Annals Of Clinical Biochemistry[JOURNAL]
Sun
200 papers
Routine laboratory triage for NT-proBNP elevation may reflect cardiorenal frailty as much as heart failure specificity.
Liu Z
Ann Clin Biochem · 2026 Jul · PMID 42381627 · Publisher ↗
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From interpretable NT-proBNP prediction to equitable laboratory stewardship.
Jayaswal RP, Thapliyal S, Badyal RK … +2 more , Ranawat RK, Chaubey KK
Ann Clin Biochem · 2026 Jul · PMID 42381605 · Publisher ↗
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Serum Sclerostin Levels in Children with Osteogenesis Imperfecta.
Reincke S, Rehberg M, Stasek S … +4 more , Junghaenel-Welzing S, Fuessgen V, Semler O, Hoyer-Kuhn H
Ann Clin Biochem · 2026 Jun · PMID 42366618 · Publisher ↗
CONTEXT: Sclerostin inhibits bone formation via the WNT/β-catenin pathway and is a therapeutic target in osteoporosis. Antibodies against sclerostin are currently under investigation for the treatment of osteogenesis imp...
CONTEXT: Sclerostin inhibits bone formation via the WNT/β-catenin pathway and is a therapeutic target in osteoporosis. Antibodies against sclerostin are currently under investigation for the treatment of osteogenesis imperfecta (OI), a rare, genetically and clinically heterogeneous bone fragility disorder. However, data on serum sclerostin levels in pediatric and adolescent patients with OI remain limited. DESIGN: This is a retrospective, cross-sectional analysis of serum sclerostin levels in a genetically heterogeneous cohort of children and adolescents with OI. PATIENTS AND METHODS: 80 serum samples from 74 OI patients (median age 8.9 years, range 0.1-20.7 years), classified by clinical severity and affected gene, were collected. Serum levels of sclerostin, osteoprotegerin (OPG), parathyroid hormone (PTH), alkaline phosphatase (AP) and 25-Hydroxy Vitamin D (25(OH)D) were measured and analyzed according to genotype and OI severity. RESULTS: The median serum sclerostin level in this cohort was 0.35 ng/ml (IQR 0.28-0.52). Disease severity showed an inverse correlation with serum sclerostin levels (Spearman ρ = -0.4547, 95% CI [-0.62, -0.25], p < 0.0001). Multivariable linear regression analysis revealed genotype-specific differences in sclerostin levels, particularly in patients with BMP1 or WNT1 mutations compared with other mutation subgroups. No significant correlations were found between sclerostin and OPG, PTH, 25(OH)D, or AP. CONCLUSIONS: In this cohort of children and adolescents with OI, disease severity was inversely associated with serum sclerostin levels, and genotype- specific differences may reflect distinct pathophysiological mechanisms of bone metabolism. These findings may contribute identifying patient subgroups most likely to benefit from targeted anti-sclerostin therapies.
Population-Specific HOMA-IR Reference Ranges in Iraq: Defining Insulin Sensitivity in a Middle Eastern Cohort.
Al-Bayaty M, Shamil M, Yousif RH
Ann Clin Biochem · 2026 Jun · PMID 42339954 · Publisher ↗
The homeostatic model assessment for insulin resistance (HOMA-IR) is one of the most commonly applied surrogate markers for the measurement of insulin resistance; however, the use of this metric does require sex-specific...
The homeostatic model assessment for insulin resistance (HOMA-IR) is one of the most commonly applied surrogate markers for the measurement of insulin resistance; however, the use of this metric does require sex-specific, age-specific, and body mass index (BMI)-specific reference ranges due to variations among populations and there is a lack of data in countries like Iraq on such reference ranges. The purpose of this investigation was to develop sex-, age-, and BMI-specific reference ranges for HOMA-IR in apparently healthy Iraqi adults aged 18 to 60 years. There were 2,160 participants enrolled in the study who were equally divided into sex-specific groups and age groups (18-30, 31-45, and 46-60 years) and BMI categories (normal weight, overweight, and obesity). In addition to measuring fasting glucose and insulin levels, the HOMA-IR was calculated. Reference ranges, which included the 2.5th and 97.5th percentiles of HOMA-IR, were developed using non-parametric statistical methods based on CLSI EP28-A3c guidelines. The results demonstrated that HOMA-IR values increased as both age and BMI increased (p < 0.001). Also, males consistently had higher HOMA-IR values compared to females within similar subgroups. All between-group comparisons were statistically significant. It is important to use sex-, age-, and BMI-specific reference intervals when interpreting HOMA-IR to avoid misclassifying subjects in clinical and epidemiologic studies. This investigation represents the first large-scale study to identify such reference intervals in Iraq and adds relevant regional data to the global research on the prevalence of insulin resistance.
