Annals of Clinical Biochemistry最新文献_第7页

In-vitro verification of tolerance limits for biotin interference of routine biochemistry and immunology assays. 生物素干扰常规生化和免疫学试验耐受限度的体外验证。

IF 1 4区医学

Annals of Clinical Biochemistry Pub Date : 2026-03-24 DOI: 10.1177/00045632261440506

Kirsty Swallow, Graeme Wild, Ravishankar Sargur

{"title":"In-vitro verification of tolerance limits for biotin interference of routine biochemistry and immunology assays.","authors":"Kirsty Swallow, Graeme Wild, Ravishankar Sargur","doi":"10.1177/00045632261440506","DOIUrl":"10.1177/00045632261440506","url":null,"abstract":"BackgroundBiotin is commonly used in many commercial assays. It is known that exogenous biotin can interfere with these tests, however, not all manufacturers have issued warnings or reassurances. Interference can lead to increased or decreased concentrations of an analyte depending on the assay format. We assessed the effect of biotin interference on all relevant assays performed in our laboratory. We investigated a variety of concentrations ranging from the recommended daily intake up to very high dose supplementation to determine the level at which a particular assay may be affected.MethodsSamples were spiked to give estimated serum concentrations equivalent to doses of 0.05-3600 mg/day exogenous biotin. Each spiked sample was tested and the result compared to a baseline. Biotin interference was deemed to have taken place if the spiked value exceeded the allowable uncertainty of measurement.ResultsNot all assays utilising biotin were affected. We confirmed interference claims made by Manufacturers. However, a few of these assays showed that biotin levels below those stated in safety notices could cause some degree of interference. Three assays for which there had not been a warning were shown to be affected.ConclusionsIn house checks should be performed on all assays containing biotin as a reagent. This allows the laboratory to understand performance characteristics and dosage effects for causing potential interference. Our data provides a guide for the level of biotin which may cause false positive or false negative results.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261440506"},"PeriodicalIF":1.0,"publicationDate":"2026-03-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147508875","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

Thank you to reviewers. 感谢审稿人。

IF 1 4区医学

Annals of Clinical Biochemistry Pub Date : 2026-03-24 DOI: 10.1177/00045632261431214

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 4区医学

Annals of Clinical Biochemistry Pub 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":"https://doi.org/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":"45632261433346"},"PeriodicalIF":1.0,"publicationDate":"2026-03-21","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

Interpretable laboratory-data model for risk stratification of elevated NT-proBNP and its deployment in diagnostic support middleware. NT-proBNP升高风险分层的可解释实验室数据模型及其在诊断支持中间件中的部署。

IF 1 4区医学

Annals of Clinical Biochemistry Pub Date : 2026-03-17 DOI: 10.1177/00045632261438009

Hidekazu Ishida, Noriko Ozawa, Masaya Tachikawa, Hiroki Nagasawa, Yohei Shirakami, Takatomo Watanabe, Hiroyuki Okura, Ryosuke Kikuchi

