Laboratory-based surveillance of chronic kidney disease in people with private health coverage in Brazil.

BACKGROUND: Although approximately 25% of Brazilians have private health coverage (PHC), studies on the surveillance of chronic kidney disease (CKD) in this population are scarce. The objective of this study was to estimate the prevalence of CKD in individuals under two PHC regimes in Brazil, who total 8,335,724 beneficiaries. METHODS: Outpatient serum creatinine and proteinuria results of individuals from all five regions of Brazil, ≥ 18 years of age, and performed between 10/01/2021 and 10/31/2022, were analyzed through the own laboratory network database. People with serum creatinine measurements were evaluated for the prevalence and staging of CKD, and those with simultaneous measurements of serum creatinine and proteinuria were evaluated for the risk category of the disease. CKD was classified according to current guidelines and was defined as a glomerular filtration rate (GFR) < 60 ml/min/1.73 m² estimated by the 2021 CKD-EPI equation. RESULTS: The number of adults with serum creatinine results was 1,508,766 (age 44.0 [IQR, 33.9-56.8] years, 62.3% female). The estimated prevalence of CKD was 3.8% (2.6%, 0.8%, 0.2% and 0.2% in CKD stages 3a, 3b, 4 and 5, respectively), and it was higher in males than females (4.0% vs. 3.7%, p < 0.001, respectively) and in older age groups (0.2% among 18-29-year-olds, 0.5% among 30-44-year-olds, 2.0% among 45-59-year-olds, 9.4% among 60-74-year-olds, and 32.4% among ≥ 75-year-olds, p < 0.001) Adults with simultaneous results of creatinine and proteinuria were 64,178 (age 57.0 [IQR, 44.8-67.3] years, 58.1% female). After adjusting for age and gender, 70.1% were in the low-risk category of CKD, 20.0% were in the moderate-risk category, 5.8% were in the high-risk category, and 4.1% were in the very high-risk category. CONCLUSION: The estimated prevalence of CKD was 3.8%, and approximately 10% of the participants were in the categories of high or very high-risk of the disease. While almost 20% of beneficiaries with PHC had serum creatinine data, fewer than 1% underwent tests for proteinuria. This study was one of the largest ever conducted in Brazil and the first one to use the 2021 CKD-EPI equation to estimate the prevalence of CKD.

Artificial intelligence in the clinical laboratory.

Laboratory medicine has become a highly automated medical discipline. Nowadays, artificial intelligence (AI) applied to laboratory medicine is also gaining more and more attention, which can optimize the entire laboratory workflow and even revolutionize laboratory medicine in the future. However, only a few commercially available AI models are currently approved for use in clinical laboratories and have drawbacks such as high cost, lack of accuracy, and the need for manual review of model results. Furthermore, there are a limited number of literature reviews that comprehensively address the research status, challenges, and future opportunities of AI applications in laboratory medicine. Our article begins with a brief introduction to AI and some of its subsets, then reviews some AI models that are currently being used in clinical laboratories or that have been described in emerging studies, and explains the existing challenges associated with their application and possible solutions, finally provides insights into the future opportunities of the field. We highlight the current status of implementation and potential applications of AI models in different stages of the clinical testing process.

Dynamic mirroring: unveiling the role of digital twins, artificial intelligence and synthetic data for personalized medicine in laboratory medicine.

In recent years, the integration of technological advancements and digitalization into healthcare has brought about a remarkable transformation in care delivery and patient management. Among these advancements, the concept of digital twins (DTs) has recently gained attention as a tool with substantial transformative potential in different clinical contexts. DTs are virtual representations of a physical entity (e.g., a patient or an organ) or systems (e.g., hospital wards, including laboratories), continuously updated with real-time data to mirror its real-world counterpart. DTs can be utilized to monitor and customize health care by simulating an individual's health status based on information from wearables, medical devices, diagnostic tests, and electronic health records. In addition, DTs can be used to define personalized treatment plans. In this study, we focused on some possible applications of DTs in laboratory medicine when used with AI and synthetic data obtained by generative AI. The first point discussed how biological variation (BV) application could be tailored to individuals, considering population-derived BV data on laboratory parameters and circadian or ultradian variations. Another application could be enhancing the interpretation of tumor markers in advanced cancer therapy and treatments. Furthermore, DTs applications might derive personalized reference intervals, also considering BV data or they can be used to improve test results interpretation. DT's widespread adoption in healthcare is not imminent, but it is not far off. This technology will likely offer innovative and definitive solutions for dynamically evaluating treatments and more precise diagnoses for personalized medicine.

