Advances in laboratory medicine最新文献

{"title":"Optimization of protein electrophoresis test orders: results after the implementation of a protocol based on scientific recommendations.","authors":"Manuel Baladrón-Segura, Nuria Alonso-Castillejos, María Lorena Navas-Gómez, Sara Martín-Gabriel, Carmen González-Sama, Sofía Cabezas-Marcos, Marta Capilla-Díez, Beatriz Calvo-Antón","doi":"10.1515/almed-2025-0129","DOIUrl":"10.1515/almed-2025-0129","url":null,"abstract":"<p><strong>Objectives: </strong>Serum protein electrophoresis is a valuable tool for diagnosing and monitoring monoclonal gammopathies, but its widespread use outside this context may be clinically unjustified. To promote more rational test ordering, a demand optimization protocol has been designed and implemented in the Valladolid Oeste Health Area (ASVAO), aligned with AEBM-ML and SEQC-ML recommendations.</p><p><strong>Methods: </strong>A retrospective observational and interventional study was conducted. The protocol included automated request blocks for patients under 40, revision of analytical profiles, electronic alerts, and automatic inclusion based on specific biochemical alterations. The protocol was disseminated and training was provided to ordering physicians in both primary care and hospital settings. Structural, process, and activity indicators have been monitored from January 2023 to June 2025.</p><p><strong>Results: </strong>Orders in patients under 50 years decreased from 23.5 % in 2023 to 14.1 % in 2025. The proportion of orders for patients ≥50 years exceeded the target (>0.80) in 2025. Inappropriate analytical profiles have been eliminated, although the rate of orders without clinical or analytical justification remained elevated (0.53 in 2025). Test volume per inhabitant remained stable. Primary Care, Gastroenterology, Nephrology, and Pediatrics significantly reduced testing in younger patients, while Rheumatology increased it.</p><p><strong>Conclusions: </strong>The protocol effectively improved test appropriateness, particularly regarding age targeting and the removal of automated orders. However, unjustified orders persist. Ongoing monitoring of indicators is recommended to consolidate improvements and address deviations.</p>","PeriodicalId":72097,"journal":{"name":"Advances in laboratory medicine","volume":"7 3","pages":"187-192"},"PeriodicalIF":1.1,"publicationDate":"2026-05-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13552803/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148914447","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Re-evaluating haemolysis rejection criteria for PT, aPTT, and D-dimer testing: evidence from paired clinical samples on the CN-3000 analyser.","authors":"Jirapa Kaewkhruawan, Wararat Masalae, Surapat Tanticharoenkarn, Pitchayaporn Riyagoon, Waroonkarn Laiklang, Kwanlada Chaiwong, Suppakorn Wongkamchai, Phandee Watanaboonyongcharoen, Chutitorn Ketloy, Orakan Limpornpugdee, Eakachai Prompetchara","doi":"10.1515/almed-2026-0028","DOIUrl":"10.1515/almed-2026-0028","url":null,"abstract":"<p><strong>Objectives: </strong>Haemolysis is the leading preanalytical cause of sample rejection in coagulation testing. This study prospectively evaluated the impact of spontaneous haemolysis on routine haemostasis assays by comparing paired haemolysed (H) and non-haemolysed (NH) clinical samples. Additionally, analyser flagging behaviour was characterised using an artificially haemolysed sample series.</p><p><strong>Methods: </strong>Thirty nine paired of H and NH samples were analysed for prothrombin time (PT), activated partial thromboplastin time (aPTT), and D-dimer (DD) on the Sysmex CN-3000. Mean biases were compared against predefined critical differences (CD) derived from biological variation data. Analyser flagging was additionally assessed using five sample pools across five haemolysis concentration levels (H1-H5).</p><p><strong>Results: </strong>When comparing H samples with NH samples, the mean bias was +0.07 s (+0.14 %) for PT (p=0.5979), +0.44 s (+0.66 %) for aPTT (p=0.8704), and +0.72 mg/L FEU (+10.63 %) for D-dimer (p=0.0199). D-dimer showed the highest relative bias but remained below the CD (64.7 %). Degree of haemolysis did not predict the magnitude of interference across the range of haemoglobin (Hb) concentrations studied. CN-3000 flagging grades were constant and correlated free Hb and irrespective of baseline sample PT/aPTT/D-dimer level.</p><p><strong>Conclusions: </strong>Mild to moderate spontaneous haemolysis does not produce clinically significant interference in PT, aPTT, or D-dimer. CN-3000 flagging behaviour is predictable and grade-dependent. Re-evaluation of automatic haemolysis rejection thresholds is warranted.