Annals of Clinical Biochemistry最新文献

{"title":"Response to letter regarding \"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, Mayur Patel, Jaimini Cegla","doi":"10.1177/00045632261420653","DOIUrl":"https://doi.org/10.1177/00045632261420653","url":null,"abstract":"","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261420653"},"PeriodicalIF":1.0,"publicationDate":"2026-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146155852","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":"Response to letter to editor to \"Procalcitonin assay variation in an Australasian external quality assurance program\": A reappraisal.","authors":"Alexander Richardson, Kristie Chapman, Peter Graham, Tony Badrick","doi":"10.1177/00045632261420659","DOIUrl":"https://doi.org/10.1177/00045632261420659","url":null,"abstract":"","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261420659"},"PeriodicalIF":1.0,"publicationDate":"2026-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146148799","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":"\"Procalcitonin assay variation in an Australasian external quality assurance program\": A reappraisal.","authors":"Thomas Masetto, Leoni Wey, Kai Prager, Guenther Gorka","doi":"10.1177/00045632261420649","DOIUrl":"https://doi.org/10.1177/00045632261420649","url":null,"abstract":"","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261420649"},"PeriodicalIF":1.0,"publicationDate":"2026-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146148856","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":"Familial pseudohyperkalaemia: An unusual cause of artefactual hyperkalaemia.","authors":"Megan Rodney, Kelly Rankin, Jenny Butler, Simon Thompson, Chris M Florkowski, Richard I King","doi":"10.1177/00045632261417119","DOIUrl":"https://doi.org/10.1177/00045632261417119","url":null,"abstract":"<p><p>Strict homoeostatic control of potassium is necessary for normal muscle and neural function, and as a result, hyperkalaemia can be life-threatening and requires timely management. Prior to treating the patient, however, it is important to determine if hyperkalaemic blood test results are authentic and not due to pre-analytical factors as treatment in this context may provoke potentially dangerous hypokalaemia. We present the case of a 47-year-old female referred for further investigation following 2 years of otherwise unexplained intermittent hyperkalaemia. Her highest recorded potassium was 8.9 mmol/L (reference interval: 3.5-5.2 mmol/L). She was otherwise healthy, not on regular medications, and asymptomatic during these episodes. There was no evidence of associated electrocardiogram (ECG) changes. She had been referred to the Emergency Department twice in 6 months due to hyperkalaemia, but these episodes resolved on repeat testing without any intervention. Further investigation revealed a significant time- and temperature-dependent increase in potassium concentration in whole blood samples, compared to a control. <i>ABCB6</i> single gene testing revealed a heterozygous variant, c.1123 C>T, p. (Arg375Trp), consistent with a diagnosis of familial pseudohyperkalaemia (FP). This is an autosomal dominant condition, which results in increased efflux of potassium from red blood cells at sub-physiological temperatures. Whilst this is an <i>ex vivo</i> phenomenon, unless recognised it poses a clinical risk to patients as they may be treated erroneously.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261417119"},"PeriodicalIF":1.0,"publicationDate":"2026-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146148797","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":"Cardiovascular-Kidney-Metabolic (CKM) Syndrome and the Clinical Laboratory.","authors":"Ishwarlal Jialal, Sridevi Devaraj","doi":"10.1177/00045632261420660","DOIUrl":"https://doi.org/10.1177/00045632261420660","url":null,"abstract":"","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261420660"},"PeriodicalIF":1.0,"publicationDate":"2026-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146148808","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":"Age-related reference intervals for thyroid function tests are beneficial in adults over 60 years.","authors":"George F G Allen, Sarah Blampied, Kashyap A Patel, Timothy J McDonald, Andrew T Hattersley, Bijay Vaidya","doi":"10.1177/00045632261426852","DOIUrl":"10.1177/00045632261426852","url":null,"abstract":"<p><p>BackgroundThe rise in serum thyroid stimulating hormone (TSH) in healthy older adults is well established. However, age-related reference intervals are not widely used. We aimed to establish all-adult and age-related reference intervals for TSH, free thyroxine (FT4) and free triiodothyronine (FT3) and determine their impact on primary care thyroid testing results.MethodsWe measured TSH, FT4 and FT3 by Roche Cobas assays in a reference cohort of 1364 anti-thyroid peroxidase antibody negative adults with no self-reported medical conditions or medications. Reference intervals were generated