Annals of Clinical Biochemistry最新文献

Standardising lipid testing and reporting in the United Kingdom; a joint statement by HEART UK and The Association for Laboratory Medicine. 英国血脂检测和报告标准化；英国心脏协会和检验医学协会的联合声明。

IF 2.1 4区医学

Annals of Clinical Biochemistry Pub Date : 2025-01-31 DOI: 10.1177/00045632251315303

Julia S Kenkre, Tina Mazaheri, R Dermot G Neely, Handrean Soran, Dev Datta, Peter Penson, Paul Downie, Alexandra M Yates, Katharine Hayden, Mayur Patel, Jaimini Cegla

{"title":"Standardising lipid testing and reporting in the United Kingdom; a joint statement by HEART UK and The Association for Laboratory Medicine.","authors":"Julia S Kenkre, Tina Mazaheri, R Dermot G Neely, Handrean Soran, Dev Datta, Peter Penson, Paul Downie, Alexandra M Yates, Katharine Hayden, Mayur Patel, Jaimini Cegla","doi":"10.1177/00045632251315303","DOIUrl":"10.1177/00045632251315303","url":null,"abstract":"Atherosclerotic cardiovascular disease remains a major cause of premature death in the United Kingdom. Lipid testing is a key tool used to assess cardiovascular risk and guide clinical management decisions. There are currently no national guidelines to provide evidence-based recommendations on lipid testing and reporting for UK laboratories and clinicians. Here we present consensus guidance, following a review of published evidence by a multidisciplinary group of UK experts across a range of laboratory and clinical services. Recommendations include the composition of a standard lipid profile; indications for, and composition of, an enhanced lipid profile including apolipoprotein B and lipoprotein (a); use of the Sampson-NIH calculation for LDL-c estimation and guidance on when to flag abnormal results. This consensus guidance on lipid testing and reporting in the United Kingdom has been endorsed by HEART UK and The Association for Laboratory Medicine.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632251315303"},"PeriodicalIF":2.1,"publicationDate":"2025-01-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142943256","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

A United Kingdom-wide audit of the laboratory investigation of primary aldosteronism.

IF 2.1 4区医学

Annals of Clinical Biochemistry Pub Date : 2025-01-28 DOI: 10.1177/00045632251319984

Sarah Davies, Daniel J Cuthbertson, Louise Ward, Ws Wassif, Mark Gurnell, Andrew Stuart Davison

{"title":"A United Kingdom-wide audit of the laboratory investigation of primary aldosteronism.","authors":"Sarah Davies, Daniel J Cuthbertson, Louise Ward, Ws Wassif, Mark Gurnell, Andrew Stuart Davison","doi":"10.1177/00045632251319984","DOIUrl":"https://doi.org/10.1177/00045632251319984","url":null,"abstract":"Objectives: Primary Aldosteronism (PA) is a common but under-recognised cause of secondary hypertension. Early diagnosis with targeted medical and/or surgical intervention is important to prevent irreversible end-organ damage. An Endocrine Society Clinical Practice Guideline was used to define audit standards against which to assess current United Kingdom (UK) laboratory practice.Methods: A survey comprising 22 questions, which captured information on screening, confirmatory testing and adrenal vein sampling (AVS), was distributed to all UK Clinical Biochemistry laboratories by the Association for Laboratory Medicine. Consultation with clinical colleagues was encouraged.Results: 50 of 147 laboratories (34.0%) responded, 17 of which provided an analytical service for plasma aldosterone concentration (PAC) and renin, measured as plasma renin activity (PRA) or direct renin concentration (DRC). PRA/DRC, PAC and aldosterone:renin ratios were used to screen for PA. Saline infusion testing was the most common confirmatory test. AVS was used to aid lateralisation. Chemiluminescence immunoassay and liquid chromatography tandem-mass spectrometry were the preferred analytical methods for PAC and PRA/DRC. However, there was considerable variation across centres in respect of reference intervals and cutoffs, which were not fully accounted for by differences in analytical platforms. Although diagnostic algorithms, with pre- and post-analytical support, were in evidence in some centres, these were not universal or always embedded in a multidisciplinary team setting.Conclusions: We observed significant heterogeneity in the laboratory investigation of PA across the UK. Therefore, this work serves as a stimulus for greater collaboration to permit national harmonisation/standardisation of analytical and clinical aspects of UK PA practice.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632251319984"},"PeriodicalIF":2.1,"publicationDate":"2025-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143057758","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

Metronidazole is a chromatographic interference on a routine HPLC-UV assay for thiopurine metabolites.

