Laboratory Capacity Research Articles

Large scale system transformation: Ukraine

Abstract In the context of the EU-Ukraine Accession agreement, Ukraine started large scale public health systems reform back in 2015. The COVID-19 pandemic tested the response capacity of the national public health system and led to some improvement during the pandemic such as on laboratory capacity. It also generated lessons for strengthening national and subnational health emergency preparedness and response. Multiple interventions, including a Joint External Evaluation led to the adoption of the Public Health System Law in 2022, laying the foundation to bolster health promotion, disease prevention, and health protection. The Ukrainian Public Health Centre was substantially strengthened, partly oriented on models in other European countries. Corresponding centers for diseases control and prevention at the oblast level were reformed and a subnational network of these centers was created. While the war has a significant impact on the public health system, infrastructure, people and more, decision makers and professionals keep working on sustaining and moving forward the achievements on public health reforms, for example with the adoption of the National Health Strategy 2030 and the adoption of the National Health Security Plan. Further legal and strategic preparations are afoot to strengthen public health services governance capacity, financing, institutional innovation and development, and public health workforce development.

Large scale public health system transformation: Germany

Abstract The COVID-19 pandemic was a stress test for public health services in Germany. Decision making was complex (party lengthy and inconsistent) due to the divided responsibilities within the federal system. Some improvements on the public health system were already enacted during the pandemic. A “pandemic radar” was established to bundle up relevant infectious disease indicators with indicators of health services use. The national electronic notification and information system for infectious diseases was extended. Digital improvements were made in the public health offices. Laboratory capacity was strengthened, so was inter-science modelling to forecast pathogen spread. A nation-wide collaborative mechanism, the cloverleaf system, was introduced between regions to avoid the overburdening of hospitals. It is now established for times of excess need for inpatient services. In 2020, a 4 billion euros investment program, the “Pact of Public Health Services”, was adopted to strengthen and modernize the German public health service institutions. The pact is implemented until 2026. The human resources component is the largest. Further priorities include digitalization, improvement of the infrastructure (of designated ports and airports) for the implementation of the International Health Regulations, research and the creation of agile and resilient public health structures. Outputs so far include the establishment of more than 4800 new public health positions, the appointment of new professorships for public health services, the initiation of several research projects, and the roll-out of more than 300 digitalization projects. A new federal institute for prevention is planned. It aims to foster networking between public health services, strengthen health communication, data use, and evidence for public health services. In this process, WHO advised the federal ministry e.g. on behavioral insights; heat health action; prevention on noncommunicable diseases and others. Many public health actors have provided opinions. However, consensus building on how Germany can overcome fragmentation in public health is ongoing.

Strengthening anthrax outbreak response and preparedness: simulation and stakeholder education in Namisindwa district, Uganda

BackgroundAnthrax is a zoonotic disease caused by Bacillus anthracis that poses a significant threat to both human health and livestock. Effective preparedness and response to anthrax outbreak at the district level is essential to mitigate the devastating impact of the disease to humans and animals. The current diseaae surveillance in animals and humans uses two different infrastructure systems with online platform supported by established diagnostic facilities. The differences in surveillance systems affect timely outbreak response especially for zoonotic diseases like anthrax. We therefore aimed to assess the feasibility of implementing a simulation exercise for a potential anthrax outbreak in a local government setting and to raise the suspicion index of different district stakeholders for a potential anthrax outbreak in Namisindwa District, Uganda.MethodsWe conducted a field-based simulation exercise and a health education intervention using quantitative data collection methods. The study participants mainly members of the District Taskforce (DTF) were purposively selected given their role(s) in disease surveillance and response at the sub-national level. We combined 26 variables (all dichotomized) assessing knowledge on anthrax and knowledge on appropriate outbreak response measures into an additive composite index. We then dichotomized overall score based on the 80% blooms cutoff i.e. we considered those scoring at least 80% to have high knowledge, otherwise low. We then assessed the factors associated with knowledge using binary logistic regression with time as a proxy for the intervention effect. Odds ratios (ORs) and 95% Confidence intervals (95%CI) have been reported.ResultsThe overall district readiness score was 35.0% (24/69) and was deficient in the following domains: coordination and resource mobilization (5/16), surveillance (5/11), laboratory capacity (3/10), case management (4/7), risk communications (4/12), and control measures (4/13). The overall community readiness score was 7 out of 32 (22.0%). We noted poor scores of readiness in all domains except for case management (2/2). The knowledge training did not have an effect on the overall readiness score, but improved specific domains such as control measures. Instead tertiary education was the only independent predictor of higher knowledge on anthrax and how to respond to it (OR = 1.57, 95% CI = 1.07–2.31). Training did not have a significant association with overall knowledge improvement but had an effect on several individual knowledge aspects.ConclusionWe found that the district’s preparedness to respond to a potential anthrax outbreak was inadequate, especially in coordination and mobilisation, surveillance, case management, risk communication and control measures. The health education training intervention showed increased knowledge levels compared to the pre-test and post-test an indicator that the health education sessions could increase the index of suspicion. The low preparedness underscores the urgency to strengthen anthrax preparedness in the district and could have implications for other districts. We deduce that trainings of a similar nature conducted regularly and extensively would have better effects. This study’s insights are valuable for improving anthrax readiness and safeguarding public and animal health in similar settings.

