Mass spectrometry methods have become an essential part of the methodological portfolio of laboratory medicine over the past three decades. At present, however, their application is still largely limited to highly specialized laboratories in relatively few countries. Nevertheless, the technology provides important impulses for laboratory diagnostics overall-for example, in clinical pharmacology through innovative applications in therapeutic drug monitoring and precision dosing. After relatively slow progress in the area of automation, the first fully automated, closed MS-based analytical systems have recently been introduced for routine medical laboratories. In terms of usability, these systems are comparable to standard platforms based on photometry or ligand-binding techniques. The aim of this article is to describe the current medical, analytical, and organizational aspects of MS applications in diagnostics.

ABSTRACT Climate change has emerged as a global challenge with significant impacts on individuals’ mental and emotional well-being. Among young people, particularly students in health-related fields, climate-related anxiety-commonly referred to as ‘eco-anxiety’ is becoming increasingly prevalent. Understanding the relationship between healthcare students’ climate anxiety and their levels of hope for mitigating climate change is essential for guiding educational strategies and fostering sustainable healthcare practices. This study aimed to examine the influence of healthcare students’ hope on their climate change anxiety. This descriptive and correlational study was conducted among students enrolled in five programs (Physiotherapy, Geriatric Care, First and Emergency Aid, Medical Laboratory Techniques, and Operating Room Services) within the School of Health Services at a state university, comprising a total population of 1027 students. The sample size was calculated using the G*Power program and the minimum required sample was determined as 194 students. In total, data were collected from 501 students. Data were gathered through face-to-face interviews using the Personal Information Form, the Climate Change Hope Scale (CCHS), and the Climate Change Worry Scale (CCWS). The collected data were analyzed using the SPSS 24 statistical software package. The students exhibited high levels of climate change worry (mean CCWS score = 34.49 ± 6.64) and high levels of hope for preventing climate change (mean CCHS score = 28.75 ± 7.43). The participating healthcare students exhibited high levels of both hope and worry regarding climate change, suggesting that climate change worry may function as a factor that fosters hope among young individuals.

The Joint Committee for Traceability in Laboratory Medicine (JCTLM) supports worldwide equivalence and comparability of measurement results in laboratory medicine to improve health care and facilitate national and international trade in in vitro diagnostic (IVD) medical devices. The 2025 biennial members and stakeholders' workshop focused on the expectations and benefits of harmonized results among medical laboratories, as well as the challenges associated with achieving this goal. Harmonization of results from end-user IVD measurement procedures (IVD-MPs) can be achieved by applying the principles of metrological traceability; however, there are several historical examples of standardization efforts that did not achieve the required level of harmonization. The reasons for these failures can be found in various elements of the calibration hierarchy including: a) an unclear definition of the measurand, b) differences in selectivity of the IVD-MPs, c) issues with the commutability characteristics of secondary certified reference materials (CRM), d) inconsistencies in handling of CRMs to prepare calibrators, and e) lack of adoption and implementation by the IVD manufacturers. The lack of harmonized results can lead to confusion, treatment delays, errors in medical decisions, and increased healthcare costs. There are still assays in common use that lack metrological traceability because they lack CRMs, reference method procedures (RMPs), and/or reference method services (RMSs). Producing and maintaining reference measurement system components is complex and expensive. There are multiple regulatory frameworks and requirements that IVD manufacturers must meet worldwide. There is a vital role for External Quality Assessment (EQA) providers to assess the agreement status of results across different IVD-MPs and identify any changes in their equivalence. However, EQA materials must be commutable with clinical samples for each of the examined IVD-MDs for results to reflect the status of harmonization of clinical sample results. The future will need leadership and cooperation between bodies such as JCTLM, the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC), and IVD manufacturers.