{"title":"Interpretable laboratory-data model for risk stratification of elevated NT-proBNP and its deployment in diagnostic support middleware.","authors":"Hidekazu Ishida, Noriko Ozawa, Masaya Tachikawa, Hiroki Nagasawa, Yohei Shirakami, Takatomo Watanabe, Hiroyuki Okura, Ryosuke Kikuchi","doi":"10.1177/00045632261438009","DOIUrl":"10.1177/00045632261438009","url":null,"abstract":"BackgroundHeart failure (HF) is a growing global burden. Although N-terminal pro-B-type natriuretic peptide (NT-proBNP) guides diagnosis, assay cost and analyzer availability limit routine use. Routine laboratory data may offer a low-cost triage alternative.MethodsWe developed and validated an interpretable decision tree to stratify the risk of elevated NT-proBNP >300 pg/mL and assessed deployment in a diagnostic support system (DSS). We analyzed 19,889 encounters at Gifu University Hospital (Aug 2022-May 2024). All 20 candidate predictors were included without prior feature selection to capture non-linear associations. Hyperparameters were tuned by 10-fold cross-validation. Final classification used a fixed decision rule optimized for high sensitivity (≥0.90 in training) to support effective triage. Performance comprised AUROC (DeLong 95% CIs) and sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy (Wilson 95% CIs) on an internal hold-out set (n = 3978) and a temporal external cohort (n = 14,903; Jun 2024-Jun 2025). Analyses were complete-case with no imputation.ResultsThe decision tree inherently utilized clinically relevant predictors including serum albumin, eGFR, and age. Internal test performance: AUROC 0.804 (0.791-0.818); sensitivity 0.879 (0.863-0.893); specificity 0.505 (0.484-0.526); and accuracy 0.674 (0.660-0.689). External performance within the DSS: AUROC 0.806 (0.799-0.813); sensitivity 0.882 (0.874-0.890); specificity 0.518 (0.508-0.529); and NPV 0.852 (0.842-0.861). Calibration and decision-curve analysis supported clinical utility.ConclusionsAn interpretable tree built from routine laboratories detects clinically relevant NT-proBNP elevation with high sensitivity and performs robustly after deployment. This scalable, low-cost approach could enable risk-directed triage and more efficient resource allocation.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261438009"},"PeriodicalIF":1.0,"publicationDate":"2026-03-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147472379","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

Falsely elevated urinary C-peptide during angiotensin receptor-neprilysin inhibitor therapy: A case report. 血管紧张素受体-奈普利素抑制剂治疗期间尿c肽错误升高：1例报告。

IF 1 4区医学

Annals of Clinical Biochemistry Pub Date : 2026-03-16 DOI: 10.1177/00045632261435413

Akihiro Morishige, Mitsuaki Nishioka, Yoko Nakabayashi, Akiyo Ishiguro, Kanae Shinkawa, Aki Fujinaga, Toshihiko Kobayashi, Masakazu Fukuda, Yutaka Suehiro, Yasuhiko Ohta, Takahiro Yamasaki

{"title":"Falsely elevated urinary C-peptide during angiotensin receptor-neprilysin inhibitor therapy: A case report.","authors":"Akihiro Morishige, Mitsuaki Nishioka, Yoko Nakabayashi, Akiyo Ishiguro, Kanae Shinkawa, Aki Fujinaga, Toshihiko Kobayashi, Masakazu Fukuda, Yutaka Suehiro, Yasuhiko Ohta, Takahiro Yamasaki","doi":"10.1177/00045632261435413","DOIUrl":"https://doi.org/10.1177/00045632261435413","url":null,"abstract":"Background Urinary C-peptide testing is widely used to evaluate insulin secretion capacity from pancreatic β-cells. We report a case in which urinary C-peptide showed abnormally high levels during treatment with an angiotensin receptor-neprilysin inhibitor (ARNI). Case presentation The patient was a 54-year-old man undergoing treatment for type 2 diabetes mellitus and hypertension. Following an abnormal electrocardiogram during a health check-up, he was diagnosed with aortic valve insufficiency. During admission to the diabetes and endocrinology department for preoperative glycemic control, a clinical laboratory technologist first recognized a marked discrepancy between urinary and serum C-peptide results and reported this to the attending physician, prompting further investigation. A literature review revealed reports suggesting that ARNI administration may suppress C-peptide metabolism, potentially leading to elevation of measured values. Results The patient's excreted urinary C-peptide level decreased markedly after ARNI therapy was discontinued, suggesting that ARNI influences an increase in urinary C-peptide. Conclusions When excreted urinary C-peptide is abnormally elevated and discrepant from the serum C-peptide level, it is important to confirm ARNI use and follow laboratory-driven recommendations for retesting after discontinuation if needed. Prompt reporting of this finding by the clinical laboratory is essential for the accurate assessment of insulin secretion capacity.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261435413"},"PeriodicalIF":1.0,"publicationDate":"2026-03-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147466832","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 4区医学

