Annals of Clinical Biochemistry最新文献

{"title":"Clinical audit of plasma Methylmalonic acid (MMA) requests following publication of NICE Guidelines on Vitamin B12 deficiency in over 16s.","authors":"Gary Roulston, Kathryn Ryan, Derek McKillop","doi":"10.1177/00045632261453328","DOIUrl":"https://doi.org/10.1177/00045632261453328","url":null,"abstract":"<p><p>Background Vitamin B12 deficiency can cause anaemia, fatigue, and neurological sequelae. Total B12 assays may not be reflective of tissue B12. Methylmalonic acid (MMA) can assess tissue B12 more accurately. NICE published clinical guidelines on Vitamin B12 deficiency in adults in 2024. They outlined MMA testing in two scenarios: in patients where nitrous oxide use is possible or who have an indeterminate total B12 result (180 - 350 ng/L) alongside symptoms or signs of B12 deficiency. MMA testing is costly, not readily available and time consuming, so increased use will have implications. Methods Case note review of patients who had MMA requested one year prior to and one year post NICE NG239 publication. Audit standards followed were NG239 indications for MMA testing. Results In the year after NG239, MMA testing increased by 96% (57 to 112). Whilst only 47% would have meet NG239 testing criteria in the prior group, this increased to 79% in the post group. More were diagnosed with B12 deficiency (16% prior, 21% post), and more commenced on B12 treatment (14% prior, 19% after). Comparing simultaneous total B12 and MMA results suggest an increase in the upper reference interval of the indeterminate range to 375 ng/L could be considered. Conclusions Demand for MMA testing almost doubled after NG239 was published, though requests appeared much more appropriate. Whilst laboratory costs increased, there may have been savings elsewhere in the system. Further analysis would be required to review the extent of these healthcare savings in practice.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261453328"},"PeriodicalIF":1.0,"publicationDate":"2026-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147855722","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":"Effects of preanalytical factors on serum vitamin B12 test results.","authors":"Tuba Batur, Ragıp Balahoroğlu, Hatice Karaoglan, Serap Sezer","doi":"10.1177/00045632261453317","DOIUrl":"https://doi.org/10.1177/00045632261453317","url":null,"abstract":"<p><strong>Introduction: </strong>While conclusions regarding the effects of serum separator tubes on some laboratory tests have been reached in previous studies, the effects of these tubes on the B12 test have not been adequately investigated. This study aimed to determine the effects of the serum separator tube position after centrifugation on serum B12 test results.</p><p><strong>Materials and methods: </strong>Two blood samples were collected by venipuncture into 5-mL Pirmax serum separator tubes from each of the 30 volunteers. The effects of the tube position after centrifugation, gentle mixing 5-10 times, recentrifugation, and short-term (15 min) standing of the tubes in an upright position on serum B12 test results were examined in a step-by-step manner. The B12 analyses were performed in an Advia Centaur XPT autoanalyzer using a chemiluminescence method. Comparisons between the groups were evaluated for statistical and clinical significance.</p><p><strong>Results: </strong>B12 levels were higher in the samples positioned horizontally than in the samples positioned vertically (p < 0.001). The total effect of horizontal position and mixing was abolished by recentrifugation (p = 0.091). The horizontal tube position and sample mixing led to an exceedance of the total allowable error limit.</p><p><strong>Conclusions: </strong>The use of serum separator tubes may be associated with spuriously elevated serum B12 concentrations in the Advia Centaur XPT assay. The serum separator tubes should be kept upright in the post-centrifugation period prior to B12 analysis. We recommend recentrifugation if the tubes have been held in a horizontal position and/or the samples have been mixed.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261453317"},"PeriodicalIF":1.0,"publicationDate":"2026-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147855725","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":"Seasonal and decadal changes in glycated albumin levels of Japanese blood donors.","authors":"Takeshi Araki, Tadashi Nagai, Shigeki Miyata, Yoshihiko Tani, Masahiro Satake","doi":"10.1177/00045632251395550","DOIUrl":"10.1177/00045632251395550","url":null,"abstract":"<p><p>BackgroundThe Japanese Red Cross Society measures levels of glycated albumin (GA), an indicator of mean blood glucose levels, in blood obtained from all donors.MethodsChanges in mean GA levels and the percentage of cases of prediabetes from 2009 to 2018 were investigated in approximately 4.2 million, healthy, first-time