Despite its growing impact, advanced liver fibrosis (ALF) remains substantially underdiagnosed in both primary and specialized care settings. Since liver cirrhosis is typically preceded by a prolonged phase of asymptomatic fibrosis, early detection of ALF, particularly in high-risk individuals, represents a public health priority. From a laboratory medicine perspective, this prolonged subclinical phase offers an interesting opportunity for early detection of ALF using blood-based noninvasive tests (NITs) that can be implemented in primary and nonhepatology care settings before overt disease develops. By critically appraising the evidence sources in the available literature, this paper provides an overview of blood-based NITs useful for the detection of ALF, with particular emphasis on the aspects and problems related to their implementation in daily laboratory practice. We explore the feasibility of different scenarios using strategies based on routine biochemical parameters and more specialized NITs that incorporate measurements of direct markers of fibrosis activity. Moreover, we highlight discrepancies existing among clinical practice guideline (CPG) recommendations that may hamper their widespread implementation in medical laboratories. Advances in understanding and increase in prevalence of ALF require earlier detection and more accurate risk assessment of this condition. Blood-based NITs may provide a widely accessible diagnostic aid, especially in primary care and resource-limited settings. Multidisciplinary collaboration focusing on their integration into clinical pathways to optimize patient evaluation and specialist referral is required. Harmonization of recommendations in international CPGs will certainly contribute to their more effective use.

Background: Sodium/glucose cotransporter-2 inhibitors (SGLT2is), such as dapagliflozin and empagliflozin, are currently a standard therapy for heart failure (HF) patients. We report the real-world use of SGLT2is in a monocentric cohort of HF patients with reduced ejection fraction (HFrEF) and improved ejection fraction (HFimpEF), comparing patient characteristics and outcomes with those observed in large-scale randomized clinical trials (RCTs). Methods: We retrospectively analyzed a cohort of 370 stable patients with HFrEF or HFimpEF who initiated therapy with dapagliflozin or empagliflozin between June 2019 and November 2023. Baseline data, including medical history, concomitant diseases, therapy, laboratory tests, echocardiographic results and cardiopulmonary exercise tests (CPETs), were collected at the start of the therapy with SGLT2is. After a median period of 18 months, follow-up data on treatment adherence, adverse events, hospitalizations, and mortality were also reviewed. A comparison was made between patients taking dapagliflozin and those taking empagliflozin and then individual populations were compared with those from the trials. Results: Among 370 patients (81% HFrEF, 19% HFimpEF), 276 received dapagliflozin and 94 empagliflozin. Empagliflozin patients were older, had higher NYHA class and LVEF, and higher incidence of diabetes, while dapagliflozin users had greater use of sacubitril/valsartan and mineralocorticoid receptor antagonists. Both groups were older than the RCT cohorts. Dapagliflozin patients had LVEF comparable to DAPA-HF, while empagliflozin patients had higher LVEF than EMPEROR-Reduced. HF hospitalizations were more frequent in the real-world groups, but mortality was lower than in RCTs. The composite outcome of death and worsening HF was higher in the real-world dapagliflozin cohort vs. DAPA-HF but similar between the real-world empagliflozin cohort and EMPEROR-Reduced. Conclusions: In this real-world cohort, the use of empagliflozin was associated with cardio-nephro-metabolic comorbidities and dapagliflozin being prescribed more frequently for patients with isolated cardiac symptoms. While outcomes were generally favorable, they differed from those seen in RCTs, highlighting the importance of real-world data in understanding the practical application of these therapies.

Exposure of plasma to low temperatures induces conversion of prorenin to renin, leading to falsely elevated renin levels, including during storage at -20°C. This survey evaluated pre‑analytical procedures for renin testing in Dutch clinical laboratories and assessed awareness of recent studies on cryoactivation and their impact on practice. A nine‑question online survey on pre‑analytical conditions for renin measurements was distributed by the Foundation for Quality Assessment in Medical Laboratory Diagnostics (SKML) to 106 Dutch clinical laboratories participating in the external quality assessment scheme for hormone measurements. Forty‑two laboratories responded. Pre‑analytical practices varied widely. Time limits for sample receipt ranged from none (31%, n=13) to <4 h (57%, n=24) or >4 h (5%, n=2). Most laboratories transported and centrifuged samples at room temperature (90% and 93%; n=38 and 39). Storage conditions differed: 79% (n=33) stored samples at -20°C, 17% (n=7) at -80°C, 2% (n=1) at -40°C, and 2% (n=1) at room temperature. Twenty‑two laboratories (52%) were aware of recent literature on cryoactivation, and 8 (36%) had changed or planned to change procedures. Only 8 laboratories (19%) followed all recommended steps to minimise cryoactivation. This survey demonstrates substantial inconsistency in pre‑analytical procedures for renin testing in the Netherlands. Despite moderate awareness of recent evidence, implementation of optimal procedures remains limited. The findings indicate that current guidelines and scientific insights have not been fully translated into practice, and that awareness alone does not necessarily lead to procedural change.

