Regulatory Guidelines Research Articles

Ultra-High-Performance Liquid Chromatography–Tandem Mass Spectrometry Analysis of Δ9-Tetrahydrocannabinol and Cannabidiol in Commercial Suk-Saiyasna Herbal Remedy: Applying Hansen Solubility Parameters for Sample Extraction to Ensure Regulatory Compliance

Background: Suk-Saiyasna is a traditional Thai herbal remedy that comprises 12 distinct herbs. Among these, cannabis leaves constitute 12 of the total 78 components in this formulation. This study specifically examines the portion of the cannabis plant, which accounts for approximately 15.8% of the overall herbal composition used in the entire remedy. According to the Thailand Narcotics Act of 2022, the Δ9-tetrahydrocannabinol (Δ9-THC) concentration in herbal extracts must not exceed 0.2% by weight. This study aims to quantify the levels of Δ9-THC and cannabidiol (CBD) in commercial Suk-Saiyasna products. Methodology: This research utilizes Hansen Solubility Parameters (HSPs) to identify the optimal solvent for ultrasonic extraction, thereby maximizing cannabinoid yield. An advanced method was developed employing ultra-high-performance liquid chromatography–tandem mass spectrometry (UHPLC-MS/MS), compliant with AOAC standards to meet regulatory guidelines. The method validation emphasized specificity, linearity, sensitivity, accuracy, and precision. Results: Dichloromethane was chosen due to its favorable HSP values, enabling highly efficient extraction of Δ9-THC and CBD, achieving recovery rates of over 99.9% after the second extraction. This investigation benefits from the accuracy of the UHPLC-MS/MS technique in quantifying cannabinoids in commercial products, with Δ9-THC concentrations observed between 0.00231% and 0.14218%, and CBD concentrations ranging from 0.00002% to 0.01541%, all remaining below the legal limit. Conclusions: The variability in cannabinoid concentrations among various commercial products highlights the need for standardization in the herbal industry. This finding underscores the critical role of rigorous quality control measures in ensuring the safety and efficacy of cannabis-derived products.

Nursing Home Administrators’ Experiences of Work Stress and Intention to Quit during the COVID-19 Pandemic

Abstract Background and Objectives The COVID-19 pandemic negatively impacted nursing home administrators (NHAs). This study explores licensed and employed NHA’s perceptions about what work stress events would drive their turnover intentions (TI) in year three of the pandemic. Research Design and Methods As part of a larger survey-based research project collecting numerical and textual data, this study conducted content analysis with qualitative data. Narrative data from 3,859 discrete responses of 1,139 NHAs, from 50 states and Washington D.C, on two open-ended electronic survey questions asking about their work stress and TI were collected February – March 2022. Categories and subcategories were counted and discussed in context as themes. Results We identified 4 main narrative categories with subcategories about NHA’s stress about the regulatory system (e.g., excessive, conflicting, changing regulations), staffing (e.g., insufficient, agency staff), organizational pressures (e.g., work overload), and macro system stressors (e.g. media representation of nursing homes). Three main TI categories with subcategories were identified: the LTC setting and system (e.g., regulatory demands, staffing, facility surveys); personal factors (e.g. stress, career opportunities), and others (e.g., “I would never quit,” or “I already decided to quit”). Discussion and Implications Whole community disaster planning, person-centered surveyor training, improved regulatory guidance, simplified reporting, adequate guidance assistance, and adequate staff could mitigate NHA stress and TI during crises. Administrator resilience should be recognized. Solutions for supporting NHAs can include long-term care industry participation in public health disaster preparedness coalitions, consistent regulatory guidelines with established communication channels, and ongoing crisis leadership training for administrators.

A Comprehensive Review of Multimodal XR Applications, Risks, and Ethical Challenges in the Metaverse

This scoping review examines the broad applications, risks, and ethical challenges associated with Extended Reality (XR) technologies, including Virtual Reality (VR), Augmented Reality (AR), and Mixed Reality (MR), within the context of Metaverse. XR is revolutionizing fields such as immersive learning in education, medical and professional training, neuropsychological assessment, therapeutic interventions, arts, entertainment, retail, e-commerce, remote work, sports, architecture, urban planning, and cultural heritage preservation. The integration of multimodal technologies—haptics, eye-, face-, and body tracking, and brain–computer interfaces—enhances user engagement and interactivity, playing a key role in shaping the immersive experiences in the Metaverse. However, XR’s expansion raises serious concerns, including data privacy risks, cybersecurity vulnerabilities, cybersickness, addiction, dissociation, harassment, bullying, and misinformation. These psychological, social, and security challenges are further complicated by intense advertising, manipulation of public opinion, and social inequality, which could disproportionately affect vulnerable individuals and social groups. This review emphasizes the urgent need for robust ethical frameworks and regulatory guidelines to address these risks while promoting equitable access, privacy, autonomy, and mental well-being. As XR technologies increasingly integrate with artificial intelligence, responsible governance is essential to ensure the safe and beneficial development of the Metaverse and the broader application of XR in enhancing human development.

