{"title":"Sample comparison of BÜHLMANN fCAL Turbo and OC-FCa faecal calprotectin methods.","authors":"Shane O'Driscoll, Carolyn Piggott, Sally C Benton","doi":"10.1177/00045632241273266","DOIUrl":"10.1177/00045632241273266","url":null,"abstract":"<p><strong>Background: </strong>Faecal calprotectin is an inflammatory marker used to triage patients for further investigation with suspected inflammatory bowel disease (IBD). Our current method requires faecal samples be sent to the laboratory, where calprotectin is extracted before analysis. This is a time-consuming, potential bottleneck in the pathway. We have recently evaluated the OC-SENSOR PLEDIA fCAL method that uses the same sampling device as used in some bowel cancer screening and symptomatic colorectal cancer programmes that detect faecal haemoglobin. The below study is a comparison of the OC-FCa method with the BÜHLMANN fCAL Turbo which is used routinely within BSPS.</p><p><strong>Method: </strong>150 homogenised and 110 non-homogenised faecal samples were loaded into OC-Sampling Bottle 3 and BÜHLMANN CALEX cap sampling devices. The samples were then analysed on their respective systems according to manufacturer's instructions.</p><p><strong>Results: </strong>The OC-FCa assay had a mean positive bias of 67.3% (homogenised) and 88.4% (non-homogenised). Homogenised samples showed substantial agreement between the methods for normal (<50 µg/g) and elevated (150+µg/g) risk categories (k = 0.794, k = 0.788, respectively) and moderate agreement for borderline (51-150 µg/g) (k = 0.25) according to the current Berkshire and Surrey Pathology Service (BSPS) guidelines. Non-homogenised samples had none to slight agreement for normal and borderline values (k = 0.02 for both) and moderate agreement for elevated (k = 0.596).</p><p><strong>Conclusion: </strong>The OC-FCa method is a viable alternative for faecal calprotectin testing, but requires an adjustment to clinical cut-off values due to the lack of standardisation and strong positive bias. A clinical comparative study is required to assess the impact of patients collecting their own samples into the devices, as this may negate any potential degradation samples may exhibit during transit to the laboratory.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"67-70"},"PeriodicalIF":2.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141878244","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}
Amira Ibrahim, Geeta Prasad, Eric S Kilpatrick, Timothy J Morris
{"title":"A case of autoimmune hepatitis associated with the PCSK9 inhibitor alirocumab.","authors":"Amira Ibrahim, Geeta Prasad, Eric S Kilpatrick, Timothy J Morris","doi":"10.1177/00045632241269657","DOIUrl":"10.1177/00045632241269657","url":null,"abstract":"<p><p>This is a case of a 61-year-old lady who presented to the lipid clinic with possible familial hypercholesterolaemia (Simon Broome Criteria). She was commenced on atorvastatin; however, 4 weeks later, she developed hepatitis, and therefore her atorvastatin was discontinued. Following that, her liver function tests normalized, and she was diagnosed with statin-induced hepatitis. Three years later, she was seen again in the lipid clinic with an uncontrolled lipid profile, and she was commenced on alirocumab, a Proprotein Convertase Subtilisin/Kexin type 9 (PCSK9) inhibitor. A few days later, she developed hepatitis, and subsequently, the alirocumab was discontinued. She underwent a liver biopsy, which confirmed that she had Autoimmune Hepatitis (AIH) with presumed superimposed drug injury. This is the first reported case of autoimmune hepatitis associated with alirocumab.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"71-74"},"PeriodicalIF":2.1,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141888294","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}
Bauke A de Boer, Tatum T van Laar, Firmin Candido, Karlijn J van Stralen, Anne Margreet de Jong
{"title":"Automated tools for identifying the causes of anaemia in general practices are particularly advantageous for patients who do not fit the typical profile.","authors":"Bauke A de Boer, Tatum T van Laar, Firmin Candido, Karlijn J van Stralen, Anne Margreet de Jong","doi":"10.1177/00045632241268252","DOIUrl":"10.1177/00045632241268252","url":null,"abstract":"<p><strong>Background: </strong>The Dutch guideline algorithm for the analysis of anaemia in patients of general practitioners (GPs) was programmed in a Clinical Decision Support system (CDS-anaemia) to support the process of diagnosing the cause of anaemia in the laboratory. This research aims to assess the supplementary benefit provided by the automated algorithm in various demographic categories, including different sexes, age groups and severities of anaemia, in comparison to the manual diagnostic approach employed by GPs.