To promote the standardization and harmonization of glycated hemoglobin A1c （HbA1c） testing results in medical laboratories across Beijing， we established a reference method for HbA1c. This method participated in the International Comparison Program for HbA1c Reference Laboratories organized by the European Reference Laboratory Network for HbA1c to validate its accuracy. The experimental samples consisted of HbA1c network reference laboratory proficiency testing samples imported annually from the Netherlands， including six calibrators （A-F）， ten intercomparison samples， several quality control materials， and additional auxiliary samples with International Federation of Clinical Chemistry and Laboratory Medicine （IFCC）-assigned values. The pre-treatment process involved digesting samples with protein endopeptidase Glu-C. The experimental samples were removed from the -80 ℃ freezer and allowed to reach room temperature. Subsequently， 50 μL of Glu-C （mass concentration： 200 μg/mL） was added to each sample vial at a ratio of total hemoglobin to enzyme of 1 mg∶0.01 mg. The volume was then adjusted to a final volume of 500 μL with ammonium acetate solution （50 mmol/L， pH 4.3）. After thorough mixing， the samples were incubated at 37 ℃ for 18-20 h. Using mobile phases of methanol and 0.1% formic acid aqueous solution under gradient elution conditions， the detection of HbA1c in international samples was performed via high performance liquid chromatography-tandem mass spectrometry （HPLC-MS/MS）. A gradient elution mode was employed for liquid chromatography separation using a Shimadzu C18 column （50 mm×3 mm， 2.2 μm）. The injector temperature was maintained at 4-8 ℃， with a column temperature of 30 ℃. The flow rate was kept constant at 0.6 mL/min， with an injection volume of 5 μL and a total run time of 8 min. The MS detection was performed using electrospray ionization （ESI） in positive ion mode with multiple reaction monitoring （MRM）. The monitored ion pairs for the precursor and product ions of non-glycated and glycated N-terminal hexapeptides are m/z 348.2/237.2 and m/z 429.2/245.2， respectively. The linearity was evaluated by performing regression analysis. The HbA1c （mmol/mol） quantification in unknown samples was achieved by performing linear regression using Analyst 1.6.2 software. Peak areas were integrated， with the abscissa （X-axis） representing the known concentration ratio of HbA1c to hemoglobin A0 （HbA0）， and the ordinate （Y-axis） representing the average peak area ratio of glycated to non-glycated hexapeptides. Both glycated and non-glycated hexapeptides eluted within 3 min， with linear correlation coefficients ranging from 0.999 6 to 0.999 8. The quality control （QC） materials （≥3 types） annually provided by the IFCC were analyzed. Since each QC material in every shipment typically consists of two replicated vials， enzymatic digestion was performed in two separate batches. For each batch， five parallel samples were processed， followed by triplicate injections of each sample. Intra-assay and total coefficients of variation （CV） were calculated. The intra-assay coefficients of variation （CVs） were 0.35%-2.20%， and the total CVs were 0.83%-2.39%. From 2018 to 2024， IFCC compared individual laboratory results with the overall median， calculating proportional bias （slope） and systematic bias （intercept） based on linear regression. Our laboratory's combined statistical test value （computed from slope and intercept） ranged from 0.1 to 3.0. The systematic bias ranged from -0.69 to 1.27， and the proportional bias ranged from -0.009 to 0.021. The residual values from all testing points in the 2024 proficiency testing （PT） program were evenly distributed around zero. Furthermore， the magnitude of residual deviations from zero was relatively small compared to those observed across the 15 participating laboratories， demonstrating satisfactory consistency in our laboratory's analytical results. The established HbA1c reference method demonstrated robust performance， achieving satisfactory results in IFCC international comparisons from 2018 to 2024.

Influences of growth media and culture time on the SERS spectral patterns of three common pathogenic bacteria: a comparative analysis.

