Annals of Clinical Biochemistry最新文献

{"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}

{"title":"The use of peripheral blood biomarkers for predicting the risk of immune related adverse events in immune checkpoint inhibitor therapy.","authors":"Louise Duvall","doi":"10.1177/00045632241312629","DOIUrl":"https://doi.org/10.1177/00045632241312629","url":null,"abstract":"<p><strong>Background: </strong>Immune checkpoint inhibitors (ICIs) have revolutionised oncology care, by enhancing the body's T cell lymphocyte response against tumour cells. ICIs block the inhibitory signalling between tumour cells and the immune system, but consequently reduce immunological tolerance. Subsequently for some, this leads to immune-related adverse events (irAE), a spectrum term for autoimmune-like toxicities induced by ICIs that affects various tissues and organs. This limited narrative review will give a brief overview of immune checkpoint inhibitors and immune related adverse events for laboratory professionals and review the current evidence for predictive biomarkers.</p><p><strong>Methods: </strong>A limited narrative review was conducted by accessing Pubmed and Google from June 2023 to January 2024 to identify references published from database inception to January 2024. Language was restricted to English.</p><p><strong>Results/findings: </strong>Professional guidance does not recommend any biomarkers for irAE prediction. Some studies have found an association between the prediction of irAE and interleukin six (IL-6), C-reactive protein (CRP), thyroid stimulating hormone (TSH), albumin, ferritin, full blood count metrics, and lactate dehydrogenase (LDH). However, these have often been single-centre retrospective studies. While an abundance of societal guidance has been produced, it is unclear what blood tests should be included within a baseline profile.</p><p><strong>Conclusions: </strong>Presently, there is no singular biomarker routinely available in clinical laboratories that can predict the onset of irAE. A custom battery of tests may be more predictive, but evidence is currently lacking. In the meantime, due to the clinical significance of these complications, laboratory professionals should proactively support prospective studies.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632241312629"},"PeriodicalIF":2.1,"publicationDate":"2024-12-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142881127","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":"Measurement of uric acid in FC Mix tubes is not accurate.","authors":"Janice Lv Reeve, Michael J O'Meara, Damian G Griffin","doi":"10.1177/00045632241308076","DOIUrl":"https://doi.org/10.1177/00045632241308076","url":null,"abstract":"","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632241308076"},"PeriodicalIF":2.1,"publicationDate":"2024-12-13","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142817068","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":"Elevated Vitamin D leading to an Incidental Diagnosis of Multiple Myeloma.","authors":"Natividad Rico Ríos, Antonio José Reche Martínez, Cristina López Tinoco, Mercedes Calero Ruiz, Ana Sáez-Benito Godino","doi":"10.1177/00045632241306063","DOIUrl":"https://doi.org/10.1177/00045632241306063","url":null,"abstract":"<p><p>A case involving the incidental diagnosis of multiple myeloma (MM) due to interference in the 25-hydroxy-vitamin D (25(OH) vitamin D) immunoassay is presented. The patient, under the care of rheumatology and receiving treatment with alendronic acid and vitamin D supplements, was referred to endocrinology for investigation of acromegaly. Acromegaly was subsequently ruled out; however, during the investigations, consistently elevated levels of 25(OH) vitamin D were noted, raising suspicion of vitamin D resistance syndrome. The laboratory and endocrinology teams engaged in discussions, and following the cessation of medication, repeated analyses for 25(OH) vitamin D and a single analysis of 1,25-dihydroxy-vitamin D levels were requested, yielding high and normal results, respectively. The laboratory conducted a three-step interference investigation, ultimately identifying a high molecular weight molecule responsible for the initially elevated 25(OH) vitamin D levels. Due to the clinical presentation of back pain, a proteinogram was requested, revealing a monoclonal band of 36 g/L. Subsequent free light chain analysis indicated an elevated ratio. With three risk factors identified, this was classified as an established MM and urgently referred to haematology for correct management. Laboratory assay interferences have the potential to disrupt the accurate diagnostic workup of patients. Collaborative discussions between laboratory and clinical teams regarding such cases aid in directing the diagnostic pathway appropriately, facilitating prompt and proper diagnosis and management.