Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine最新文献

{"title":"The Case of Negative Low Density Lipoprotein Cholesterol.","authors":"Earnest Jp Daniel, Sridevi Devaraj","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Accurate estimation of low-density lipoprotein cholesterol (LDL-C) is critical for lipid assessment and cardiovascular risk stratification, yet conventional calculation methods may fail in specific clinical contexts in pediatric population. The Friedewald equation, long considered standard, is unreliable in moderately elevated TG (TG ≥400 mg/dL) and in low total cholesterol (TC) scenarios. Alternative equations, including Martin-Hopkins and Sampson-NIH, have been developed to improve accuracy, but pediatric validation remains limited. We present two pediatric cases highlighting these challenges. Case 1 involved a 5-year-old male with perinatally acquired HIV/AIDS, low TC, and moderately elevated triglyceride (TG) <300 mg/dL. Friedewald-calculated LDL-C was negative, while direct beta-quantification revealed LDL-C of 36 mg/dL and Martin-Hopkins equation underestimated LDL-C by 70%. Case 2 involved a female with type 2 diabetes and high-risk B-cell acute lymphoblastic leukemia, with extreme hypertriglyceridemia >1000 mg/dL and elevated TC. In this case, both Friedewald and Martin-Hopkins calculations failed, whereas Sampson-NIH 2025 provided a calculable LDL-C of 26 mg/dL. These cases demonstrate that TG-to-TC ratios, rather than TG alone, predict calculation failure, and that alternative equations, particularly Sampson-NIH 2025, offer improved reliability. These findings are especially relevant for patients receiving cholesterol-lowering therapies, in whom low LDL-C and elevated TG may lead to significant underestimation of residual atherogenic risk. Further studies using comparative beta-quantification are needed to identify the most accurate LDL-C estimation methods across diverse pediatric populations and low-cholesterol states.</p>","PeriodicalId":37192,"journal":{"name":"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine","volume":"37 3","pages":"553-557"},"PeriodicalIF":0.0,"publicationDate":"2026-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13543529/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148897885","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":"Polycystic Ovary Syndrome Prediction Using Machine Learning: A Comparative Analysis of Classification Algorithms.","authors":"Usha Adiga, Vasishta Sampara, Pedda Reddemma P, Supriya P, Sireesha Kanchi, Kasala Farzia","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Polycystic ovary syndrome (PCOS) represents one of the most prevalent endocrine disorders affecting women of reproductive age, with significant implications for metabolic, reproductive, and psychological health. Early and accurate diagnosis remains challenging due to heterogeneous clinical presentations and the complexity of diagnostic criteria.</p><p><strong>Objective: </strong>This study aimed to develop and compare multiple machine learning algorithms for predicting PCOS diagnosis, evaluating their performance across various metrics to identify the most effective computational approach for clinical decision support.</p><p><strong>Methods: </strong>A comprehensive dataset containing clinical, biochemical, and anthropometric parameters from patients was analyzed using twelve different machine learning algorithms. The dataset underwent rigorous preprocessing including missing value imputation, feature engineering, and categorical encoding. Models evaluated included Logistic Regression, Support Vector Machine, K-Nearest Neighbors, Naive Bayes, Decision Tree, Random Forest, Gradient Boosting, XGBoost, AdaBoost, Neural Network, LightGBM, and HistGradientBoosting. Performance was assessed using accuracy, F1-score, sensitivity, specificity, and ROC-AUC scores.</p><p><strong>Results: </strong>Gradient Boosting, XGBoost, and HistGradientBoosting demonstrated superior performance with accuracy of 92.66%, while ensemble methods generally outperformed single classifiers. Gradient Boosting achieved the highest F1-score of 87.87% and ROC-AUC of 95.39%. Random Forest exhibited exceptional specificity at 98.63%, while Naive Bayes showed the highest sensitivity of 94.44%. Traditional machine learning approaches like SVM and Neural Networks showed comparatively limited performance in this context.</p><p><strong>Conclusion: </strong>Machine learning algorithms, particularly gradient boosting methods, demonstrate substantial potential for accurate PCOS prediction and can serve as valuable tools for clinical decision support, potentially enabling earlier intervention and improved patient outcomes.