Optimizing Laboratory Quality with Sigma Metrics: Application of CLIA 2024 Total Allowable Error Guidelines.
Sankhyan A, Taywade OK, Sharma S
Ann Clin Biochem · 2026 Jun · PMID 42339833 · Publisher ↗
Background- Statistical quality control continues to serve as the cornerstone for ensuring the accuracy and reliability of laboratory investigations. The current research aimed to evaluate the performance of biochemistry...
Background- Statistical quality control continues to serve as the cornerstone for ensuring the accuracy and reliability of laboratory investigations. The current research aimed to evaluate the performance of biochemistry parameters using Six Sigma metrics in light of revised CLIA (Clinical Laboratory Improvement Amendments) total allowable error (TEa) 2024 guidelines, to guide the application of appropriate quality control strategies. Methods- Quality control data for 20 chemistry parameters analyzed on the Fully Automated Biochemistry analyzer were evaluated using Six Sigma methodology. Internal quality control (IQC) and external quality assessment scheme (EQAS) data from December 2023 to May 2024 were collected. Coefficient of variation (%), bias (%) and TEa based on CLIA and Ricos biological variation guidelines were used to calculate sigma metrics. All quality control data were entered and analyzed using Microsoft Excel (Microsoft Corporation, Redmond, WA, USA). Results- The laboratory showed excellent (≥6 sigma) performance for direct bilirubin and HDL-cholesterol. Albumin, alkaline phosphatase, aspartate transaminase, cholesterol, glucose, iron, potassium, total iron binding capacity and triglycerides achieved minimum sigma performance standard (>3) at one level. However, the other chemistry parameters did not meet the minimum sigma performance standard across all assay range. Conclusion- The laboratories need to reassess the performance of various biochemical parameters to redefine quality control protocols as the CLIA 2024 guidelines have tightened the total allowable error goals.
Suspected thermal amplitude of cryoglobulin likely more clinically significant than size detected: A case report.
Shortall S, Niblock A, Logue P … +1 more , Maguire K
Ann Clin Biochem · 2026 Jun · PMID 42249763 · Publisher ↗
Cryoglobulins are proteins that are temperature sensitive, precipitating at temperatures below 37°C, and dissolve upon rewarming. However, at lower temperatures cryoglobulins can result in damage subsequently leading to...
Cryoglobulins are proteins that are temperature sensitive, precipitating at temperatures below 37°C, and dissolve upon rewarming. However, at lower temperatures cryoglobulins can result in damage subsequently leading to vascular compromise. We present a case of a patient with a known lymphoplasmacytic lymphoma. The patient developed extensive finger necrosis and toe necrosis. Cryoglobulin was requested and a small type I was found. Given how common type I cryoglobulins are, more evidence was needed that this was the underlying aetiology of the necrosis. A biopsy of the tissue immediately proximal to the necrosis was performed. Histological evaluation confirmed cryoglobulin occlusions. Given the small cryoglobulin level, we assume the thermal amplitude of this resulted in this degree of vascular damage. Thermal amplitude of cryoglobulins is not generally performed. However, we know from testing the thermal amplitude of the red cell agglutination that the more active the antibody is at higher temperatures like those experienced in both the central and peripheral circulation, the more clinically significant the haemolysis. As this lady had chronic stable haemolysis, we sent the sample to the red cell reference lab to investigate the thermal range of the red cell antibody. This was checked at 4°C, room temperature, and 37°C. The cold antibody titre was 65536 at 4°C, 2048 at room temperature, and 1 at 37°C. This activity, despite having large titres at the cold range, demonstrated a wide thermal amplitude. Therefore, given these findings it is likely that the cryoprecipitate within the plasma had a similarly high thermal range.
Systematic identification of human anti-mouse antibody interference causing falsely elevated B-type natriuretic peptide: A case study.
Li S, Yao J
Ann Clin Biochem · 2026 Jun · PMID 42244334 · Publisher ↗
B-type natriuretic peptide (BNP) is crucial for heart failure diagnosis. However, immunoassays are vulnerable to heterophilic antibody interference, which may lead to false-positive results and significant clinical misma...
