Annals of Clinical Biochemistry最新文献_第9页

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 : 2026-03-01 Epub 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":"152-158"},"PeriodicalIF":1.0,"publicationDate":"2026-03-01","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

Procalcitonin assay variation in an Australasian external quality assurance program. 降钙素原测定在澳大利亚外部质量保证计划中的变化。

IF 1 4区医学

Annals of Clinical Biochemistry Pub Date : 2026-03-01 Epub Date: 2025-08-14 DOI: 10.1177/00045632251372749

Alexander Richardson, Kristie Chapman, Peter Graham, Tony Badrick

{"title":"Procalcitonin assay variation in an Australasian external quality assurance program.","authors":"Alexander Richardson, Kristie Chapman, Peter Graham, Tony Badrick","doi":"10.1177/00045632251372749","DOIUrl":"10.1177/00045632251372749","url":null,"abstract":"Sepsis accounts for approximately 20% of global deaths, and early diagnosis is a critical factor in intervention. In 2017, the FDA approved procalcitonin (PCT) to guide antibiotic use for patients with suspected sepsis, and there are recognized intervals for clinical interpretation. Therapeutic algorithms incorporating PCT measurement have implications for antibiotic stewardship in the age of antibiotic resistance. A 2021 review of external quality assurance programs for PCT, including the Royal College of Pathologists of Australasia Quality Assurance Programs (RCPAQAP) PCT program, highlighted variable performance between assays. We reviewed the RCPAQAP's PCT program results from 2019 to 2021 to analyse any variation in reported results. The RCPAQAP's PCT program is conducted annually and consists of a lyophilized human/bovine serum albumin base with added recombinant PCT sent to participating laboratories. Results received for the 2019, 2020 and 2021 PCT programs were analysed using two-way ANOVA with Tukey's multiple comparison test and a Student's t-test to investigate variation in assay performance. We found significant variation between the different assay manufacturers at all PCT concentrations analysed. Additionally, bimodal reporting was observed, where bioMerieux/Beckman Coulter/Siemens methods had significantly higher results when compared to Roche/Abbott methods. There was also a significant increase in the average coefficient of variation between 2019 and 2020/2021, coinciding with reported method changes. Finally, variable performance of the semi-quantitative PCT method at both low and high PCT concentrations was detected. These findings suggest that clinical decision cut-offs must be validated for each assay. However, the commutability of the program material has yet to be determined.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"167-173"},"PeriodicalIF":1.0,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144854278","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

From analytical interference to the detection of intoxication. 从分析干扰到中毒检测。

IF 1 4区医学

Annals of Clinical Biochemistry Pub Date : 2026-03-01 Epub Date: 2025-08-12 DOI: 10.1177/00045632251367247

Sonali Suresh Karnani-Khemlani, María José de la Vega-Prieto, Juana Reyes Padrón-Morales, Fuensanta Gómez-Bernal, Elene Laburu-Dañobeitia, Marta Rodríguez-García, Darío Cabana-Ramos, Sergio Luis-Lima

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 : 2026-03-01 Epub 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":"141-151"},"PeriodicalIF":1.0,"publicationDate":"2026-03-01","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

Elevated CA19-9 in IgG4-related disease. igg4相关疾病中CA19-9升高。

IF 1 4区医学

Annals of Clinical Biochemistry Pub Date : 2026-03-01 Epub Date: 2025-08-07 DOI: 10.1177/00045632251370803

Derrick Hy Chong, Andre Mattman, Aaron Dou, Anthony So, Howard J Lim, Junyan Shi, Richard Cleve, David F Schaeffer, Eric Cs Lam, Jennifer J Telford, Luke Yc Chen, Mollie N Carruthers