Early detection of severe hypertriglyceridemia using teleconsultation in a clinical laboratory setting.

BACKGROUND: Teleconsultation in the context of clinical laboratories is a valuable tool for the early detection of dyslipidemia and prevention of cardiovascular risk. Here, we describe a patient who was referred to the Lipid Unit of the Virgen Macarena Hospital due to an alert for severe hypertriglyceridemia through its teleconsultation program. CASE PRESENTATION: A comprehensive clinical and biochemical study of the patient was carried out, and genetic testing was performed on the patient and his family. The proband and his family showed mild to severe hypertriglyceridemia and various secondary factors, together with a genetic background associated with a triglyceride-raising effect. CONCLUSION: This extensive study has identified a family at high risk of cardiovascular disease and acute pancreatitis. These findings can help maximize lifestyle changes and improve the clinical management of their dyslipidemia.

Evaluating proficiency testing implementation and identifying challenges that government comprehensive specialized hospital laboratories in northwest Ethiopia faced as they participated in the external quality assessment scheme: A document-based, interview-driven evaluation.

OBJECTIVES: To assess the implementation of proficiency testing in the northwest Ethiopian government comprehensive specialized hospital laboratories, with a focus on identifying and understanding the challenges encountered during their participation in the external quality assessment scheme. METHODS: A cross-sectional study was conducted among 3 comprehensive specialized hospitals in northwest Ethiopia, analyzing 41 documented laboratory test parameters from 2020 to 2022. In addition, face-to-face, in-depth interviews were carried out to identify the major challenges the participating institutions faced. RESULTS: The study covered a total of 41 tests across 9 cycles. Overall, proper implementation of proficiency testing was observed in 59.3% of the tests, with 61.8% maintaining consistent implementation status over 3 consecutive years. In addition, the overall performance of the laboratory was 54.3%, with a 68.7% participation rate. The predominantly identified challenges included the lack of participation, insufficient reagents and supplies, inadequacy of suitable proficiency testing materials, equipment malfunction and downtime, lack of management support, insufficient budget, and inadequate training and awareness. CONCLUSIONS: The results of this study highlight the ineffective implementation of proficiency testing. Contributing factors include personnel issues, equipment and supplies challenges, managerial shortcomings, difficulties with proficiency testing providers, budgetary constraints, and a lack of training and motivation.

Artificial Intelligence - Perception of Clinical Laboratories' Technical Staff a Nationwide Multicentre Survey in Pakistan.

Introduction: As Artificial Intelligence (AI) technology continues to assimilate into various industries, there is a huge scope in the healthcare industry specifically in clinical laboratories. The perspective of the laboratory professionals can give valuable insight on the ideal path to take for AI implementation. Methods: The study utilized a cross-sectional survey design and was conducted at the section of Chemical Pathology, Department of Pathology and Laboratory Medicine, the Aga Khan University (AKU), Karachi, Pakistan in collaboration with Consultant Pathologists of 9 clinical laboratories associated with teaching hospitals across Pakistan from October-November 2023. The survey was for a duration of 2 weeks and was circulated to all working laboratory technical staff after informed consent. Results: A total of 351 responses were received, of which 342 (male=146, female=196) responses were recorded after exclusion. Respondents ranged from technologists, faculty, residents, and coordinators, and were from different sections (chemical pathology, microbiology, haematology, histopathology, POCT). Out of the total 312 (91.2%) of respondents stated that they were at least somewhat familiar with AI technology. Experts in AI were only 2.0% (n=7) of all respondents, but 90% (n=6) of these were < 30 years old. 76.3% (n=261) of the respondents felt the need to implement more AI technology in the laboratories, with time saving (26.1%) and improving performances of tests (17.7%) cited to be the greatest benefits of AI. Security concerns (n=144) and a fear of decreasing personal touch (n=143) were the main concerns of the respondents while the younger employees had an increased fear of losing their jobs. 76.3% were in favour of an increase in AI usage in the laboratories. Conclusion: This study highlights a favourable perspective among laboratory professionals, acknowledging the potential of AI to enhance both the efficiency and quality of laboratory practices. However, it underscores the importance of addressing their concerns in the thoughtful implementation of this emerging technology.

Impact of Sample Type on D-Dimer Screening.

