{"title":"A multicenter study comparing a point-of-care blood glucose metre with a blood gas analyser in infants by the Shikoku Neonatal Medical Research Group.","authors":"Toru Kuboi, Masashiro Sugino, Takaaki Sadamura, Nana Kawaguchi, Yoko Tadatomo, Kosei Takada, Natsumi Okamoto, Kiwako Miyamoto, Akiko Nakano, Noriko Miura, Yusei Nakata, Kenichi Suga, Masaaki Ota, Shinji Nakamura, Kosuke Koyano, Takashi Kusaka","doi":"10.1177/00045632251326460","DOIUrl":"10.1177/00045632251326460","url":null,"abstract":"<p><p>BackgroundThere have been no reports on blood glucose metres for measurements in a wide variety of infant patients, from very preterm infants to mature infants and from the early neonatal period onwards. In this study, we evaluated the accuracy of the Glutest Mint II, a point-of-care blood glucose metre, by comparing blood glucose levels measured by this device with those measured by a blood gas analyser in infants of all gestational ages and birth weights at a number of time points after birth.MethodsInfants aged 22 weeks and 0 days of gestation or older who were born at any of six tertiary neonatal intensive care units between March 2022 and January 2023 and needed blood glucose monitoring were enrolled. Samples were collected into capillary tubes when the physician determined that a blood glucose test was necessary and could be taken at any time after birth and any number of times from the same individual. Blood glucose was measured using a Glutest Mint II and then using a blood gas analyser.ResultsIn total, 2943 blood glucose points were measured in 285 infants. Blood glucose levels measured using the Glutest Mint II were significantly correlated with those measured using a blood gas analyser. Neonatal-specific parameters such as hematocrit and total serum bilirubin levels may not have an effect.ConclusionsThe Glutest Mint II device can measure blood glucose levels with very high accuracy in the range used in the neonatal setting, comparable to the blood gas analyser.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632251326460"},"PeriodicalIF":2.1,"publicationDate":"2025-02-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143531188","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":"Determination of the biological variation and reference change value of lipoprotein (a).","authors":"Kofi Antwi, Paul Downie, Wycliffe Mbagaya","doi":"10.1177/00045632251324063","DOIUrl":"10.1177/00045632251324063","url":null,"abstract":"<p><strong>Background: </strong>Understanding lipoprotein (a) [Lp(a)] measurement variability is essential in establishing its coronary heart disease (CHD) association, and optimizing assessment and management of atherosclerotic cardiovascular disease (ASCVD) risk. We established the components of biological variation (BV) and reference change value (RCV) of Lp(a) in a UK cohort.</p><p><strong>Method: </strong>22 healthy individuals were recruited to the study. Blood samples were collected for six consecutive weeks and analysed in duplicate using the Lp(a) assay by Sentinel Diagnostics on the Beckman Coulter AU5800. Outlier, heterogeneity, normality, and trend analysis were performed, followed by CV-ANOVA to determine estimates of BV, adhering to the 14 BIVAC quality items. RCV was calculated based on estimated CV<sub>A</sub> and CV<sub>I</sub>.</p><p><strong>Results: </strong>Four participants were excluded from the analysis as their mean Lp(a) levels fell below the functional sensitivity of the assay. Mean Lp(a) concentration ranged from 14 to 241 nmol/L. The overall estimate of CV<sub>I</sub> for all participants was 10.9% (95% CI of 9.1 - 13.0%). The RCV for Lp(a) was +31.6%/-24.0%.</p><p><strong>Conclusion: </strong>Our study obtained a CV<sub>I</sub> estimate for Lp(a) that aligned consistently with recent studies adhering to the quality specifications outlined in the BIVAC checklist. The CV<sub>I</sub> estimate was significantly lower than Lp(a) estimates reported in studies up to 2003. The CV<sub>I</sub> estimate highlights the limitations of relying solely on a single Lp(a) measurement for prognosticating ASCVD risk and identifying candidates for novel Lp(a) therapies, particularly when the measured value is near clinical decision thresholds.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632251324063"},"PeriodicalIF":2.1,"publicationDate":"2025-02-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143413051","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}
Andrew A Wood, Sophie Rothwell Mason, Anna F Robson