B-type natriuretic peptide (BNP) is crucial for heart failure diagnosis. However, immunoassays are vulnerable to heterophilic antibody interference, which may lead to false-positive results and significant clinical mismanagement. Studies suggest such interference may account for a notable proportion of unexplained biomarker elevations. This report describes a case of a 36-year-old female with a markedly elevated BNP (2735.7 ± 54.3 pg/mL) incongruent with her clinical presentation. Therefore, we conducted a detailed analysis through a stepwise investigation, including serial dilution (showing non-linear recovery), cross-platform comparison (normal result on an alternative platform), and heterophilic blocking reagent treatment (partial correction). Ultimately, the addition of purified mouse IgG, but not anti-goat IgG or IgM blockers, normalized the BNP level in a dose-dependent manner, confirming human anti-mouse antibody (HAMA) interference. This case demonstrates that such interference is one of the potential causes of unexplained elevations in clinical immunoassay results. A systematic workflow was established in the case, ranging from suspicion to confirmation and ultimately to laboratory-adoptable conclusions. This process facilitates accurate diagnosis and helps clinicians avoid unnecessary interventions.
Response to the letter to the editor by Drs Burmeister and Zazay regarding "NT-proBNP and its correlation with left ventricular ejection fraction and heart failure: The DEMONSTRATE database.
Larsson A
Ann Clin Biochem · 2026 May · PMID 42200785 · Publisher ↗
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UK recommendations for the validation and adoption of capillary blood testing within the routine clinical laboratory: Consensus opinion from the LabMed patient-centred testing and sampling (PaCTS) group.
Woolley T, Hepburn S, Perkins K
Ann Clin Biochem · 2026 May · PMID 42198942 · Publisher ↗
Venepuncture is traditionally regarded as the gold standard for collecting blood samples. However, self-collected capillary blood sampling has emerged as a practical alternative in various settings, fostering a more pati...
Venepuncture is traditionally regarded as the gold standard for collecting blood samples. However, self-collected capillary blood sampling has emerged as a practical alternative in various settings, fostering a more patient-centred, personalised, and cost-effective healthcare model. The NHS UK strategic plans published in 2023-2025 emphasise a shift in care from hospitals to community settings and from treating illness to preventing it. Self-collected capillary sampling with back-to-laboratory analysis is a strong option to support the shift of healthcare provision into the community while maintaining high-quality results and direct delivery to the electronic patient record.Routine clinical laboratories, particularly those within the NHS, should consider this potential delivery model. However, most assay manufacturers do not currently include capillary blood in their instructions for use. Consequently, UK Accreditation Service-accredited laboratories that wish to conduct routine tests using capillary blood must perform additional comparison studies to obtain accreditation. If this is not done, they must be able to distinguish between non-accredited (capillary blood) and accredited (venous blood) tests.This document has been created to guide clinical laboratorians through the rapidly evolving field of patient-centric sampling and how to enable safe working within a routine clinical laboratory.
NT-proBNP and left ventricular ejection fraction correlation: Methodological considerations and clinical heterogeneity.
Burmeister JR, Zazay I
Ann Clin Biochem · 2026 May · PMID 42163578 · Publisher ↗
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Phosphate enemas causing profound refractory hypocalcaemia: A case report.
Nobes J, Murphy MJ
Ann Clin Biochem · 2026 May · PMID 42163069 · Publisher ↗
A 37-year-old woman attended hospital with melaena and coffee-ground vomiting on a background of alcohol-related liver disease (ALD). Following upper gastro-intestinal (GI) endoscopy she was admitted to the medical high...
A 37-year-old woman attended hospital with melaena and coffee-ground vomiting on a background of alcohol-related liver disease (ALD). Following upper gastro-intestinal (GI) endoscopy she was admitted to the medical high dependency unit and commenced on multiple medications, in accordance with the decompensated cirrhosis care bundle of the British Association for the Study of the Liver (BASL). The patient was severely encephalopathic, prompting the addition of regular enemas to minimise colonic nitrogen production. On Day 4 post admission, the patient was noted to be hypocalcaemic (adjusted calcium 1.62 mmol/L) and intravenous calcium gluconate was prescribed. By Day 5, adjusted calcium had fallen to a nadir of 0.85 mmol/L; phosphate was 6.4 mmol/L. The rapidly developing inverse relation between calcium and phosphate strongly suggested a causal association. Since Day 3 the patient had received enemas three times daily for severe hepatic encephalopathy. We postulated that rectal absorption of phosphate in the enemas was occurring, contrary to the intended mechanism of action, and recommended they were stopped. Following discontinuation of the phosphate enemas, serum phosphate fell to within the reference range over 72 h. In total, over 70 mmol of calcium (infused as 280 mL of 10% calcium gluconate over a period of 5 days) was required to replace the sequestered calcium. By Day 11, calcium, phosphate and sodium were all within their respective reference ranges.