for all-adult, 18-60 and over 60 years. Reference intervals were applied to 21,286 primary care tests with no known thyroid disease to assess effect on test interpretation.ResultsIn the reference cohort, 23.2% were over 60 years compared to 50.4% of those undergoing thyroid testing in primary care. With an all-adult reference interval, 8.2% of over 60s had an elevated TSH, 7.0% were classified as subclinical hypothyroid and 0.8% as overt hypothyroid. With age-related reference intervals, this fell to 4.4% with an elevated TSH, 3.7% subclinical hypothyroid and 0.4% overt hypothyroid. Minimal changes were seen in the 18-60 years group.ConclusionsAn all-adult reference interval derived from healthy and therefore younger individuals is less appropriate for the older subset of the population being tested. Application of an age-related reference interval for over 60s would reduce the proportion of patients with abnormal thyroid test results. In turn, this would decrease potentially unnecessary cascade and repeat testing as well as regular follow-up in primary care.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261426852"},"PeriodicalIF":1.0,"publicationDate":"2026-02-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146148870","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":"Establishment of a candidate reference method and verification of reference intervals for serum copper in pregnant and non-pregnant women.","authors":"Mengyu Xu, YunGang Pu, Tianyue Zhang, Zhenni Liu, Qian Zhang, Weiyan Zhou, Yuhang Deng, Chao Zhang, Hao Zheng, Haijian Zhao, Jiangtao Zhang, Tianjiao Zhang, Jing Wang, Jie Zeng, Chuanbao Zhang","doi":"10.1177/00045632261426839","DOIUrl":"10.1177/00045632261426839","url":null,"abstract":"<p><p>BackgroundSerum copper is an essential trace element, and accurate quantification is important for assessing copper status in pregnancy and supporting early clinical interventions. However, current serum copper assays face several challenges, including potential inaccuracy, poor comparability between methods, and difficulties in transferring reference intervals (RIs) between populations. This study aimed to establish a simple inductively coupled plasma mass spectrometry (ICP-MS)-based candidate reference method for serum copper to strengthen the reference measurement system, and to verify whether recently proposed multicenter RIs for serum copper can be transferred to a Chinese population.MethodsCobalt was used as the internal standard. After digestion with Optima-grade ultrapure nitric acid, samples were diluted 100-fold with ultrapure water. The ⁶³Cu/⁵⁹Co ratio was measured in helium collision mode, with the gas flow rate set to 5 mL/min. Analytical performance was validated, and serum copper RIs in pregnant and non-pregnant women were subsequently verified.ResultsA candidate reference method was established. The method demonstrated excellent linearity, with a correlation coefficient (R) exceeding 0.99998 over the range 0-13.75 μg/g. The total precision ranged from 0.30% to 0.40%. The spike recovery was 100.06% (99.95-100.14%). Trueness was confirmed by measurements of NIST SRM 1598a, which fell within the certified value and its stated uncertainty. The RI for healthy non-pregnant women was transferable to healthy Chinese women, whereas the pregnancy-specific RI for serum copper was not fully transferable and requires further adjustment for Chinese women.ConclusionA highly sensitive and specific candidate reference method for serum copper was established, strengthening the reference measurement system and contributing to the standardization and harmonization of serum copper assays. Pregnancy-specific RIs for serum copper in Chinese women should be established.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261426839"},"PeriodicalIF":1.0,"publicationDate":"2026-02-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146148816","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":"Improved transcutaneous bilirubinometer for enhanced measurement accuracy in neonatal hyperbilirubinemia.","authors":"Kosuke Koyano, Makoto Arioka, Yuta Noguchi, Yuta Shinabe, Tomoaki Kusaka, Hirosuke Morita, Katsufumi Nishioka, Yasuhiro Nakao, Kota Inoue, Aya Morimoto, Shinji Nakamura, Sonoko Kondo, Yukihiko Konishi, Saneyuki Yasuda, Hitoshi Okada, Konomu Hirao, Takashi Kusaka","doi":"10.1177/00045632261424727","DOIUrl":"10.1177/00045632261424727","url":null,"abstract":"<p><p>BackgroundConventional transcutaneous bilirubinometers often underestimate total bilirubin (TB) levels at high concentrations, limiting their clinical utility in cases of neonatal hyperbilirubinemia. We aimed to address this shortcoming by developing and testing a novel type of advanced transcutaneous bilirubinometer that may enhance the early identification of severe hyperbilirubinemia, potentially reducing the need for invasive testing and exchange transfusions.MethodsWe developed a novel transcutaneous bilirubinometer with adjustable light intensity and detection distances. Transcutaneous