A comprehensive study on the production of potassium sorbate and sodium benzoate reference material in orange juice

Controlling the content of preservatives in soft drinks is of paramount important for assessing their quality during production and consumption, as well as for ensuring consumer health. To effectively enhance laboratory capacity in preservatives analysis, the requirement for reference materials (RMs) of non-alcoholic beverages containing common preservatives such as potassium sorbate and sodium benzoate is fundamentally essential. This research was conducted to provide a procedure for the production of reference materials for potassium sorbate and sodium benzoate in orange juice. The concentration of potassium sorbate and sodium benzoate in the reference materials complied with Circular No.24/2019/TT-BYT which regulates the management and use of food additives. The two RMs of natural and flavored orange juice were homogeneous and stable, however, their quality and stability were strongly affected by the storage temperature. At a particular condition of 5°C, synthetic orange juice witnessed a higher stability than natural at 532 days and 318 days, respectively. Furthermore, an accelerated aging study demonstrated that at -20°C, the integrity of potassium sorbate and sodium benzoate in natural orange juice was identically maintained for a substantial period of almost 3 years (expected shelf life 1,049 days).

The home-based breathing and chest mobility exercise improves cardiorespiratory functional capacity in long COVID with cardiovascular comorbidities: a randomized study

BackgroundBeyond the acute phase, a considerable proportion of patients recovering from the coronavirus disease 2019 (COVID-19) experience long-term sequelae that profoundly impact their quality of life, particularly their physical fitness. This study aims to assess the effect of home-based breathing and chest mobility exercise on the cardiorespiratory functional capacity of long COVID with cardiovascular comorbidity.MethodsIn this randomized, controlled, single-blind clinical trial, 46 long COVID with cardiovascular comorbidities were randomly assigned to either intervention or control group. The intervention group (n = 23) received additional home-based breathing and chest mobility exercise 3x/week for 12 weeks supervised by attending physicians, whereas the control group only received a home-based cardiac rehabilitation program. Baseline and post-intervention assessments consisted of laboratory (D-Dimer and CRP levels) and functional capacity, assessed through 6-minute walking test (6-MWT), exercise stress test’s metabolic equivalents (METS), and predicted peak oxygen consumption (VO2 peak), peak expiratory flow rate (PEFR), peak cough flow (PCF), chest expansion, and EuroQoL’s quality of life. Intention to treat analysis was performed.ResultsAt the 12th week, intervention subjects had significantly greater functional capacity with higher mean PEFR (p = .031) and PCF (p = .016). Similarly, 6-MWT was higher in the group receiving home-based breathing and chest mobility training (p = .032). The bottom part of the chest circumference was statistically different between the two groups (p = .01). METS and predicted VO2 peak were also higher in the intervention group. However, laboratory parameters and quality of life did not differ markedly (p > .05).ConclusionsHome-based respiratory and chest mobility exercise could be an adjunct to cardiac rehabilitation in long COVID with cardiovascular comorbidities for improving cardiorespiratory functional capacity.Trial registrationThe study protocol was registered at http://ClinicalTrial.gov.id NCT05077943 (14/10/2021).