Clinical performance of a urine albumin-to-creatinine ratio (ACR) strip test compared with quantitative measurement.
Gabrysiak A, Służałek D, Żuradzka K … +3 more , Michalska-Witas W, Studnicka S, Dudek P
Ann Clin Biochem · 2026 May · PMID 42159587 · Publisher ↗
BackgroundAlbuminuria is an early marker of kidney damage and an essential component of chronic kidney disease (CKD) risk stratification. Quantitative measurement of the urine albumin-to-creatinine ratio (ACR) in a spot,...
BackgroundAlbuminuria is an early marker of kidney damage and an essential component of chronic kidney disease (CKD) risk stratification. Quantitative measurement of the urine albumin-to-creatinine ratio (ACR) in a spot, preferably morning, urine sample is the recommended standard. In low-throughput laboratories and point-of-care settings, semi-quantitative strip tests are sometimes used for screening, although their diagnostic performance is limited.ObjectiveTo evaluate the clinical utility of a commercial semi-quantitative urine strip test for albumin and creatinine by comparison with quantitative ACR measurement.MethodsEighty-four spot urine samples were analysed. Semi-quantitative ACR categories were obtained using an ACON Mission strip test, according to the manufacturer's instructions. Quantitative ACR was measured on a Beckman Coulter AU480 analyser (immunochemical albumin, enzymatic creatinine). Diagnostic performance was assessed using sensitivity, specificity, positive and negative predictive values, Matthew's correlation coefficient (MCC) and Cohen's κ. A decision threshold of 3 mg/mmol (30 mg/g) was applied.ResultsSensitivity for detecting albuminuria (≥3 mg/mmol, ≥30 mg/g) was 80.6% (95% CI 62.5-92.5) and specificity was 60.4% (95% CI 46.0-73.5). The negative and positive predictive values were 84.2% and 54.3%, respectively. Overall categorical agreement across A1-A3 was 63.1% (κ = 0.334; MCC = 0.398). Most discrepancies reflected overclassification of low-grade albuminuria by the strip test in samples classified as normoalbuminuric by quantitative ACR.ConclusionsThe semi-quantitative strip test shows high sensitivity with moderate specificity and is suitable for screening for albuminuria. Positive results should be confirmed by quantitative ACR measurement in accordance with current guidelines.
Classification of serum protein and immunofixation electrophoresis images by computer vision-based deep learning models: A single- and dual-modality study.
Alagöz MH, Erdem S, Doğan P … +4 more , Derman İU, Günver MG, Çakır Madenci Ö, Ademoğlu E
Ann Clin Biochem · 2026 May · PMID 42126005 · Publisher ↗
ObjectivesThe objective of this study was to develop deep learning models for the automated classification of serum protein electrophoresis (SPE) and immunofixation electrophoresis (IFE) images into oncologic, non-oncolo...
ObjectivesThe objective of this study was to develop deep learning models for the automated classification of serum protein electrophoresis (SPE) and immunofixation electrophoresis (IFE) images into oncologic, non-oncologic, and healthy categories, and to compare the predictive performance of single- and dual-modality approaches.MethodsWe retrospectively collected SPE and IFE images from 1,919 patients who underwent both tests at Kartal Dr Lütfi Kırdar City Hospital. MobileNetV2-based models were developed using transfer learning. Single-modality (SPE or IFE) and dual-modality (SPE and IFE) models were trained, and their performance was evaluated using accuracy, precision, recall, specificity, F1-score, and ROC-AUC. Grad-CAM visualizations were generated to assess model interpretability.ResultsThe dual-modality model achieved higher accuracy and robustness compared to single-modality models. Oncologic cases were detected with near-perfect recall and ROC-AUC, while single-modality models demonstrated moderate performance in distinguishing non-oncologic and healthy groups. Grad-CAM outputs confirmed that the models focused on diagnostically relevant electrophoretic bands.ConclusionDeep learning models can reliably classify electrophoresis images into oncologic, non-oncologic, and healthy categories. Combining SPE and IFE improves diagnostic performance and may assist laboratory specialists and hematologists in reducing subjectivity, particularly in borderline cases. Validation in larger, multicenter cohorts is warranted prior to clinical implementation.