Background: The quality of laboratory test results depends on various factors, including sample type selection. Blood samples, such as whole blood, plasma and serum are commonly used for most clinical laboratory examinations. D-dimer parameters are frequently analysed in haematology laboratories and serve as biomarkers for coagulation activation and fibrinolysis. This study aimed to assess the impact of using different sample types on the quality of D-dimer test results. Method: An observational analytical method was used. D-dimer examination was performed using the fluorescent lateral flow immunoassay method. The study sample consisted of 26 participants aged between 18 years old and 22 years old who had no blood disorders. Whole blood and ethylenediaminetetraacetic acid (EDTA) plasma samples were used for the examination of D-dimer levels. Results: D-dimer levels in 26 participants using whole blood samples had a mean value of 0.23 mg/L (230 ng/mL), while plasma samples yielded a mean value of 0.14 mg/L (140 ng/mL). D-dimer levels obtained from whole blood samples were higher than plasma samples but remained within the normal range of 0 mg/L-0.5 mg/L (0 ng/mL-500 ng/mL). Conclusion: The results showed that whole blood samples were more practical than plasma samples. Nevertheless, plasma samples gave results within the normal range of D-dimer values.

How New Regulation of Laboratory-Developed Antimicrobial Susceptibility Tests Will Affect Infectious Diseases Clinical Practice.

Antimicrobial resistance (AMR) affects 2.8 million Americans annually. AMR is identified through antimicrobial susceptibility testing (AST), but current and proposed regulatory policies from the United States Food and Drug Administration (FDA) jeopardize the future availability of AST for many microorganisms. Devices that perform AST must be cleared by the FDA using their susceptibility test interpretive criteria, also known as breakpoints. The FDA list of breakpoints is relatively short. Today, laboratories supplement FDA breakpoints using breakpoints published by the Clinical and Laboratory Standards Institute, using legacy devices and laboratory-developed tests (LDTs). FDA proposes to regulate LDTs, and with no FDA breakpoints for many drug-bug combinations, the risk is loss of AST for key clinical indications and stifling innovation in technology development. Effective solutions require collaboration between manufacturers, infectious diseases clinicians, pharmacists, laboratories, and the FDA.

Analysis of laboratory data transmission between two healthcare institutions using a widely used point-to-point health information exchange platform: a case report.

Objective: The objective was to identify information loss that could affect clinical care in laboratory data transmission between 2 health care institutions via a Health Information Exchange platform. Materials and Methods: Data transmission results of 9 laboratory tests, including LOINC codes, were compared in the following: between sending and receiving electronic health record (EHR) systems, the individual Health Level Seven International (HL7) Version 2 messages across the instrument, laboratory information system, and sending EHR. Results: Loss of information for similar tests indicated the following potential patient safety issues: (1) consistently missing specimen source; (2) lack of reporting of analytical technique or instrument platform; (3) inconsistent units and reference ranges; (4) discordant LOINC code use; and (5) increased complexity with multiple HL7 versions. Discussion and Conclusions: Using an HIE with standard messaging, SHIELD (Systemic Harmonization and Interoperability Enhancement for Laboratory Data) recommendations, and enhanced EHR functionality to support necessary data elements would yield consistent test identification and result value transmission.

Critical test result management at Danish hospital laboratories: a national survey.

Critical test results in clinical laboratories are crucial for timely patient care, serving as indicators of potentially life-threatening conditions. Despite their importance, a notable heterogeneity in management practices exists globally. This study investigates the current practices of managing critical results at Danish clinical biochemistry laboratories and identifies areas prone for improvement. A comprehensive online survey was distributed to all 21 Danish clinical biochemistry laboratories regarding their critical result management, including documentation practices, critical limit selection, and quality assurance measures. A total of 17 laboratories (81%) responded. The answers revealed a generally uniform approach to managing critical results, with all laboratories having 24-h reporting, local instructions and using the telephone as communication channel. However, variations were noted in documentation practices and critical limit selection. Notably, 23.5% of the laboratories reported that one out of every ten critical results was not reported, indicating a significant risk of delayed critical results. This is further complicated by the limited use of predefined timeframes for reporting and also, only few laboratories actively monitored response times. The findings emphasize the need for more standardized documentation and evaluation practices to align with international standards and to enhance patient safety. While the laboratories showed a commitment to standardized procedures, the study emphasizes the necessity of a National or Nordic guideline to supplement the ISO 15189:2022. This study is a step towards optimizing critical result management, not only in Danish clinical biochemistry laboratories but also across various laboratory specialties, thereby improving overall laboratory quality, efficiency, and patient safety.

