Annals of Clinical Biochemistry最新文献_第4页

Establishment of a reference interval for calculated globulin on the Roche platform. 罗氏平台计算球蛋白参考区间的建立。

IF 1 4区医学

Annals of Clinical Biochemistry Pub Date : 2025-07-29 DOI: 10.1177/00045632251367264

Colleen Flannery, Alison Griffin, John Quinn, Clodagh Loughrey, Shari Srinivasan

{"title":"Establishment of a reference interval for calculated globulin on the Roche platform.","authors":"Colleen Flannery, Alison Griffin, John Quinn, Clodagh Loughrey, Shari Srinivasan","doi":"10.1177/00045632251367264","DOIUrl":"10.1177/00045632251367264","url":null,"abstract":"BackgroundCalculated globulin, based on direct measurement of total protein and albumin, can be a useful addition to the routinely requested liver profile. However, a reference interval, established using CLSI EP28-A3c recommended direct methods, is lacking for the commonly used Roche method [albumin bromocresol green (BCG), total protein (biuret)].MethodsThis direct reference interval study was carried out between January and March 2024, based on Roche methods for total protein (biuret) and albumin (BCG). Reference individuals comprised 310 highly selected adults from primary care, ages ranging from 16 to 89 years. The CLSI guideline, EP28-A3c, was strictly followed. We also established a reference interval using an indirect approach for comparative purposes, using results from 8466 unselected primary care patients.ResultsThe reference interval for calculated globulin established using direct sampling techniques was 23 g/L (90% CI 22-24 g/L) - 35 g/L (90% CI 34-36 g/L). The reference interval established using indirect sampling techniques in a much larger unselected reference group was 22 g/L (90% CI 22-22 g/L) - 37 g/L (90% CI 37-37 g/L).ConclusionsWe have established a reference interval for calculated globulin, specific to the Roche total protein and BCG albumin methods. This will be a useful tool for other laboratories which use the Roche BCG albumin method, allowing adoption of this reference interval with a simple transference study. The range was a little broader but not materially altered (medians exactly the same) when strict exclusion criteria were removed and also when using a data mining approach, which resulted in a 27-fold larger reference group.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632251367264"},"PeriodicalIF":1.0,"publicationDate":"2025-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144726925","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

Validation of the Japan Society of Clinical Chemistry (JSCC) recommended reference measurement procedure for glycated albumin determination. 验证日本临床化学学会推荐（JSCC）糖化白蛋白测定参考测量程序。

IF 1 4区医学

Annals of Clinical Biochemistry Pub Date : 2025-07-29 DOI: 10.1177/00045632251367235

Shu Meguro, Yusuke Iwasaki, Junpei Ueda, Mikiko Okahashi, Yukio Kume, Takuji Kohzuma, Eri Shimizu, Hiroko Takeda, Satoshi Hirayama, Emiko Hosoba, Terumichi Nakagawa, Asako Sato

{"title":"Validation of the Japan Society of Clinical Chemistry (JSCC) recommended reference measurement procedure for glycated albumin determination.","authors":"Shu Meguro, Yusuke Iwasaki, Junpei Ueda, Mikiko Okahashi, Yukio Kume, Takuji Kohzuma, Eri Shimizu, Hiroko Takeda, Satoshi Hirayama, Emiko Hosoba, Terumichi Nakagawa, Asako Sato","doi":"10.1177/00045632251367235","DOIUrl":"10.1177/00045632251367235","url":null,"abstract":"BackgroundTo clarify the fundamental characteristics of the Japan Society of Clinical Chemistry reference measurement procedure (JSCC RMP) for glycated albumin (GA), an additional performance study was performed and the correlation between the HPLC method and JSCC RMP was re-evaluated.MethodsRepeatability, detection limit, addition recovery, uncertainty of measurement, inter-laboratory comparison, correlation between JSCC RMP and HPLC method were evaluated.ResultsThe coefficient of variation (CV) of the total repeatability for the nine pretreated samples including isotope dilution and hydrolysis, defining that the averages of each of nine MS measurement samples are independent measurement vials, was 1.0%(n = 9). The limit of detection and Quantification of the GA values were 7.4 and 29.5 mmol/mol, respectively. Addition recovery rates were 99.6%-100.4%. The strong correlation (r = 0.999) of measured six serum samples between two laboratories was observed. Certified values and expanded uncertainties for JCCRM 611-2 (M, H, HH) using the JSCC RMP were as follows: JCCRM 611-2M: 232 and 9 mmol/mol, JCCRM611-2H: 359 and 14 mmol/mol, JCCRM611-2HH: 556 and 22 mmol/mol, respectively. The regression equation obtained using the Passing-Bablok method was GA (%)HPLC = 0.0523 × GA (mmol/mol) JSCC RMP + 1.315.ConclusionThe basic performance of the JSCC reference procedure for GA measurement was good, and similar results were obtained at other facilities, so it was considered to be robust and suitable as a reference method for GA measurement. Additionally, an equation was established to convert JSCC RMP (mmol/mol) values to the HPLC% values used in clinical practice.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632251367235"},"PeriodicalIF":1.0,"publicationDate":"2025-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144726928","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