{"title":"Elevated CA19-9 in IgG4-related disease.","authors":"Derrick Hy Chong, Andre Mattman, Aaron Dou, Anthony So, Howard J Lim, Junyan Shi, Richard Cleve, David F Schaeffer, Eric Cs Lam, Jennifer J Telford, Luke Yc Chen, Mollie N Carruthers","doi":"10.1177/00045632251370803","DOIUrl":"10.1177/00045632251370803","url":null,"abstract":"BackgroundIgG4-related disease (IgG4-RD) is an inflammatory disease that can clinically mimic pancreatic and hepatobiliary cancer. Serum carbohydrate antigen 19-9 (CA19-9) is a tumour marker that is frequently used to aid in the diagnosis of biliary cancer. There have been reported cases that patients with IgG4-RD also have elevated CA19-9.MethodsThis study has two components, first, a quality assurance component that observes paired IgG4 and CA19-9 measurements from patients with unknown diagnoses were compared to determine if serum IgG4 interferes with CA19-9 measurement. In addition, a mixing study is used to investigate if high levels of IgG4 interfered with CA19-9 measurements. Second, a retrospective chart review was performed to compare patients diagnosed with IgG4-RD with normal versus elevated CA19-9.ResultsAmong 487 unique individuals with paired measurements, no association between CA19-9 and serum IgG4 was found. Mixing studies revealed no interference. Among 20 patients with IgG4-RD, 11 had elevated CA19-9 (median 150 kU/L) and nine had normal CA19-9. There was no difference in bilirubin between the two groups (63.2 µmol/L vs 39.4 µmol/L, P = .47).ConclusionThere is no relationship between CA19-9 and serum IgG4. Patients with IgG4-RD and elevated CA19-9 did not have higher bilirubin than those with normal CA19-9. Together, these results suggest that elevated CA19-9 in IgG4-RD may be related to the disease rather than to interference from high serum IgG4 or from biliary obstruction.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"132-140"},"PeriodicalIF":1.0,"publicationDate":"2026-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144798028","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

Automated management of internal quality control alarming for secondary measurement channels: An ICT solution. 二级测量通道内部质量控制报警的自动化管理：ICT解决方案。

IF 1 4区医学

Annals of Clinical Biochemistry Pub Date : 2026-03-01 Epub Date: 2025-08-14 DOI: 10.1177/00045632251367233

Marije van der Schaar, Ruben Moritz, Huub H van Rossum

引用次数: 0

Sternal wound infection post cardiac surgery is a preventable complication. 心脏手术后胸骨伤口感染是一种可预防的并发症。

IF 1 4区医学

Annals of Clinical Biochemistry Pub Date : 2026-03-01 Epub Date: 2025-08-11 DOI: 10.1177/00045632251367237

Khaled Ebrahim Al-Ebrahim

引用次数: 0

Diagnostic performance of FOB Gold® in symptomatic primary care patients. 黄金离岸价在有症状的初级保健患者中的诊断性能。

IF 1 4区医学

Annals of Clinical Biochemistry Pub Date : 2026-02-16 DOI: 10.1177/00045632261428928

Alan Cheung, Steven McCann

{"title":"Diagnostic performance of FOB Gold® in symptomatic primary care patients.","authors":"Alan Cheung, Steven McCann","doi":"10.1177/00045632261428928","DOIUrl":"10.1177/00045632261428928","url":null,"abstract":"BackgroundFaecal immunochemical tests (FIT) detect and quantify faecal haemoglobin (f-Hb) to triage symptomatic primary care patients for the risk of colorectal cancer (CRC).MethodFIT was performed using FOB Gold® on a Siemens ADVIA Chemistry XPT analyser at Stepping Hill Hospital. Diagnostic accuracy was assessed by following up FIT results between June 2023 and June 2024. Results of ≥10 μg of haemoglobin per gram of faeces (µg/g) were considered as positive. The FIT results were matched with data from the Somerset cancer register, concluding if patient had CRC or non-CRC findings.ResultsA total of 12,640 patients were included in this study. Colonoscopies (or contrast CT) were performed on 1476 patients with f-Hb results of ≥10 µg/g and on 617 patients with f-Hb <10 µg/g as the clinician had further concerns. A total of 98 cancers were found (89 had f-Hb ≥10 µg/g and 9 had f-Hb <10 µg/g). The remaining 10,547 with f-Hb <10 µg/g were considered as non-CRC due to lack of follow-up for >6 months. Using the 10 µg/g cut-off, FOB Gold® sensitivity for CRC was 90.8% and the specificity was 88.9%; the positive predictive value was 6.0% and the negative predictive value was 99.9%. The receiver operating characteristic curve had an area under the curve of 0.92 (95% CI 0.89 to 0.95).ConclusionFOB Gold® has comparable diagnostic performance for detecting CRC in symptomatic primary care patients as other FIT systems at 10 µg/g.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261428928"},"PeriodicalIF":1.0,"publicationDate":"2026-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146199984","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