</p>","PeriodicalId":37192,"journal":{"name":"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine","volume":"37 3","pages":"432-440"},"PeriodicalIF":0.0,"publicationDate":"2026-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13543484/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148897906","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":"The Changing Landscape of Clinical Chemistry in Pakistan: Roles, Training Experiences, and Career Pathways- a National Survey.","authors":"Sibtain Ahmed, Amal Mahmood, Aamir Ijaz, Nimarta Heman, Ayesha Sadiqa, Imran Siddiqui","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Chemical pathology is a fast-growing field, with an even greater demand for pathologists in Pakistan. This study aims to evaluate the current landscape of FCPS-certified chemical pathologists in Pakistan, evaluating their training experiences and current leadership roles in their field.</p><p><strong>Methods: </strong>This was a nationwide cross-sectional survey conducted of FCPS-trained chemical pathologists. The study was conducted via an online questionnaire (Google Forms) containing questions regarding the demographics, training experiences and current roles.</p><p><strong>Results: </strong>A total of 82 respondents were included in the study and most of them were females (68%, n=56). Over half of the respondents were aged 31-40 years (51%). Most participants were from Punjab (57%) and were employed full-time (79%), primarily in government (38%) or private (43%) sectors. The majority worked in urban areas (89%), and the type of work setting varied significantly by gender (p = 0.034). 63% practised solely in chemical pathology, while 70% reported that their work involved other pathology disciplines as well. Research involvement was high overall (85%), with all male participants engaged in research compared to 79% of female participants (p = 0.011). The majority of the participants rated their training experience positively as either excellent (30%) or very good (29%).</p><p><strong>Conclusion: </strong>FCPS-certified chemical pathologists are overall satisfied with their training experiences. This study highlights the need for structured mentorship and institutional support to strengthen the future chemical pathology workforce.</p>","PeriodicalId":37192,"journal":{"name":"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine","volume":"37 3","pages":"441-449"},"PeriodicalIF":0.0,"publicationDate":"2026-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13543507/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148897854","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":"Toward Standardization of Laboratory Terminology.","authors":"Young Bae Lee Hansen, Fatma Meriç Yilmaz, Gunnar Nordin, Koh Furuta, Madeleen Bosma, Rebecca Ceder, Sridevi Devaraj","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Laboratory medicine is fundamental to evidence-based healthcare, providing critical data on human properties for diagnosing and managing diseases. The increasing complexity and size of laboratory data necessitate robust information technology (IT) systems for efficient management.</p><p><strong>Purpose: </strong>This manuscript elucidates the roles and infrastructure requirements of laboratory IT systems by stating the purposes of laboratory medicine and examining the challenges and prerequisites associated with their achievement.</p><p><strong>Methods: </strong>We explore the primary purpose of laboratory medicine in supporting clinical decisions and the opportunities for secondary data use. The challenges of data heterogeneity, insufficient and lack of metadata, and the need for standardized terminologies are addressed. We further emphasize the prerequisites including international collaboration and education.</p><p><strong>Results: </strong>Technological advancements have enabled automation in laboratories, reducing errors, improving quality, and increasing efficiency and capacity for 24/7 sample processing. IT systems facilitate rapid results, enhance resource allocation, and manage the entire testing process from ordering to result interpretation. The establishment of two coherent and comprehensive laboratory information models - one for communication in the laboratory and another for communication between diverse health care providers - is proposed as essential for accurate data exchange and maximizing data utility.</p><p><strong>Conclusion: </strong>Achieving successful exchange of laboratory results and optimal use of laboratory data hinge on international collaboration, shared resource commitment, and an approach to standardised terminologies and data structures. This work lays the foundation for ongoing efforts to develop international laboratory information models, critical for advancing patient care and leveraging the full potential of laboratory medicine.