This study aimed to explore the application and pedagogical innovation of liquid chromatography-tandem mass spectrometry （LC-MS/MS） in undergraduate thesis training for medical laboratory science students. Using the development of 25-hydroxyvitamin D2 （25（OH）D2） and 25-hydroxyvitamin D3 （25（OH）D3） external quality assessment （EQA） samples as a teaching platform， an experimental teaching model driven by research tasks and clinical practice was established. The teaching design encompassed the entire workflow， including sample preparation， instrument operation， data processing， and result evaluation， enabling students to acquire hands-on experience with core LC-MS/MS techniques and quality control procedures. Through the implementation of the experimental project， students participated in EQA sample preparation， reference method-based quantification， homogeneity and stability assessments， and EQA result analysis， thereby gaining comprehensive exposure to the process from experimental design to result interpretation. The results demonstrated that the prepared EQA samples exhibited satisfactory homogeneity and stability， meeting the quality standards established by the China National Accreditation Service for Conformity Assessment （CNAS）. In the "2024 Beijing Serum Vitamin D EQA" activity， a total of 16 medical laboratory institutions in Beijing participated. Teaching practice revealed that this project significantly enhanced students' comprehensive abilities in experimental design， instrument operation， data analysis， and quality assessment， while also fostering scientific thinking and teamwork. By introducing advanced analytical techniques into the undergraduate curriculum under the educational concept of "research-driven teaching and integration of industry and education"， this approach not only optimized course content and experimental procedures but also broadened students' practical perspectives in clinical laboratory and research applications. This study provides a replicable teaching model for undergraduate laboratory education and offers valuable insights for promoting the integration of advanced analytical technologies into medical laboratory science training.

Clinical utilization of beta-hydroxybutyrate and comparison with urine ketones in a quaternary care health system.

Work-related musculoskeletal risks in student laboratory settings are under-characterized. We conducted a cross-sectional study of 31 healthy male medical laboratory students to quantify upper-limb ergonomic risk using the Rapid Upper Limb Assessment (RULA) and examine associations with physical activity (International Physical Activity Questionnaire-Short Form), sleep quality (Pittsburgh Sleep Quality Index), quality of life (WHOQOL-BREF), and anthropometry. Standardized 5-min task videos were independently scored by three trained assessors. RULA scores clustered at mid action levels, indicating investigation and possible modification for most and prompt action for a notable minority. Across physical-activity strata, between-group differences for upper-arm posture (χ2(2) = 6.07, p = 0.04), the upper-limb composite Score A (χ2(2) = 7.69, p = 0.02), and the adjusted upper-limb composite Score C (χ2(2) = 6.35, p = 0.04), with the high-activity group generally exhibiting more favorable scores. In multivariable ordinal models, higher BMI predicted worse wrist-posture categories (OR = 1.33, 95% CI [1.02-1.73], p = 0.03), whereas PSQI, overall QoL, and IPAQ contrasts were not independent predictors of Score A or upper-arm posture. These findings identify upper-limb postural load as the predominant ergonomic concern and suggest anthropometric fit and movement behaviors as actionable targets. Given the small, single-site, male-only sample, results are preliminary; curriculum-embedded ergonomic adjustments (bench/eyepiece height, forearm support, micro-breaks) warrant evaluation in larger, mixed-gender, multi-site studies.

Sarcopenia has a prevalence of between 10 and 27% among people over 60 years of age in Iran. Sarcopenia, as a multifactorial disorder, can lead to serious consequences, including reduced physical ability, lower quality of life, and increased risk of mortality. This study aimed to shed more light on the association of physical activity and sedentary time with sarcopenia. This cross-sectional study was conducted using the data collected during phase II of the Bushehr Elderly Health cohort. Demographic information, past medical history, anthropometric indices, and laboratory tests were analyzed. Sedentary time and physical activity were determined using a verified questionnaire. Sarcopenia was defined according to the revised edition of the European Working Group on Sarcopenia in Older People (EWGSOP-2). A total of 2374 individuals were analyzed, with a mean age of 69.3 years (± 6.3), 52.06% of whom were female, and 852 participants (35.8%) demonstrated sarcopenia. Univariate analysis found age, sex, smoking, socioeconomic status, BMI, waist circumference, hip circumference, and triglyceride to be associated with sarcopenia. After adjustment, older adults with moderate (ORmoderate/low=2.32, 95% CI = 1.02-5.27, P = 0.045) or high (ORhigh/low = 3.07, 95% CI = 1.45-6.48, P = 0.003) sedentary time were significantly more affected by sarcopenia than individuals with low sedentary time. In addition, the risks of sarcopenia in individuals with physical activity were 25% lower compared to people with no physical activity (ORlow active/active/no active/sedentary = 0.75, 95% CI = 0.58-0.96, P = 0.025). Both physical activity and sedentary time are independently associated with sarcopenia. Changing the attitudes and practices of the elderly or their caregivers regarding the necessity of regular physical activity and reducing sedentary behavior is recommended as a strategy for preventing sarcopenia.

