Annals of Clinical Biochemistry最新文献

{"title":"A method comparison of the Roche intact PTH method versus the Roche whole PTH (1-84) method: Examining the differences based on eGFR.","authors":"Byrne E, Twomey Pj, Crowley Rk, McKenna Mj, Kilbane M","doi":"10.1177/00045632251356826","DOIUrl":"10.1177/00045632251356826","url":null,"abstract":"<p><p>AimThird-generation whole PTH (1-84) parathyroid hormone (PTH) assays do not recognize the PTH 7-84 fragment whereas second-generation (intact) assays detect both 1-84 and 7-84 PTH fragments. This study aimed to compare the second-generation Roche intact PTH method with the third-generation Roche whole PTH (1-84) method, examining differences based on estimated glomerular filtration rate (eGFR).MethodsThe intact PTH method and whole PTH (1-84) method were compared using 100 serum samples selected across eGFR quintiles for chronic kidney disease (CKD) stages 1-5 in accordance with Kidney Disease: Improving Global Outcomes (KDIGO).ResultsMethod comparison based on eGFR showed that differences between both PTH methods were not significant at eGFR >60 mL/min/1.73 m². There was a statistically significant difference at eGFR <60 mL/min/1.73 m². The whole PTH (1-84) method produced lower results as eGFR decreased: CKD Stage 3 (mean difference: -21%; 95% confidence interval: -16 to -26%) to CKD Stage 5 (mean difference: -46%; 95% confidence interval: -40 to -52%).ConclusionsDifferences observed between the two assays may be due to second-generation PTH assays overestimating PTH concentration by measuring both 1-84 PTH and C-terminal fragments, notably PTH (7-84) in patients with significant renal impairment. The whole PTH (1-84) assay may be used to monitor metabolic bone disease risk. Initial dual reporting of PTH by both methods is recommended for eGFR <60 mL/min to educate users due to the difference in results.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632251356826"},"PeriodicalIF":2.1,"publicationDate":"2025-06-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144473796","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 influence of hemolysis in patient samples on biochemical tests analyzed using Roche Cobas® 8000 Analyzer.","authors":"Wei-Ling Lin, Yu-En Hung, Yin-I Chiu, Shu-Chu Shiesh, Ying-Chun Lin, Chung-Ling Cheng, Kai-Yun Syue","doi":"10.1177/00045632251356827","DOIUrl":"https://doi.org/10.1177/00045632251356827","url":null,"abstract":"<p><p>Background Modern analyzers employ the hemolysis index (HI) to identify interference in biochemical assays, yet manufacturer-defined HI thresholds may be inappropriate for true hemolysis effects, resulting in unnecessary sample rejections. This study aimed to validate these thresholds using non-simulated hemolyzed patient samples. Methods Paired samples (hemolyzed primary and non-hemolyzed recollected) from 678 patients were analyzed for hemolysis interference. Biochemical analytes and serum indices were measured using a Roche Cobas® 8000 analyzer. Hemolysis effects on test results and lipemia index (LI) were assessed. HI thresholds were derived from reference change value (RCV) limits and regression of HI versus percentage bias, then compared to the conventional 10% deviation criterion and Roche-defined cut-offs. Results Samples exhibited predominantly moderate hemolysis (72.3%, HI: 101-300). Strong HI correlations were observed for lactate dehydrogenase (51% change per 100-unit HI, R² = 0.6524, P <0.0001), potassium (14% per 100-unit HI, R² = 0.5630, P <0.0001), and sodium (-0.6% per 100-unit HI, R² = 0.5414, P <0.0001). Elevated biases exceeded the RCV for these analytes, plus ammonia, aspartate aminotransferase, creatine kinase, γ-glutamyltransferase, and bilirubin-direct, whereas sodium showed a clinically significant reduction at heavy hemolysis (HI 560). RCV-derived thresholds exhibited comparable or higher than 10% change and Roche cut-offs. The elevated LI in hemolyzed samples with HI greater than 100 decreased significantly after recollection. Conclusions Patient-based hemolysis data indicated that biases for most analytes remain within clinically acceptable limits, suggesting the manufacturer's HI thresholds may overestimate interference, supporting lab-validated, RCV-based cut-offs enhance clinical relevance and decrease unnecessary sample rejection.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632251356827"},"PeriodicalIF":2.1,"publicationDate":"2025-06-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144473798","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":"Clinical profile and utility of biomarkers in children with cobalamin (vitamin B12) deficiency: A cross-sectional study.","authors":"Sruthi Sankar, Ranjini Srinivasan, Vandana Bharadwaj, Sarita Devi","doi":"10.1177/00045632251356816","DOIUrl":"10.1177/00045632251356816","url":null,"abstract":"<p><p>BackgroundTo assess utility of novel biomarkers in diagnosing children with clinical cobalamin deficiency. Current practice uses total vitamin B12 levels to confirm diagnosis, which lacks sensitivity when used in isolation.MethodsBetween November 2020 and September 2022, a prospective cross-sectional study was carried out in a tertiary teaching hospital. Children between 1 month and 18 years with clinical symptoms/at-risk of developing B12 deficiency were included. Relevant clinical and laboratory information (including total B12 and biomarker levels) was documented. Sensitivity and specificity of individual biomarkers were assessed using 4cB12, an indicator of functional B12 status. Version 4.2.1 of R language was used for statistical analysis.ResultsAnalysis was performed on 67 children. Anorexia, fatigue and behavioural abnormalities were among the leading clinical characteristics. 