Proteomic profiling identifies circulating soluble MCAM/CD146 as a candidate biomarker for abnormal semen parameters in male infertility.
Kikuchi R, Shibata T, Nakatochi M … +15 more , Sei H, Kobayashi Y, Kidoya H, Muramatsu F, Furusawa N, Kano K, Mishiro-Sato E, Ishida H, Katagiri Y, Suzuki A, Matsubara H, Takano K, Furui T, Kajiyama H, Okura H
Ann Clin Biochem · 2026 May · PMID 42120337 · Publisher ↗
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 infe...
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, < 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, < 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.
Awareness, attitudes, and perceived barriers to artificial intelligence adoption in Turkish clinical biochemistry laboratories: An exploratory cross-sectional survey.
İncir S, Palaoğlu KE, Oğuz O … +4 more , Özgenç A, Gören Y, Topcu Dİ, Konukoğlu D
Ann Clin Biochem · 2026 May · PMID 42120333 · Publisher ↗
BackgroundArtificial intelligence (AI) is increasingly recognized as transformative in laboratory medicine, yet adoption lags behind radiology and cardiology. Limited data exist on AI-related attitudes and perceived barr...
BackgroundArtificial intelligence (AI) is increasingly recognized as transformative in laboratory medicine, yet adoption lags behind radiology and cardiology. Limited data exist on AI-related attitudes and perceived barriers in Turkish clinical laboratories. This study evaluated professional awareness, attitudes, and perceived barriers to AI adoption among Turkish clinical laboratory professionals.MethodsA cross-sectional survey was conducted among Turkish clinical biochemistry staff between May and June 2025. The 30-item questionnaire covered demographics, AI knowledge, training, current use, future perspectives, and ethical or legal concerns. In total, 170 eligible participants, including laboratory directors, physicians, residents, and technologists, completed the survey.ResultsAmong the participants, 43% self-rated their AI knowledge as "basic," with no participant aged ≥60 years reporting good or expert-level knowledge. The greatest knowledge deficits were in image processing (49.4% reported "no knowledge") and predictive analytics (35.9%). More than half (57.6%) had never received AI-related training, and current use of AI tools in routine practice was minimal. Despite these gaps, attitudes toward AI implementation were overwhelmingly positive, with 75.3% believing increased AI use would improve job satisfaction and 59.4% expecting laboratory transition to AI-supported systems within 5 years. Major barriers included insufficient digital infrastructure (47%), absence of trained personnel (83.5%), lack of standard operating procedures (70%), and inadequate legal/ethical regulations (52.9%).ConclusionsAI implementation in Turkish clinical laboratories remains at an early stage but is met with strong professional interest. Overcoming structural barriers through standardized education, infrastructure investment, and clear legal frameworks is essential for sustainable AI implementation in clinical laboratories.
Performance validation and clinical utility of a smartphone-based colorimetric system for differentiating exudative and transudative pleural effusions and ascites via total protein quantification.
Liang D, Zhao Y, Guo Y … +2 more , Li Z, Yang Z
Ann Clin Biochem · 2026 May · PMID 42120330 · Publisher ↗
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 s...
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.
Evaluation of an automated device for fingertip blood collection by comparing test results with venous blood.
Doi H, Irie T, Takenaka K … +4 more , Adachi S, Sakazume T, Kato T, Ito H
Ann Clin Biochem · 2026 May · PMID 42120326 · Publisher ↗
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...
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.
Stability of urinalysis in two different preservative tubes: A comparative analysis.
Bayraktar N, Vurgun E, Savran SN … +1 more , Yeşildal F
Ann Clin Biochem · 2026 May · PMID 42120325 · Publisher ↗
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 c...
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.
Reference intervals for kidney tubular secretion markers in the general population: The HUNT3 study.
Øvrehus MA, Kristiansen KA, Langlo KA … +5 more , Garimella PS, Ix JH, Shlipak MG, Bruheim P, Hallan SI
Ann Clin Biochem · 2026 May · PMID 42120322 · Publisher ↗
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 prognosti...
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 m). 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.
Methods and reagent-lot comparisons by regression analysis: False positives.
Sadler WA
Ann Clin Biochem · 2026 May · PMID 42120312 · Publisher ↗
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 especial...
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.
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