</p><p><strong>Methods: </strong>This was a retrospective cohort study of 5399 primary care patients where the cause of anaemia was diagnosed by GPs with or without the aid of CDS-anaemia within the age groups 18-44, 45-64, 65-79 and 80 and older. Anaemia was defined according to the Dutch College of General Practitioners (DCGP) guideline. Causes of anaemia were based on the DCGP guidelines with the corresponding blood tests. By calculation of rate ratios and percentage differences of the determined cause of anaemia we evaluated the effect of the diagnostic algorithm.</p><p><strong>Results and conclusion: </strong>The percentage patients in which an underlying cause of anaemia was found increased 34 and 46 percentage points in females and males, respectively, when GPs were supported by CDS-anaemia compared to GPs who were not supported by CDS-anaemia. The highest increase in percentage points when CDS-anaemia was used, was found in younger- and middle-aged males and mild or moderate anaemia.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"480-483"},"PeriodicalIF":2.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141756764","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}
Saniye Başak Oktay, Şeyma Sehlikoğlu, Sevler Yildiz, Behice Han Almiş, İsmail Gürkan Çikim
{"title":"The effect of lithium variation coefficient on the risk of attack in patients with bipolar disorder: A pilot study.","authors":"Saniye Başak Oktay, Şeyma Sehlikoğlu, Sevler Yildiz, Behice Han Almiş, İsmail Gürkan Çikim","doi":"10.1177/00045632241262873","DOIUrl":"10.1177/00045632241262873","url":null,"abstract":"<p><strong>Background: </strong>This study examines the association between the coefficient of variation (%CV) of lithium levels and episode risk and frequency in bipolar patients maintaining serum lithium levels within the therapeutic range.</p><p><strong>Methods: </strong>We retrospectively reviewed patients with bipolar disorder under care from 2018 to 2022. Inclusion criteria were at least 2 years of follow-up, a minimum of three annual lithium level measurements within the therapeutic range. Patients were categorized based on seizure status. We calculated mean lithium levels, standard deviation (SD), and %CV.</p><p><strong>Results: </strong>The study included 75 patients (patients with-without episodes, 39-36). Demographic data revealed no significant differences. While mean lithium levels showed no significant disparity between groups, SD and %CV were notably higher in patients with episodes (<i>P</i> < .05). ROC analysis demonstrated AUC values of 0.722 (95% CI: 0.607-0.836 <i>P</i> = .001) for %CV and 0.709 (95% CI: 0.593-0.826; <i>P</i> = .002) for SD. The optimal %CV cutoff was 17.39, with 67% sensitivity and 69% specificity. A weak correlation was found between %CV and the number of episodes (<i>P</i> = .001, r = 0.376). The post-hoc power analysis for this study was 0.78.</p><p><strong>Conclusions: </strong>Despite acceptable lithium levels, patients with recent episodes exhibited significant lithium level fluctuations. Integrating %CV with real-time lithium measurements during bipolar disorder follow-up may enhance clinical monitoring and seizure prediction.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"446-450"},"PeriodicalIF":2.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141260681","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}
Joel D Smith, Vasiliki Karlaftis, Stephen Hearps, Chantal Attard, Helen Savoia, Janine Campbell, Paul Monagle
{"title":"Continuous reference intervals for holotranscobalamin, homocysteine and folate in a healthy paediatric cohort.","authors":"Joel D Smith, Vasiliki Karlaftis, Stephen Hearps, Chantal Attard, Helen Savoia, Janine Campbell, Paul Monagle","doi":"10.1177/00045632241280344","DOIUrl":"10.1177/00045632241280344","url":null,"abstract":"<p><strong>Background: </strong>The detection of deficiencies in B<sub>12</sub> and folate children is important. However, despite the availability of various markers to assess B<sub>12</sub> and folate metabolism, there are limited studies describing the reference intervals (RIs) and changes during growth and development for these markers in healthy children.</p><p><strong>Methods: </strong>Using samples collected from 378 children aged 30 days-< 18 years, we derived continuous RIs for holotranscobalamin, homocysteine and red cell folate.</p><p><strong>Results: </strong>The lower RI for holotranscobalamin was lowest at birth, rising during early childhood and then declining following ages 4-6 years whereas red cell folate was highest early in life and then declined steadily towards adulthood. Total homocysteine, reflective of both B<sub>12</sub> and folate status was elevated early in life, reaching a nadir at age 2 and then increasing towards adulthood.</p><p><strong>Conclusions: </strong>Continuous central 95<sup>th</sup> percentile RI for holotranscobalamin, homocysteine and red cell folate for children ages 30 days to <18 years were established. Each marker shows dynamic changes throughout childhood and adolescence which will assist clinicians in more appropriately assessing B<sub>12</sub> and folate status in this population.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"469-473"},"PeriodicalIF":2.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142008175","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}