Annals of Clinical Biochemistry Pub Date : 2026-03-16 DOI: 10.1177/00045632261435392

Kenji Ohba, Yumiko Kashiwabara, Mitsuaki Tokumaru, Takayuki Iwaki, Hirotomo Saitsu, Masato Maekawa

引用次数: 0

Paraprotein interference in bilirubin assays: A case of multiple myeloma highlighting the reliability of dry chemistry. 胆红素检测中的副蛋白干扰：一例多发性骨髓瘤突出了干化学的可靠性。

IF 1 4区医学

Annals of Clinical Biochemistry Pub Date : 2026-03-16 DOI: 10.1177/00045632261435377

Aditya Narayanan S, Ramya Devi D A, Renuka Pangaluri, Vinodhini V M, Arul Senghor K A

{"title":"Paraprotein interference in bilirubin assays: A case of multiple myeloma highlighting the reliability of dry chemistry.","authors":"Aditya Narayanan S, Ramya Devi D A, Renuka Pangaluri, Vinodhini V M, Arul Senghor K A","doi":"10.1177/00045632261435377","DOIUrl":"https://doi.org/10.1177/00045632261435377","url":null,"abstract":"The presence of paraproteins in multiple myeloma can cause analytical interference, resulting in unusual and misleading biochemical outcomes. An uncommon but clinically relevant finding is the reporting of a negative direct bilirubin result on wet chemistry analyzers-an impossible outcome that strongly suggests analytical interference. A 60-year-old male presented with nonspecific symptoms. Liver function tests carried out on a wet chemistry analyzer indicated a total bilirubin of 0.39 mg/dL and a direct bilirubin of -7.67 mg/dL, which was not physiologically possible. There was no evidence of jaundice, and imaging appeared normal. Repeat testing with a dry chemistry analyzer indicated a total bilirubin of 1.0 mg/dL and a direct bilirubin of 0.1 mg/dL, aligning with the clinical picture. Further investigations confirmed the diagnosis of multiple myeloma with IgG-kappa monoclonal gammopathy. The discrepancy was attributed to paraprotein interference in the wet chemistry method. This case highlights a rare but important laboratory artifact-negative direct bilirubin due to paraprotein interference-and emphasizes the reliability of dry chemistry in such scenarios. Awareness of this interference is important for accurate diagnosis and avoiding unnecessary workup.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261435377"},"PeriodicalIF":1.0,"publicationDate":"2026-03-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147466848","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

Response from the authors. 作者的回应。

IF 1 4区医学

Annals of Clinical Biochemistry Pub Date : 2026-03-14 DOI: 10.1177/00045632261435397

Emma Stevenson, Chelsey Walsh, Luke Hibberd

引用次数: 0

A survey of clinical laboratories in the Netherlands regarding pre-analytical conditions of renin measurements to prevent cryoactivation. 荷兰临床实验室关于肾素测定预防冷冻活化的分析前条件的调查。

IF 1 4区医学

Annals of Clinical Biochemistry Pub Date : 2026-03-03 DOI: 10.1177/00045632261433341

