Saleem Ansari, Robert D Garmany Neely, Jules Payne, Jaimini Cegla
{"title":"The current status of lipoprotein (a) measurement in clinical biochemistry laboratories in the UK: Results of a 2021 national survey.","authors":"Saleem Ansari, Robert D Garmany Neely, Jules Payne, Jaimini Cegla","doi":"10.1177/00045632231210682","DOIUrl":"10.1177/00045632231210682","url":null,"abstract":"<p><strong>Background: </strong>Lipoprotein(a) (Lp(a)) is now established as a causal risk factor for cardiovascular disease (CVD) and accurate laboratory measurement is of pivotal importance in reducing Lp(a) associated risk. The consensus statement by HEART UK in 2019 included recommendations to improve standardisation of clinical laboratory measurement and reporting of Lp(a).</p><p><strong>Methods: </strong>A 16 question, electronic audit survey was circulated to 190 accredited clinical biochemistry laboratories to assess the adoption of these recommendations in the UK.</p><p><strong>Results: </strong>Responses were received from 65 of 190 laboratories (34%). Only 5 (8%) did not offer Lp(a) measurement. Of those providing the test, 23% (n = 14) offered an in-house service (IHS), the remaining laboratories (77%; n = 46) used an external referral service (ERS). The majority (10 of 14 or 71%) of IHS laboratories responded with details of their method, stating whether it minimised sensitivity to the effect of Lp(a) isoform size and used calibrators certified for traceability to the WHO/IFCC reference material, however, only a minority ERS laboratories (13 of the 46 or 28%) were able to specify the method used by their referral laboratory. Of the laboratories who specified their reporting units, 6 of 10 IHS and 7 of 23 ERS laboratories reported in nmol/L. Among the 60 laboratories who responded, the HEART UK recommendations appear to have been adopted in full by only 3 IHS laboratories.</p><p><strong>Conclusions: </strong>Further efforts are needed to standardise the measurement and reporting of Lp(a) so that results and interpretation are comparable across clinical biochemistry laboratories in the UK.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"195-203"},"PeriodicalIF":2.2,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11080397/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"41231896","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}
Jennifer Holmes, Ray Higginson, John Geen, Aled Phillips
{"title":"Utilising routine clinical laboratory data to support quality improvement in health care: Application of a national acute kidney injury alert system as a proof of concept.","authors":"Jennifer Holmes, Ray Higginson, John Geen, Aled Phillips","doi":"10.1177/00045632231216593","DOIUrl":"10.1177/00045632231216593","url":null,"abstract":"<p><strong>Background: </strong>Acute kidney injury (AKI) is a global health issue known to cause avoidable harm and death. Improvement in its prevention and management is therefore considered an important goal for the health-care sector. The work here aimed to develop a tool which could be used to robustly and reliably measure, monitor, and compare the effectiveness of health-care interventions related to AKI across the Welsh NHS, a mechanism which did not exist previously.</p><p><strong>Methods: </strong>Using serum creatinine (SCr) as a biomarker for AKI and a validated national data-set collected from the all Wales Laboratory Information Management System, work involved applying Donabedian's framework to develop indicators with which to measure outcomes related to AKI, and exploring the potential of statistical process control (SPC) techniques for analysing data on these indicators.</p><p><strong>Results: </strong>Rate of AKI incidence and 30-day AKI-associated mortality are proposed as valid, feasible indicators with which to measure the effectiveness of health-care interventions related to AKI. The control chart, funnel plot, and Pareto chart are proposed as appropriate, robust SPC techniques to analyse and visualise variation in AKI-related outcomes.</p><p><strong>Conclusions: </strong>This work demonstrates that routinely collected large SCr data offer a significant opportunity to monitor and therefore inform improvement in patient outcomes related to AKI. Moreover, while this work concerns utilisation of SCr data for improvement in AKI strategies, it is a proof of concept which could be replicated for other routinely collected clinical laboratory data, to improve the prevention and/or management of the conditions to which they relate.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"218-229"},"PeriodicalIF":2.2,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72013210","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}
Rihab Makhlouf, Sana Fendri, Dana Jallouli, Zeinab Labiadh, Lotfi Fritis, Khansa Chaabouni, Aida Elleuch, Fatma Makni Ayadi
