Annals of Clinical Biochemistry最新文献

{"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":"10.1177/00045632241305936","url":null,"abstract":"<p><p>BackgroundThe 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.MethodsIn 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.ResultsThe 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).ConclusionsInherent 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":"184-190"},"PeriodicalIF":2.1,"publicationDate":"2025-05-01","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":"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":"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":"215-220"},"PeriodicalIF":2.1,"publicationDate":"2025-05-01","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><p>IntroductionThe 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.Materials and methodsA 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.ResultsThe 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.ConclusionThis 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":"208-214"},"PeriodicalIF":2.1,"publicationDate":"2025-05-01","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":"The effects of controlled acute psychological stress on serum cortisol and plasma metanephrine concentrations in healthy subjects.","authors":"Aaron Vage, Gerard Gormley, Paul K Hamilton","doi":"10.1177/00045632241301618","DOIUrl":"10.1177/00045632241301618","url":null,"abstract":"<p><p>BackgroundAs cortisol and metanephrine are involved in the stress response, it is often recommended that individuals are relaxed at the time of venepuncture, however, evidence behind these recommendations is lacking. We investigated the effects of acute psychological stress on serum cortisol and plasma metanephrine concentrations in healthy individuals exposed to varying levels of psychological stress and compared these results to self-reported measures of stress.MethodsTen medical students completed two medical in-person simulations (one low-complexity, one high-complexity) in a random order. At four times, participants completed the State-Trait Anxiety Inventory (STAI) and serum cortisol and plasma metanephrine/normetanephrine were tested.ResultsMedian (interquartile range) STAI prior to the low-complexity simulation was 44 (18) versus 33 (13) afterwards (<i>P</i> = 0.050). STAI prior to the high-complexity simulation was 33 (10) versus 48 (17) afterwards (<i>P</i> = 0.007). Cortisol prior to the low-complexity simulation was 272 nmol/L (115) versus 247 (115) afterwards (<i>P</i> = 0.333). Prior to the high-complexity simulation, cortisol was 246 (70) versus 261 (137) afterwards (<i>P</i> = 0.859). Metanephrine prior to the low-complexity simulation was 242 pmol/L (79) versus 247 (93) afterwards (<i>P</i> = 0.515). Metanephrine prior to the high-complexity simulation was 220 (81) versus 251 pmol/L (120) afterwards (<i>P</i> = 0.074). Normetanephrine prior to the low-complexity simulation was 593 pmol/L (247) versus 682 (281) afterwards (<i>P</i> = 0.047 for the difference). Normetanephrine prior to the high-complexity simulation was 696 (123) versus 705 pmol/L (224) afterwards (<i>P</i> = 0.169).ConclusionsThe trend in cortisol levels largely reflected changes in STAI. We outline some implications of these findings for current practice and future research.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"165-173"},"PeriodicalIF":2.1,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12049574/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142646799","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}

{"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":"10.1177/00045632241305927","url":null,"abstract":"<p><p>ObjectiveThis 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.MethodsA 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.ResultsCompared 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.ConclusionsDecreased SLC7A11 and GPX4 levels may reflect disease severity of AIS.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"191-201"},"PeriodicalIF":2.1,"publicationDate":"2025-05-01","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}