49% children had peripheral smear (PS) suggestive of cobalamin deficiency, and 43% had low total B12 levels. Among biomarkers, 85% children had low holotranscobalamin (HoloTC), and 73% and 55% had high methylmalonic acid (MMA) and elevated homocysteine (Hcy) levels, respectively. Sensitivity of total B12 was 51%, HoloTC 87%, MMA 83% and Hcy 64%. Combination of low HoloTC, macrocytosis and abnormal PS had 94% sensitivity while HoloTC with mean corpuscular volume (MCV) alone was 88% sensitive in detecting cobalamin deficiency.ConclusionLow total B12 levels lack sensitivity to diagnose cobalamin deficiency. Although combination of low HoloTC with abnormal smear and macrocytosis was found to have better sensitivity, reporting an abnormal smear is time consuming and requires skilled personnel. Combination of low HoloTC with macrocytosis has good sensitivity and can be considered a better screening tool for detecting B12 deficiency.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632251356816"},"PeriodicalIF":2.1,"publicationDate":"2025-06-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144473797","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":"Sweat testing and cystic fibrosis - Test performance before and after a quality improvement project in a South African tertiary hospital laboratory.","authors":"Asande Zama, Annalise E Zemlin, Marizna Korf","doi":"10.1177/00045632251350514","DOIUrl":"10.1177/00045632251350514","url":null,"abstract":"<p><p>BackgroundThe diagnosis of cystic fibrosis (CF) is challenging due to high quantity not sufficient (QNS) rates of sweat tests, leading to frequent retesting, increasing costs and adverse impacts on patient care. This study aimed to assess sweat test performance and implement a quality improvement project (QIP) to reduce QNS rates.MethodsA two-part retrospective audit was conducted. Part one spanned 2 years reviewing the two-tiered testing with sweat conductivity as a screening tool, followed by chloride testing. Part two evaluated the QNS rates over two 6-month periods, separated by a QIP, which involved technologist training, clinician education, patient preparation protocols and revised testing procedures.ResultsOver the 2-year period, 425 sweat tests were performed on 291 patients. Sweat conductivity testing demonstrated a lower QNS rate, 13% (31/238), compared to sweat chloride testing's 31% (33/105). High QNS rates were observed in younger infants and in malnourished or acutely ill patients. Post-QIP, the QNS rates for the total study population decreased by 5%, from an initial 30% to 25% in the sweat chloride cohort, while the acceptable QNS rate of 12% remained unchanged in the sweat conductivity cohort.ConclusionAchieving target QNS rates remains challenging, especially in younger infants, with improved QNS rates in older infants and children. Recommendations include limiting sweat testing to experienced technologists and ensuring patient readiness.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632251350514"},"PeriodicalIF":2.1,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144265067","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":"Is there utility in testing IgA-endomysial antibodies in patients with weak-positive or equivocal IgA-tissue transglutaminase antibodies in the diagnosis of coeliac disease? A critique of current NICE guidance (NG20).","authors":"Samuel D Brown, Jacqueline Hitchins, Newton Acs Wong, Amy Hayes, Alice Ogden, Adrian Heaps, Philip Bright","doi":"10.1177/00045632251350488","DOIUrl":"10.1177/00045632251350488","url":null,"abstract":"<p><p>BackgroundCurrent coeliac disease (CD) NICE guidelines recommend testing IgA-endomysial antibodies (EMA) following a weak-positive IgA-tissue transglutaminase antibody (tTGA). Outside of patients with very high IgA-tTGA results, a positive IgA-EMA necessitates duodenal biopsy to confirm CD diagnosis, meaning a positive IgA-EMA does not alter the diagnostic pathway. Therefore, to be helpful, a negative IgA-EMA needs to reliably exclude CD.ObjectivesWe aimed to evaluate the negative predictive value (NPV) of IgA-EMA, following a weak-positive/positive IgA-tTGA, and to evaluate whether IgA-EMA result (positive or negative) affects duodenal biopsy rates.MethodsRetrospective patient cohort (<i>n</i> = 963) study of patients with IgA-EMA and IgA-tTGA testing, with or without evidence of duodenal biopsy. The NPV of IgA-EMA was assessed