ANNALS OF CLINICAL BIOCHEMISTRY临床生物化学年鉴
ANNALS OF CLINICAL BIOCHEMISTRY(英文缩写 ANN CLIN BIOCHEM),ISSN 0004-5632,eISSN 1758-1001,中文译名:临床生物化学年鉴 是一本学术期刊。本页汇总该期刊的最新影响因子、分区信息以及最新收录于 PubMed 的文献,帮助您快速了解期刊全貌。
发文量统计区间：2025-09-27 至 2026-09-27，按本站收录文献的发表日期统计。
期刊介绍
历年影响因子趋势
| JCR 数据年份 | 影响因子 | JCR 分区 |
|---|---|---|
| 2021 | 2.587 | Q3 |
| 2022 | 2.200 | Q3 |
| 2023 | 2.100 | Q3 |
| 2024 | 1.000 | Q4 |
| 2025 | 1.100 | Q4 |
ANNALS OF CLINICAL BIOCHEMISTRY 最新收录文献
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1. Strengthening pre-analytic management of biotin interference in clinical immunoassays.
PMID:日期:2026-09-24该文献暂无摘要。
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2. Comparability of Total Bilirubin methods for neonatal samples across 6 NHS trusts within North West England.
PMID:日期:2026-09-15The 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. 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. 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. 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.
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3. CSF Kappa Free Light Chain: An enhancement to Oligoclonal Bands? A Tertiary Centre Cohort.
PMID:日期:2026-09-15Background 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.
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4. Clinical significance of inter-assay discrepancies in serum CA19-9 values: A comparison between CLIA and ECLIA.
PMID:日期:2026-09-10BackgroundSerum 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-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 = 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.
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5. Insulin/C-peptide interpretation in infants with hypoglycaemia of unknown origin.
PMID:日期:2026-09-04BackgroundHypoglycaemia 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.
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6. Reduction in sample recollection number following the implementation of automated pre-analytical interference detection in coagulation testing.
PMID:日期:2026-09-02BackgroundPre-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 ≤ .005 considered significant.ResultsA significant reduction in recollections was observed after the implementation of automated inspection (0.49% vs 0.35%; < .001). PT showed a statistically significant decrease in recollections ( = .003), while other tests demonstrated non-significant reductions. Monthly average recollections decreased by 18.9% ( < .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.
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7. Machine learning for the identification of mild to moderate EDTA contamination of serum samples.
PMID:日期:2026-09-02BackgroundKEDTA 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 KEDTA 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 KEDTA 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 KEDTA. 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 KEDTA contamination more accurately than standard approaches (-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 KEDTA serum contamination and improve patient safety. For laboratories unable to implement machine learning models, the best alternative is the potassium/calcium ratio.
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8. Optimization of HBsAg retesting process: An improvement in laboratory management system based on health economics.
PMID:日期:2026-09-01ObjectiveTo 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 ( < .01). In the interval (1, 2], although there was no significant difference in the qualitative results before and after the retest ( = .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.
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9. Evaluating diagnostic accuracy and analytical performance of HELIOS in detecting autoimmune disorders using external proficiency data as a tool: A three-year analysis.
PMID:日期:2026-09-01ObjectiveTo 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.
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10. Comparability of serum folate concentration measured by a microbiological method, LC-MS/MS and immunoassay.
PMID:日期:2026-09-01BackgroundFolate, 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, including nutritional surveys. 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.Methods58 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).ResultsThe 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.ConclusionsThis 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 circulating forms of folate.