blood donors aged 16-64 years, and the seasonal characteristics of GA and the association of the GA level with body mass index (BMI) were clarified.ResultsMean GA levels decreased over the decade, with a decrease of 0.42-0.77% in male and 0.39-0.49% in female donors in the groups categorised by age. The percentage of prediabetes cases also decreased over the decade, with the largest decrease in those in their 60s. GA levels were higher in the warm season than in the cold season. In 2018, the seasonal difference in the GA level was 0.48% (95% confidence interval [CI] 0.45-0.50%) for male and 0.45% (95% CI 0.41-0.48%) for female donors. GA had a linear negative correlation with BMI in the younger generation. A trend of increasing GA with BMI was noted in those in their 30s and older.ConclusionsMean GA levels and the percentage of prediabetic cases have decreased, possibly resulting from public health promotion efforts and early diagnosis of diabetes mellitus. The present data on GA seasonal variation, showing higher levels in the warm season, and the association between BMI and GA may be useful for clinical practice.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"264-272"},"PeriodicalIF":1.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145375883","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":"Clinical impact of current evidence on cardiac troponin structure, function and release mechanisms - An up to date review.","authors":"James Hatherley, Paul Collinson, Eduard Shantsila, David Gaze, Aleem Khand","doi":"10.1177/00045632251378025","DOIUrl":"10.1177/00045632251378025","url":null,"abstract":"<p><p>Myocardial infarction remains a significant cause of mortality globally. High-sensitivity cardiac troponin is an essential criterion in the fourth universal definition of myocardial infarction. Our understanding of the structure and release mechanisms of troponin has been updated over the last decade, facilitated by ever more sensitive assays. This review initially outlines the structure and function of the troponin complex, then details the currently proposed mechanisms of release and elimination of troponin. It concludes by using this updated understanding to critique the current universal definition of myocardial infarction and injury.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"191-207"},"PeriodicalIF":1.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144939341","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":"Environmental sustainability of clinical laboratories: A scoping review.","authors":"R J Shorten, A Sanders, M Farley, S Josse, S Shafiq, C Harris, A Clegg, J Hill","doi":"10.1177/00045632251391759","DOIUrl":"10.1177/00045632251391759","url":null,"abstract":"<p><p>IntroductionThe climate crisis presents a complex and growing challenge for healthcare systems around the world. Healthcare systems can contribute to substantial global emissions, with the UK's National Health Service (NHS) alone responsible for 4%-5% of the country's total carbon footprint. A wide range of clinical disciplines have already begun to assess and design interventions to tackle this issue. However, clinical and diagnostic laboratories remain underexplored.AimsWhat studies have been undertaken to assess and improve the environmental impact of clinical laboratories?MethodsThis scoping review undertook a multi-database search from date of inception to 5th February 2024. All primary studies that assessed the environmental outcomes of clinical laboratories were included. Studies were screened and data extracted by one reviewer with a 10% verification process at each stage. Studies were assessed based upon year of publication, geographical region, interconnectivity and area and type of clinical laboratory or test.FindingsThere has been some longstanding interest in understanding the environmental impact of clinical laboratories, and this field of investigation has gained popularity within the scholarly community in the last decade. Despite this recent increase in popularity there is a relatively limited number of intervention studies aimed at improving sustainability within clinical laboratories. Most research in this area originates from the United States, United Kingdom, and Australia, although the topic appears to be of global scholarly interest. There is limited interconnectivity of studies included in this review. Studies in this field have primarily been conducted at the clinical laboratory level, with a focus on quantifying waste in kilograms, measuring carbon dioxide equivalent (CO₂e) emissions, and categorizing laboratory waste by type. To a lesser degree these outcomes have been assessed for specific clinical tests. Across both clinical laboratory and specific test assessments there is notable heterogeneity in both methods used, and areas explored.DiscussionWhile this scoping review highlights a growing interest and awareness in this important field, the diversity of reported outcomes and the limited interconnectivity of studies indicate that it remains a developing area. The lack of consensus in methodologies and outcome measures suggests that establishing a baseline analysis remains a distant goal. Ideally, future efforts should prioritize improving the assessment of individual laboratory tests, fostering greater standardization, and enhancing repeatability to strengthen the reliability of environmental impact evaluations.