodicalIF":1.1,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145538848","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

IF 1.1 4区医学

Annals of Clinical Biochemistry Pub Date : 2026-09-01 Epub Date: 2026-02-09 DOI: 10.1177/00045632261426852

George F G Allen, Sarah Blampied, Kashyap A Patel, Timothy J McDonald, Andrew T Hattersley, Bijay Vaidya

{"title":"Age-related reference intervals for thyroid function tests are beneficial in adults over 60 years.","authors":"George F G Allen, Sarah Blampied, Kashyap A Patel, Timothy J McDonald, Andrew T Hattersley, Bijay Vaidya","doi":"10.1177/00045632261426852","DOIUrl":"10.1177/00045632261426852","url":null,"abstract":"BackgroundThe rise in serum thyroid stimulating hormone (TSH) in healthy older adults is well established. However, age-related reference intervals are not widely used. We aimed to establish all-adult and age-related reference intervals for TSH, free thyroxine (FT4) and free triiodothyronine (FT3) and determine their impact on primary care thyroid testing results.MethodsWe measured TSH, FT4 and FT3 by Roche Cobas assays in a reference cohort of 1364 anti-thyroid peroxidase antibody negative adults with no self-reported medical conditions or medications. Reference intervals were generated for all-adult, 18-60 and over 60 years. Reference intervals were applied to 21,286 primary care tests with no known thyroid disease to assess effect on test interpretation.ResultsIn the reference cohort, 23.2% were over 60 years compared to 50.4% of those undergoing thyroid testing in primary care. With an all-adult reference interval, 8.2% of over 60s had an elevated TSH, 7.0% were classified as subclinical hypothyroid and 0.8% as overt hypothyroid. With age-related reference intervals, this fell to 4.4% with an elevated TSH, 3.7% subclinical hypothyroid and 0.4% overt hypothyroid. Minimal changes were seen in the 18-60 years group.ConclusionsAn all-adult reference interval derived from healthy and therefore younger individuals is less appropriate for the older subset of the population being tested. Application of an age-related reference interval for over 60s would reduce the proportion of patients with abnormal thyroid test results. In turn, this would decrease potentially unnecessary cascade and repeat testing as well as regular follow-up in primary care.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"394-402"},"PeriodicalIF":1.1,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13550734/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146148870","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

False-positive point-of-care urine beta human chorionic gonadotropin testing: Insights from two clinical cases. 假阳性护理点尿β人绒毛膜促性腺激素测试：从两个临床病例的见解。

IF 1.1 4区医学

Annals of Clinical Biochemistry Pub Date : 2026-09-01 Epub Date: 2026-03-21 DOI: 10.1177/00045632261433346

Gayani Nilmini Dissanayake, Hanine Fourie, Gordana Fricker, Darmiga Thayabaran, Mayur Patel, Ingrid Granne, Brian Shine

{"title":"False-positive point-of-care urine beta human chorionic gonadotropin testing: Insights from two clinical cases.","authors":"Gayani Nilmini Dissanayake, Hanine Fourie, Gordana Fricker, Darmiga Thayabaran, Mayur Patel, Ingrid Granne, Brian Shine","doi":"10.1177/00045632261433346","DOIUrl":"10.1177/00045632261433346","url":null,"abstract":"Case oneA young woman presented to the Early Pregnancy Assessment Unit (EPAU) with abdominal pain, amenorrhoea and variably positive home-pregnancy tests. On review, a point-of-care test (POCT) for urine beta-HCG (β-HCG) was negative but a blood test using the Abbott i-STAT β-HCG POCT device was positive. Initial transvaginal ultrasound did not demonstrate an intra- or extra-uterine pregnancy. Over the following 2 months, weekly plasma POCT iSTAT β-HCG checks remained positive. After a further ultrasound suggesting a possible ectopic pregnancy, the patient underwent a diagnostic laparoscopy which was unremarkable. Post-operatively, POCT iSTAT β-HCG levels remained elevated, and a blood sample was sent for laboratory analysis revealing an undetectable β-HCG of <1.20 IU/L (reference interval 0-4).Case twoA middle-aged woman presented to the emergency department with mons pubis pain and swelling and was admitted to the gynaecology ward for drainage of bilateral abscesses. On review, she had raised blood β-HCG levels, measured using the Abbott i-STAT POCT device. A subsequent blood sample sent for laboratory analysis showed β-HCG levels within the post-menopausal reference interval. Discussion: In both cases, POCT immunoassay interference was confirmed by consistent results produced when contemporaneous samples were analysed by different analytical platforms. Immunoassay interference, though rare, can lead to inaccurate results from POCT devices, potentially impacting patient diagnosis and management. Clinical teams should remain vigilant for this possibility; if test results do not align with clinical expectations, it is essential to promptly send a blood sample for laboratory analysis.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"458-461"},"PeriodicalIF":1.1,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147493294","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

Incidental diagnosis of glycerol kinase deficiency during investigation of hyponatraemia and acute kidney injury. 在低钠血症和急性肾损伤的调查中偶然诊断甘油激酶缺乏。

IF 1.1 4区医学

Annals of Clinical Biochemistry Pub Date : 2026-09-01 Epub Date: 2026-02-13 DOI: 10.1177/00045632261424751

Rachel Brixey-McCann, Fawaz Ali, Soha Zouwail

引用次数: 0

LabMedUK26 Conference Birmingham - Editorial. LabMedUK26伯明翰会议-编辑。

IF 1.1 4区医学

Annals of Clinical Biochemistry Pub Date : 2026-09-01 Epub Date: 2026-10-01 DOI: 10.1177/00045632261467595

引用次数: 0