Diagnostics for detection and surveillance of priority epidemic-prone diseases in Africa: an assessment of testing capacity and laboratory strengthening needs.

In 2023, Africa experienced 180 public health emergencies, of which 90% were infectious diseases and 75% were related to zoonotic diseases. Testing capacity for epidemic-prone diseases is essential to enable rapid and accurate identification of causative agents, and for action to prevent disease spread. Moreover, testing is pivotal in monitoring disease transmission, evaluating public health interventions and informing targeted resource allocation during outbreaks. An online, self-assessment survey was conducted in African Union Member States to identify major challenges in testing for epidemic-prone diseases. The survey assessed current capacity for diagnosing priority epidemic-prone diseases at different laboratory levels. It explored challenges in establishing and maintaining testing capacity to improve outbreak response and mitigate public health impact. Survey data analysed diagnostic capacity for priority infectious diseases, diagnostic technologies in use, existing surveillance programmes and challenges limiting diagnostic capacity, by country. The survey result from 15 Member States who responded to the survey, showed high variability in testing capacity and technologies across countries and diverse factors limiting testing capacity for certain priority diseases like dengue and Crimean-Congo haemorrhagic fever. At the same time diagnostic capacity is better for coronavirus disease 2019 (COVID-19), polio, and measles due to previous investments. Unfortunately, many countries are not utilizing multiplex testing, despite its potential to improve diagnostic access. The challenges of limited laboratory capacity for testing future outbreaks are indeed significant. Recent disease outbreaks in Africa have underscored the urgent need to strengthen diagnostic capacity and introduce cost-effective technologies. Small sample sizes and differing disease prioritisation within each country limited the analysis. These findings suggest the benefits of evaluating laboratory testing capacity for epidemic-prone diseases and highlight the importance of effectively addressing challenges to detect diseases and prevent future pandemics.

Multidisciplinary Collaboration in Combatting Antimicrobial Resistance: Insights and Outcomes From the National Alliance of Medical Professionals on Antimicrobial Resistance (NAMP-AMR) Initiative.

Antimicrobial resistance (AMR) poses a critical global health challenge, requiring a coordinated and vigorous response. Despite numerous global and national efforts, a unified multidisciplinary approach has been missing. The National Alliance of Medical Professionals on Antimicrobial Resistance (NAMP-AMR), led by the Indian Medical Association in collaboration with key stakeholders such as NITI Aayog and the Ministry of Health, seeks to address this gap. This alliance unites 52 medical specialty organizations and associations to enhance efforts across various sectors, developing comprehensive strategies for awareness, surveillance, infection control, and optimization of antimicrobial use. The foundational meeting of NAMP-AMR on July 7, 2024, established a collaborative roadmap, promising to bolster India's efforts against AMR and support the forthcoming National Action Plan on AMR 2.0. The meeting concentrated on six key areas: improving AMR awareness and advocacy; strengthening laboratory capacities and surveillance; enhancing infection prevention and control (IPC); optimizing antimicrobial use through stricter regulations and stewardship programs; advancing AMR research and innovation; and fostering strong national and international collaborations. This initiative marks a significant advancement in combating AMR and positions India as a leader in global health efforts against this critical issue.

Strengthening the Application of the DAIDS GCLP Guidelines: The Implementation of an Integrated Laboratory Oversight Framework.

