Annals of Clinical Biochemistry最新文献

{"title":"Performance validation and clinical utility of a smartphone-based colorimetric system for differentiating exudative and transudative pleural effusions and ascites via total protein quantification.","authors":"Dandan Liang, Yonghua Zhao, Yufei Guo, Ziqi Li, Zehua Yang","doi":"10.1177/00045632261454287","DOIUrl":"10.1177/00045632261454287","url":null,"abstract":"<p><p>BackgroundTotal protein (TP) is a key indicator to differentiate between pleural effusion (PE) and ascites as exudate or transudate. Rapid quantification of TP can provide more accurate clinical treatment.ObjectiveThis study developed a smartphone-based colorimetric method for the rapid quantification of TP in PE and ascites by measuring the RGB values of reaction products and establishing a correlation between these values and TP concentration.MethodsThe smartphone colorimetric system was validated according to Clinical and Laboratory Standards Institute (CLSI) guidelines, assessing precision, accuracy, detection limit, linearity, and clinical reportable range. To evaluate clinical applicability, we compared results from 43 clinical samples (12 ascites and 31 PE specimens) obtained using the smartphone system with those from an automated biochemical analyzer.ResultsThe G value showed the strongest correlation with TP concentration and was used to generate the standard curve. Validation studies confirmed that the smartphone system's precision and accuracy met clinical requirements, with analytical performance parameters including a limit of blank (3.36 g/L), limit of detection (8.94 g/L), and limit of quantification (13.09 g/L). The method demonstrated good linearity (15.8-93.7 g/L) and a wide clinical reportable range (13.09-374.8 g/L). Deming regression showed excellent agreement with no significant bias. The smartphone-based method and biochemical analyzer achieved near-perfect concordance in differentiating exudative and transudative fluids (PE κ = 0.92, ascites κ = 1.00).ConclusionThe smartphone-based colorimetric system provides a clinically viable solution for the rapid and quantitative measurement of TP in PE and ascites.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261454287"},"PeriodicalIF":1.0,"publicationDate":"2026-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147925814","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":"Stability of urinalysis in two different preservative tubes: A comparative analysis.","authors":"Nilüfer Bayraktar, Eren Vurgun, Seyyide Nur Savran, Fatih Yeşildal","doi":"10.1177/00045632261454297","DOIUrl":"10.1177/00045632261454297","url":null,"abstract":"<p><p>BackgroundSample stability represents a major challenge in the preanalytical phase of urinalysis. This study aimed to evaluate and compare the stability of urine samples stored at room temperature for up to 72 h in two commercially available chlorhexidine-based preservative tubes.MethodsThe study included 44 pathological urine samples. Urinalysis was performed after storage in BD Vacutainer® and Vacusera® tubes at 4, 8, 24, 48, and 72 h. These results were compared with those obtained from refrigerated, non-additive polystyrene (PS) tubes at 0, 4, and 8 h. A level of ≥90% agreement or a kappa value (κ) of ≥0.8 was deemed to represent perfect agreement and stability.ResultsSpecific gravity, pH, glucose, bilirubin, urobilinogen and nitrite were stable in all tubes and conditions. Within the first 4 h, instability was detected in protein in the non-additive PS tube, in ketone and red blood cells (RBC) in the BD tube, and in white blood cells (WBC) in all tubes. By the 8-h mark, ketone and RBC in the non-additive PS tube, as well as bacteria count in the BD tube, failed to maintain stability. Notably, blood and leukocyte esterase remained stable for at least 8 h across all tubes.ConclusionsStorage of urine samples in chlorhexidine-based preservative tubes has minimal impact on urinalysis; however, inter-manufacturer variability exists. To ensure reliable results, analysis should be performed within 4-8 h of collection.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261454297"},"PeriodicalIF":1.0,"publicationDate":"2026-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147925883","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":"Reference intervals for kidney tubular secretion markers in the general population: The HUNT3 study.","authors":"Marius A Øvrehus, Kåre A Kristiansen, Knut Ar Langlo, Pranav S Garimella, Joachim H Ix, Michael G Shlipak, Per Bruheim, Stein I Hallan","doi":"10.1177/00045632261454284","DOIUrl":"10.1177/00045632261454284","url":null,"abstract":"<p><p>BackgroundChronic kidney disease (CKD) prevalence and prognosis are currently based exclusively on glomerular functions, but the kidney tubule possesses numerous additional functions with pathophysiological and prognostic value. Tubular secretion is also critical for toxin and drug elimination but has not been well described in healthy individuals and corresponding reference ranges have not been established.Material and methodsAmong participants from