Drug-related pancreatitis is seen in only about 1.4%-2% of cases. Amiodarone is a commonly used medication for the treatment of different atrial and ventricular arrhythmias. Its common side effects include hepatotoxicity, thyroid dysfunction, and pulmonary fibrosis. Acute pancreatitis is a rare side effect of amiodarone. There are only a few cases reported worldwide of amiodarone causing acute pancreatitis as a side effect. We present a case of a 61-year-old female patient who, while receiving treatment for non-ST-elevation myocardial infarction with ventricular tachycardia and amiodarone, had abrupt nausea, vomiting, and epigastric soreness. A computed tomography scan of her abdomen revealed the classic features of acute pancreatitis, which led to the diagnosis. The common causes of pancreatitis were excluded by reviewing the patient’s medical history, lab results, and imaging. Since the pancreatitis symptoms started soon after beginning amiodarone, and no other cause was identified, we diagnosed the condition as amiodarone-induced pancreatitis. The patient’s symptoms completely disappeared within a week of stopping the medication. Given the high risk of complications and mortality from acute pancreatitis, and the simplicity of treating it by discontinuing amiodarone, this serious side effect should be identified promptly in appropriate clinical situations.

Reference intervals (RIs) are essential for interpreting laboratory test results. It is recommended that each medical laboratory establishes and reviews its own RIs. The use of direct methods is often unfeasible for most laboratories, while indirect methods are a more viable alternative. However, these methods require not only medical, but also statistical and technical expertise, thereby limiting accessibility for many laboratories. To address this challenge, a web-based application was developed to facilitate the estimation and verification of RIs using real-world laboratorydata. The application was developed using R Studio and the Shiny web framework. The tool supports five indirect methods for reference interval estimation: refineR, TMC, TML, kosmic and reflimR. Furthermore, a Docker container was designed to enable a secure local deployment. Up to 200,000 laboratory test results can be included via a straightforward copy-and-paste input. The tool provides recommendations for sex-based stratification by performing statistical analysis. In addition, a drift-detection algorithm was developed to analyze whether age-based stratification is necessary. The results of RI estimation are displayed and visualized alongside the underlying data distribution. Existing RIs can be verified by comparing them against calculated intervals. ReferenceRangeR is a user-friendly tool for estimating and verifying RIs using real-world laboratory data, eliminating the need for statistical or technological expertise, thereby supporting laboratory professionals in meeting the current regulatory standards.

The purpose of this study was to assess how the red cell distribution width (RDW)-albumin ratio (RAR), an indicator of nutrition, oxidative stress, and inflammation, relates to the severity of retinal vein occlusion (RVO). 55 patients with RVO who presented to the Ophthalmology Polyclinic of Atatürk University Research Hospital between January 2025 and April 2025 and 30 healthy controls were evaluated. While 37 of the patient group had branch RVO (BRVO), 18 had central RVO (CRVO). Fundus fluorescein angiography was used to differentiate between ischemic and non-ischemic retinal vein occlusion in the patient group. All patients underwent comprehensive physical examinations, which included a thorough medical history and laboratory assessments such as complete blood count parameters, hemogram, RDW, and serum albumin levels. When the demographic and biochemical characteristics of the participants were compared by gender, no statistically significant differences were found between the groups. Similarly, although albumin levels and the RDW/albumin ratio (RAR) showed differences between the groups, these differences were not statistically significant (P = .108 and P = .109, respectively). RDW-CV values showed a statistically significant difference between the groups (P = .006). It was observed that RDW-CV values were significantly higher in the ischemic occlusion group. Although albumin levels differed between the groups, this difference was not statistically significant (P = .118). However, a significant difference in the RDW/albumin ratio (RAR) was observed between the groups (P = .016). This difference was found to be due to the comparison between the control group and the ischemic occlusion group, where RAR values were higher in the ischemic group. RAR demonstrates a significant association with RVO and offers a simple, cost-effective, safe, and readily available laboratory marker for assessing RVO severity. It can be considered that especially ischemic type RVO may be associated with high RAR level.