</p>","PeriodicalId":72097,"journal":{"name":"Advances in laboratory medicine","volume":"7 3","pages":"179-186"},"PeriodicalIF":1.1,"publicationDate":"2026-05-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13552810/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148914466","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"First-trimester free thyroxine as an independent predictor of gestational diabetes mellitus: a retrospective cohort study.","authors":"Thu T T Do, Thuy T Le, Thu T T Ho, Lan T N Vu, Thuy C Bui, Huong Thanh Hoang","doi":"10.1515/almed-2026-0007","DOIUrl":"10.1515/almed-2026-0007","url":null,"abstract":"<p><strong>Objectives: </strong>Gestational diabetes mellitus (GDM) and thyroid dysfunction are two common endocrine diseases during pregnancy, both of which can adversely affect maternal and fetal health. Numerous studies have shown that abnormalities in thyroid hormones, particularly TSH and FT4, are associated with an increased risk of developing gestational diabetes. However, current research results are inconsistent due to differences in race, geographic location, and testing reference thresholds. This study aimed to evaluate the early predictive value of first-trimester thyroid stimulating hormone (TSH) and free thyroxine (FT4) levels for the development of GDM.</p><p><strong>Methods: </strong>A retrospective cohort study was conducted on 272 pregnant women from December 2023 to March 2025. Participants meeting inclusion criteria had TSH and FT4 levels measured in the first trimester (9-13 weeks) and underwent a 75 g oral glucose tolerance test between 24 and 28 weeks of gestation.</p><p><strong>Results: </strong>FT4 concentrations were significantly lower in the GDM group compared to the non-GDM group, whereas TSH levels showed no significant difference. An FT4 cut-off of ≤1.17 ng/dL predicted GDM with an area under the curve (AUC) of 0.715, a sensitivity of 86.5 %, and a specificity of 52.3 %. Multivariate logistic regression identified FT4≤1.17 ng/dL and pre-pregnancy body mass index BMI≥23 kg/m² as independent risk factors associated with GDM.</p><p><strong>Conclusions: </strong>Low first-trimester FT4 levels are significantly associated with an increased risk of GDM. FT4 may serve as a valuable early predictive biomarker, suggesting a potential role for thyroid function screening in early pregnancy to optimize risk stratification.</p>","PeriodicalId":72097,"journal":{"name":"Advances in laboratory medicine","volume":"7 2","pages":"132-139"},"PeriodicalIF":1.1,"publicationDate":"2026-04-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13169816/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147944004","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pharmacogenetic biomarkers for predicting therapeutic response to JAK inhibitors in rheumatoid arthritis.","authors":"Chamaida Plasencia-Rodríguez, Marta Novella-Navarro, Juan Luis Valdivieso Shephard, Ana Martínez-Feito, Keren Reche-Yebra, Manuel Juárez-García, Alejandro Villalba-Yllán, Tania S Rubio-Lepe, Pedro Arias, Victoria Lucia Collada Sánchez, Susana Martin-López, Itsaso Losantos-García, Alberto M Borobia, Rocío Rosas-Alonso","doi":"10.1515/almed-2025-0180","DOIUrl":"10.1515/almed-2025-0180","url":null,"abstract":"<p><strong>Objectives: </strong>Rheumatoid arthritis (RA) is a chronic inflammatory disease of immune-mediated origin. Janus kinase inhibitors (JAK inhibitors) have expanded therapeutic options in recent years; however, clinical response varies among patients, and no biomarkers are currently available to predict their efficacy. The aim of this study was to analyze the association between pharmacogenetic variants and clinical response to JAK inhibitors in patients with RA.</p><p><strong>Methods: </strong>An observational, ambispective, single-center study was conducted in adult patients diagnosed with RA and treated with JAK inhibitors. Sociodemographic and clinical characteristics were collected from electronic medical records. Five genetic variants previously associated with response to biological therapies in RA were analyzed through genotyping.</p><p><strong>Results: </strong>A total of 56 patients were included in the study. A statistically significant association was observed between the rs20575 variant of the <i>TNFRSF10A</i> gene and clinical remission, with CG or CC genotypes being more frequent among patients who achieved remission at the last available follow-up. Additionally, the rs1801274 polymorphism of the <i>FCGR2A</i> gene was associated with a lower likelihood of achieving low disease activity or remission in patients with the AA genotype, both at 12 months and at the last available follow-up.