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"208-227"},"PeriodicalIF":1.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145421092","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":"The importance of identifying pseudohypertriglyceridaemia.","authors":"Christopher Stockdale, Ann Bowron, Christopher Boot, Ahai Luvai","doi":"10.1177/00045632251395540","DOIUrl":"10.1177/00045632251395540","url":null,"abstract":"","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"281-282"},"PeriodicalIF":1.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145457544","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":"Pseudohyperphosphatemia in multiple myeloma: Removal of interfering paraproteins.","authors":"Michelle De Bruyn, Matthias Cuykx","doi":"10.1177/00045632251383402","DOIUrl":"10.1177/00045632251383402","url":null,"abstract":"<p><p>BackgroundMultiple myeloma patients may present with spuriously elevated serum phosphate levels resulting from the presence of paraproteins interfering in the phosphomolybdate UV assay. If this phenomenon is not recognized, patients possibly receive unnecessary treatments. This short report highlights the existence of paraprotein-related pseudohyperphosphatemia, and aims to provide accessible solutions to eliminate this interference.Material and MethodsIn a patient known with IgG multiple myeloma and unexplained hyperphosphatemia, the correlation between serum phosphate levels (phosphomolybdate UV assay) and IgG concentrations (immunoturbidimetry) was evaluated. To investigate the effect of the paraprotein on phosphate levels, phosphate was measured in one serum sample before and after protein removal by either dilution, protein precipitation with sulfosalicylic acid or zinc sulphate, or ultrafiltration.ResultsA patient with multiple myeloma presented with an unexplained hyperphosphatemia which correlated positively with serum IgG concentrations. As serum dilution normalized the phosphate level, it was hypothesized that precipitation of the paraprotein during the assay reaction interfered with the measurement and resulted in pseudohyperphosphatemia. Protein removal by precipitation with sulfosalicylic acid or zinc sulphate efficiently reduced the IgG level below the detection limit but did not result in a reliable phosphate measurement. Successful removal of proteins and a serum phosphate level that matched the patient's other biochemistry parameters and clinical condition were obtained by ultrafiltration.ConclusionParaproteins can interfere with the reaction components in the phosphomolybdate UV assay and result in pseudohyperphosphatemia. If the presence of this phenomenon is established, a reliable phosphate concentration can be obtained after ultrafiltration of the sample.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"273-276"},"PeriodicalIF":1.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145068969","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":"Diagnostic accuracy and rapid testing of a novel acute heart failure biomarker: A laboratory evaluation and comparison with natriuretic peptides.","authors":"Kevin Rouet, Philippe Rouet, François Koukoui, Michel Galinier","doi":"10.1177/00045632251378035","DOIUrl":"10.1177/00045632251378035","url":null,"abstract":"<p><p>BackgroundDiagnosing acute heart failure in patients presenting with acute dyspnea remains challenging. Current methods, including natriuretic peptide measurement and echocardiography, are time-consuming and not always immediately accessible. A novel biomarker, FILDARIA, may complement natriuretic peptides and enable faster diagnosis.MethodsIn this study (ClinicalTrials.gov: NCT01024049), samples were collected from 235 patients diagnosed via echocardiography: 89 with non-cardiac dyspnea (NCD), 55 with chronic heart failure (CHF), and 91 with acute heart failure (AHF). Levels of BNP and FILDARIA in each patient were measured using both ELISA and lateral flow assay tests.ResultsBNP levels were significantly elevated in AHF and CHF patients compared to NCD patients (905 vs 58 pg/mL, <i>p</i> < .0001; and 447 vs 58 pg/mL, <i>p</i> < .0001, respectively). Similarly, FILDARIA levels were markedly higher in AHF and CHF patients than in NCD patients (1493 vs 223 ng/mL, <i>p</i> < .0001; and 800 vs 223 ng/mL, <i>p</i> < .0001, respectively). The FILDARIA heart failure diagnostic rapid test device accurately identified all 91 AHF patients and correctly excluded 88 of 89 NCD patients, yielding one false positive. Overall diagnostic accuracy was 99.4% (95% CI: 96.9%-99.9%).ConclusionFILDARIA biomarker demonstrates strong potential as a rapid <u>diagnostic</u> tool for AHF in patients with acute dyspnea. Its high accuracy and compatibility with whole blood could make it an excellent solution for point-of-care testing. Further multicentre research could facilitate wider clinical use and clarify its utility in areas such as <u>prognosis</u> (ClinicalTrials.gov: NCT01024049).