Annals of Clinical Biochemistry最新文献

{"title":"Folic and folinic acid load tests for dynamic assessments of compliance and metabolism in folate deficiency and hyperhomocysteinaemia patients unresponsive to high-dose folate replacement.","authors":"Tejas Kalaria, Agata Sobczyńska-Malefora, Himabindu Rebbapragada, Rawya Hussein, Dominic J Harrington, Rousseau Gama, Supratik Basu","doi":"10.1177/00045632241312616","DOIUrl":"10.1177/00045632241312616","url":null,"abstract":"<p><p>We describe the utility of 'folic and folinic acid load tests' in the investigation of a 26-year-old woman with persistently low serum folate and moderate hyperhomocysteinaemia unresponsive to folic acid supplements. Serum folate, plasma 5-methyltetrahydrofolate (5-MTHF), red cell 5-MTHF and plasma total homocysteine at baseline, 2-h, 4-h and 2- or 4-days (if applicable) post administration of a large dose of oral folic acid, or oral or parenteral folinic acid were measured. The tests confirmed non-compliance but also suggested an unsuspected possible defect in the folate pathway based on differential response to folic versus folinic acid supplements. The folic and folinic acid load tests identify non-compliance and can help identify possible defects related to the absorption, transportation, or metabolism of folate.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"326-331"},"PeriodicalIF":2.1,"publicationDate":"2025-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142926310","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":"Relationships of serum levels of tocilizumab to interleukin-6 and endogenous markers of CYP3A activity in patients with rheumatoid arthritis.","authors":"Takashi Mochizuki, Kaito Shibata, Takafumi Naito, Kumiko Shimoyama, Noriyoshi Ogawa, Junichi Kawakami","doi":"10.1177/00045632251357148","DOIUrl":"https://doi.org/10.1177/00045632251357148","url":null,"abstract":"<p><p>Background Tocilizumab co-administration and inflammatory conditions potentially alter the activity of cytochrome P450 (CYP) 3A4 by modulating the interleukin-6 (IL-6) signaling pathway in patients with rheumatoid arthritis (RA). This study aimed to evaluate the correlations of serum levels of tocilizumab with IL-6 and CYP3A activity in RA. Methods RA patients (n = 35) with controllable disease activity using intravenous or subcutaneous tocilizumab were enrolled. Serum tocilizumab was monitored at the trough point after reaching steady-state. Serum levels of IL-6, its soluble receptor (sIL-6R), 4β-hydroxycholesterol (4β-OHC), and 25-hydroxyvitamin D (25-OHD) and CYP3A5 genotype were determined. Results The RA patients had a wide variation of serum tocilizumab level (interquartile range, 9.8-24.6 µg/mL). Tocilizumab treatment led to abnormally high levels of serum IL-6 and sIL-6R. The serum level of tocilizumab was correlated with that of IL-6, but not sIL-6R. In the tocilizumab-treated RA patients, the median serum levels of 4β-OHC and 25-OHD were 36.7 and 17.7 ng/mL, respectively, and no correlations with the serum level of tocilizumab were observed. CYP3A5 genetic polymorphisms were not also associated with the serum level of 4β-OHC. RA patients with the <i>CYP3A5*1</i> allele exhibited a correlation between serum levels of tocilizumab and 4β-OHC, while those with <i>CYP3A5*3/*3</i> did not. Conclusions Tocilizumab treatment raised the serum IL-6 level in a concentration-dependent manner. In the RA patients with functional CYP3A5 protein, the serum tocilizumab level partially explained the interindividual variation in CYP3A activity.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632251357148"},"PeriodicalIF":2.1,"publicationDate":"2025-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144493722","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 ergosterol as a maitake mushroom intake biomarker.","authors":"Naoko Kuwabara, Eri M Jogi, Masaharu Kato, Yuki Masuda, Morichika Konishi, Kenji Yamasaki, Shuzo Ohata, Setsushi Kato, Michio Hashimoto, Shinji Sato, Saori Nakagawa","doi":"10.1177/00045632251357138","DOIUrl":"10.1177/00045632251357138","url":null,"abstract":"<p><p>BackgroundDyslipidemia is a lifestyle-related disease; therefore, cholesterol biosynthesis inhibitors in foods can be easily ingested on a daily basis and are effective in aiding treatment and prevention. To assess the impact of this diet on health, it is of the essential thing that food intake can be properly measured, and it is important to find biomarkers of food intake. Previously, we reported that ergosterol, which is present in mushrooms, inhibits cholesterol biosynthesis. In this study, we measured serum ergosterol levels in healthy participants who consumed maitake mushroom bread to confirm actual ingestion of maitake mushrooms.MethodsSerum samples from healthy participants who consumed maitake mushroom bread (<i>n</i> = 24) or normal bread without maitake mushroom (placebo, <i>n</i> = 26) were analysed for ergosterol levels using liquid chromatography-tandem mass spectrometry with diene derivatization.ResultsIn the placebo group, there was no significant difference in ergosterol concentrations between baseline (before consumption) and 18 weeks. In contrast, the ergosterol concentration was 5-fold higher at 18 weeks than at baseline in the maitake mushroom bread-intake group.ConclusionMaitake mushroom bread intake for 18 weeks significantly increased serum ergosterol levels in healthy participants, suggesting that ergosterol is useful as a biomarker of mushroom intake.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632251357138"},"PeriodicalIF":2.1,"publicationDate":"2025-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144493692","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":"Diurnal variation in salivary testosterone independent of food consumption.","authors":"Jonathan Fenn, Henry Gill, Tejas Kalaria, Lauren Starbrook, Loretta Ford, Hayley Sharrod-Cole, Clare Ford, Rousseau Gama","doi":"10.1177/00045632251357140","DOIUrl":"10.1177/00045632251357140","url":null,"abstract":"<p><p>BackgroundWe previously reported that salivary testosterone (Sal T) decreased following a morning meal but concluded that this decrease could be a postprandial effect or an inherent circadian rhythm or both. Since no studies describing diurnal variations in Sal T have considered the effect of meals, we investigated the temporal variation of Sal T independent of food consumption.MethodsSalivary samples were collected from 17 males at 09.00 h, 10.00 h, and 11.00 h and then at 22.00 h, 23.00 h, and 24.00 h following an 8 h fast for each collection period.ResultsMean (standard deviation) Sal T concentrations were 191.2 (56.68) pmol/L at 09.00 h, 174.2 (53.29) pmol/L at 10.00 h, 168.1 (52.61) pmol/L at 11.00, 120.2 (46.04) pmol/L at 22.00 h, 130.3 (35.72) pmol/L at 23.00 h and 125.1 (29.75) pmol/L at 24.00 h. Sal T at 09.00 h was higher (<i>P</i> < .05) than at all other time points. Sal T at 10.00 h was similar (<i>P</i> = .65) to that at 11.00 h and both were higher (<i>P</i> < .05) compared to all evening time points. Although some patients exhibited a nadir in Sal T at 22:00 followed by an increase, overall evening levels were not significantly different (<i>P</i> > .80).ConclusionWe report an inherent circadian rhythm in Sal T with higher levels in the morning than evening and report for the first time that it is independent of food consumption.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632251357140"},"PeriodicalIF":2.1,"publicationDate":"2025-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144482912","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":"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":"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}