by comparison to duodenal biopsy. Duodenal biopsy rates were compared between patients with a positive/negative IgA-EMA (after positive/weak-positive IgA-tTGA).ResultsThe NPVs for CD of a negative IgA-EMA, in the context of a weak-positive or positive IgA-tTGA, were 41% and 0%, respectively (<i>n</i> = 45). There was a significant reduction in the proportion of patients who had a duodenal biopsy with a negative IgA-EMA (9.4%) compared to patients with a positive IgA-EMA (28.5%), following a positive/weak-positive IgA-tTGA (<i>n</i> = 963).ConclusionIgA-EMA does not reliably exclude CD following a positive/weak-positive IgA-tTGA result. Our data indicates that clinicians are utilizing a negative IgA-EMA, following a positive/weak-positive IgA-tTGA result, to inappropriately exclude CD. We recommend IgA-EMA be exclusively used in the context of a 'non-biopsy' approach to CD diagnosis, following a high positive IgA-tTGA, and that a negative IgA-EMA result should not be used to exclude CD in the context of a weak-positive/positive IgA-tTGA.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632251350488"},"PeriodicalIF":2.1,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144265066","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":"Detection of urinary SERPINA4 by electrochemiluminescence immunoassay and development of a diagnostic model for diabetic nephropathy.","authors":"LiMei Yang, Huan Li, Fei Chen, Hui Zhang, Feng Wang, WenQian Guo, Ying Shen, ZiJie Liu","doi":"10.1177/00045632251350505","DOIUrl":"10.1177/00045632251350505","url":null,"abstract":"<p><p>Background and objectivesSERPINA4 has been identified as a potential diagnostic biomarker for diabetic nephropathy (DN) in our previous research. This study aims to develop electrochemiluminescence immunoassay (ECLIA) methods for the detection of SERPINA4 and to establish a diagnostic model that incorporates additional indicators for DN.Materials and methodsAntibodies utilized in the ECLIA for the detection of SERPINA4 were labelled with ruthenium and biotin, respectively. The reliability of ECLIA was evaluated based on its linear range, precision, and hook effect. A total of 28 indicators were collected from 98 patients, including SERPINA4/UCr, diabetic retinopathy (DR), and duration of diabetes mellitus. A diagnostic model was developed employing Random Forest, Support Vector Machine (SVM), and Naive Bayes algorithms. The performance of the model was assessed using metrics such as area under the curve (AUC), precision, recall, and F1 score; ultimately selecting the best-performing model for final diagnosis.ResultThe ECLIA method established in this study for urinary SERPINA4 demonstrates a linearity range from 7.5 ng/mL to 16,000 ng/mL, with within-run precision (CV%) values of 0.25% and 3.78%. The diagnostic model developed using random forest exhibits optimal performance, achieving an AUC of 0.89, accuracy of 90%, sensitivity of 100%, and specificity of 70%. The top five variables ranked by importance are serum creatinine, microalbumin, SERPINA4/UCr ratio, systolic blood pressure, and total urine protein.ConclusionA method for the detection of urinary SERPINA4 using ECLIA has been successfully established. The combination of SERPINA4/UCr with other clinical indicators demonstrated strong performance in the diagnostic model developed through the random forest algorithm.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632251350505"},"PeriodicalIF":2.1,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144265065","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":"Variability in SHBG assays and the effect thereof on calculated estimates of free testosterone.","authors":"Joeri Walravens, Joanne Adaway, Tim Reyns, Nick Narinx, Jennifer Afrakoma Nyamaah, Leen Antonio, Jean-Marc Kaufman, Brian Keevil, Tom Fiers, Bruno Lapauw","doi":"10.1177/00045632251350676","DOIUrl":"https://doi.org/10.1177/00045632251350676","url":null,"abstract":"<p><p>BackgroundSerum free testosterone is commonly used as a parameter to evaluate testosterone exposure and is mostly calculated using mathematical approximations. As the principal testosterone-binding protein, SHBG concentration is always included in such calculations. However, variability in SHBG measurements may affect reported SHBG levels and consequently free testosterone calculations. In this study, we re-evaluate the effects of SHBG assay choice and interlaboratory variability on calculated free testosterone (cFT).MethodsSerum samples from 113 men and 106 women were collected. SHBG levels were measured using three different SHBG immunoassays (Roche, Abbott and Siemens). Testosterone levels were measured using LC-MS/MS. Afterwards, cFT was calculated using the Vermeulen formula and measured directly. SHBG concentrations, and derived cFT concentrations, from different assays were compared. To simulate interlaboratory SHBG variability, measured levels were modified by 15% after which cFT was recalculated using the Vermeulen, Ly, Sartorius and Södergard formulae. The proportions of diagnoses of hypogonadism or hyperandrogenism were compared.ResultsAssessed SHBG assays showed very good conformity. The largest difference was 7%, between the Abbott and Siemens assay. The difference in cFT levels was at most 3% between the Abbott and Siemens assay. Interlaboratory variability affected the proportion of diagnoses depending on the used formula.ConclusionsOur results do not show large differences between SHBG assays and only minor effects on cFT levels. Therefore, SHBG assay choice is not expected to greatly influence clinical decision making. In contrast, interlaboratory variation in SHBG measurements and choice of formula might considerably affect cFT results and their interpretation.