Annals of Clinical Biochemistry最新文献

{"title":"Insulin/C-peptide interpretation in Infants with Hypoglycaemia of Unknown Origin.","authors":"Adel A A Ismail, Hilde Maria Wilkinson-Herbots","doi":"10.1177/00045632261489517","DOIUrl":"https://doi.org/10.1177/00045632261489517","url":null,"abstract":"<p><p>Hypoglycaemia is not a disease per se but a manifestation of underlying perturbations of glucose homeostasis. 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. The focus of this review is to highlight the significance of the \"maternal-fetal-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 (IAA), 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 fetus 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 has also the potential to interfere in immunoassays causing fictitious results. Irrespective 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 avoids diagnostic misapplications.</p>","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}

{"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":"https://doi.org/10.1177/00045632261488734","url":null,"abstract":"<p><strong>Background: </strong>Pre-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.</p><p><strong>Objective: </strong>Evaluate the impact of automated pre-analytical interferent detection on the number of sample recollections due to hemolysis in routine coagulation tests.</p><p><strong>Methods: </strong>A retrospective study compared two one-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 ≤ 0.005 considered significant.</p><p><strong>Results: </strong>A significant reduction in recollections was observed after implementation of automated inspection (0.49% vs. 0.35%; p < 0.001). PT showed a statistically significant decrease in recollections (p = 0.003), while other tests demonstrated non-significant reductions. Monthly average recollections decreased by 18.9% (p < 0.001). 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.</p><p><strong>Conclusions: </strong>Automated 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.</p>","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}

{"title":"Machine learning for the identification of mild to moderate EDTA contamination of serum samples.","authors":"Christopher-John Lancaster Farrell, Julie Sherfan, Tony Badrick","doi":"10.1177/00045632261488751","DOIUrl":"https://doi.org/10.1177/00045632261488751","url":null,"abstract":"<p><p>Background K2EDTA 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. Methods Artificial 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. Results All 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 accuracy of 79.7%, sensitivity of 68.7%, specificity of 90.7%, and AUROC of 0.9233. Conclusions Using 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.</p>","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}

{"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":"https://doi.org/10.1177/00045632261488246","url":null,"abstract":"<p><strong>Objective: </strong>To 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.</p><p><strong>Methods: </strong>131 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.</p><p><strong>Results: </strong>In the interval of initial cutoff (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<0.01). In the interval (1,2], although there was no significant difference in the qualitative results before and after the retest (p=0.47), 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.</p><p><strong>Conclusion: </strong>On 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.</p>","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}

{"title":"A 3-year review of external proficiency testing, evaluating analytical performance and diagnostic accuracy of HELIOS in detecting autoimmune disorders.","authors":"Nayab Zehra, Asif Loya, Hiba Asif, Mudassar Hussain, Hina Maqbool, Umer Nisar","doi":"10.1177/00045632261488247","DOIUrl":"https://doi.org/10.1177/00045632261488247","url":null,"abstract":"<p><strong>Objective: </strong>To 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.</p><p><strong>Methods: </strong>Total 09 CAP shipments over the period of 03 years were included in our study, comprising of 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.</p><p><strong>Results: </strong>The 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 huge 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.</p><p><strong>Conclusion: </strong>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.</p><p><strong>Key words: </strong>Autoimmune disorders, External Proficiency testing, HELIOS, Analytical Performance.</p>","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}

{"title":"Comparability of serum folate concentration measured by a microbiological method, LC-MS/MS and immunoassay.","authors":"Sarah Meadows, Amanda McKillion, Damon A Parkington, Albert Koulman, Kerry S Jones","doi":"10.1177/00045632261488256","DOIUrl":"https://doi.org/10.1177/00045632261488256","url":null,"abstract":"<p><p>Background Folate, vitamin B9, is an essential micronutrient for DNA replication and repair. Deficiency is associated with megaloblastic anaemia and fetal neural tube defects. Serum folate measurement provides a convenient biomarker of folate status in clinical and research settings. The overall aim of this evaluation was to compare serum folate results measured from three different technologies within the same laboratory to determine systematic biases and equivalence between methods. Methods 58 serum samples from the UK National Diet and Nutrition Survey were used to compare a microbiological method, a liquid chromatography tandem mass spectrometry method (LC-MS/MS) and a commercial immunoassay (Tosoh CL1200). Results Within-run imprecision of all three assays was ≤7%, measured at two concentrations. The microbiological and LC-MS/MS methods were accurate against NIST Standard Reference Material and VITAL External Quality Assessment (EQA) target values. The plasma-based sample used for the NIST Standard Reference Material (SRM) was unsuitable for analysis by the Tosoh immunoassay, however comparison with the VITAL EQA target values showed good accuracy. Using the serum samples, both the LC-MS/MS and Tosoh immunoassay methods showed a slight positive proportional bias compared to the microbiological method, whilst the Tosoh method also had an additional constant bias of 3-4 nmol/L compared to the other methods. Conclusions This data shows that the microbiological method, LC-MS/MS and Tosoh CL1200 immunoassay have acceptable accuracy, imprecision and agreement. The small concentration dependant bias is likely explainable by the expected characteristics of the individual methods and ability to detect and respond to different forms of folate.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261488256"},"PeriodicalIF":1.1,"publicationDate":"2026-09-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148862775","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}