Evaluation of sample integrity and turnaround time upon implementation of a high-speed carrier-free pneumatic tube system. 高速无载体气动管道系统实施后样品完整性和周转时间的评估。

IF 1 4区医学

Annals of Clinical Biochemistry Pub Date : 2026-02-16 DOI: 10.1177/00045632261428924

Hyun-Woo Lee, Sang-Mi Kim, Hyun-Young Kim, Soo-Youn Lee, Hyung-Doo Park

{"title":"Evaluation of sample integrity and turnaround time upon implementation of a high-speed carrier-free pneumatic tube system.","authors":"Hyun-Woo Lee, Sang-Mi Kim, Hyun-Young Kim, Soo-Youn Lee, Hyung-Doo Park","doi":"10.1177/00045632261428924","DOIUrl":"10.1177/00045632261428924","url":null,"abstract":"BackgroundPneumatic tube systems (PTSs) have revolutionized sample transport efficiency, yet concerns about sample integrity remain unresolved. This study evaluated the AirLab system (PazKorea, Hanam-si, Korea), a novel high-speed carrier-free PTS, for its impact on sample integrity and turnaround time (TAT) under controlled pre-analytical conditions.MethodsBlood specimens were collected in duplicate from 42 participants (30 healthy volunteers and 12 outpatients with chronic alcohol use) and randomly assigned to PTS or manual transport. Multiple laboratory parameters were analysed, including chemistry, hematology, coagulation, and heavy metal tests. Sample integrity was assessed by comparing test results between transport methods using both statistical analysis and clinical significance criteria based on total allowable error (TAE). Pre-analytical, analytical and total TATs were compared between transport methods.ResultsAmong 20 measurands, four showed statistically significant differences: glucose, potassium (K), lactate dehydrogenase (LD), and mean corpuscular volume (MCV). PTS yielded higher results for glucose, K and LD (average percentage biases: 1.88%, 2.01%, and 15.80%, respectively), while producing lower results for MCV (average percentage bias: -0.47%). Only LD showed clinically significant differences, as its average percentage bias exceeded its desirable TAE. PTS significantly reduced both pre-analytical and total TATs for all test types, with reductions ranging from 12.12% to 22.82% and 7.32% to 8.98%, respectively, whereas analytical TATs remained unchanged.ConclusionsThe AirLab system effectively preserves sample integrity for most laboratory parameters while improving operational efficiency through TAT reduction. However, the clinically significant elevation in LD levels necessitates careful interpretation when employing this system in clinical laboratories.","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261428924"},"PeriodicalIF":1.0,"publicationDate":"2026-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146199962","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

Incidental diagnosis of glycerol kinase deficiency during investigation of hyponatraemia and acute kidney injury. 在低钠血症和急性肾损伤的调查中偶然诊断甘油激酶缺乏。

IF 1 4区医学

Annals of Clinical Biochemistry Pub Date : 2026-02-13 DOI: 10.1177/00045632261424751

Rachel Brixey-McCann, Fawaz Ali, Soha Zouwail

引用次数: 0