Objective: To reveal the role of dietary composition in the onset and prognosis of patients with liver cirrhosis by analyzing, exploring, and observing the correlational features between dietary composition and clinical indicators and mortality. Methods: A cirrhosis population was obtained from the National Health and Nutrition Examination survey from 2001 to 2018. Patients with cirrhosis (155 cases) were matched with healthy controls (615 cases) in accordance with a 1:4 ratio. Data on 37 food patterns, clinical indicators such as personal medical history and laboratory tests, and the status and cause of death of patients were obtained from the database. Univariate and logistic regression analyses were used to identify influencing factors. Kaplan-Meier survival curves were used to examine the impact of specific dietary intake on patient mortality. Results: Multivariate analysis revealed that patients with cirrhosis had higher daily alcohol consumption than healthy controls (OR=1.11, 95%CI: 1.03-1.19, P<0.01), while there was no statistically significant difference in food intake (P>0.05). Total starchy vegetable intake was lower in patients with cirrhosis than in controls (OR=0.38, 95%CI: 0.17-0.88, P=0.02) among the subgroup of patients with cirrhosis who drank alcohol. Total starchy vegetable intake was higher in patients with cirrhosis than in controls (OR=1.55, 95%CI: 1.01-2.38, P=0.04) among the subgroup of patients with cirrhosis who did not drink alcohol. Subgroup analysis by gender revealed that male patients with cirrhosis consumed less dark green vegetables (OR=0.24, 95%CI: 0.06-0.96, P=0.04), while female patients consumed more meat (OR=1.28, 95%CI: 1.05-1.54, P=0.01). Spearman analysis revealed no statistically significant correlation between any dietary composition and the aspartate aminotransferase-to-platelet ratio index and mortality. Conclusion: Excessive intake of starchy vegetables and meat and insufficient intake of dark green vegetables may be associated with the onset of cirrhosis in non-drinking female and male populations, respectively, suggesting the potential significance of dietary factors in the course of cirrhotic diseases.