Analysis of first-trimester maternal serum proprotein convertase subtilisin/kexin type 9 (PCSK9) levels as a potential non-invasive biomarker for fetal aneuploidy and NTDs. 妊娠早期孕妇血清枯草素/酮素9型（PCSK9）蛋白转化酶水平作为胎儿非整倍体和NTDs潜在的非侵入性生物标志物的分析

IF 1 4区医学

Annals of Clinical Biochemistry Pub Date : 2025-07-29 DOI: 10.1177/00045632251367280

Karthick E, Sathya Selvarajan, Dhivya Senthil Kumar, Sowmya K, Sridharan K S

{"title":"Analysis of first-trimester maternal serum proprotein convertase subtilisin/kexin type 9 (PCSK9) levels as a potential non-invasive biomarker for fetal aneuploidy and NTDs.","authors":"Karthick E, Sathya Selvarajan, Dhivya Senthil Kumar, Sowmya K, Sridharan K S","doi":"10.1177/00045632251367280","DOIUrl":"10.1177/00045632251367280","url":null,"abstract":"ObjectivesChromosomal abnormalities and congenital anomalies have huge impact on infant mortality and morbidity. The combined incidence affects approximately 1 per 1000 pregnancies. Current diagnostic modalities include ultrasonography and biomarkers like Beta hCG, PAPP-A and Alpha fetoprotein which have limitations due to their varied sensitivity and specificity in aneuploidy and NTD detection. PCSK9, a proprotein converters appears to have an escalating role in neurogenesis, neuronal differentiation and neurological diseases apart from its role in lipid metabolism. This study estimates serum PCSK9 levels in pregnant women with normal gestation and those with high risk for Aneuploidy and NTDs.MethodsThis prospective case control study included 40 pregnant women with high risk of aneuploidy and NTDs (cases) diagnosed by prenatal screening with ultrasonography findings, Beta HCG, PAPP-A and 40 pregnant women with a healthy singleton pregnancy (controls). Statistical analyses were performed in SPSS software version 16. Fetal and maternal characteristics, serum Beta HCG, PAPP-A, PCSK-9 and aneuploidy risk scores were compared between two groups.ResultsThis study observed significant difference in Beta HCG, PAPP-A and PCSK9 levels between the groups (P < .05). The PCSK9 levels were lower in cases [82.95 (70.41-90.74)] than control group [123.84 (102.515-152.70)]. PCSK9 levels <96.8 ng/mL had an 85% sensitivity and specificity. Further PCSK9 correlated with Trisomy 21 risk score and Beta HCG (P < .05).ConclusionsMaternal serum PCSK9 is decreased in high-risk pregnancy during first trimester. With 85% sensitivity, the marker could be a reliable screening tool during prenatal screening which needs further validation.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632251367280"},"PeriodicalIF":1.0,"publicationDate":"2025-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144726924","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

Quantitative effects of bilirubin photoisomers on the measurement of direct bilirubin by the enzymatic bilirubin oxidase method. 胆红素光异构体对酶促胆红素氧化酶法测定直接胆红素的定量影响。

IF 1 4区医学

Annals of Clinical Biochemistry Pub Date : 2025-07-29 DOI: 10.1177/00045632251367245