{"title":"Influence of pneumatic tube delivery system on laboratory results.","authors":"Rihab Makhlouf, Sana Fendri, Dana Jallouli, Zeinab Labiadh, Lotfi Fritis, Khansa Chaabouni, Aida Elleuch, Fatma Makni Ayadi","doi":"10.1177/00045632231213743","DOIUrl":"10.1177/00045632231213743","url":null,"abstract":"<p><strong>Introduction: </strong>The pneumatic tube system (PTS) is an automated and fast modality of transportation of biological samples, but it has been reported to induce preanalytical errors.</p><p><strong>Aim: </strong>To study the influence of transportation by PTS on biochemistry tests which are particularly sensitive to haemolysis and atmospheric pressure variation.</p><p><strong>Materials and methods: </strong>We compared laboratory results of arterial blood gas, sodium, potassium, chloride, lactate dehydrogenase, aspartate aminotransferase, alanine aminotransferase, glucose and haemolysis index of samples conveyed simultaneously by PTS and by courier.</p><p><strong>Results: </strong>We recruited 30 patients from the sampling room and 40 patients from the intensive care unit. Transport through PTS resulted in a significant increase in aspartate aminotransferase and potassium without exceeding the limits of acceptability. Potassium was significantly more increased for samples transported in a higher speed line (<i>p</i> = .048) but without exceeding the limits of acceptability. No significant impact was noted on haemolysis indices. The pO<sub>2</sub> variations due to PTS transportation exceeded the limit of acceptability with significant intra-individual variations.</p><p><strong>Conclusion: </strong>Our PTS is validated for biochemistry tests results. It reduces turnaround times without affecting sample quality. However, the interpretation of arterial blood gas results should be careful for samples transported by PTS.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"210-217"},"PeriodicalIF":2.2,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"71419855","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}
Bobby Li, Richard King, Christiaan Sies, Simon Thompson, Chris Florkowski
{"title":"Reference intervals for deconjugated urine metanephrines by Bhattacharya analysis.","authors":"Bobby Li, Richard King, Christiaan Sies, Simon Thompson, Chris Florkowski","doi":"10.1177/00045632231204505","DOIUrl":"10.1177/00045632231204505","url":null,"abstract":"<p><strong>Background: </strong>Urine metanephrines are used to screen for phaeochromocytoma or paraganglioma (PPGL). Current reference intervals (RI) derived in healthy individuals are not age or sex-stratified, and lower than in hypertensive patients, leading to high false positive rates. This study aims to determine age and sex-stratified RI from a contingent screening population.</p><p><strong>Methods: </strong>Patients with 24-h deconjugated urine metanephrines from 3/6/2010 to 27/8/2022 were included (2936 males, 5285 females), initially by liquid chromatography-electrochemical detection (LC-ECD) then liquid chromatography-tandem mass spectrometry (LC-MS/MS). Bhattacharya analysis was used after log transformation to determine age and sex-stratified RI for metanephrine excretion, normetanephrine excretion, metanephrine/creatinine and normetanephrine/creatinine ratios.</p><p><strong>Results: </strong>Normetanephrine excretion increases with age (RI: males: 18-<30 years: <3.4 µmol/24 h, 30-<40 years: <3.7 µmol/24 h, 40+ years: <5.3 µmol/24 h; females: 18-<30 years: <2.7 µmol/24 h, 30-<40 years: <3.1 µmol/24 h, 40+ years: <3.7 µmol/24 h), while metanephrine excretion was consistent across adulthood (RI: males: 18+ years: <1.8 µmol/24 h; females: 18+ years: <1.2 µmol/24 h). However, normetanephrine/creatinine and metanephrine/creatinine increase steadily with age after early adulthood, likely due to a decrease in muscle mass, with females having higher normetanephrine/creatinine and metanephrine/creatinine ratios.</p><p><strong>Conclusions: </strong>Age and sex-stratified RI were derived for metanephrine excretion, normetanephrine excretion, metanephrine/creatinine and normetanephrine/creatinine ratios. This is expected to reduce false positives while flagging most PPGL.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"173-181"},"PeriodicalIF":2.2,"publicationDate":"2024-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10591712","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}
Md Nahidul Islam, Claire Lyons, Tomas P Griffin, Siobhan Hamon, Fidelma P Dunne, Paula M O'Shea
{"title":"Maintaining glucose integrity ex-vivo: Impact of preanalytical specimen handling.","authors":"Md Nahidul Islam, Claire Lyons, Tomas P Griffin, Siobhan Hamon, Fidelma P Dunne, Paula M O'Shea","doi":"10.1177/00045632231199374","DOIUrl":"10.1177/00045632231199374","url":null,"abstract":"<p><strong>Background: </strong>Adopting the WHO protocol for glucose analysis is arguably impractical in the routine clinical setting. Deviations may develop due to a lack of understanding regarding the impact of glycolysis on the accuracy of results.</p><p><strong>Aim: </strong>We sought to assess the stability of glucose in two different blood collection tubes (BCT), BD Vacutainer® FX 'Fl-Ox' and Greiner Vacuette® FC-Mix 'FC-Mix' stored at room temperature (RT:18-22°C) and 4°C over 8.5 days.</p><p><strong>Method: </strong>Each participant provided venous whole blood collected into 51 BCTs; 'Fl-Ox' (n = 26) and 'FC-Mix' (n = 25). One Fl-Ox sample from each participant was handled according to the WHO recommended method. The remaining BCTs were stored at 4°C/RT prior to analyses at designated study timepoints. Glucose was measured using the hexokinase assay on the Cobas® 8000 platform.