IF 2.1 4区医学

Annals of Clinical Biochemistry Pub Date : 2025-01-28 DOI: 10.1177/00045632251319917

Andrew Arthur Arthur Wood, Sophie Rothwell Mason, Anna Frances Robson

{"title":"Metronidazole is a chromatographic interference on a routine HPLC-UV assay for thiopurine metabolites.","authors":"Andrew Arthur Arthur Wood, Sophie Rothwell Mason, Anna Frances Robson","doi":"10.1177/00045632251319917","DOIUrl":"https://doi.org/10.1177/00045632251319917","url":null,"abstract":"Background Thiopurine metabolites, 6-thioguanine (6TG) and 6-methylmercaptopurine (6MMP), are monitored to aid therapeutic management of thiopurine drugs. At Manchester University NHS Foundation Trust (MFT), thiopurine metabolites are measured by high performance liquid chromatography with ultraviolet detection (HPLC-UV). Whole blood samples are lysed and subjected to hydrolysis with derivatisation of 6MMP before HPLC-UV detection at 304nm for the 6MMP-derivative and 342nm for 6TG. For some samples, 6MMP cannot be reported due to a chromatographic interference at 304nm co-eluting with the 6MMP peak. An investigation was performed to identify the interfering compound. Methods Patient medication histories were examined to identify candidate compounds for the interference. Candidate compounds were spiked into blood at supraphysiological concentrations and tested on the assay. Results Metronidazole was identified as being prescribed to all patients whose samples demonstrated the interference. Metronidazole and its metabolite, hydroxymetronidazole, were spiked into blood. HPLC-UV analysis of spiked blood demonstrated similar UV absorbance patterns to those seen in patient samples with the interference. Hydroxymetronidazole co-eluted with 6MMP causing interference in the measurement. Conclusion Metronidazole and its major metabolite can interfere with 6MMP measurement by HPLC-UV analysis at 304 nm.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632251319917"},"PeriodicalIF":2.1,"publicationDate":"2025-01-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143057759","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

Biochemical osteomalacia in adults undergoing vitamin D testing in the North-East of Scotland.

IF 2.1 4区医学

Annals of Clinical Biochemistry Pub Date : 2025-01-25 DOI: 10.1177/00045632251315671

Angus D Macleod, Mark J Bolland, Andrew Balfour, Andrew Grey, Josh Newmark, Alison Avenell