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632251350676"},"PeriodicalIF":2.1,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144273974","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":"Application of the six sigma model to evaluate the analytical performance of serum lipid analytes and design quality control strategies: A multi-centre study.","authors":"Qian Liu, Yu Lin, Fang Yang, Yaping Dai, Huan Hang, Menglin Wang, Ming Hu, Fumeng Yang","doi":"10.1177/00045632251350503","DOIUrl":"10.1177/00045632251350503","url":null,"abstract":"<p><p>BackgroundThe six sigma model is widely used in laboratory quality management. For the first time, this study introduced total allowable error (TEa) from WS/T403-2024 and 'desirable' biological variation (BV) as dual quality goals to evaluate serum lipid analytes in six laboratories and develop individualized quality control (QC) strategies.MethodsWe collected internal quality control (IQC) and external quality assessment (EQA) data to calculate sigma values for each serum lipid analyte. Normalized sigma method decision charts were employed, and the Westgard sigma rule flow chart with batch size plus the quality goal index (QGI) guided individualized QC strategies and improvement plans.ResultsUnder the same quality goal, different QC concentrations produced varying sigma values. Sigma values also differed significantly between the two quality goals. When WS/T403-2024 was applied, all analytes except triglycerides (TGs) showed lower sigma values than under 'desirable' BV. Normalized sigma method decision charts effectively highlighted these differences. Based on the Westgard sigma rule flow chart with batch size and QGI, individualized QC strategies were created, and priority improvement measures were proposed for analytes with sigma values below six.ConclusionsThe six sigma model is a valuable tool for laboratory quality management, guiding laboratories to enhance the detection capabilities of serum lipid analytes through targeted QC strategies and improvement measures.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632251350503"},"PeriodicalIF":2.1,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144265064","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 early diagnostic value of C-reactive protein (CRP) in deep sternal wound infection after cardiac surgery.","authors":"Shanshan Jia, Jie Zhao, Jixun Zhang, Duyin Jiang","doi":"10.1177/00045632251350489","DOIUrl":"10.1177/00045632251350489","url":null,"abstract":"<p><p>BackgroundThis study aimed to evaluate the early diagnostic value of C-reactive protein (CRP), procalcitonin (PCT), white blood cell count (WBC), neutrophil ratio (NEUT%), and neutrophil-to-lymphocyte ratio (NLR) in patients with deep sternal wound infection (DSWI).MethodsA retrospective case-control study was conducted on 241 patients who underwent cardiac surgery (30 patients with DSWI and 211 patients without DSWI). The differences in inflammatory markers were compared between the two groups at 5 time points (days 1, 4, 7, 10, and 14 after cardiac surgery), and the optimal cut-off values of the inflammatory factors independently correlated with DSWI were determined.ResultsUnivariate and multivariate logistic regression analyses showed that CRP on days 10 and 14, and PCT on day 10, were independently correlated with the occurrence of DSWI. The ROC curve showed the optimal cut-off value of them (CRP on day 10: AUC = 0.786, optimal cut-off point = 170.205 mg/L, sensitivity = 50.0%, specificity = 95.7%; CRP on day 14: AUC = 0.800, optimal cut-off point = 64.36 mg/L, sensitivity = 83.3%, specificity = 70.1%; PCT on day 10: AUC = 0.728, optimal cut-off point = 2.359 ng/mL, sensitivity = 43.3%, specificity = 97.6%). There was no correlation between WBC, NEUT%, NLR, and the occurrence of DSWI.ConclusionsFor patients who underwent sternotomy, CRP levels from the 10th postoperative day were correlated with the occurrence of DSWI. Early diagnosis of DSWI using CRP may be effective and can be used as a focused indicator to detect the presence of DSWI in patients as early as possible.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632251350489"},"PeriodicalIF":2.1,"publicationDate":"2025-06-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144265068","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":"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}