Omer Ozcan, Annemieke C Heijboer, Wendy Pj den Elzen

{"title":"A survey of clinical laboratories in the Netherlands regarding pre-analytical conditions of renin measurements to prevent cryoactivation.","authors":"Omer Ozcan, Annemieke C Heijboer, Wendy Pj den Elzen","doi":"10.1177/00045632261433341","DOIUrl":"10.1177/00045632261433341","url":null,"abstract":"BackgroundExposure of plasma to low temperatures induces the conversion of prorenin to renin, causing falsely elevated levels of renin. This also happens at storage temperatures of -20°C. Our survey evaluated the pre-analytical procedures used by clinical laboratories in the Netherlands for renin testing and assessed their awareness of recent studies on cryoactivation and their impact on pre-analytical procedures.MethodsA nine-question online survey about pre-analytical conditions for renin measurements in clinical laboratories was distributed by the Foundation for Quality Assessment in Medical Laboratory Diagnostics (SKML) to 106 clinical laboratories in the Netherlands participating in the external quality assessment scheme for hormone measurements.ResultsOf the 42 labs that responded, pre-analytical practices varied considerably. Time limits for sample receipt ranged from none (31%, n = 13) to <4 h (57%, n = 24) or >4 h (5%, n = 2). Most laboratories transported and centrifuged samples at room temperature (90% and 93%; n = 38 and 39). Storage conditions differed: 79% (n = 33) stored at -20°C, 17% (n = 7) at -80°C, 2% (n = 1) at -40°C, and 2% (n = 1) at room temperature. Twenty-two respondents (52%) were aware of recent literature, and 8 (36%) had changed or planned to change procedures accordingly. Overall, only eight laboratories (19%) followed all recommended steps to minimize cryoactivation.ConclusionsThis survey shows considerable inconsistency in pre-analytical procedures of renin testing in clinical laboratories in the Netherlands. Despite moderate awareness of recent evidence, implementation of optimal preanalytical procedures remains limited. The survey results show that guidelines and scientific evidence have not been fully implemented, and that awareness of the latest evidence does not directly lead to a change in practice.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261433341"},"PeriodicalIF":1.0,"publicationDate":"2026-03-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147343562","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

The implementation of electronic clinical decision tools to reduce inappropriate urine and swab requests: A diagnostic stewardship intervention to reduce the environmental impact of laboratory testing. 实施电子临床决策工具以减少不适当的尿液和拭子请求：一种诊断管理干预措施，以减少实验室检测对环境的影响。

IF 1 4区医学

Annals of Clinical Biochemistry Pub Date : 2026-03-02 DOI: 10.1177/00045632261433352

Shahaan Shafiq, Lana Roberts, Greg Williams, Robert Shorten

{"title":"The implementation of electronic clinical decision tools to reduce inappropriate urine and swab requests: A diagnostic stewardship intervention to reduce the environmental impact of laboratory testing.","authors":"Shahaan Shafiq, Lana Roberts, Greg Williams, Robert Shorten","doi":"10.1177/00045632261433352","DOIUrl":"10.1177/00045632261433352","url":null,"abstract":"BackgroundThe NHS accounts for approximately 4-5% of England's total carbon footprint and was the first healthcare organisation to commit to a net-zero target. Reducing the inappropriate use of diagnostic tests could play a meaningful role in reaching this goal. In 2024, the microbiology laboratory at Lancashire Teaching Hospitals NHS Foundation Trust received >90,000 urine and >15,000 wound samples. Local audit data highlights samples are sent for testing in the absence of clinical signs and symptoms of infection. Furthermore, 25 % of superficial swabs and 10% of urines grew mixed-faecal organisms.PurposeThe aim was to implement a diagnostic stewardship intervention to reduce inappropriate urine and wound swab submissions from primary care and estimate associated carbon savings.Research DesignA pre-analytical stage diagnostic stewardship intervention was implemented consisting of a computerised clinical decision support tool (CCDS). The tool prompts clinicians, using evidence-based guidance, on when to obtain samples for testing. Study Sample: 3-month intervention period data was compared with two 3-month pre-intervention periods (I and II).Data AnalysisThe UK Government 2024 greenhouse gas conversion factors were used to calculate the total CO2e associated with testing urine and wound samples. ResultsComparing number of samples received during the intervention period with pre-intervention II, urine samples decreased by 10.2%, saving 190.5 kg CO2e. Similarly, wound samples decreased by 12.9%, saving 80 kg CO2e.ConclusionThe CCDS tool effectively reduced unnecessary testing and associated carbon emissions, supporting the NHS's net-zero ambitions. Similar tools can be employed in other areas of pathology to reduce the impact of inappropriate testing whilst supporting sustainable healthcare.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261433352"},"PeriodicalIF":1.0,"publicationDate":"2026-03-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147324407","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