The Division of AIDS (DAIDS) Good Clinical Laboratory Practice (GCLP) Guidelines establish a framework to guide the oversight of laboratories supporting DAIDS-sponsored clinical research or trials. Compliance with these guidelines promotes data reliability, validity, and safety of the clinical research or trial participants and laboratory staff and ensures adherence to regulatory requirements. Acknowledgment and adoption of the DAIDS GCLP Guidelines are critical in building laboratory capacity and preparedness for conducting clinical trials. In collaboration with DAIDS, laboratory experts support the implementation of the DAIDS Integrated Laboratory Oversight Framework (Framework) activities. This article describes the implementation of the GCLP Guidelines, the Framework activities, and the coordinated efforts to strengthen laboratory performance. The Framework activities include four components: Quality Assurance Oversight, GCLP Audits, GCLP Training, and Laboratory Quality Improvement. Comparison of GCLP Guidelines with other regulations or standards, including U.S. Clinical Laboratory Improvement Amendments regulation 42 CFR 493, College of American Pathologists, World Health Organization GCLP, and International Organization for Standardization, ISO 15189:2012 standards, highlighted the differences and similarities to guide integration and harmonization efforts. Processes related to the Framework activities are outlined in detail, including key data derived from the managed activities of over 175 laboratories worldwide. Via the evolution of the DAIDS GCLP Guidelines and laboratory oversight workflows, the laboratories participating in DAIDS-sponsored clinical research and trials have successfully participated in internal and external regulatory audits. The collaborative and integrated oversight approach promotes knowledge-sharing and accountability to support the implementation of the DAIDS GCLP Guidelines and compliance monitoring. Lessons learned have helped with the implementation of the DAIDS integrated laboratory oversight approach and quality oversight programs at multiple laboratories worldwide.

An improved similarity method for stiffened plates subjected to combined loads of longitudinal compression and lateral pressure

Structures’ ultimate strength has been increasingly valued in the past few decades. The model test is an important and reliable way to estimate the ultimate strength. For large and complex structures, like ship hull structures, the test subject is usually scale models due to the limitation of loading capacity and space of laboratories. Therefore, the similarity method and the design of scale models are of great importance. The stiffened plate is the minimum unit that makes up thin-walled structures. The similarity method of the ultimate strength of stiffened plates is the base of the similarity method of large and complex structures. This paper is a further study of an existing similarity method proposed in our previous work. A stiffened plate from a real ship is taken as the subject. 22 combinations of scale ratios are used to design scale models. The 23 models (including the original model) are subjected to a combined load of longitudinal compression and lateral pressure. The non-linear finite element method is used to analyze these models. The results revealed that the previous method is only suitable for scale models with small degrees of geometrical distortion. It didn't consider the effect of geometrical distortions. An improved similarity method and scale model design method are proposed to solve these problems. The improved methods consider the geometrical distortion of scale models and are applicable to more geometrically distorted scale models. More numerical examples are performed to verify the correctness and advantage of the improved methods.

RE: 'Laboratory capacity expansion: lessons from establishing molecular testing in regional referral laboratories in Ethiopia'.

RE: 'Laboratory capacity expansion: lessons from establishing molecular testing in regional referral laboratories in Ethiopia'.

Deposition morphology and mechanical properties of lean cemented gangue backfill material: Laboratory test and field application

Backfilling mining technology provides an efficient and environmentally-friendly solution for treating additional products (such as tailings, coal gangue and other solid waste) in coal mining process, which are filled into the underground goaf area, thus reducing surface subsidence, roof strata damage, and associated geological disasters. In this study, a novel backfill material called lean cemented gangue backfill material (LCGBM) is introduced, and various experiments, including uniaxial compression tests, creep tests, CT-SEM scanning and reconstruction are carried out to evaluate its mechanical properties and engineering practicability. The test results indicate that the strength and volume fraction of self-compacting cement (SCC) slurry and solid waste aggregate jointly control the uniaxial compressive strength and failure mode of LCGBM, reflecting the bucket effect under the influence of two components. Although the volume fraction of aggregate and SCC slurry is intentionally reduced to control the cost, this cemented granular material shows excellent compressive strength, overall stiffness and long-term bearing capacity in laboratory and field tests. In the process of engineering application, the uniaxial compressive strength of the LCGBM reaches 14 MPa, and the initial setting time is 120 s, which reduces the consumption of gangue aggregate by 35 % and greatly reduces the construction time. In addition, a calculation method of the optimal mixing ratio of raw materials is proposed, which can adjust the strength and volume fraction of SCC slurry according to the optimal mixing range, so as to maximize the utilization of the strength of LCGBM, and reduce the construction time and aggregate of backfilling. The research findings emphasize the potential of the LCGBM in promoting clean and sustainable coal mining practice.