Divya N Mallikarjun, Shubham Jain, Palash Kumar Malo, Bratati Kahali, Jonas S Sundarakumar, Latha Diwakar, Vijayalakshmi Ravindranath
{"title":"Distribution of biochemical and haematological parameters in an aging population from southern India: A cross-sectional analysis.","authors":"Divya N Mallikarjun, Shubham Jain, Palash Kumar Malo, Bratati Kahali, Jonas S Sundarakumar, Latha Diwakar, Vijayalakshmi Ravindranath","doi":"10.1177/00045632241267905","DOIUrl":"10.1177/00045632241267905","url":null,"abstract":"<p><strong>Background: </strong>Examining the distribution of biochemical and haematological tests in different age groups of rural population is necessary to ensure that health care facilities are equipped to address the prevalent health conditions and manage age-related illness effectively. Hence, this study is aimed at seeing the distributions of blood biochemical and haematological parameters in rural population.</p><p><strong>Methods: </strong>This cross-sectional study investigated the distribution of 26 different haematological and biochemical parameters in longitudinal cohort study (Srinivaspura Aging, NeuoSenescence and COGnition - SANSCOG), from the villages of Srinivaspura, Kolar district, India. A total of 2592 participants (1240 males and 1352 females), aged ≥45 years who are cognitively healthy were included for the analysis. Mean, 2.5<sup>th</sup>, 5<sup>th</sup>, 25<sup>th</sup>, 50<sup>th</sup>, 75<sup>th</sup>, 95<sup>th</sup> and 97.5<sup>th</sup> percentiles were calculated for the entire sample. Additionally, median and percentiles were determined for both gender and age categories (45-54, 55-64, 65-74, and ≥75 years).</p><p><strong>Results: </strong>We observed the distinct distributions of various haematological and biochemical parameters, with elevated levels of glycaemic, lipid, liver, and thyroid parameters.</p><p><strong>Conclusion: </strong>Findings revealed the notable variations from the established reference ranges, indicating the potential undiagnosed cases and highlighting the gaps in health awareness and health seeking behaviour.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"451-458"},"PeriodicalIF":2.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141756765","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}
Angela D Burns, Christina Kanonidou, Jane McNeilly
{"title":"Misleading thyroid function tests in congenital dysfibrinogenemia.","authors":"Angela D Burns, Christina Kanonidou, Jane McNeilly","doi":"10.1177/00045632241263494","DOIUrl":"10.1177/00045632241263494","url":null,"abstract":"<p><p>The presence of latent fibrin clots is a recognised pre-analytical factor that causes inaccurate immunoassay results. This report details a case of a patient with Graves' disease and congenital dysfibrinogenemia (CD) that had serum thyroid function test results (TFTs) that were not in keeping with clinical signs or symptoms. Analysis of plasma samples taken from the patient was shown to provide more accurate results than those obtained using serum samples. Further cases of patients with CD, all sharing the same genetic mutation of fibrinogen, and discordant TFTs are described, where TFTs measurement in serum samples proved to be unreliable. Despite evidence of fibrin effecting immunoassays, this is the first report of its kind linking CD to erroneous immunoassay results. The mechanism is postulated to be related to atypical forms of fibrinogen resulting in latent fibrin in serum samples blocking the antigen binding site and leading to incorrect results. Congenital dysfibrinogenemia is asymptomatic in most patients and therefore abnormal, albeit inaccurate, TFTs may be the first finding. Recognition of CD as a cause of discordant results is important when interpreting TFTs to avoid unnecessary investigations and inappropriate clinical interventions to those with the disorder and potentially identify undiagnosed cases.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"474-479"},"PeriodicalIF":2.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141282802","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}
Esmond Urwin, Joanne Martin, Neil Sebire, Andy Harris, Jenny Johnson, Erum Masood, Gordon Milligan, Lucy Mairs, Antony Chuter, Michael Ferguson, Philip Quinlan, Emily Jefferson