Nana Kawaguchi, Kosuke Koyano, Hirosuke Morita, Dk Nur Rosyiidah Apryll Czarina Pengiran Mohamad Fadly, Yuta Shinabe, Yuta Noguchi, Makoto Arioka, Yasuhiro Nakao, Miyo Ozaki, Shinji Nakamura, Sonoko Kondo, Yukihiko Konishi, Toru Kuboi, Hitoshi Okada, Saneyuki Yasuda, Susumu Itoh, Koji Murao, Takashi Kusaka

{"title":"Quantitative effects of bilirubin photoisomers on the measurement of direct bilirubin by the enzymatic bilirubin oxidase method.","authors":"Nana Kawaguchi, Kosuke Koyano, Hirosuke Morita, Dk Nur Rosyiidah Apryll Czarina Pengiran Mohamad Fadly, Yuta Shinabe, Yuta Noguchi, Makoto Arioka, Yasuhiro Nakao, Miyo Ozaki, Shinji Nakamura, Sonoko Kondo, Yukihiko Konishi, Toru Kuboi, Hitoshi Okada, Saneyuki Yasuda, Susumu Itoh, Koji Murao, Takashi Kusaka","doi":"10.1177/00045632251367245","DOIUrl":"10.1177/00045632251367245","url":null,"abstract":"BackgroundBilirubin photoisomers, generated during phototherapy or incidental light exposure, may interfere with direct bilirubin (DB) measurement using the bilirubin oxidase method. This interference is particularly relevant in neonates, who physiologically exhibit elevated levels of unconjugated bilirubin.MethodsResidual serum samples from 30 neonates were irradiated under controlled conditions to selectively produce bilirubin configurational isomers (BCIs) and structural isomers (BSIs). DB and total bilirubin (TB) were measured pre- and post- irradiation using the bilirubin oxidase method. BCI and BSI concentrations were quantified using high-performance liquid chromatography (HPLC), and their contributions to DB values were evaluated using linear and multiple regression analyses.ResultsPost-irradiation, DB levels increased significantly in correlation with BCI and BSI concentrations. Approximately 11% of BCI and 32% of BSI were quantified as DB using the bilirubin oxidase method. These findings were consistent across both individual and multiple regression models.ConclusionsBilirubin photoisomers significantly influence DB values measured by the bilirubin oxidase method, potentially leading to overestimation of conjugated bilirubin. In neonatal care, accurate interpretation of DB values requires attention to sample handling and awareness of photoisomer interference, particularly under light-expose conditions.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632251367245"},"PeriodicalIF":1.0,"publicationDate":"2025-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144726926","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 missing piece: Who is responsible for ensuring clinical chemistry assays used in the UK are fit for purpose? 缺失的部分：谁负责确保在英国使用的临床化学分析符合目的？

IF 1 4区医学

Annals of Clinical Biochemistry Pub Date : 2025-07-29 DOI: 10.1177/00045632251367288

Rachel Marrington, Gordon Sinclair, Finlay MacKenzie

{"title":"The missing piece: Who is responsible for ensuring clinical chemistry assays used in the UK are fit for purpose?","authors":"Rachel Marrington, Gordon Sinclair, Finlay MacKenzie","doi":"10.1177/00045632251367288","DOIUrl":"10.1177/00045632251367288","url":null,"abstract":"Over the past 50 years, External Quality Assessment (EQA) Schemes in the UK have changed from being overseen by the Department of Health and Social Security (DHSS) to a self-funding model post-1990, increasing competition among schemes. Despite reforms, there is no single source for assessing UK laboratories' performance. Laboratories often use a single manufacturer, which can restrict laboratories to having to use a poor method for some assays. Regulatory changes like the EU In Vitro Diagnostics Regulation (IVDR) impact manufacturers. The Medicines & Healthcare products Regulatory Agency (MHRA) oversees assay performance, focusing on patient harm. Participation in EQA is mandatory for ISO 15189 accreditation, but the holistic quality of EQA services vary. Four cases studies (calcium, testosterone, paracetamol and total bilirubin) are presented that illustrate how the current systems are being used in practice. These show different elements of quality assurance, but crucially in all cases patient management will have been impacted. Most performance issues are manufacturer-related. EQA helps monitor assay quality, but gaps in oversight remain. Diagnostic reform is progressing, but differences in assay results pose risks. Laboratories must collaborate with stakeholders to ensure high-quality services. Mechanisms are needed to rectify sub-optimal assays. The current system can lead to patient misdiagnosis or incorrect clinical pathways. A mechanism is required to ensure accurate results for the public, within acceptable error margins, and at a sustainable cost for the NHS.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632251367288"},"PeriodicalIF":1.0,"publicationDate":"2025-07-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144726927","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