PD-BAT: A novel approach of pooling basophil donors for expansion of commercial laboratory testing of Chronic Spontaneous Urticaria.

The type II autoimmune subtype of Chronic Spontaneous Urticaria (CSU) is characterized by the presence of IgG autoantibodies targeting IgE or the IgE high-affinity receptor (FcεRI) on mast cells and basophils. In evaluation of CSU patients, indirect basophil activation testing (BAT), has been utilized, involving the mixing of patient serum with heterologous peripheral blood donors, followed by flow cytometric assessment of basophil markers. However, the reliability of the indirect BAT results hinges on the quality of the donor basophils utilized. In this study, we introduce an innovative approach where multiple potential basophil donors undergo rigorous BAT characterization alongside control samples. By selecting and pooling donors with optimal performance, we significantly enhance the inter-assay reproducibility of the indirect BAT test.

Future clinical prospects of C-peptide testing in the early diagnosis of gestational diabetes.

Gestational diabetes is typically diagnosed in the late second or third trimester of pregnancy. It is one of the most common metabolic disorders among expectant mothers, with potential serious short- and long-term complications for both maternal and offspring health. C-peptide is secreted from pancreatic beta-cells into circulation in equimolar amounts with insulin. It is a useful biomarker to estimate the beta-cell function because it undergoes negligible hepatic clearance and consequently it has a longer half-life compared to insulin. Pregnancy induces increased insulin resistance due to physiological changes in hormonal and metabolic homeostasis. Inadequate compensation by islet beta-cells results in hyperglycemia. The standard oral glucose tolerance test at 24-28 wk of gestation sets the diagnosis. Accumulated evidence from prospective studies indicates a link between early pregnancy C-peptide levels and the risk of subsequent gestational diabetes. Elevated C-peptide levels and surrogate glycemic indices at the beginning of pregnancy could prompt appropriate strategies for secondary prevention.

Advances in sepsis biomarkers.

Sepsis, a dysregulated host immune response to an infectious agent, significantly increases morbidity and mortality for hospitalized patients worldwide. This chapter reviews (1) the basic principles of infectious diseases, pathophysiology and current definition of sepsis, (2) established sepsis biomarkers such lactate, procalcitonin and C-reactive protein, (3) novel, newly regulatory-cleared/approved biomarkers, such as assays that evaluate white blood cell properties and immune response molecules, and (4) emerging biomarkers and biomarker panels to highlight future directions and opportunities in the diagnosis and management of sepsis.

Lung cancer tumor marker analysis: A clinical laboratory perspective.

 Clinical laboratories are responsible for performing lung cancer tumor marker testing as part of routine clinical care. It is their responsibility to guarantee that the reported tumor marker results are reliable and meet the necessary quality standards for proper clinical use. During the different laboratory phases, pre-analytical, analytical and post-analytical, specific steps and processes can introduce errors and generate incorrect clinical interpretation. This editorial briefly outlines critical laboratory issues related to lung cancer tumor markers, specific for each of these three laboratory phases.

Using a Systems Engineering Approach to Build a PCR Testing System at a Medical School During the COVID-19 Pandemic.

Background: During the COVID-19 pandemic, there was an increasing need to expand diagnostic testing in hospitals. At Keio University Hospital (KUH), clinical staff were concerned that the demand for PCR testing might exceed the capacity of the Clinical Laboratory. In response, basic researchers at Keio University School of Medicine (KUSM) set out to build a new, collaborative, PCR testing system. To be authorized to perform such diagnostic PCR testing, KUSM registered its core laboratory as an external clinical laboratory (ECL). Methods: In the pandemic, there was a pressure to build the PCR system quickly. Speed required discussions that developed a shared understanding of the unprecedented, new KUH/KUSM PCR system. To design, construct, and archive the new PCR testing system, we used a systems engineering (SE) approach. This included diagram visualization of functional flows and application of the Unified Architecture Framework (UAF), both of which are often used in system building. We considered daily demand for PCR testing at KUH and KUSM, and daily COVID-19 infections in Japan. Results: We operated the collaborative PCR testing system from August 2020 to June 2022. Given public health insurance reimbursement policies, KUH focused on individuals with suspicious symptoms, while the ECL at KUSM screened samples from asymptomatic individuals. KUSM performed about half as many tests as KUH. Interviewing KUH staff revealed that diagrams helped promote a better understanding of the KUH/KUSM PCR testing system. Conclusion: When designing temporary systems that may be repurposed in the future, we suggest using an SE approach with diagrams and UAF perspectives. This approach will enable stakeholders to understand what is being proposed to be built, and facilitate achieving an informed consensus on the proposed system. We suggest that SE approaches should be widely used in projects that involve building and operating complex, collaborative systems, and documenting the process.