</p>","PeriodicalId":37192,"journal":{"name":"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine","volume":"37 3","pages":"389-395"},"PeriodicalIF":0.0,"publicationDate":"2026-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13543440/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148897935","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":"Anti-N-methyl-D-Aspartate Receptor Autoimmune Encephalitis Due to Ovarian Teratoma in a 17-Year-Old Young Woman: Case Report and Review of the Literature.","authors":"Ennio Polilli, Anna D'Andreagiovanni, Pierluigi Tocco, Maurizio Rosati, Ylenia Della Rocca, Giancarlo Di Iorio, Maria Vittoria De Angelis, Giustino Parruti, Antonella Frattari","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>Many cases of encephalitis are caused by an autoimmune response, and some are associated with underlying malignancies. Here we present the case of a 17-year-old female patient who was admitted to the pediatric ward with acute gastroenteritis, seizures, and behavioral changes. A brain computed tomography (CT) scan ruled out acute infarction, haemorrhage, mass lesions, and other intracranial injuries, while the initial EEG showed no epileptic discharges. In the absence of a definitive diagnosis, midazolam was administered to treat tonic-clonic seizures, while ceftriaxone and acyclovir were started for suspected infection. However, her condition deteriorated further and she was transferred to the ICU, where she was intubated. A Cell-Based Assay (CBA) revealed the presence of anti-NMDAR antibodies and a contrast-enhanced brain MRI showed leptomeningeal enhancement without limbic involvement. She was subsequently treated with intravenous immunoglobulins and high-dose corticosteroids. A subsequent transabdominal ultrasound scan revealed an oval, fluid-filled ovarian cyst. Based on these findings, her right ovary was removed, resulting in a gradual improvement in her condition. This case highlights that paraneoplastic autoimmune encephalitis may be misclassified due to persistent psychiatric symptoms with negative EEG and CSF findings. When clinical suspicion remains high despite negative initial instrumental and laboratory findings, it is essential to repeat these investigations. In such cases, neuroantibody testing may play a crucial role in establishing the diagnosis.</p>","PeriodicalId":37192,"journal":{"name":"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine","volume":"37 3","pages":"572-577"},"PeriodicalIF":0.0,"publicationDate":"2026-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13543410/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148897705","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":"Comparative Performance Analysis of Three Point-of-Care Glucose Testing Devices against a Central Laboratory Reference Method.","authors":"Auliya Ashar, Fauqa Arinil Aulia, Ferdy Royland Marpaung, M Robiul Fuadi, Yessy Puspitasari","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Point-of-care testing (POCT) glucose systems are widely used in clinical practice due to their rapid turnaround time and operational convenience. However, concerns remain regarding their analytical agreement with laboratory reference methods, particularly in relation to accuracy and potential clinical impact.</p><p><strong>Methods: </strong>This cross-sectional analytical study included 196 adult outpatients at Dr. Soetomo General Academic Hospital, Surabaya, Indonesia. Capillary blood glucose was measured using three POCT devices (StatStrip, Accu-Chek Inform II, and Rightest), while venous plasma glucose was analyzed using a hexokinase-based reference method (Alinity C). Analytical performance was evaluated using correlation analysis, Bland-Altman plots, Passing-Bablok regression, and ISO 15197 accuracy criteria.</p><p><strong>Results: </strong>All POCT devices demonstrated strong correlations with the reference method (r = 0.967-0.982; p < 0.001). StatStrip showed a small negative bias (-2.89 mg/dL; p = 0.003), while Accu-Chek Inform II exhibited a larger deviation (-7.80 mg/dL; p < 0.001). In contrast, Rightest showed no statistically significant bias (-0.14 mg/dL; p = 0.870) and demonstrated the closest agreement with the reference method. Agreement analysis confirmed minimal systematic and proportional bias for Rightest, whereas Accu-Chek Inform II showed wider variability. ISO 15197 evaluation indicated the highest accuracy for Rightest and lower compliance for Accu-Chek Inform II, particularly at glucose levels <200 mg/dL.</p><p><strong>Conclusion: </strong>Although all POCT systems showed strong correlations with the reference method, clinically relevant differences in analytical agreement and accuracy were identified. Rightest demonstrated the best overall performance. These findings highlight the importance of evaluating agreement beyond correlation and support the use of POCT primarily for glucose monitoring rather than definitive diagnosis.