</p><p><strong>Conclusions: </strong>This study highlights the potential of pharmacogenetics to personalize RA treatment by establishing, for the first time, that specific genetic variants involved in immune response may significantly influence the efficacy of JAK inhibitors. These findings open new perspectives for optimizing therapeutic decisions, although further studies are needed to validate them.</p>","PeriodicalId":72097,"journal":{"name":"Advances in laboratory medicine","volume":"7 2","pages":"124-131"},"PeriodicalIF":1.1,"publicationDate":"2026-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13169820/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147944032","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reducing hemolysis in emergency departments: effectiveness of BD Barricor™ low-vacuum tubes.","authors":"Berta Sufrate-Vergara, Daniel Prieto Arribas, Isabel Moreno-Parro, Jorge Díaz-Garzón Marco, Roberto Mora Corcovado, Enrique Torres Rodríguez, Alberto Iglesias Sigüenza, Ana María Souto Novas, Antonio Buño Soto, Pilar Fernández-Calle","doi":"10.1515/almed-2025-0185","DOIUrl":"10.1515/almed-2025-0185","url":null,"abstract":"<p><strong>Objectives: </strong>Hemolysis is the leading cause of sample rejection in laboratories, particularly in emergency departments (EDs), where rates often exceed recommended limits. Hemolysis not only delays diagnosis and treatment but also increases costs. Despite protocol reinforcement and staff training, in our tertiary hospital's ED we experienced consistently high hemolysis rates, meaning a high percentage of results were not reported to clinicians due to the interference. Low-vacuum tubes, such as BD Barricor™ (that has a mechanical separator), may reduce hemolysis and improve sample quality.</p><p><strong>Methods: </strong>We conducted a single-centre prospective pilot study over 1 week substituting standard lithium-heparin tubes with BD Barricor™ tubes in the ED. Sample handling, transportation, centrifugation, and analysis remained unchanged. Hemolytic index (HI), potassium, LDH, AST, creatinine and phosphate results were extracted from the laboratory information system for the trial week and 2 weeks before and after. Statistical analysis was performed with R (v.4.2.3).</p><p><strong>Results: </strong>During the trial week, median HI decreased a 28 % (p<0.05). Samples exceeding established HI thresholds dropped from 16-19 % to <6 % (p<0.05). The proportion of unreported tests fell from an average of 250 per week to 43 (0.8 %) during the trial week. The use of Barricor™ tubes enabled nearly all results to be reported.</p><p><strong>Conclusions: </strong>Implementing low-vacuum Barricor™ tubes in our ED significantly reduced hemolysis and decreased non-reported tests. Our findings suggest that implementing technological solutions may be hihgly effective when protocol reinforcement alone did not work. Long-term studies are warranted to assess cost-effectiveness and broader clinical impact.</p>","PeriodicalId":72097,"journal":{"name":"Advances in laboratory medicine","volume":"7 2","pages":"116-123"},"PeriodicalIF":1.1,"publicationDate":"2026-04-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13169830/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147944027","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Comparison of capillary and venous hemoglobin determination among school-age children: insights from Zanzibar, Tanzania.","authors":"Kaunara Azizi, Tedson Lukindo, Stanslaus Hendry, Asha Salmin, Francis Millinga, Erick Killel, Kombo Mdachi, Hawa Msola, Ray Masumo, Ramadhani Mwiru, Ramadhani Noor, Patrick Codjia, Germana Leyna, Geofrey Mchau","doi":"10.1515/almed-2025-0053","DOIUrl":"10.1515/almed-2025-0053","url":null,"abstract":"<p><strong>Objectives: </strong>There is apprehension regarding the agreement between capillary and venous hemoglobin (Hb) concentrations, which may have far-reaching consequences for global anemia prevalence estimates, heavily dependent on capillary Hb data.</p><p><strong>Methods: </strong>We investigated the discrepancies in Hb concentrations obtained from venous and capillary blood samples collected among school-age children in Zanzibar. Hb concentrations were measured in 810 children aged 10-19 years old. Both capillary and venous Hb measurements used a HemoCue 201+ analyzer (HemoCue, Angelholm, Sweden). Hb means, standard deviations, and anemia prevalence were analyzed using Stata. The means of the anemia categories were compared using paired t-tests. The agreement between capillary and venous Hb measurements was assessed using Pearson's correlation coefficients, a Passing-Bablok regression, and a Bland-Altman plot.