Biomedical laboratory scientists and technicians in digital pathology - Is there a need for professional development?

Objective: Digital pathology (DP) is moving into Danish pathology departments at high pace. Conventionally, biomedical laboratory scientists (BLS) and technicians have prepared tissue sections for light microscopy, but workflow alterations are required for the new digital era with whole slide imaging (WSI); digitally assisted image analysis (DAIA) and artificial intelligence (AI). We aim to explore the role of BLS in DP and assess a potential need for professional development. Methods: We investigated the roles of BLS in the new digital era through qualitative interviews at Danish Pathology Departments in 2019/2020 before DP implementation (supported by a questionnaire); and in 2022 after DP implementation. Additionally, senior lecturers from three Danish University Colleges reported on how DP was integrated into the 2023 bachelor's degree educational curricula for BLS students. Results: At some Danish pathology departments, BLS were involved in the implementation process of DP and their greatest concerns were lack of physical laboratory requirements (69%) and implementation strategies (63%). BLS were generally positive towards working with DP, however, some expressed concern about extended working hours for scanning. Work-task transfers from pathologists were generally greeted positively from both management and pathologists; however, at follow-up interviews after DP implementation, job transfers had not been effectuated. At Danish university colleges, DP had been integrated systematically in the curricula for BLS students, especially WSI. Conclusion: Involving BLS in DP implementation and development may benefit the process, as BLS have a hands-on workflow perspective with a focus on quality assurance. Several new work opportunities for BLS may occur with DP including WSI, DAIA and AI, and therefore new qualifications are warranted, which must be considered in future undergraduate programmes for BLS students or postgraduate programmes for BLS.

Laboratory Data Timeliness and Completeness Improves Following Implementation of an Electronic Laboratory Information System in Côte d'Ivoire: Quasi-Experimental Study on 21 Clinical Laboratories From 2014 to 2020.

BACKGROUND: The Ministry of Health in Côte d'Ivoire and the International Training and Education Center for Health at the University of Washington, funded by the United States President's Emergency Plan for AIDS Relief, have been collaborating to develop and implement the Open-Source Enterprise-Level Laboratory Information System (OpenELIS). The system is designed to improve HIV-related laboratory data management and strengthen quality management and capacity at clinical laboratories across the nation. OBJECTIVE: This evaluation aimed to quantify the effects of implementing OpenELIS on data quality for laboratory tests related to HIV care and treatment. METHODS: This evaluation used a quasi-experimental design to perform an interrupted time-series analysis to estimate the changes in the level and slope of 3 data quality indicators (timeliness, completeness, and validity) after OpenELIS implementation. We collected paper and electronic records on clusters of differentiation 4 (CD4) testing for 48 weeks before OpenELIS adoption until 72 weeks after. Data collection took place at 21 laboratories in 13 health regions that started using OpenELIS between 2014 and 2020. We analyzed the data at the laboratory level. We estimated odds ratios (ORs) by comparing the observed outcomes with modeled counterfactual ones when the laboratories did not adopt OpenELIS. RESULTS: There was an immediate 5-fold increase in timeliness (OR 5.27, 95% CI 4.33-6.41; P<.001) and an immediate 3.6-fold increase in completeness (OR 3.59, 95% CI 2.40-5.37; P<.001). These immediate improvements were observed starting after OpenELIS installation and then maintained until 72 weeks after OpenELIS adoption. The weekly improvement in the postimplementation trend of completeness was significant (OR 1.03, 95% CI 1.02-1.05; P<.001). The improvement in validity was not statistically significant (OR 1.34, 95% CI 0.69-2.60; P=.38), but validity did not fall below pre-OpenELIS levels. CONCLUSIONS: These results demonstrate the value of electronic laboratory information systems in improving laboratory data quality and supporting evidence-based decision-making in health care. These findings highlight the importance of OpenELIS in Côte d'Ivoire and the potential for adoption in other low- and middle-income countries with similar health systems.