Abstract Background: Accurate detection of HER2 gene amplification via in situ hybridization (ISH) is critical for guiding targeted therapy use in patients with breast cancer. Traditionally, this involves manual quantification of the HER2-to-chromosome 17 (HER2/CHR17) signal ratio; however, this process is often time-consuming and may be complicated by factors such as chromosome 17 polysomy or intratumoral heterogeneity. The uPath HER2 Dual ISH image analysis algorithm is a tool for research use only, developed to assist medical laboratory scientists with determining HER2 gene status from images of formalin-fixed, paraffin-embedded (FFPE) neoplastic breast tissue. The algorithm was previously validated with samples stained using the VENTANA BenchMark ULTRA platform, but its performance across alternative staining platforms has not yet been evaluated. Methods: This study was designed to evaluate agreement between the BenchMark ULTRA and XT staining platforms, and between manual and algorithm-assisted methods for scoring across both platforms. In total, 120 advanced breast cancer FFPE samples with varying levels of HER2 amplification were selected for analysis (amplified [HER2/CHR17 ratio &amp;gt; 2.6], n = 50; non-amplified [HER2/CHR17 ratio &amp;lt; 1.4], n = 50; borderline amplified [HER2/CHR17 ratio ≥ 2.0 and ≤ 2.5], n = 10; borderline non-amplified [HER2/CHR17 ratio ≥ 1.5 and ≤ 1.9], n = 10). Tissue sections were prepared and stained using the VENTANA HER2 Dual ISH DNA probe cocktail using both the BenchMark ULTRA and XT platforms. Two trained medical laboratory scientists performed blinded manual quantification of HER2 ISH across all samples. These results were then checked by pathologists (n = 3). Following a washout period, these pathologists repeated the analysis using the algorithm. Results: High inter-platform agreement was observed with the algorithm across 118 evaluable samples, with an overall percent agreement (OPA) of 94.9% (95% confidence interval [CI], 89.3-97.6); positive percent agreement (PPA) and negative percent agreement (NPA) were 95.1% (95% CI, 86.5-98.3) and 94.7% (95% CI, 85.6-98.2), respectively. High agreement was observed between the algorithm and manual reads irrespective of the platform used for staining ( Table 1 ). Perfect agreement was observed between manual reads across the two platforms. Conclusions: These data demonstrate that the uPath HER2 Dual ISH image analysis algorithm offers similar performance to manual scoring across samples stained using either the BenchMark ULTRA or XT platforms, and across samples with varying levels of HER2 amplification. With further validation, the algorithm may provide pathologists with a reliable adjunctive tool to support the diagnosis of patients with breast cancer. Citation Format: N. Thampy, K. Young-Zvandasara, C. M. Bacon, C. Chen, N. Harris, M. Howe, A. Long, L. Mansfield, J. Ness, K. A. Wharton Jr, S. Dance, L. J. Inge. Analytical performance of an image analysis algorithm developed as an adjunctive aid for determining HER2 gene status from in situ hybridization [abstract]. In: Proceedings of the San Antonio Breast Cancer Symposium 2025; 2025 Dec 9-12; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2026;32(4 Suppl):Abstract nr PS2-05-26.

Considering the concept of quality as a degree of excellence, the term quality of laboratory work tells us how excellent our results are in all areas of laboratory work. Therefore, quality indicators have been introduced with the aim of monitoring and measuring quality. Quality indicators describe the efficiency of the laboratory process in the form of a numerical value, providing objective evidence of the conformity of the specified laboratory process with respect to predefined criteria. The Working Group for Postanalytics of the Croatian Society of Medical Biochemistry and Laboratory Medicine has decided to describe the necessary steps in designing and monitoring quality indicators, with an emphasis on the quality of the postanalytical and post-postanalytical phase. The main purpose of these recommendations is to facilitate the incorporation of quality indicators into laboratories' daily routines. Laboratories in the Republic of Croatia are recommended to monitor three quality indicators in the postanalytical phase of laboratory work: turnaround time, withdrawn or retracted laboratory test reports, and notification of critical results. Additionally, two indicators are recommended in the post-postanalytical phase: monitoring issuance of laboratory test reports and monitoring user satisfaction. Harmonising acceptable performance limits and monitoring of the most commonly used quality indicators opens up the possibility of comparisons between laboratories and a uniform quality of laboratory services throughout the healthcare system.

Introduction: Diabetes mellitus, defined by chronic hyperglycemia (fasting blood glucose ≥ 1.26 g/L or ≥ 2 g/L at any time), is frequently associated with atherogenic dyslipidemia, which exacerbates cardiovascular risk. Methods: This was a retrospective, descriptive, and analytical study conducted among diabetic patients followed at CHNDJ. Patients were recruited from the biochemistry department of the medical analysis laboratory between August 2019 and February 2020. The main objective was to assess atherogenic risk in these patients. Results: Mean age 57.4 ± 13.8 years; 74.9% women; dyslipidemia prevalence 67.1%. Mean AIP and AI values were elevated in the study population (Table 1), and their variation according to dyslipidemia showed that these indices exceeded recommended thresholds in both dyslipidemic and non-dyslipidemic patients. Atherogenicity indices were elevated (mean AIP 0.24; Castelli I 3.9), more perturbed in patients ≥ 60 years (p &lt; 0.05 for AIP, CRI-I, CRIII) and in cases of glycemic imbalance (p &lt; 0.05 for CRI-I, CRI-II, AIP, AI). Conclusion: This study demonstrates that exploration of the lipid profile and atherogenicity indices is essential in diabetic patients to better prevent and manage cardiovascular disease risk.

External Quality Assurance Scheme in Clinical Biochemistry: Experience of CMC EQAS on the Continuous Improvement in Indian Medical Laboratories