</p>","PeriodicalId":37192,"journal":{"name":"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine","volume":"37 3","pages":"459-467"},"PeriodicalIF":0.0,"publicationDate":"2026-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13543465/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148897926","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":"Monoclonal Gammopathy with Double M-bands Mimicking Biclonal Gammopathy: A Case Series.","authors":"Dharmendra Kumar, Koushik Biswas, Kanu Tiwari, Mala Mahto","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Monoclonal gammopathies are characterised by the presence of a serum or urine monoclonal protein (M-pro-tein), typically detected as a single narrow band on serum protein electrophoresis (SPEP). Rarely, double M-bands may appear, raising the suspicion of biclonal gammopathy. Distinguishing true biclonality from paraprotein polymerization is crucial to prevent diagnostic misclassification and inform appro-priate clinical decisions.</p><p><strong>Case: </strong>We report a case series of four multiple myeloma patients with twin M-bands who presented to AIIMS Patna between March 2023 and March 2024. All four patients exhibited two discrete M-bands on SPEP, initially suggestive of biclonal gammopathy. However, immunofixation electrophoresis confirmed that both bands in each case belonged to the same immunoglobulin isotype and light chain, establishing a monoclonal origin. Treatment of samples with β-mercaptoethanol resulted in the collapse of double bands into a single monoclonal band, confirming paraprotein polymerization. IgA and IgM paraproteins were most frequently implicated in dual-band appearance.</p><p><strong>Conclusion: </strong>The presence of double M-band on serum protein electrophoresis does not necessarily indicate biclonal gammopathy. Depending on SPEP results alone may lead to misclassification, and confirmatory techniques such as IFE and reducing agent studies are essential to establish the correct diagnosis.</p>","PeriodicalId":37192,"journal":{"name":"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine","volume":"37 3","pages":"545-552"},"PeriodicalIF":0.0,"publicationDate":"2026-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13543495/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148897877","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":"Bisalbuminemia: A Rare Finding Identified via Serum Protein Agarose Gel Electrophoresis and Capillary Electrophoresis Techniques.","authors":"Qian Ren, Tong Liu, Jing Li, Yulong Fan, Shoulei Wang, Lele Wang, Yansheng Wang, Zhaojing Liu, Yonghui Xia, Guoqing Zhu, Yansong Ren","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>Bisalbuminemia is a rare abnormality characterized by detection of two distinct albumin bands or double peaks through serum protein agarose gel electrophoresis or capillary electrophoresis, suggesting the coexistence of normal and modified albumin in the same patient. However, it is challenging to visualize the double bands due to the limited resolution of agarose gel electrophoresis. Besides, capillary electrophoresis cannot directly visualize serum proteins.</p><p><strong>Methods: </strong>Serum samples were obtained from the Hematology Hospital of the Chinese Academy of Medical Sciences and analyzed using agarose gel electrophoresis and capillary electrophoresis. Agarose gel electrophoresis and capillary electrophoresis were performed using a SPIFE4000 electrophoresis apparatus from Helena or Capillarys3 Tera system.</p><p><strong>Results: </strong>Three samples of bisalbumin were detected in the albumin region in patients diagnosed with multiple myeloma via agarose gel electrophoresis and capillary electrophoresis techniques.</p><p><strong>Conclusions: </strong>These findings suggest that capillary electrophoresis technology combined with traditional agarose gel electrophoresis methods can significantly improve the detection rate of bisalbuminemia. Serum dilution or depolymerization may be utilized to enhance detection when bisalbumin bands are not readily identifiable in agarose gel electrophoresis, thereby ensuring the accuracy of bisalbuminemia diagnosis.</p>","PeriodicalId":37192,"journal":{"name":"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine","volume":"37 3","pages":"425-431"},"PeriodicalIF":0.0,"publicationDate":"2026-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13543513/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148897861","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":"The College of American Pathologists (CAP) Laboratory Accreditation Program (LAP): Accreditation Process and its Impact on Laboratory Practice and Patient Safety.","authors":"Abdelaziz Sanad Abdelaziz, Samir Y Marzouk, Mai S Mabrouk","doi":"","DOIUrl":"","url":null,"abstract":"<p><p>This study aimed to assess the laboratory professional perceptions on how the College of American Pathologists (CAP) Laboratory Accreditation Program (LAP) is associated with the laboratory processes and patient safety across multiple countries in the Middle East and South Asia. The objective was to determine how CAP LAP influences laboratory quality and safety culture, and participants reported that error-related events appeared to decrease following the CAP LAP. A quantitative, cross-sectional design was used, employing a structured electronic questionnaire distributed to CAP-accredited laboratories in Saudi Arabia, other Gulf countries, Egypt, and Pakistan. A