{"title":"First report of daratumumab interference in urine immunofixation electrophoresis confirmed by the HYDRASHIFT 2/4 Daratumumab assay.","authors":"Hyun-Woo Lee, Sooho Yu, Se-Eun Koo, Ghee Young Kwon, Kihyun Kim, Hyung-Doo Park","doi":"10.1177/00045632261479641","DOIUrl":"https://doi.org/10.1177/00045632261479641","url":null,"abstract":"<p><p>A case of analytical interference in urine immunofixation electrophoresis (IFE) caused by daratumumab is presented. Daratumumab, an IgG1-kappa monoclonal antibody, is well-known to produce a false IgG-kappa band in serum IFE, but urinary interference has not been reported because intact IgG is generally not filtered through the glomerulus. A 67-year-old man presented with nephrotic syndrome and was found to have markedly elevated serum creatinine (3.10 mg/dL), free kappa light chains (453.42 mg/dL) and kappa/lambda ratio (23.23). Baseline serum and urine electrophoresis and IFE showed no monoclonal protein (M-protein), while bone marrow examination confirmed light chain deposition disease with kappa restriction. Following two cycles of daratumumab-based chemotherapy, new IgG-kappa bands appeared in both serum and urine IFE despite improving free light chain levels and unremarkable protein electrophoretic patterns. Suspecting therapeutic antibody interference, the HYDRASHIFT 2/4 Daratumumab assay (HYDRASHIFT assay) was applied to both serum and concentrated urine samples. The IgG-kappa bands in both serum and urine IFE disappeared and exhibited a cathodal shift, confirming that they represented daratumumab rather than endogenous M-protein. This case demonstrates that daratumumab may become detectable in urine in the setting of severely impaired glomerular permeability and highlights that the HYDRASHIFT assay can be effectively applied to urine to resolve analytical interference. Awareness of this phenomenon is important for the accurate interpretation of urine IFE results in patients receiving daratumumab.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261479641"},"PeriodicalIF":1.1,"publicationDate":"2026-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148787536","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}

{"title":"Cryoglobulinaemia is more frequently associated with IgM paraproteins than previously reported, interfering with their quantification, and resulting in potential treatment delays.","authors":"Aaron Niblock, Philip Logue, Kerrie Sweeney","doi":"10.1177/00045632261479628","DOIUrl":"https://doi.org/10.1177/00045632261479628","url":null,"abstract":"","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261479628"},"PeriodicalIF":1.1,"publicationDate":"2026-08-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148787570","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}

{"title":"Pseudo-hypouricemia in four patients with lymphoma and one patient with breast cancer: Interference analysis and elimination.","authors":"Guanqiao Shen, Qi Zhang, Shunchang Li","doi":"10.1177/00045632261478795","DOIUrl":"https://doi.org/10.1177/00045632261478795","url":null,"abstract":"<p><p>ObjectiveTo investigate the interfering factors and correction methods in the determination of serum uric acid (UA) using the uricase method in patients with elevated immunoglobulin M (IgM).Materials and MethodsIn clinical practice, the UA levels of five patients with elevated IgM were measured using the Beckman AU5800 analyzer with its reagents or Zhongyuan reagents. The reaction curves were analyzed. Three methods dilution with normal saline, dilution with saturated saline, and polyethylene glycol 6000 (PEG 6000) precipitation were applied to eliminate interference. For comparison, UA was also measured using the Abbott Ci8200 analyzer with its reagents.ResultsThe serum IgM levels for cases 1 to 5 were 12.39, 27.0, 12.09, 7.33, and 11.05 g/L, respectively. The initial UA results obtained with the Beckman AU5800 and its reagents were 48.4, 101.3, 96.6, 0.6, and 66.6 μmol/L. All five cases exhibited abnormal biochemical reaction curves. After treatment with normal saline, samples 1 and 5 yielded negative values, while after saturated saline treatment, sample 5 still showed a negative value and sample 1 showed an extremely low value, indicating incomplete correction of the interference. In contrast, the PEG precipitation method markedly improved the UA results, and the obtained values were comparable to those from the Abbott system.ConclusionThe PEG precipitation method provides superior correction compared to dilution with normal or saturated saline and yields results that are closer to the patient's true value.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261478795"},"PeriodicalIF":1.1,"publicationDate":"2026-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148787544","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}

{"title":"Preparation and evaluation of in-house multi-analyte quality control materials for ANA, Anti-dsDNA, and autoantibody profile assays.","authors":"Lin Xu, Hongxiang Xie","doi":"10.1177/00045632261481996","DOIUrl":"10.1177/00045632261481996","url":null,"abstract":"<p><p>BackgroundThis study explored the preparation and evaluation of in-house quality control (QC) materials for antinuclear antibody (ANA) and anti-double-stranded DNA antibody (anti-dsDNA) testing by indirect immunofluorescence test (IIFT), and ANA profile testing by line immunoassay (LIA), with the aim of providing a reference for other in-house QC materials.MethodsPatient sera were pooled to prepare a QC serum positive for all targets, while sera from healthy individuals were pooled to prepare a negative control. QC materials were heat-inactivated, centrifuged, aliquoted, and stored at -20°C. Stability was assessed at 37°C and during long-term storage at -20°C. Inter-vial variation was evaluated using 20 vials, and intra-vial variation was assessed by 20 replicates of one vial.ResultsDuring the 8-day 37°C stability test, ANA and anti-dsDNA titers remained within ±1 serial dilution of the baseline value, and all ANA profile antibodies remained within the predefined ±20% acceptance criterion. During long-term storage, ANA and anti-dsDNA titers also remained within ±1 serial dilution, and the CVs of all ANA profile antibodies were below 20%. Both inter-vial and intra-vial variation met predefined criteria, and all negative controls remained negative.ConclusionsThe in-house QC materials showed good stability and reproducibility, with simple preparation and potential suitability for routine use in primary healthcare laboratories.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261481996"},"PeriodicalIF":1.1,"publicationDate":"2026-08-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148762985","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}