the Norwegian population-based HUNT3 study we identified a healthy subset by excluding those reporting poor general health, or smoking, diabetes, cardiovascular disease, treated hypertension, severe, and CKD (eGFR <60 mL/min/1.73 m²). We measured 12 well-characterized markers of tubular secretion in blood and urine using liquid chromatography mass spectrometry (LC-MS). Tubular secretory function was reported for each marker as urine/plasma-ratio (UPR, with and without indexing to urine creatinine and osmolality), clearance, and fractional excretion.ResultsWe included 636 healthy participants (295 men) with mean age 47 years (SD 14). Less than 3.2% of participants in age and sex subgroups fell outside the upper and lower limits of a common reference interval, so partitioning for age and sex was not necessary. Median urine/plasma ratio indexed for creatinine (UPRcreat) ranged from 3 to 87 uM/uM·mmol, and plasma clearance ranged from 35 to 976 mL/min. Phenylacetylglutamine, isovalerylglycine, 2-methylsuccinic acid, and hippuric acid demonstrated the highest UPRcreat values (87, 75, 72, and 61 uM/uM·mmol, respectively). We also measured 1,7-dimethyluric acid, kynurenic acid, adipic acid, suberic acid, cinnamoylglycine, 1,2,7-trimethyluric acid, indoxyl sulfate, and p-cresol sulfate. Reference intervals based on 2.5th and 97.5th percentiles were similar across age and sex.ConclusionThis study quantifies reference ranges of endogenous tubular secretory solutes among a population of community dwelling healthy adults.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261454284"},"PeriodicalIF":1.0,"publicationDate":"2026-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147925918","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":"Evaluation of an automated device for fingertip blood collection by comparing test results with venous blood.","authors":"Hiroki Doi, Takashi Irie, Kei Takenaka, Sakuichiro Adachi, Taku Sakazume, Taku Kato, Hiroyasu Ito","doi":"10.1177/00045632261454296","DOIUrl":"10.1177/00045632261454296","url":null,"abstract":"<p><p>BackgroundCapillary blood collection offers a less burdensome alternative to venous sampling and may improve access to laboratory testing in resource-limited settings. However, manual procedures can yield pre-analytical variation, resulting in the need for skilled personnel. To address these limitations, we developed a prototype device that automates fingertip blood collection.MethodsThe device automatically punctures a fingertip using a disposable lancet, applies intermittent compression to the fingertip using a cuff, sequentially collects blood into two microtubes, and completes hemostasis with gauze. We evaluated the device in 58 healthy volunteers aged 20-60 years by comparing capillary blood collected with the device to venous blood via standard phlebotomy. Paired samples were processed and analyzed under hospital laboratory quality control. Measurements included 8 CBC parameters, glucose and HbA1c in whole blood, 3 electrolytes, and 15 biochemical analytes in serum. Agreement was assessed using Deming regression, and bias with 95% confidence intervals at medical decision levels (MDLs) was calculated.ResultsMost analytes exhibited biases within the allowable limits defined by the Clinical Laboratory Improvement Amendments (CLIA), except for white blood cell count (WBC), potassium (K), lactate dehydrogenase (LD), and glucose. Compared with the BD MiniDraw™, which involves manual finger compression, our device showed greater biases in WBC and K, likely due to the margination effect and hemolysis, respectively-both enhanced by stronger compression.ConclusionThe device demonstrated acceptable analytical performance for most parameters. Optimizing compression strength and duration may reduce bias. Automated capillary collection could support decentralized testing and reduce phlebotomy workload.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261454296"},"PeriodicalIF":1.0,"publicationDate":"2026-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147925785","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":"Methods and reagent-lot comparisons by regression analysis: False positives.","authors":"William A Sadler","doi":"10.1177/00045632261454285","DOIUrl":"10.1177/00045632261454285","url":null,"abstract":"<p><p>BackgroundThe significance level specified for a statistical analysis indicates the expected false positive rate. Failure to confine false positives to their expected rates can lead to misleading conclusions and especially in studies investigating required sample sizes. A simulation study was used to investigate false positives associated with regression analysis.MethodsRandomly generated X, Y pairs with zero underlying bias were subjected to Deming regression analysis. The design incorporated equal X, Y errors, unequal but parallel errors and non-parallel errors, each in combination with small (2:1), moderate (10:1) and large (2667:1) maximum:minimum range ratios. Bias (false positives in this context) was signified by failure of 95% confidence intervals (CIs) or, alternatively, the joint 95% slope, intercept confidence region (CR) to enclose target values.ResultsFalse positive rates assessed by CIs ranged from 6 to 10% and were clearly range ratio dependent, while those assessed by CRs were stable and very close to the expected 5% throughout.ConclusionsCRs are distinctly more reliable than CIs in controlling false positive rates and should be the preferred option when using regression analysis in methods and reagent-lot comparisons. The computer program used to perform the study is freely available.