bilirubin (TcB) measurements were obtained using both the novel device and a conventional JM-105 bilirubinometer in 66 instances in 62 neonates (≥36 weeks gestation). TB values measured in patient blood samples were used as reference values for calculating correlations and error metrics (i.e. mean squared error [MSE] and mean absolute error [MAE]).ResultsThe novel device showed strong correlation with TB values across all concentrations (R² = 0.96), including those ≥15 mg/dL (R² = 0.84), outperforming the JM-105 device (R² = 0.60 for TBs ≥15 mg/dL). The novel device also yielded lower MSE (1.53 vs 2.95) and MAE values (1.00 vs 1.39) than the JM-105.ConclusionsOur novel transcutaneous bilirubinometer demonstrated improved accuracy at higher bilirubin concentrations compared with a conventional JM-105 device.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261424727"},"PeriodicalIF":1.0,"publicationDate":"2026-02-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146103604","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":"Exploring the stability of whole blood samples for remote health care applications towards reliable home-based blood testing.","authors":"M H Elise van Driel, Alan Han, Dirk J Grünhagen, Christian Ramakers","doi":"10.1177/00045632261424746","DOIUrl":"10.1177/00045632261424746","url":null,"abstract":"<p><p>ObjectivesTo evaluate the stability of commonly used biomarkers in whole blood under various storage conditions, in order to assess their suitability for home-based blood collection in remote care settings.MethodsWhole blood samples were stored at 4-8°C, 20-25°C and 37°C for up to 72 h. Six pooled samples and two healthy volunteer samples were aliquoted and analysed at four time points (T0, T24, T48 and T72 h). A panel of 47 routine chemistry and immunochemistry biomarkers was measured in all samples. Recoveries relative to T0 were compared to within subject coefficients of variation of the individual biomarkers.ResultsMost biomarkers remained stable at refrigerated and room temperature conditions up to 72 h with a subset of biomarkers, mostly proteins and tumour markers also showing good to acceptable stability at 37°C. Several biomarkers, including potassium, inorganic phosphate and iron, consistently fell outside acceptable limits under multiple conditions. Others, such as sodium, calcium, ferritin, aspartate aminotransferase and cytokeratin fragment 21-1, were unstable only at 37°C. A few transient deviations were observed, but these were not consistent over time.ConclusionsHome-based blood sampling is feasible for a broad range of biomarkers, provided that heat exposure during transport is minimised. These findings are a first step in the further validation of selected analytes under real-world, capillary blood sampling conditions.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261424746"},"PeriodicalIF":1.0,"publicationDate":"2026-02-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"146103598","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":"Sweat testing and cystic fibrosis - Test performance before and after a quality improvement project in a South African tertiary hospital laboratory.","authors":"Asande Zama, Annalise E Zemlin, Marizna Korf","doi":"10.1177/00045632251350514","DOIUrl":"10.1177/00045632251350514","url":null,"abstract":"<p><p>BackgroundThe diagnosis of cystic fibrosis (CF) is challenging due to high quantity not sufficient (QNS) rates of sweat tests, leading to frequent retesting, increasing costs and adverse impacts on patient care. This study aimed to assess sweat test performance and implement a quality improvement project (QIP) to reduce QNS rates.MethodsA two-part retrospective audit was conducted. Part one spanned 2 years reviewing the two-tiered testing with sweat conductivity as a screening tool, followed by chloride testing. Part two evaluated the QNS rates over two 6-month periods, separated by a QIP, which involved technologist training, clinician education, patient preparation protocols and revised testing procedures.ResultsOver the 2-year period, 425 sweat tests were performed on 291 patients. Sweat conductivity testing demonstrated a lower QNS rate, 13% (31/238), compared to sweat chloride testing's 31% (33/105). High QNS rates were observed in younger infants and in malnourished or acutely ill patients. Post-QIP, the QNS rates for the total study population decreased by 5%, from an initial 30% to 25% in the sweat chloride cohort, while the acceptable QNS rate of 12% remained unchanged in the sweat conductivity cohort.ConclusionAchieving target QNS rates remains challenging, especially in younger infants, with improved QNS rates in older infants and children. Recommendations include limiting sweat testing to experienced technologists and ensuring patient readiness.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"22-31"},"PeriodicalIF":1.0,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144265067","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}