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632241306063"},"PeriodicalIF":2.1,"publicationDate":"2024-12-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142811862","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":"Exploratory study on reference intervals of calprotectin and pentraxin 3.","authors":"Igor Alfirevic, Andrea Saracevic, Helena Cicak, Hrvoje Galic, Vanja Radisic Biljak, Ana-Maria Simundic","doi":"10.1177/00045632241307186","DOIUrl":"10.1177/00045632241307186","url":null,"abstract":"<p><strong>Introduction: </strong>The aim of our study was to determine reference intervals for serum pentraxin 3 and calprotectin, as well as for urine calprotectin according to the CLSI EP28-A3C guidelines for defining, establishing, and verifying reference intervals in the clinical laboratory.</p><p><strong>Materials and methods: </strong>A total of 120 serum and urine samples from either healthy volunteers or outpatients were used for reference interval establishment. The participants had CRP levels, leucocyte counts, serum urea levels, creatinine levels, and estimated glomerular filtration rates (CKD-EPI eGFRs) within the reference range and no medical history of acute/chronic inflammatory diseases/conditions or cancer. Calprotectin was measured via a commercially available turbidimetric method - the Bühhlmann fCAL® Turbo Reagent Kit - while pentraxin 3 was measured using the Human Pentraxin 3 ELISA Kit from the BioVendor Group.</p><p><strong>Results: </strong>The serum calprotectin reference range was ≤3.6 mg/L, the 90% CI for the upper reference range was 3.1-4.1 mg/L, while the serum pentraxin 3 reference concentration was ≤3.0 µg/L, and the 90% CI for the upper reference range being 2.7-3.2 µg/L. Additionally, the urinary calprotectin concentration was ≤1.4 mg/L, with a 90% CI for the upper reference range of 1.0-1.7 mg/L.</p><p><strong>Conclusion: </strong>This study reports sample and method-specific reference intervals for the detection of various inflammatory conditions.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632241307186"},"PeriodicalIF":2.1,"publicationDate":"2024-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142754432","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":"Interference in immunoassay: An estimate based on \"real-world\" experience. (Reply).","authors":"Adel Aa Ismail","doi":"10.1177/00045632241305925","DOIUrl":"https://doi.org/10.1177/00045632241305925","url":null,"abstract":"","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632241305925"},"PeriodicalIF":2.1,"publicationDate":"2024-12-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142798971","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 sex-specific reference intervals for PIVKA-II in Southwest China: A real-world data analysis.","authors":"Bin Wei, Yalin Zheng, Lixin Li, Limei Luo, Ying Guo","doi":"10.1177/00045632241306074","DOIUrl":"https://doi.org/10.1177/00045632241306074","url":null,"abstract":"<p><strong>Objective: </strong>We aim to establish the sex-related reference intervals (RIs) of PIVKA-II in southwest China by indirect method with the real-world data.</p><p><strong>Methods: </strong>Between 29 July 2016 and 5 February 2024, PIVKA-II test data were collected from 120,780 healthy adult participants (aged 18 to 97 years) in the Laboratory Information System (LIS) of West China Hospital to establish reference intervals. Additionally, a validation group comprised of 2068 healthy adults was evaluated using the same detection algorithm and platform. Following the CLSI EP28-A3 guideline, Box-Cox transformation was applied for normal transformation, and outliers were identified using the Tukey method. Furthermore, we employed the standard normal deviate test (z-test) recommended by Harris and Boyd to determine whether to stratify reference intervals by age and sex subclasses.</p><p><strong>Results: </strong>We successfully established population-specific RI for PIVKA-II in southwest China using an indirect method. By utilizing a robust dataset and conducting rigorous statistical analyses, we delineated sex-specific RIs, with values of 0-35 mAU/mL for males and 0-29 mAU/mL for females according to the normal distribution method, and 0-32 mAU/mL for males and 0-28 mAU/mL for females using the non-parametric method. These intervals are more suitable for the local population than those derived from manual methods.</p><p><strong>Conclusion: </strong>These RIs provide valuable guidance for the accurate interpretation of PIVKA-II levels in the local population.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632241306074"},"PeriodicalIF":2.1,"publicationDate":"2024-12-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142783497","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 variability of measured and calculated low-density lipoprotein (LDL) cholesterol in statin-treated diabetes patients.","authors":"Eric S Kilpatrick, Anders Kallner, Stephen L Atkin, Thozhukat Sathyapalan","doi":"10.1177/00045632241305936","DOIUrl":"https://doi.org/10.1177/00045632241305936","url":null,"abstract":"<p><strong>Background: </strong>The Sampson-NIH and Martin-Hopkins low-density lipoprotein cholesterol (LDL-C) equations are advocated as being superior to the Friedewald calculation. However, their mathematical complexity means they may have different biological and analytical variation when tracking LDL-C in the same patient. This study has established the biological variation (BV) of calculated and directly measured LDL-C (dLDL-C) in patients taking equivalent doses of a long (atorvastatin) and short (simvastatin) half-life statin. It also modelled how analytical imprecision might add to these BVs.