total of 300 valid responses were analyzed using descriptive statistics and marginal homogeneity testing to compare the respondents' perceived condition pre- and post-accreditation performance in areas such as staff competency, quality management, turnaround time, and safety practices. Respondents assessed conditions before and after accreditation in pre-analytical, analytical, and post-analytical areas, including quality management systems, staff competence, turnaround time, equipment upkeep, communication, and safety culture. We examined paired ordinal responses using marginal homogeneity tests. The CAP LAP was therefore viewed as highly valuable for improving both laboratory performance and patient safety. This study provides empirical evidence from multi-country CAP LAP accredited laboratories, filling a regional gap in accreditation research. It demonstrates that the CAP LAP functions as a strong governance mechanism enhancing quality and safety within diverse healthcare systems. It is advisable to conduct future longitudinal and comparative studies among CAP, ISO 15189:2022, and national accreditation systems to evaluate the durability of enhancements and their impact on laboratory personnel behavior. These results indicate that laboratory professionals view CAP LAP as linked to significant enhancements in laboratory operations and safety protocols. However, the results are based on people's own reports of their perceptions and don't show cause-and-effect relationships or measure objective safety outcomes. Future research incorporating objective performance metrics and longitudinal methodologies is essential to assess the causal influence of accreditation on patientsafety.</p>","PeriodicalId":37192,"journal":{"name":"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine","volume":"37 3","pages":"506-516"},"PeriodicalIF":0.0,"publicationDate":"2026-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13543442/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148897875","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":"Advisory and Interpretative Services under ISO 15189:2022: A Prospective Study of Patient-Initiated Laboratory Consultations.","authors":"Vivek Pant, Santosh Pradhan, Keyoor Gautam, Devish Pyakurel, Abha Shrestha, Neha Neupane","doi":"","DOIUrl":"","url":null,"abstract":"<p><strong>Background: </strong>ISO 15189:2022 requires accredited medical laboratories to establish advisory and interpretative services to support appropriate test selection, result interpretation, and effective utilization of laboratory examinations.Direct-to-consumer and patient-initiated laboratory testing is reshaping traditional healthcare communication. Patients increasingly seek direct consultation with laboratory physicians for test selection and result interpretation. This study describes the drivers, patterns and perceived value of such interactions in routine laboratory practice.</p><p><strong>Methods: </strong>A prospective observational study was conducted over 12 months at a high-volume ISO 15189:2022 accredited referral laboratory. All unsolicited, patient-initiated advisory consultations with laboratory physicians were systematically documented using a structured logbook. Consultations were categorized by type (pre-examination advice, post-examination interpretation, clarification of abnormal findings, and resolution of inter-laboratory discrepancies). All abnormal or discordant results discussed during consultation had undergone analytical verification in accordance with internal quality control and validation procedures. Patient satisfaction was assessed using a 5-point Likert scale. Descriptive statistics were applied.</p><p><strong>Results: </strong>A total of 1,800 advisory consultations were recorded during the study period. The most common categories were postexamination interpretative consultation (35.6%) and clarification of abnormal results (28.3%), followed by pre-examination advice (20.0%) and resolution of inter-laboratory discrepancies (12.2%). Frequently discussed analytes included glucose profiles, lipid parameters, infectious disease serology, and screening tests. Satisfaction data were available for 1,625 consultations, with a mean score of 4.5 ± 0.6; 90% of respondents rated the consultation as satisfactory or very satisfactory.</p><p><strong>Conclusions: </strong>These findings highlight the growing demand for professional laboratory interpretation in patient-initiated testing environments and support the inclusion of advisory consultations as a measurable quality indicator within laboratory management systems.</p>","PeriodicalId":37192,"journal":{"name":"Electronic Journal of the International Federation of Clinical Chemistry and Laboratory Medicine","volume":"37 3","pages":"476-481"},"PeriodicalIF":0.0,"publicationDate":"2026-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13543432/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148897578","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}