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261454285"},"PeriodicalIF":1.0,"publicationDate":"2026-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147925825","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":"Proteomic profiling identifies circulating soluble MCAM/CD146 as a candidate biomarker for abnormal semen parameters in male infertility.","authors":"Ryosuke Kikuchi, Takahiro Shibata, Masahiro Nakatochi, Haruka Sei, Yumiko Kobayashi, Hiroyasu Kidoya, Fumitaka Muramatsu, Naomi Furusawa, Keiko Kano, Emi Mishiro-Sato, Hidekazu Ishida, Yasuo Katagiri, Atsuo Suzuki, Hirokazu Matsubara, Kyohei Takano, Tatsuro Furui, Hiroaki Kajiyama, Hiroyuki Okura","doi":"10.1177/00045632261454320","DOIUrl":"10.1177/00045632261454320","url":null,"abstract":"<p><p>BackgroundA growing body of evidence suggests that male infertility is a precursor to future health problems. This study aimed to develop a unique circulating biomarker that could contribute to the diagnosis of male infertility.Materials and methodsThe study included 114 adult male participants aged 20-50 years who underwent sperm collection for in vitro fertilization and embryo transfer at Nagoya University Hospital, Gifu University Hospital, and Misao Ladies Hospital.ResultsCirculating VEGF-A and sFlt-1 levels did not differ significantly between men with normal and abnormal semen parameters. In contrast, proteomic analysis identified VEGFR1/2-related proteins associated with sperm motility, among which soluble MCAM/CD146 was significantly elevated in participants with abnormal semen parameters (84.0 [20.9-183.8] pg/mL vs 352.7 [115.8-1236.3] pg/mL, <i>p</i> < 0.0001), and in similar those with reduced sperm motility (106.5 [25.1-282.6] pg/mL vs 352.7 [125.5-1133.4] pg/mL, <i>p</i> < 0.0001). Receiver operating characteristic analysis demonstrated the diagnostic potential of soluble MCAM/CD146, with an area under the curve of 0.787, 66.7% sensitivity, and 78.6% specificity at the optimal threshold, supporting its role as a candidate biomarker for male infertility.ConclusionsCirculating soluble MCAM/CD146 may represent a potential biomarker associated with abnormal semen parameters.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261454320"},"PeriodicalIF":1.0,"publicationDate":"2026-05-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147925838","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 audit of plasma methylmalonic acid (MMA) requests following publication of NICE guidelines on Vitamin B12 deficiency in over 16s.","authors":"Gary Roulston, Kathryn Ryan, Derek McKillop","doi":"10.1177/00045632261453328","DOIUrl":"10.1177/00045632261453328","url":null,"abstract":"<p><p>BackgroundVitamin B12 deficiency can cause anaemia, fatigue, and neurological sequelae. Total B12 assays may not be reflective of tissue B12. Methylmalonic acid (MMA) can assess tissue B12 more accurately. NICE published clinical guidelines on Vitamin B12 deficiency in adults in 2024. They outlined MMA testing in two scenarios: in patients where nitrous oxide use is possible or who have an indeterminate total B12 result (180-350 ng/L) alongside symptoms or signs of B12 deficiency. MMA testing is costly, not readily available, and time consuming, so increased use will have implications.MethodsThis is a Case note review of patients who had MMA requested one year prior to and one year post-NICE NG239 publication. Audit standards followed were NG239 indications for MMA testing.ResultsIn the year after NG239, MMA testing increased by 96% (57 to 112). Whilst only 47% would have meet NG239 testing criteria in the prior group, this increased to 79% in the post group. More were diagnosed with B12 deficiency (16% prior and 21% post), and more commenced on B12 treatment (14% prior and 19% after). Comparing simultaneous total B12 and MMA results suggests an increase in the upper reference interval of the indeterminate range to 375 ng/L could be considered.ConclusionsDemand for MMA testing almost doubled after NG239 was published, though requests appeared much more appropriate. Whilst laboratory costs increased, there may have been savings elsewhere in the system. Further analysis would be required to review the extent of these healthcare savings in practice.