{"title":"Interference in immunoassay: An estimate based on \"real-world\" experience. (Reply).","authors":"Adel Aa Ismail","doi":"10.1177/00045632241305925","DOIUrl":"10.1177/00045632241305925","url":null,"abstract":"","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"221-222"},"PeriodicalIF":2.1,"publicationDate":"2025-05-01","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 reference intervals for estimated glomerular filtration rate in apparently healthy adults based on the full age spectrum equation: A single-centre study.","authors":"Qian Liu, Huan Hang, Tongdao Xu, Yidi Zhang, Fang Yang, Xizhen Wang, Yali Ren, Fumeng Yang","doi":"10.1177/00045632241306060","DOIUrl":"10.1177/00045632241306060","url":null,"abstract":"<p><p>BackgroundIdentifying gender and age-related eGFR trends is crucial for precise renal function assessment. This study aims to analyse eGFR distribution with the full age spectrum (FAS) equation and establish reference intervals based on gender and age in a single-centre cohort.MethodsFollowing the inclusion and exclusion criteria outlined in this study, a total of 24,024 reference individuals were ultimately selected. Using the approach recommended by the CLSI C28-A3 guidelines, we assessed the distribution of eGFR across different gender and age groups. The two-sided nonparametric method (P_2.5-P_97.5) was applied to establish the eGFR reference intervals for a healthy Chinese population.ResultsThe eGFR levels in healthy adults exhibited a non-normally distributed pattern. Notably, there were significant differences in eGFR levels between males and females, with females showing a notably higher eGFR level than males. Additionally, eGFR levels demonstrated significant variations across different age groups within both male and female cohorts. As age increased, eGFR showed a significant decline, except in individuals aged 20-29 and 30-39 years. Therefore, reference intervals for eGFR were created based on both gender and age.ConclusionsWe established the reference interval for eGFR using the FAS equation, drawing from a large sample population at a single centre. This establishes a potential framework for evaluating renal function in healthy individuals and for diagnosing and treating kidney-related diseases.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"174-183"},"PeriodicalIF":2.1,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142778926","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":"10.1177/00045632241305926","url":null,"abstract":"","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"222-223"},"PeriodicalIF":2.1,"publicationDate":"2025-05-01","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":"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":"10.1177/00045632241306074","url":null,"abstract":"<p><p>ObjectiveWe aim to establish the sex-related reference intervals (RIs) of PIVKA-II in southwest China by indirect method with the real-world data.MethodsBetween 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.ResultsWe 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.ConclusionThese 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":"202-207"},"PeriodicalIF":2.1,"publicationDate":"2025-05-01","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":"Coefficients of variation analyses of internal quality control status for blood lead in China from 2015 to 2023.","authors":"Han Ma, Wei Wang, Na Dong, Jiali Liu, Shuai Yuan, Chuanbao Zhang, Chao Zhang, Jie Zeng, Ying Yan, Zhiguo Wang","doi":"10.1177/00045632241297885","DOIUrl":"10.1177/00045632241297885","url":null,"abstract":"<p><p>BackgroundBlood lead test is widely conducted in Chinese laboratories, while the imprecision of blood lead measurement based on internal quality control (IQC) across China has not been comprehensively evaluated nowadays.MethodsUsing the IQC data of blood lead collected through a web-based external quality assessment (EQA) reporting system, we analysed current coefficients of variation (CVs) of blood lead from 2015 to 2023 among Chinese laboratories. Two allowable total error (TEa) imprecision levels from EQA were applied to calculate the pass rates, namely percentages of laboratories meeting precision quality specifications. Besides, CV values and pass rates by different subgroups were further performed to assess potential differences.ResultsGenerally, median CV values significantly declined year by year from 6.8% in February 2015 to 5.9% in March 2023. The pass rates based on 1/3 TEa showed upward trends increasing from 15.3% in February 2015 to 20.0% in March 2023, but these percentages were non-ideal with less than 25%. No significant differences in CVs were found between tertiary hospitals and non-tertiary hospitals and between accredited and non-accredited laboratories. Significant time trends were observed in tertiary hospitals and non-accredited laboratories. As for manufacturers, Bohui and self-made QC sample were most widely used with obvious interannual declining trends of CVs.ConclusionsThe CVs of blood lead demonstrated continuous overall improvements in the past twenty years. However, relatively lower pass rates indicated the non-ideal imprecision performance, and more proper performance specifications are warranted. Thus, imprecision improvement and ongoing investigation for blood lead IQC are still needed.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"155-164"},"PeriodicalIF":2.1,"publicationDate":"2025-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142493404","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}