Potential risks of Oropouche virus importation into Europe.

Imported cases of Oropouche fever were recently detected in Italy. Upcoming mass events, i.e. the 2024 Olympic Games in Paris and the 2025 Jubilee in Rome, represent increasing likelihood of further OROV importation and potential spread in new areas, underscoring the importance of strengthening surveillance, laboratory capacity and ecology studies.

A Situation Analysis of the Capacity of Laboratories in Faith-Based Hospitals in Zambia to Conduct Surveillance of Antimicrobial Resistance: Opportunities to Improve Diagnostic Stewardship.

Antimicrobial resistance (AMR) is a public health problem exacerbated by the overuse and misuse of antibiotics and the inadequate capacity of laboratories to conduct AMR surveillance. This study assessed the capacity of laboratories in seven faith-based hospitals to conduct AMR testing and surveillance in Zambia. This multi-facility, cross-sectional exploratory study was conducted from February 2024 to April 2024. We collected and analysed data using the self-scoring Laboratory Assessment of Antibiotic Resistance Testing Capacity (LAARC) tool. This study found an average score of 39%, indicating a low capacity of laboratories to conduct AMR surveillance. The highest capacity score was 47%, while the lowest was 25%. Only one hospital had a full capacity (100%) to utilise a laboratory information system (LIS). Three hospitals had a satisfactory capacity to perform data management with scores of 83%, 85%, and 95%. Only one hospital had a full capacity (100%) to process specimens, and only one hospital had good safety requirements for a microbiology laboratory, with a score of 89%. This study demonstrates that all the assessed hospitals had a low capacity to conduct AMR surveillance, which could affect diagnostic stewardship. Therefore, there is an urgent need to strengthen the microbiology capacity of laboratories to enhance AMR surveillance in Zambia.

Mycology laboratory diagnostic capacity for invasive fungal diseases in public hospitals in Vietnam.

This was a cross-sectional study on the availability of laboratory infrastructure and capacity for the diagnosis of invasive fungal diseases in 24 public hospitals in Vietnam in 2023. Among the hospitals surveyed, 66.7% (14/21) had specialised personnel assigned for mycology testing, and 95.8% (23/24) had a separate microbiology laboratory space. Microscopy and culture methods are available in nearly all laboratories for isolate identification. Antifungal susceptibility testing is only performed for yeasts in 16/24 (66.7%) laboratories. Non-culture methods are hardly used in laboratories. Strengthening local laboratory capacities is essential to meeting health needs in these endemic regions.

The Importance of Networks and Relationships: Leveraging the Biocontainment Unit Leadership Workgroup for Special Pathogen Outbreak Response.

Developing and sustaining relationships and networks before an emergency occurs is crucial. The Biocontainment Unit Leadership Workgroup is a consortium of the 13 Regional Emerging Special Pathogen Treatment Centers in the United States. Established in 2017, the volunteer-based workgroup is composed of operational leaders dedicated to maintaining readiness for special pathogen care. Monthly meetings focus on addressing operational challenges, sharing best practices, and brainstorming solutions to common problems. Task forces are leveraged to tackle more complex issues that are identified as priorities. In 2022, members of the workgroup were harnessed for response efforts related to mpox, Sudan ebolavirus, and Marburg virus disease. The weekly Outbreak Readiness call is a shared effort between the Biocontainment Unit Leadership Workgroup and the Special Pathogens Research Network of the National Emerging Special Pathogens Training and Education Center. Call participants included leaders of the Regional Emerging Special Pathogen Treatment Centers and federal partners who shared weekly updates on operational readiness of units, case counts, laboratory capacity, available medical countermeasures, and other pertinent information. The routine exchange of real-time information enabled learning and collegial sharing of experiences, highlighted the experience of the network to federal partners, and provided situational awareness of special pathogen outbreaks across the country. The consortium enabled this rapid convening of partners to meet an urgent need for special pathogen response. The weekly Outbreak Readiness call is a communication model and scalable framework that serves both domestic preparedness efforts and international efforts should the need for a collaborative global response arise. In this case study, we describe the framework and experience of this partnership, along with the structure of rapid deployment for group convening.