</p><p><strong>Results: </strong>Participants (n = 8, Male = 2) were aged 24-56 years. Plasma glucose measured in FI-Ox BCTs according to the WHO sample-handling method had a median concentration of 5.73 mmol/L (Range: 5.39-10.37 mmol/L). Glucose decreased by greater than minimal difference (>0.26 mmol/L) in blood collected into Fl-Ox and stored @4°C/RT within 24 h of phlebotomy. FC-Mix BCT maintained glucose <0.26 mmol/L @4°C over a period of 8.5 days and up to 4 days @RT when compared to the WHO recommended method.</p><p><strong>Conclusion: </strong>Glucose in FC-Mix BCT stored @4°C demonstrated the best agreement with results determined using the WHO specifications. When FC-Mix tubes were stored @RT, glucose was stable for 4 days. These findings suggest that the FC-Mix BCT effectively inhibits glycolysis and should be introduced into routine clinical practice.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"133-142"},"PeriodicalIF":2.2,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10521411","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}
Eunkyoung You, Chan-Jeoung Park, Young-Uk Cho, Seongsoo Jang, Min Young Lee, Hery Kim, Kyung Nam Koh, Ho Joon Im, Eun-Ji Choi, Je-Hwan Lee, Kyoo-Hyung Lee
{"title":"Increased PD-1 expression of bone marrow T-cells in acute myeloid leukaemia patients after stem cell transplantation, and its association with overall survival.","authors":"Eunkyoung You, Chan-Jeoung Park, Young-Uk Cho, Seongsoo Jang, Min Young Lee, Hery Kim, Kyung Nam Koh, Ho Joon Im, Eun-Ji Choi, Je-Hwan Lee, Kyoo-Hyung Lee","doi":"10.1177/00045632231184716","DOIUrl":"10.1177/00045632231184716","url":null,"abstract":"<p><strong>Background: </strong>Immune checkpoints are involved in mechanisms by which tumours escape from the host immune system. Our aim was to evaluate acute myeloid leukaemia (AML) patients to determine expression levels of checkpoint molecules according to diagnosis and treatments, and to identify optimal candidates for checkpoint blockade.</p><p><strong>Methods: </strong>Bone marrow (BM) samples were obtained from 279 AML patients at different disease status and from 23 controls. Flow cytometric analyses of PD-1 and PD-L1/PD-L2 expression were performed.</p><p><strong>Results: </strong>Programmed death-1 (PD-1) expression levels on CD8<sup>+</sup> T-cells at AML diagnosis were increased compared to controls. PD-L1 and PD-L2 expression levels on leukaemic cells at diagnosis were significantly higher in secondary AML than in <i>de novo</i> AML. PD-1 levels on CD8<sup>+</sup> and CD4<sup>+</sup> T-cells after allo-SCT were significantly higher than those at diagnosis and after CTx. PD-1 expression on CD8<sup>+</sup> T-cells increased in the acute GVHD group than in the non-GVHD group. The overall survival of patients with high PD-1 expression on CD8<sup>+</sup> T-cells was significantly shorter than that of patients with low PD-1 expression.</p><p><strong>Conclusions: </strong>In conclusion, patients who underwent allo-SCT exhibited high PD-1 expression, suggesting that allo-SCT increases PD-1 expression on T-cells, and the patients with high PD-1 expression on CD8<sup>+</sup> T-cells after allo-SCT showed the poor prognosis. For these patients, PD-1 blockade could be an immunotherapeutic strategy.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"79-89"},"PeriodicalIF":2.2,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"9630852","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":"Can artificial intelligence replace biochemists? A study comparing interpretation of thyroid function test results by ChatGPT and Google Bard to practising biochemists.","authors":"Emma Stevenson, Chelsey Walsh, Luke Hibberd","doi":"10.1177/00045632231203473","DOIUrl":"10.1177/00045632231203473","url":null,"abstract":"<p><strong>Background: </strong>Public awareness of artificial intelligence (AI) is increasing and this novel technology is being used for a range of everyday tasks and more specialist clinical applications. On a background of increasing waits for GP appointments alongside patient access to laboratory test results through the NHS app, this study aimed to assess the accuracy and safety of two AI tools, ChatGPT and Google Bard, in providing interpretation of thyroid function test results as if posed by laboratory scientists or patients.</p><p><strong>Methods: </strong>Fifteen fictional cases were presented to a team of clinicians and clinical scientists to produce a consensus opinion. The cases were then presented to ChatGPT and Google Bard as though from healthcare providers and from patients. The responses were categorized as correct, partially correct or incorrect compared to consensus opinion and the advice assessed for safety to patients.</p><p><strong>Results: </strong>Of the 15 cases presented, ChatGPT and Google Bard correctly interpreted only 33.3% and 20.0% of cases, respectively. When queries were posed as a patient, 66.7% of ChatGPT responses were safe compared to 60.0% of Google Bard responses. Both AI tools were able to identify primary hypothyroidism and hyperthyroidism but failed to identify subclinical presentations, non-thyroidal illness or secondary hypothyroidism.