</p><p><strong>Methods: </strong>In a crossover study of lipid BV involving 26 patients with type 2 diabetes (T2DM) initially taking either simvastatin 40 mg or atorvastatin 10 mg, fasting lipids were measured 10 times over 5 weeks after a 3 month run-in. The same procedure was then followed for the alternate statin. Outlier removal and CV-ANOVA established the BV of dLDL and each formula. Analytical measurement uncertainty was estimated from 6 months of real-world data.</p><p><strong>Results: </strong>The intra-individual BV of dLDL-C measurement was considerably lower with atorvastatin than simvastatin (CV 1.3%(95% CI 1.1-1.5%) vs. 11.1%(10.2-12.2%), respectively). No equation could distinguish this difference (Friedewald 11.0%(95% CI 10.0-12.1%) vs. 12.9%(11.8-14.2%), Sampson-NIH 10.4%(9.5-11.5%) vs. 11.7% (10.7-12.8%) and Martin-Hopkins 9.3%(8.5-10.3%) vs. 11.3%(10.3-12.4%)). Real-world analytical CVs were 2.6% (Sampson-NIH), 2.6% (Martin-Hopkins) 2.8% (Friedewald) and 2.0% (dLDL-C).</p><p><strong>Conclusions: </strong>Inherent biological LDL-C variability using these formulae is substantially greater than direct measurement in T2DM patients taking atorvastatin. Typical analytical imprecision was also greater. Together, this may fundamentally limit these equations' ability to track true LDL-C changes in patients taking popular statin treatments.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632241305936"},"PeriodicalIF":2.1,"publicationDate":"2024-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142783509","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":"Interference in immunoassay.","authors":"Ruggero Dittadi","doi":"10.1177/00045632241305926","DOIUrl":"https://doi.org/10.1177/00045632241305926","url":null,"abstract":"","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632241305926"},"PeriodicalIF":2.1,"publicationDate":"2024-12-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142783507","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":"Decreased serum SLC7A11 and GPX4 levels may reflect disease severity of acute ischaemic stroke.","authors":"Chuan-Peng Liu, Su Zheng, Ping Zhang, Guang-Hui Chen, Yuan-Yuan Zhang, Hui-Lin Sun, Li Peng","doi":"10.1177/00045632241305927","DOIUrl":"https://doi.org/10.1177/00045632241305927","url":null,"abstract":"<p><strong>Objective: </strong>This study aimed to examine the levels of solute carrier family seven number 11 (SLC7A11) and glutathione peroxidase 4 (GPX4) in the serum of patients with acute ischaemic stroke (AIS) and their relationship with disease severity.</p><p><strong>Methods: </strong>A total of 148 patients with AIS together with 148 healthy controls (HCs) were enrolled. The expression levels of SLC7A11 and GPX4 in serum were detected immediately as early as possible. Radiographic severity was detected by Alberta Stroke Program Early CT Score (ASPECTS). Disease severity was evaluated using modified Rankin Scale (mRS). High-sensitivity C-reactive protein (hs-CRP) and matrix metalloproteinase-9 (MMP-9) expression levels were also measured. A correlation analysis was conducted to determine the relationship between the expression levels of SLC7A11 and GPX4 with the clinical severity of the disease and the levels of hs-CRP and MMP-9. Furthermore, receiver operating characteristic (ROC) curve analysis was utilized to assess the potential of SLC7A11 and GPX4 as diagnostic markers.</p><p><strong>Results: </strong>Compared to the HC group, the serum expression levels of SLC7A11 and GPX4 were significantly lower in the AIS group. Serum SLC7A11 levels were positively associated with serum GPX4 levels. The AIS group included 50 patients with mild neurological impairment, 52 with moderate neurological impairment, and 46 with severe neurological impairment. AIS patients with mild neurological impairment had drastically higher serum SLC7A11 and GPX4 levels compared with those with moderate neurological impairment. AIS patients with moderate neurological impairment showed significantly higher serum SLC7A11 and GPX4 concentrations compared with those with severe neurological impairment. ROC curve analysis demonstrated that both serum SLC7A11 and GPX4 may both act as potential indicators for evaluating of AIS disease severity. In addition, both serum SLC7A11 and GPX4 levels were positively correlated with ASPECTS. Both serum SLC7A11 and GPX4 levels were negatively associated with hs-CRP as well as MMP-9 levels. Serum SLC7A11 and GPX4 levels were significantly increased following comprehensive therapy.</p><p><strong>Conclusions: </strong>Decreased SLC7A11 and GPX4 levels may reflect disease severity of AIS.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632241305927"},"PeriodicalIF":2.1,"publicationDate":"2024-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142778919","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}