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261453328"},"PeriodicalIF":1.0,"publicationDate":"2026-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147855722","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":"Effects of preanalytical factors on serum vitamin B12 test results.","authors":"Tuba Batur, Ragıp Balahoroğlu, Hatice Karaoglan, Serap Sezer","doi":"10.1177/00045632261453317","DOIUrl":"10.1177/00045632261453317","url":null,"abstract":"<p><p>IntroductionWhile conclusions regarding the effects of serum separator tubes on some laboratory tests have been reached in previous studies, the effects of these tubes on the B12 test have not been adequately investigated. This study aimed to determine the effects of the serum separator tube position after centrifugation on serum B12 test results.Materials and MethodsTwo blood samples were collected by venipuncture into 5-mL Pirmax serum separator tubes from each of the 30 volunteers. The effects of the tube position after centrifugation, gentle mixing 5-10 times, recentrifugation, and short-term (15 min) standing of the tubes in an upright position on serum B12 test results were examined in a step-by-step manner. The B12 analyses were performed in an ADVIA Centaur XPT autoanalyzer using a chemiluminescence method. Comparisons between the groups were evaluated for statistical and clinical significance.ResultsB12 levels were higher in the samples positioned horizontally than in the samples positioned vertically (<i>P</i> < 0.001). The total effect of horizontal position and mixing was abolished by recentrifugation (<i>P</i> = 0.091). The horizontal tube position and sample mixing led to an exceedance of the total allowable error limit.ConclusionsThe use of serum separator tubes may be associated with spuriously elevated serum B12 concentrations in the ADVIA Centaur XPT assay. The serum separator tubes should be kept upright in the post-centrifugation period prior to B12 analysis. We recommend recentrifugation if the tubes have been held in a horizontal position and/or the samples have been mixed.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"45632261453317"},"PeriodicalIF":1.0,"publicationDate":"2026-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147855725","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":"Seasonal and decadal changes in glycated albumin levels of Japanese blood donors.","authors":"Takeshi Araki, Tadashi Nagai, Shigeki Miyata, Yoshihiko Tani, Masahiro Satake","doi":"10.1177/00045632251395550","DOIUrl":"10.1177/00045632251395550","url":null,"abstract":"<p><p>BackgroundThe Japanese Red Cross Society measures levels of glycated albumin (GA), an indicator of mean blood glucose levels, in blood obtained from all donors.MethodsChanges in mean GA levels and the percentage of cases of prediabetes from 2009 to 2018 were investigated in approximately 4.2 million, healthy, first-time blood donors aged 16-64 years, and the seasonal characteristics of GA and the association of the GA level with body mass index (BMI) were clarified.ResultsMean GA levels decreased over the decade, with a decrease of 0.42-0.77% in male and 0.39-0.49% in female donors in the groups categorised by age. The percentage of prediabetes cases also decreased over the decade, with the largest decrease in those in their 60s. GA levels were higher in the warm season than in the cold season. In 2018, the seasonal difference in the GA level was 0.48% (95% confidence interval [CI] 0.45-0.50%) for male and 0.45% (95% CI 0.41-0.48%) for female donors. GA had a linear negative correlation with BMI in the younger generation. A trend of increasing GA with BMI was noted in those in their 30s and older.ConclusionsMean GA levels and the percentage of prediabetic cases have decreased, possibly resulting from public health promotion efforts and early diagnosis of diabetes mellitus. The present data on GA seasonal variation, showing higher levels in the warm season, and the association between BMI and GA may be useful for clinical practice.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"264-272"},"PeriodicalIF":1.1,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145375883","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 impact of current evidence on cardiac troponin structure, function and release mechanisms - An up to date review.","authors":"James Hatherley, Paul Collinson, Eduard Shantsila, David Gaze, Aleem Khand","doi":"10.1177/00045632251378025","DOIUrl":"10.1177/00045632251378025","url":null,"abstract":"<p><p>Myocardial infarction remains a significant cause of mortality globally. High-sensitivity cardiac troponin is an essential criterion in the fourth universal definition of myocardial infarction. Our understanding of the structure and release mechanisms of troponin has been updated over the last decade, facilitated by ever more sensitive assays. This review initially outlines the structure and function of the troponin complex, then details the currently proposed mechanisms of release and elimination of troponin. It concludes by using this updated understanding to critique the current universal definition of myocardial infarction and injury.</p>","PeriodicalId":8005,"journal":{"name":"Annals of Clinical Biochemistry","volume":" ","pages":"191-207"},"PeriodicalIF":1.1,"publicationDate":"2026-05-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144939341","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}