</p><p><strong>Conclusions: </strong>This study has demonstrated that AI tools do not currently have the capacity to generate consistently correct interpretation and safe advice to patients and should not be used as an alternative to a consultation with a qualified medical professional. Available AI in its current form cannot replace human clinical knowledge in this scenario.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"143-149"},"PeriodicalIF":2.2,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10214754","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":"Use of finer needles for venipuncture increases <i>in vitro</i> haemolysis despite reducing persistent pain and nerve injury: A retrospective study.","authors":"Hiroshi Umemura, Hiromichi Takahashi, Yoshiaki Fukuda, Hitoshi Soma, Rumiko Aoki, Norihisa Takei, Tomohiro Nakayama","doi":"10.1177/00045632231196045","DOIUrl":"10.1177/00045632231196045","url":null,"abstract":"<p><strong>Background: </strong>Although venipuncture is minimally invasive, and is the most frequently performed medical procedure, it carries the small risk of causing persistent pain, including nerve damage. Recently, our hospital stopped using 22-gauge needles for venipuncture in outpatients and switched to using only 23- and 25-gauge needles. We investigated the impact of using only the finer needles on the incidence of persistent or neuropathic pain and the prevalence of haemolysis, as well as the impact of haemolysis associated with the needle change on other laboratory data.</p><p><strong>Methods: </strong>We retrospectively collected and analysed data on venipuncture-associated pain complaints made during the 1-year period prior and 1-year period after the change in needles, as well as the frequency of haemolysis before and after the change. We also focused on 90 cases that showed significant haemolysis after the needle change and compared the serum aspartate aminotransferase, lactate dehydrogenase, and potassium levels before and after the needle change.</p><p><strong>Results: </strong>The incidence of persistent pain was significantly reduced from 1 in 10,825 venipunctures before the change to 1 in 29,747 venipunctures after the change. Notably, no patients experienced neuropathic pain after the change. However, the prevalence of haemolysis was significantly increased. Additionally, the serum aspartate aminotransferase, lactate dehydrogenase, and potassium levels were significantly elevated in the cases that showed moderate to gross haemolysis after the needle change.</p><p><strong>Conclusion: </strong>Using finer needles involves both advantages and disadvantages, and careful consideration is needed to determine which type of needle is in the best interests of the patient.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"107-114"},"PeriodicalIF":2.2,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10457082","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":"Practical approaches to the detection of macrotroponin.","authors":"Leo Lam, Campbell Kyle","doi":"10.1177/00045632231197301","DOIUrl":"10.1177/00045632231197301","url":null,"abstract":"<p><strong>Introduction: </strong>Macrotroponin is increasingly recognised as a cause of confusion in interpreting high-sensitivity cardiac troponin (hs-cTnI) results. In this study, we sought to evaluate two practical approaches to detecting macrotroponin. These two approaches are PEG precipitation and SVM (support vector machine) analysis to classify discrepancies between hs-cTn assays.</p><p><strong>Method: </strong>Residual serum and heparin plasma specimens (n = 483) with initially elevated hs-cTnI from hospital and community laboratories were retested on multiple hs-cTn platforms before and after PEG precipitation and Protein A immunoglobulin depletion. SVM analysis was conducted to identify a linear equation that best discriminated specimens with macrotroponin using a combination of results from two different hs-cTn assays.</p><p><strong>Findings: </strong>The diagnostic performance of PEG precipitation was carried out using Protein A immunoglobulin depletion as the reference comparator. When a cutoff residual activity after PEG precipitation of ≤ 20% was used, this threshold carried a high specificity of 92% (confidence interval 83-98%; n = 189) using the Siemens hs-cTnI Vista assay and 95% specificity (86%-98%; n = 242) using the Abbott hs-cTnI Architect assay. SVM analysis generated a linear equation identifying macrotroponin specimens from results obtained on two hs-cTn assays. This approach can be highly specific, comparable to PEG precipitation when certain assay combinations and concentrations are used.</p><p><strong>Conclusion: </strong>We describe and identify practical alternatives to detecting macrotroponin. These approaches can be optimised for high specificity, reducing the need for more complex laboratory methods.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"122-132"},"PeriodicalIF":2.2,"publicationDate":"2024-03-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"10138562","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}