</p><p><strong>Results: </strong>The correlation between paired measurements of capillary and venous Hb concentration was high, r=0.72 (p<0.001). The prevalence of anemia using venous samples was 20.5 %, and using capillary samples was 44.7 %. Mean Hb concentrations were higher in venous than capillary samples (mean ± SD: 12.994 ± 1.54 vs. 12.085 ± 1.36 g/dL, p<0.001). The mean difference between the methods is -0.909 g/dL, and the limits of agreement are (-3.065 - 1.247). Passing-Bablok regression analysis showed no evidence of systematic error between capillary and venous hemoglobin measurements.</p><p><strong>Conclusions: </strong>Capillary and venous hemoglobin measurements differ significantly; capillary Hb cannot replace venous Hb for accurate anemia assessment.</p>","PeriodicalId":72097,"journal":{"name":"Advances in laboratory medicine","volume":"7 2","pages":"140-147"},"PeriodicalIF":1.1,"publicationDate":"2026-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13169453/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147943979","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Is full automation in ESR measurement clinically reliable? Revisiting a classic test.","authors":"Alaitz Vélez de Mendizabal, Anna Marull Arnall, Leire Saiz Sierra, Maite Serrando Querol","doi":"10.1515/almed-2025-0191","DOIUrl":"10.1515/almed-2025-0191","url":null,"abstract":"","PeriodicalId":72097,"journal":{"name":"Advances in laboratory medicine","volume":"7 2","pages":"163-165"},"PeriodicalIF":1.1,"publicationDate":"2026-04-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13169447/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147943969","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Determination of HE4 in pleural fluid and ratio: considerations and diagnostic performance for malignant pleural effusion.","authors":"Elisa Nuez-Zaragoza, Indira Bhambi-Blanco, Isabel Aparicio-Calvente, Mònica Vidal-Pla, M Rosa Escoda-Giralt, Joana Gallardo-Campos, Joan C Ferreres, Luis Frisancho, Laia Mas-Maresma, Patricia Aguilera-Fernández, Sonia Marco-Continente, Marina Sierra-Boada, Pablo Andreu-Cobo, Miquel Gallego, Vicente Aguadero, Jaume Trapé","doi":"10.1515/almed-2025-0175","DOIUrl":"10.1515/almed-2025-0175","url":null,"abstract":"<p><strong>Objectives: </strong>The objectives of this study included assessing the diagnostic performance of HE4 in malignant pleural effusions (MPEs) and identifying the benign etiologies associated with higher HE4 concentrations.</p><p><strong>Methods: </strong>The study involved patients with pleural effusion (PE) treated at Part Taulí University Hospital. PE and serum samples were collected and analyzed. Diagnosis of MPE was established by the presence of a positive cytology and/or positive pleural biopsy. HE4 concentrations in LP and serum - among other parameters - were measured on an ECLIA-Cobas e801 (Roche Diagnostics) analyzer. Subsequently, pleural fluid to serum HE4 ratio (PF/serum HE4 ratio) was calculated. Patients were assigned to different groups according to final diagnosis, transudate vs. exudate, MPE etiology and estimated glomerular filtration rate (eGFR). An evaluation was performed of the diagnostic performance of HE4 for MPE.</p><p><strong>Results: </strong>A total of 253 PF and serum samples were included. In patients with benign pleural effusion (BPE), transudates contained higher levels of HE4, as compared to exudates. The highest PF-HE4 concentrations and ratios were observed in MPEs, especially in patients with non-small cell lung cancer + ovarian cancer. The cut-off values established showed a sensitivity of 16.7 % (PF-HE4) and 12.1 % (ratio), with a 100 % specificity, respectively. Following cut-off adjustment, higher sensitivity values were observed in patients with an eGFR ≥ 30 mL/min/1.73 m².</p><p><strong>Conclusions: </strong>Elevated HE4 concentrations may support MPE diagnosis and predict histology. Transudates contain elevated levels of HE4 and lower PF/serum-HE4 ratios. In the investigation of solid neoplasms, different serum HE4 cut-off values should be used for patients with PE, heart failure, cirrhosis or renal insufficiency.