</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"228-239"},"PeriodicalIF":1.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144939612","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":"Predicting the outcome of short Synacthen test based on baseline cortisol levels: A single-centered retrospective cohort study at a tertiary care hospital in Sri Lanka.","authors":"T Premadasa, Epa Samarathunga, E M Sujith, Nmf Shameela, Bmks Basnayaka, C N Antonypillai, Rdp Jayawardana","doi":"10.1177/00045632251383417","DOIUrl":"10.1177/00045632251383417","url":null,"abstract":"<p><p>IntroductionShort Synacthen Test (SST), a standard diagnostic test to confirm Adrenal insufficiency (AI), involves substantial expenses.ObjectivesThis study aimed to assess the predictive value of baseline Cortisol levels for SST outcomes and establish baseline cut-off levels for confirming AI to minimize the necessity of SST.MethodsAll SST data from 2019 to 2024 at National Hospital Kandy, Sri Lanka, were obtained retrospectively. A peak Cortisol ≥500 nmol/L at 30 or 60-min post-SST was considered as a normal adrenal reserve, whereas failure indicated AI. Pearson's correlation and Logistic Regression analysis assessed baseline and post-SST Cortisol at 30 and 60-min. A 2 × 2 table assesses test agreement. Receiver operating characteristic (ROC) curve analysis evaluated the SST outcomes at 30 and 60-min separately assessing sensitivity, specificity, and area under the curve (AUC).ResultsA total of 307 patients were enrolled, and 63.19% exhibited a failed SST response. Baseline Cortisol positively correlated with post-SST Cortisol at 30-min (r = 0.74, <i>P</i> < .05) and 60-min (r = 0.68, <i>P</i> < .05) with a good AUC for both 30 min (AUC = 0.855) and 60 min (AUC = 0.829). Baseline Cortisol demonstrated the higher odds ratio per unit (OR = 1.015 per nmol/L), indicating greater sensitivity to small changes. ROC curves were utilized to derive cut-offs for baseline Cortisol levels predicting SST outcomes. At 30-min, baseline Cortisol <135 nmol/L suggests AI (100% sensitivity, 44% specificity), and >381.5 nmol/L indicates normal adrenal reserve (100% specificity, 21.8% sensitivity). Similarly at 60-min, baseline Cortisol <75.3 nmol/L suggests AI (100% sensitivity, 19.7% specificity), and >357 nmol/L indicates normal adrenal reserve (100% specificity, 16.8% sensitivity).ConclusionsApplying these cut-offs could avoid 41.69% (30 min) or 19% (60 min) of total SSTs, excluding AI and normal adrenal reserve. 30-min SST Cortisol correlates more strongly with baseline Cortisol, showing a higher r-value, higher OR and AUC. Hence, 30-min provides better cut-offs with higher sensitivity and specificity minimizing need for SST. Patients with baseline Cortisol between 135 and 381 nmol/L can undergo SST with only a 30-min Cortisol measurement.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"258-263"},"PeriodicalIF":1.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145068947","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":"Indapamide interference in liquid chromatography-tandem mass spectrometry aldosterone assay.","authors":"Amy R Frank, Susan Johnston","doi":"10.1177/00045632251388531","DOIUrl":"10.1177/00045632251388531","url":null,"abstract":"<p><p>The aldosterone renin ratio (ARR) is used as a screening test for primary aldosteronism (PA), and this requires measurement of both aldosterone and renin. Aldosterone is usually measured using immunoassay or liquid chromatography-mass spectrometry techniques. Antihypertensive medications should be discontinued prior to screening as they can interfere with interpretation of results. Indapamide is a thiazide-like diuretic commonly used in the treatment of hypertension. NICE guidance (NG136 2019) recommends the use of indapamide over more conventional thiazide diuretics. Indapamide has been noted to cause interference in a liquid chromatography-mass spectrometry method by interfering in the measurement of aldosterone-d4 internal standard. This leads to falsely increased concentrations of aldosterone which can lead to unnecessary further investigations.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"277-280"},"PeriodicalIF":1.0,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145211424","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}