{"title":"A SARS-CoV-2 minimum data standard to support national serology reporting.","authors":"Esmond Urwin, Joanne Martin, Neil Sebire, Andy Harris, Jenny Johnson, Erum Masood, Gordon Milligan, Lucy Mairs, Antony Chuter, Michael Ferguson, Philip Quinlan, Emily Jefferson","doi":"10.1177/00045632241261274","DOIUrl":"10.1177/00045632241261274","url":null,"abstract":"<p><strong>Background: </strong>Healthcare laboratory systems produce and capture a vast array of information, yet do not always report all of this to the national infrastructure within the United Kingdom. The global COVID-19 pandemic brought about a much greater need for detailed healthcare data, one such instance being laboratory testing data. The reporting of qualitative laboratory test results (e.g. positive, negative or indeterminate) provides a basic understanding of levels of seropositivity. However, to better understand and interpret seropositivity, how it is determined and other factors that affect its calculation (i.e. levels of antibodies), quantitative laboratory test data are needed.</p><p><strong>Method: </strong>36 data attributes were collected from 3 NHS laboratories and 29 CO-CONNECT project partner organisations. These were assessed against the need for a minimum dataset to determine data attribute importance. An NHS laboratory feasibility study was undertaken to assess the minimum data standard, together with a literature review of national and international data standards and healthcare reports.</p><p><strong>Results: </strong>A COVID serology minimum data standard (CSMDS) comprising 12 data attributes was created and verified by 3 NHS laboratories to allow national granular reporting of COVID serology results. To support this, a standardised set of vocabulary terms was developed to represent laboratory analyser systems and laboratory information management systems.</p><p><strong>Conclusions: </strong>This paper puts forward a minimum viable standard for COVID-19 serology data attributes to enhance its granularity and augment the national reporting of COVID-19 serology laboratory results, with implications for future pandemics.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"418-445"},"PeriodicalIF":2.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11528979/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141160438","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}
Ingo Mrosewski, Viola Dannheim, Robert Klett, Matthias Urbank, Silvia Stobbe, Jochen R Ittner, Martin Bidlingmaier
{"title":"Rare coincidence: Macro-thyroid-stimulating hormone and multiple manufacturer-specific interferences in thyroid hormone immunoassays.","authors":"Ingo Mrosewski, Viola Dannheim, Robert Klett, Matthias Urbank, Silvia Stobbe, Jochen R Ittner, Martin Bidlingmaier","doi":"10.1177/00045632241262920","DOIUrl":"10.1177/00045632241262920","url":null,"abstract":"<p><p>Immunoassays are widely used for laboratory assessment of endocrine functions including thyroid hormones. While usually adequate for patient evaluation, they are known to potentially suffer from interference from a variety of factors. We report the case of a 44 year-old male patient without clinical symptoms of thyroid disease who presented for specialist evaluation after pathological thyroid function tests prompted a transferal by his primary care practitioner. Thyroid function tests showed discrepant results across immunoassays and platforms of different manufacturers. Polyethylene glycol precipitation prompted the diagnosis of macro-thyroid-stimulating hormone, while heterophilic and non-specific antibody blocking reagents proved ineffective in eliminating the interference in thyroid-stimulating hormone, free triiodothyronine and free thyroxine measurements. Further assessment ruled out a diagnosis of familial dysalbuminemic hyperthyroxinemia, leaving an exclusion diagnosis of manufacturer-specific interference in free triiodothyronine and free thyroxine assays due to unknown factors. Both clinicians and laboratory specialists must be aware of potential interference in immunoassays which otherwise might be misleading, potentially triggering unnecessary (invasive) follow-up procedures or therapeutic interventions. Close communication is required for successful troubleshooting. To our knowledge, no other case of both macro-thyroid-stimulating hormone and manufacturer-specific interference in a single patient has been documented thus far.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"484-489"},"PeriodicalIF":2.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141436556","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":"Impact of Hub & Spoke organization on the measurement of plasma ammonia.","authors":"Davide Camerlengo, Valentina Moioli, Claudia Arrigo, Silvio Contorno, Felicia Stefania Falvella, Alberto Dolci","doi":"10.1177/00045632241266169","DOIUrl":"10.1177/00045632241266169","url":null,"abstract":"","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"490-491"},"PeriodicalIF":2.1,"publicationDate":"2024-11-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141733440","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}