{"title":"Biochemical osteomalacia in adults undergoing vitamin D testing in the North-East of Scotland.","authors":"Angus D Macleod, Mark J Bolland, Andrew Balfour, Andrew Grey, Josh Newmark, Alison Avenell","doi":"10.1177/00045632251315671","DOIUrl":"https://doi.org/10.1177/00045632251315671","url":null,"abstract":"Background: International guidelines give greatly varying definitions of 25-hydroxyvitamin D (25OHD) insufficiency and deficiency. Vitamin D testing is increasing despite 2016 UK guidance for adults advising routine vitamin D supplementation October-March and year-round for high risk groups. A service evaluation of vitamin D testing and biochemical osteomalacia in the North-East of Scotland (57-58°N) could inform definitions and testing guidance.Methods: We identified adult 25OHD requests 8/7/2008-29/2/2020 and albumin-adjusted serum calcium (aCa), parathyroid hormone (PTH) and alkaline phosphatase (ALP) within 6 months of 25OHD testing. After excluding renal impairment and liver disease, we defined biochemical osteomalacia as ALP >130 IU/L and aCa <2.0 mmol/L and elevated PTH >9.2 or >6.8 pmol/L, depending on the assay. Possible biochemical osteomalacia was defined as 2 of these abnormalities in the absence of the third measurement. From these cases anonymised clinical data were then examined to confirm the diagnosis of osteomalacia.Results: 25,379 eligible patients had 25OHD measured: 25% were <25 nmol/L (6,258/25,379) and 18% <20 nmol/L (4,536/25,379). 0.5% (126/25,379) of eligible patients had biochemical or possible biochemical osteomalacia. After reviewing clinical records, only 0.1% (29/25,379) had clinically confirmed osteomalacia, equivalent to 2-3 cases/y for a population of 0.5 million, none of the untreated cases of clinically confirmed osteomalacia had 25OHD >25 nmol/L. For the entire tested population, when 25OHD was <25 nmol/L untreated osteomalacia confirmed by clinical records was rare (0.4%).Conclusions: Osteomalacia is rare in North-East Scotland. Our data call into question designating 25OHD 25-50 nmol/L 'insufficiency'. The risk of osteomalacia even when 25OHD is <25 nmol/L is very low.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632251315671"},"PeriodicalIF":2.1,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143035770","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 diagnostic and prognostic value of serum angiopoietin-like 4 level in neonatal respiratory distress syndrome. 血清血管生成素样4水平对新生儿呼吸窘迫综合征的诊断及预后价值。

IF 2.1 4区医学

Annals of Clinical Biochemistry Pub Date : 2025-01-12 DOI: 10.1177/00045632241312634

Xiuyun Song

{"title":"The diagnostic and prognostic value of serum angiopoietin-like 4 level in neonatal respiratory distress syndrome.","authors":"Xiuyun Song","doi":"10.1177/00045632241312634","DOIUrl":"10.1177/00045632241312634","url":null,"abstract":"Objectives: Neonatal respiratory distress syndrome (NRDS) is the most common respiratory disease in preterm infants (PIs). The implication of Angiopoietin-like 4 (ANGPTL4) was reported in lung diseases. We delved into the role of serum ANGPTL4 in NRDS diagnosis/prognosis.Methods: Totally 256 PIs were prospectively selected, including 128 NRDS infants and 128 non-NRDS PIs. NRDS infants were assigned into Survival and Death groups. ANGPTL4 level in PIs and its diagnostic and prognostic value for NRDS were separately assessed by ELISA and receiver operating characteristic curve. The independent risk factors (IRFs) for death in NRDS infants were analysed by multivariate logistic regression.Results: NRDS infants exhibited reduced gestational age, birth weight, and 5 min Apgar score. ANGPTL4 level rose in NRDS infants, and increased with NRDS severity. Serum ANGPTL4 level was negatively correlated with 5 min Apgar score in NRDS infants. The area under the curve of serum ANGPTL4 for the diagnosis of NRDS was 0.902, with 88.28% sensitivity, 86.72% specificity, and 255.98 ng/mL cut-off value; the AUC for the diagnosis of severe NRDS was 0.741, with 66.67% sensitivity, 79.52% specificity, and 625.5 ng/mL cut-off value. Low gestational age, birth weight and 5 min Apgar score, severe NRDS, and elevated serum ANGPTL4 levels were IRFs for death in NRDS infants. NRDS infants with increased serum ANGPTL4 level displayed decreased survival rate and short survival time.Conclusions: ANGPTL4 exhibited high diagnostic value and predictive value for death in NRDS, and it served as a biomarker for the diagnosis and prognosis of NRDS.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632241312634"},"PeriodicalIF":2.1,"publicationDate":"2025-01-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142881126","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

Biological variation data: An important old topic with new standards and new look resources. 生物变异数据：一个具有新标准和新资源的重要老课题。

IF 2.1 4区医学

Annals of Clinical Biochemistry Pub Date : 2025-01-04 DOI: 10.1177/00045632241311453