Bovine leukemia virus transmission rates in persistent lymphocytotic infected dairy cows.

Bovine leukemia virus (BLV) establishes a lifelong persistent infection in dairy cattle. White blood cell count (WBC) is correlated with proviral load in the blood and milk of BLV-infected cattle, and testing WBC can be used to assess both BLV infectiousness levels and risk of BLV transmission from different types of infected animals. The objective of the study was to compare effective transmission rates (β) and the basic reproduction ratio (R o) among two types of BLV-infected dairy cows in Chile: those affected with persistent lymphocytosis (PL) vs. aleukemic (AL).The estimated (β) coefficient was higher in PL cattle [1.1; 95% Confidence interval (CI) (-1.6, 3.8)], compared to AL cattle (-3.1; 95% CI = -3.7, -2.5). In addition, the R o was higher in PL cattle (60.4; 95% CI = 3.5; 820.6), compared to AL cattle (1.5; 95% CI = 0.7, 3.1). The ratio between PL/AL expected rate of cases was 73.9. The estimated effective transmission rate and the Ro were higher in PL cattle compared to AL cattle. The WBC test is a convenient alternative that can be considered for risk identification and risk management of BLV infection in dairy herds; particularly in livestock regions where laboratory capacity is limited (e.g., use of PCR or gene sequencing techniques) and/or molecular tests are not cost-effective. Therefore, when prevalence of infection is high, the removal of PL cattle should be engaged to control BLV within-herds.

Implementing an integrated molecular classification for gastric cancer from endoscopic biopsies using on-slide tests.

The availability of more effective biological therapy can improve outcomes of gastric cancer (GC), but most patients do not have access to personalized treatment. GC molecular classification helps identify patients suitable for specific therapies and provides useful prognostic information. To date, only a small number of patients have access to molecular classification. We proposed a working molecular classification that can be delivered using on-slide tests available in most histopathology laboratories. We used eight on-slide tests [in situ hybridization (ISH) for Epstein-Barr virus-encoded small ribonucleic acid (EBER) and immunohistochemistry (IHC) for MutL homolog 1 (MLH1), PMS1 homolog 2 (PMS2), MutS homolog 2 (MSH2), MutS homolog 6 (MSH6), E-cadherin, β-catenin and p53] to classify GC into one of six categories: GC associated with Epstein-Barr virus (GC-EBV), GC mismatch repair deficient (GC-dMMR), GC with epithelial-mesenchymal transition (GC-EMT), GC with chromosomal instability (GC-CIN), GC genomically stable (GC-GS) and GC not otherwise specified (GC-NOS)∕indeterminate. The classification has provision also for current and future on-slide companion diagnostic (CDx) tests necessary to select specific biological therapies and, as proof of principle, in this study we used three CDx tests currently required for the management of GC [human epidermal growth factor receptor 2 (Her2), programmed cell death-ligand 1 (PD-L1) 22C3 and Claudin18.2 (CLDN18.2)]. This paper describes the necessary tissue pathways and laboratory workflow and assesses the feasibility of using this classification prospectively on small endoscopic biopsies of gastric and gastroesophageal junction adenocarcinoma. This work demonstrates that such molecular classification can be implemented in the context of a histopathology diagnostic routine with little impact on turnaround times and laboratory capacity. The widespread adoption of a molecular classification for GC will help refine prognosis and guide the choice of more appropriate biological therapy for these patients.

Laboratory capacity expansion: lessons from establishing molecular testing in regional referral laboratories in Ethiopia.