Erratum to "Current practice and recommendations for managing transgender patient data in clinical laboratories in the United Kingdom and Republic of Ireland". “英国和爱尔兰共和国临床实验室管理跨性别患者数据的当前实践和建议”的勘误。

IF 2.1 4区医学

Annals of Clinical Biochemistry Pub Date : 2025-07-16 DOI: 10.1177/00045632251357380

引用次数: 0

Response to Cearcero-Marin D, Martinez-Zamoran L, Gisbert-Alonso A, et al. Metamizole (dipyrone) as an interferent in biochemical assays. Ann Clin Biochem 2025. 对cercero - marin D， Martinez-Zamoran L， Gisbert-Alonso A等的响应。甲基咪唑（双吡咯酮）在生化检测中的干扰作用。安·克林生物化学2025。

IF 2.1 4区医学

Annals of Clinical Biochemistry Pub Date : 2025-07-11 DOI: 10.1177/00045632251360165

Oswald Sonntag

引用次数: 0

Biochemical osteomalacia in adults undergoing vitamin D testing in the North-East of Scotland. 生化骨软化在成人接受维生素D测试在苏格兰东北部。

IF 2.1 4区医学

Annals of Clinical Biochemistry Pub Date : 2025-07-01 Epub 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":"10.1177/00045632251315671","url":null,"abstract":"BackgroundInternational 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.MethodsWe 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.Results25,379 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%).ConclusionsOsteomalacia 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":"303-311"},"PeriodicalIF":2.1,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12227805/pdf/","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":"OA","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 : 2025-07-01 Epub Date: 2025-01-04 DOI: 10.1177/00045632241311453

William A Bartlett

引用次数: 0

The use of peripheral blood biomarkers for predicting the risk of immune-related adverse events in immune checkpoint inhibitor therapy. 使用外周血生物标志物预测免疫检查点抑制剂治疗中免疫相关不良事件的风险。

IF 2.1 4区医学

Annals of Clinical Biochemistry Pub Date : 2025-07-01 Epub Date: 2025-01-06 DOI: 10.1177/00045632241312629

Louise E Duvall

{"title":"The use of peripheral blood biomarkers for predicting the risk of immune-related adverse events in immune checkpoint inhibitor therapy.","authors":"Louise E Duvall","doi":"10.1177/00045632241312629","DOIUrl":"10.1177/00045632241312629","url":null,"abstract":"BackgroundImmune checkpoint inhibitors (ICIs) have revolutionised oncology care, by enhancing the body's T cell lymphocyte response against tumour cells. ICIs block the inhibitory signalling between tumour cells and the immune system, but consequently reduce immunological tolerance. Subsequently for some, this leads to immune-related adverse events (irAE), a spectrum term for autoimmune-like toxicities induced by ICIs that affects various tissues and organs. This limited narrative review will give a brief overview of immune checkpoint inhibitors and immune-related adverse events for laboratory professionals and review the current evidence for predictive biomarkers.MethodsA limited narrative review was conducted by accessing Pubmed and Google from June 2023 to January 2024 to identify references published from database inception to January 2024. Language was restricted to English.Results/findingsProfessional guidance does not recommend any biomarkers for irAE prediction. Some studies have found an association between the prediction of irAE and interleukin six (IL-6), C-reactive protein (CRP), thyroid stimulating hormone (TSH), albumin, ferritin, full blood count metrics, and lactate dehydrogenase (LDH). However, these have often been single-centre retrospective studies. While an abundance of societal guidance has been produced, it is unclear what blood tests should be included within a baseline profile.ConclusionsPresently, there is no singular biomarker routinely available in clinical laboratories that can predict the onset of irAE. A custom battery of tests may be more predictive, but evidence is currently lacking. In the meantime, due to the clinical significance of these complications, laboratory professionals should proactively support prospective studies.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"236-256"},"PeriodicalIF":2.1,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142881127","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