William A Bartlett

引用次数: 0

Folic and folinic acid load tests for dynamic assessments of compliance and metabolism in folate deficiency and hyperhomocysteinaemia patients unresponsive to high-dose folate replacement. 叶酸和叶酸负荷试验用于动态评估叶酸缺乏和高同型半胱氨酸血症患者对高剂量叶酸替代无反应的依从性和代谢

IF 2.1 4区医学

Annals of Clinical Biochemistry Pub Date : 2025-01-04 DOI: 10.1177/00045632241312616

Tejas Kalaria, Agata Sobczyńska-Malefora, Himabindu Rebbapragada, Rawya Hussein, Dominic J Harrington, Rousseau Gama, Supratik Basu

引用次数: 0

Benchtop centrifugation: An effective method for reducing lipaemia associated interference in grossly lipaemic samples? 台式离心：一种有效的方法，以减少血脂相关的干扰严重血脂样品？

IF 2.1 4区医学

Annals of Clinical Biochemistry Pub Date : 2025-01-04 DOI: 10.1177/00045632241312622

James L Hall, Henry C Carlton, Kate E Shipman

{"title":"Benchtop centrifugation: An effective method for reducing lipaemia associated interference in grossly lipaemic samples?","authors":"James L Hall, Henry C Carlton, Kate E Shipman","doi":"10.1177/00045632241312622","DOIUrl":"10.1177/00045632241312622","url":null,"abstract":"Background: Grossly lipaemic samples are a significant cause of analytical errors, potentially impacting patient care. The causes of lipaemia are varied and often unavoidable, while methods to reduce lipaemia through gold-standard ultracentrifugation are limited by availability, transportation and cost. Benchtop centrifugation has been proposed as an alternative method to reduce lipaemia.Methods: Fifty-three grossly lipaemic serum samples (lipaemia >201.8 mg/dL) that were unsuitable for analysis were selected and centrifugated at 18840 g for different time-periods with lipaemia measured prior to and after centrifugation. Core analytes were measured on serum samples free of lipaemia before and after 30 min of centrifugation at 18840 g to assess the effect of the centrifugation process.Results: After centrifugation for 5 min, 90% of grossly lipaemic samples were either ideal (lipaemia <50 mg/dL) or adequate (lipaemia 50.1-201.7 mg/dL) for analyte testing. All samples were either adequate or ideal for testing following centrifugation for 30 min. Although some analytes showed a statistically significant change in the measured concentration post high-speed centrifugation, none had clinically significant changes according to analyte specific reference change value (RCV) analysis. Aspartate aminotransferase (AST) and creatine kinase (CK) demonstrated the most notable reductions in activity, but these did not exceed their RCV.Conclusions: Benchtop centrifugation shows potential laboratory utility in reducing lipaemia whilst maintaining clinically reliable results, however small sample sizes preclude firm conclusions. Further research is warranted to increase the sample size with finer time-point tuning, sub-group analysis and temperature analysis, due to the potential for sample heat injury, to balance practicality and accuracy.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632241312622"},"PeriodicalIF":2.1,"publicationDate":"2025-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142881125","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 evaluation of the GreenCare A1c and Cera-Stat HbA1c point-of-care testing assays. GreenCare A1c 和 Cera-Stat HbA1c 床旁检测试剂盒的分析性能评估。

IF 2.1 4区医学

Annals of Clinical Biochemistry Pub Date : 2025-01-01 Epub Date: 2024-09-23 DOI: 10.1177/00045632241282580