{"title":"Metronidazole is a chromatographic interference on a routine HPLC-UV assay for thiopurine metabolites.","authors":"Andrew A Wood, Sophie Rothwell Mason, Anna F Robson","doi":"10.1177/00045632251319917","DOIUrl":"10.1177/00045632251319917","url":null,"abstract":"<p><strong>Background: </strong>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 304 nm for the 6MMP-derivative and 342 nm for 6TG. For some samples, 6MMP cannot be reported due to a chromatographic interference at 304 nm co-eluting with the 6MMP peak. An investigation was performed to identify the interfering compound.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusion: </strong>Metronidazole and its major metabolite can interfere with 6MMP measurement by HPLC-UV analysis at 304 nm.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632251319917"},"PeriodicalIF":2.1,"publicationDate":"2025-02-21","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}
{"title":"Falsely elevated type IV collagen caused in part by heterophilic antibodies: A case report.","authors":"Xian-Min Lv, Long Xiao, Hong-Lei Yu, Lu-Wei Yan","doi":"10.1177/00045632251322316","DOIUrl":"https://doi.org/10.1177/00045632251322316","url":null,"abstract":"<p><p>Immunoassays, which are used ubiquitously in clinical practice, are inherently vulnerable to distortions arising from endogenous immunoglobulins, particularly heterophilic antibodies. While many studies have explored interference in substances measured using chemiluminescence or electrochemiluminescence methods based on the double-antibody sandwich principle, there are limited data on interference in immunoturbidimetric assays, particularly for type IV collagen. This article presents the first report of a noteworthy increase in serum type IV collagen levels stemming from heterophilic antibody interference detected through an immunoturbidimetric assay. The present study investigated the mechanisms of this interference and the differences introduced by heterophilic antibodies between the two methodologies. Additionally, it outlines strategies for identifying and mitigating such interference, and discusses the principles, limitations, and considerations of each corrective approach. The objective is to raise awareness among clinical laboratory professionals concerning the potential interference of heterophilic antibodies in immunoturbidimetric assays. Increased awareness will aid in the prompt detection and correction of this issue, ensuring the provision of accurate and reliable laboratory data for informed clinical decision-making and the prevention of adverse medical outcomes.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632251322316"},"PeriodicalIF":2.1,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143456743","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}
Sarah L Davies, Daniel J Cuthbertson, Louise J Ward, Wassif S Wassif, Mark Gurnell, Andrew S Davison
{"title":"A United Kingdom-wide audit of the laboratory investigation of primary aldosteronism.","authors":"Sarah L Davies, Daniel J Cuthbertson, Louise J Ward, Wassif S Wassif, Mark Gurnell, Andrew S Davison","doi":"10.1177/00045632251319984","DOIUrl":"10.1177/00045632251319984","url":null,"abstract":"<p><strong>Objectives: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>We observed significant heterogeneity in the laboratory investigation of PA across the United Kingdom. Therefore, this work serves as a stimulus for greater collaboration to permit national harmonisation/standardisation of analytical and clinical aspects of UK PA practice.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632251319984"},"PeriodicalIF":2.1,"publicationDate":"2025-02-13","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}
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":"<p><p>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.</p>","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}
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":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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%).</p><p><strong>Conclusions: </strong>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.</p>","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}
{"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":"<p><strong>Objectives: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","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}
{"title":"Biological variation data: An important old topic with new standards and new look resources.","authors":"William A Bartlett","doi":"10.1177/00045632241311453","DOIUrl":"https://doi.org/10.1177/00045632241311453","url":null,"abstract":"","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632241311453"},"PeriodicalIF":2.1,"publicationDate":"2025-01-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142926309","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":"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":"<p><strong>Background: </strong>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.</p><p><strong>Methods: </strong>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.</p><p><strong>Results: </strong>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.</p><p><strong>Conclusions: </strong>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.</p>","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}