Respiratory viruses contribute to high morbidity and mortality in Africa. In 2020, the Ohio State University's Global One Health Initiative, in collaboration with the Ethiopian Public Health Institute and the US Centers for Disease Control and Prevention, took action to strengthen Ethiopia's existing respiratory virus surveillance system through decentralization of laboratory testing and scale-up of national and regional capacity for detecting respiratory viruses. In August 2022, four regional laboratories were established, thereby raising the number of reference laboratories conducting respiratory virus surveillance to five. This article highlights lessons learned during implementation and outlines processes undertaken for laboratory scale-up and decentralization.

Evaluation of the implementation of the rational use of laboratory tests in the clinical chemistry laboratory

Abstract Objectives The ‘Rational Laboratory Use Project’ (RLUP) was launched in 2018 by the Department of Examination and Diagnosis Services under the General Directorate of Health Services of the Republic of Turkey’s Ministry of Health. In this study, we aimed to determine the rate of implementation of RLUP in medical biochemistry laboratories, and to contribute to new regulations by collecting the information and opinions of the laboratory experts participating the survey. Methods Thirty questions were uploaded to an online survey tool (SurveyMonkey®, San Mateo, ABD). The first five were descriptive for laboratories. Among the remaining 25 questions, one is open-ended and addresses the various topics encompassed by the project’s scope. Results The questionnaire was completed by 202 medical biochemistry specialists, of whom 82.12 % reported that they did not implement autoverification. 55.65 % defined consultations in Hospital Management Information System (HIMS), but; 70.49 % were not using it actively. 57.69 % of the participants answered, “I agree” to the statement “I think RLUP is feasible”. It was observed that the specialists tried to implement rational laboratory practices partially depending on their laboratory capacity, hospital administration and Laboratory Information Management System (LIMS). Conclusions Increasing clinicians’ awareness could increase the success of this project, which might provide more effective diagnosis and treatment for the patient. In our view, actively involving stakeholders of the information management system, which is not under the direct control of laboratory professionals, in the RLUP will accelerate the development of the project.

Implementing pharmacogenetic testing to optimize proton-pump inhibitors use among Indian population based on CPIC-CYP2C19-PPI dosing guidelines: The need of the hour.

Proton-pump inhibitors (PPIs) are widely prescribed to decrease stomach acid and treat various acid-related Gastrointestinal tract (GIT) diseases. However, genetic variations, particularly in the CYP2C19 gene, affect PPIs metabolism and efficacy. Variants in CYP2C19 can result in different rates of PPI metabolism, influencing their effectiveness. Personalized medicine strategies, such as genotyping for CYP2C19, have the potential to enhance the effectiveness of PPI therapy and patient safety. This review aims to describe the relevance of CYP2C19 genetic profiling in the indian population, including normal function (e.g. CYP2C19*1, *11, *13, *15, *18, *28, and 38), decreased function (e.g., CYP2C19*9, *10, *16, *19, *25, and 26), loss of function (e.g., CYP2C19*2, *3, *4, *5, *6, *7, *8, *22, *24, *35, *36, and *37), and increased function (e.g., CYP2C19*17) variants. This review also examines the clinical pharmacogenomics implementation consortium (CPIC)-CYP2C19-PPI guidelines to highlight the importance of pharmacogenomics (PGx)-informed personalized PPI therapy for gastroesophageal reflux disease and peptic ulcer disease treatment. On average, each person in India possesses eight pharmacogenetic (PGx) variants that can be clinically significant, underscoring the need for preemptive testing. Implementing CYP2C19 genetic testing in India requires expanding laboratory capacity, increasing accessibility in primary care, increasing public awareness, collaboration between pharmacovigilance and PGx programs, investing in advanced sequencing technologies, data management systems, and integration with electronic health records and clinical decision support systems. Addressing challenges such as genetic diversity, socioeconomic factors, health-care access issues, and shortage of trained professionals is essential for implementation. Due to the lack of definitive country-specific policies and PGx guidelines from Indian drug regulatory agencies, guidelines from international consortia such as the Clinical Pharmacogenetics Implementation Consortium and drug labeling offer crucial foundational evidence. This evidence can be used to enhance patient outcomes and ensure the safe and effective use of PPIs in India.