Joon Hee Lee, Sun-Hee Jun, Jikyo Lee, Sang Hoon Song, Kyunghoon Lee

{"title":"Analytical performance evaluation of the GreenCare A1c and Cera-Stat HbA1c point-of-care testing assays.","authors":"Joon Hee Lee, Sun-Hee Jun, Jikyo Lee, Sang Hoon Song, Kyunghoon Lee","doi":"10.1177/00045632241282580","DOIUrl":"10.1177/00045632241282580","url":null,"abstract":"Background: The escalating prevalence of diabetes underscores the need for precise diagnostic tools to facilitate effective management. Hemoglobin A1c (HbA1c) is a crucial biomarker for long-term glycemic control in diabetic patients. Point-of-care testing (POCT) for HbA1c offers rapid, accessible alternatives to conventional laboratory methods, but uncertainties persist regarding the accuracy and reliability of POCT assays.Methods: This study evaluates the analytical performance of two boronate-affinity based HbA1c POCT assays, the GreenCare A1c and Cera-Stat HbA1c. Various analytical parameters including precision, linearity, comparison, and accuracy are assessed following guidelines from Clinical and Laboratory Standards Institute (CLSI), with results applied to certification criteria from the National Glycohemoglobin Standardization Program (NGSP) and International Federation of Clinical Chemistry and Laboratory Medicine (IFCC). Furthermore, 52 and 13 frozen EDTA whole blood samples were respectively used for additional evaluation of accuracy and interference due to Hb variants for the GreenCare A1c assay.Results: Both GreenCare and Cera-Stat demonstrated good precision (repeatability CV% 1.5-1.9 and total imprecision CV% 1.6-2.2), linearity (R2 = 0.9996 & 0.9990), and correlation (r = 0.982 & 0.978) with an established HbA1c analyzer, the Bio-Rad D100. The GreenCare also exhibited good accuracy with frozen EDTA samples with known HbA1c values. Both assays met the certification criteria from NGSP and IFCC, classifying them as \"standard\" according to IFCC model for quality targets for HbA1c.Conclusions: This evaluation affirms the reliability of GreenCare and Cera-Stat POCT assays for HbA1c measurements, which can potentially reduce unnecessary referrals and enhance the overall quality of diabetes diagnosis and treatment.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"46-56"},"PeriodicalIF":2.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142085884","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

Development and validation of interpretable machine learning models to predict glomerular filtration rate in chronic kidney disease Colombian patients. 开发和验证可解释的机器学习模型，以预测哥伦比亚慢性肾病患者的肾小球滤过率。

IF 2.1 4区医学

Annals of Clinical Biochemistry Pub Date : 2025-01-01 Epub Date: 2024-09-21 DOI: 10.1177/00045632241285528

Luis H Rojas, Angela J Pereira-Morales, William Amador, Albert Montenegro, Walberto Buelvas, Víctor de la Espriella

{"title":"Development and validation of interpretable machine learning models to predict glomerular filtration rate in chronic kidney disease Colombian patients.","authors":"Luis H Rojas, Angela J Pereira-Morales, William Amador, Albert Montenegro, Walberto Buelvas, Víctor de la Espriella","doi":"10.1177/00045632241285528","DOIUrl":"10.1177/00045632241285528","url":null,"abstract":"Background: ML predictive models have shown their capability to improve risk prediction and assist medical decision-making, nevertheless, there is a lack of accuracy systems to early identify future rapid CKD progressors in Colombia and even in South America.Objective: The purpose of this study was to develop a series of interpretable machine learning models that predict GFR at 6-months, 9-months, and 12-months.Study design and setting: Over 29,000 CKD patients stage 1 to 3b (estimated GFR, <60 mL/min/1.73 m2) with an average of 3-year follow-up data were included. We used the machine learning extreme gradient boosting (XGBoost) to build three models to predict the next eGFR. Models were internally and externally validated. In addition, we included SHapley Additive exPlanation (SHAP) values to offer interpretable global and local prediction models.Results: All models showed a good performance in development and external validation. However, the 6-months XGBoost prediction model showed the best performance in internal (MAE average = 6.07; RSME = 78.87), and in external validation (MAE average = 6.45, RSME = 18.94). The top 3 most influential features that pushed the predicted eGFR value to lower values were the interpolated values for eGFR and creatinine, and eGFR at baseline.Conclusion: In the current study we have developed and validated machine learning models to predict the next eGFR value at different intervals. Furthermore, we attempted to approach the need for prediction explanation by offering transparent predictions.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"57-66"},"PeriodicalIF":2.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142144993","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