</p>","PeriodicalId":72097,"journal":{"name":"Advances in laboratory medicine","volume":"7 2","pages":"105-115"},"PeriodicalIF":1.1,"publicationDate":"2026-04-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13169826/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147943973","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Carcinocythemia detection in peripheral blood smears: a literature review.","authors":"Javier Laguna, Anna Merino","doi":"10.1515/almed-2025-0169","DOIUrl":"10.1515/almed-2025-0169","url":null,"abstract":"<p><p>Carcinocythemia, or carcinoma cell leukemia, is a rare but striking manifestation of advanced malignancy in which circulating tumor cells (CTCs) are visible in peripheral blood (PB) smears using conventional staining. It is typically associated with advanced stage disease and poor prognosis. This review updates current knowledge on the pathophysiology, cytological features, detection methods, and clinical relevance of carcinocythemia. It explores mechanisms such as bone marrow infiltration, splenic dysfunction, and immune evasion that may facilitate tumor cell release into circulation. Morphologically, CTCs are large atypical cells often mistaken for hematologic blasts, with features that vary by tumor type. Immunocytochemistry using cytokeratins and epithelial markers (e.g. AE1/AE3, EpCAM) is crucial for confirmation. While most cases involve breast or lung cancer, other malignancies, ranging from melanoma to rhabdomyosarcoma, have also been implicated. Carcinocythemia often mimics acute leukemia and coexists with disseminated intravascular coagulation or thrombosis. To date, 95 cases have been reported, but its true prevalence may be underestimated. Recognition of this phenomenon in PB smear reviews is critical for accurate diagnosis and prognostication, especially in acutely ill or cytopenic patients. Further research is needed to elucidate its biology and clinical implications.</p>","PeriodicalId":72097,"journal":{"name":"Advances in laboratory medicine","volume":"7 2","pages":"90-104"},"PeriodicalIF":1.1,"publicationDate":"2026-03-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13169457/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147943976","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Calculation of reference intervals using an indirect approach from laboratory database.","authors":"Victor Martin-Riera, Pablo Gabriel-Medina, Albert Blanco-Grau, Gonzalo Gonzalez-Silva, Yolanda Villena, Andrea Caballero-Garralda, Lydia Peris-Serra, Sarai Garriga Edo, Clara Sanz Gea, Fernando Moreno, Andrea Arias-García, Jaume Barallat, Celia Monteagudo-Lopez, Laura Conesa","doi":"10.1515/almed-2025-0088","DOIUrl":"10.1515/almed-2025-0088","url":null,"abstract":"<p><strong>Objectives: </strong>The establishment of reference intervals (RIs) for biochemical parameters is crucial for the accurate interpretation of laboratory test results and clinical decision-making. This study aims to evaluate the feasibility of determining RIs using an indirect approach, which analyzes routine clinical samples instead of recruiting healthy individuals, thus leveraging large datasets while applying strict statistical criteria to exclude pathological values.</p><p><strong>Methods: </strong>This is a prospective study in which patients fulfilling inclusion criteria were recruited from the routine primary care to achieve a high proportion of healthy individuals. Biochemical magnitudes as creatinine, esterified bilirubin, ferritin, and transferrin were analyzed. A patient exclusion protocol was implemented to minimize results suggestive of pathology but ensuring a sufficient sample size for the calculation of new RIs. The new ones were compared with the RIs used in the laboratory, provided by the manufacturer.</p><p><strong>Results: </strong>The comparison between the newly calculated RIs and the existing laboratory RIs did not reveal statistically significant differences. The indirect approach provided robust RIs while maintaining data quality and a sufficient sample size.</p><p><strong>Conclusions: </strong>The findings support the effectiveness of this indirect approach for RI determination, provided that rigorous data quality standards and adequate sample sizes are maintained. The adoption of these RIs in clinical practice could enhance diagnostic accuracy and optimize healthcare resource utilization.</p>","PeriodicalId":72097,"journal":{"name":"Advances in laboratory medicine","volume":"7 1","pages":"34-42"},"PeriodicalIF":1.1,"publicationDate":"2026-02-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12994705/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"147482286","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}