Advancements in Virtual Bioequivalence: A Systematic Review of Computational Methods and Regulatory Perspectives in the Pharmaceutical Industry

Background/Objectives: The rise of virtual bioequivalence studies has transformed the pharmaceutical landscape, enabling more efficient drug development processes. This systematic review aims to explore advancements in physiologically based pharmacokinetic (PBPK) modeling, its regulatory implications, and its role in achieving virtual bioequivalence, particularly for complex drug formulations. Methods: We conducted a systematic review of clinical trials using computational methods, particularly PBPK modeling, to carry out bioequivalence assessments. Eligibility criteria are emphasized during in silico modeling and pharmacokinetic simulations. Comprehensive literature searches were performed across databases such as PubMed, Scopus, and the Cochrane Library. A search strategy using key terms and Boolean operators ensured that extensive coverage was achieved. We adhered to the PRISMA guidelines in regard to the study selection, data extraction, and quality assessment, focusing on key characteristics, methodologies, outcomes, and regulatory perspectives from the FDA and EMA. Results: Our findings indicate that PBPK modeling significantly enhances the prediction of pharmacokinetic profiles, optimizing dosing regimens, while minimizing the need for extensive clinical trials. Regulatory agencies have recognized this utility, with the FDA and EMA developing frameworks to integrate in silico methods into drug evaluations. However, challenges such as study heterogeneity and publication bias may limit the generalizability of the results. Conclusions: This review highlights the critical need for standardized protocols and robust regulatory guidelines to facilitate the integration of virtual bioequivalence methodologies into pharmaceutical practices. By embracing these advancements, the pharmaceutical industry can improve drug development efficiency and patient outcomes, paving the way for innovative therapeutic solutions. Continued research and adaptive regulatory frameworks will be essential in navigating this evolving field.

Understanding the Challenges Associated with Approval of Anticancer Products to Facilitate the Regulatory Approvals: A Cross-sectional Study

Purpose: Oncological medications face a myriad of challenges, including technological, pre-clinical, clinical, and manufacturing, that lead to regulatory approval delays or failures. The present study aims to identify some challenges encountered by researchers or regulators during the development of novel cancer therapies. Methods: The present cross-sectional observational study used a mixed-method design methodology. The participants were selected via a non-random sampling method via self-selection and snowballing approach. A survey questionnaire was developed and circulated among the selected participants as a hard copy or email or a Google form. Open-ended and closed-ended questions were incorporated to identify the regulatory challenges faced during oncology drug development. The responses were collected from September 2021 to June 2022. These responses were then coded and themes were identified for the challenges. Results: A total of 87 responses were obtained for the questionnaire among the individuals contacted. Seven themes were identified from the collated responses that depicted the challenges for the regulatory approval of anticancer drug products. The majority of responders (38.2%) suggested reduced approval time whereas endpoint selection and study design were considered as a challenge by 12.0% of responders each. Furthermore, 6.0% of responders admit that timely interaction with the regulators is also a challenge that delays approval. Many challenges also exist during the product development phase; hence, 12.0% of responders reported safety issues, and 22.0% of responders reported technical issues during manufacturing as the cause of regulatory failure. Moreover, 12.0% of responders suggested the need for improvements in regulatory guidelines for oncology drug development. Conclusion: The survey indicates a lack of Indian guidelines for anticancer products, whereas limited guidance is available from other countries such as Europe or the United States. Thus, the survey points to the necessity for improvement in the regulatory guidelines and drug approval process to address the challenges unique to cancer drug development.

A Review on Genotoxic Impurities in Pharmaceutical Dosage Forms and Strategies for Identification

Abstract: Genotoxic pollutants can be broadly defined as pollutants that, regardless of the mechanism, cause significant changes in genetic material. People all over the world suffer from various health problems due to genotoxic pollutants. Recent recommendations from drug regulatory agencies in Europe and the United States (USA) require the monitoring of genotoxic and potentially genotoxic contamination in drug formulations at the ppm level. Therefore, this review evaluates several regulatory agency guidelines for monitoring genotoxic contamination, impurity levels, and toxicity in pharmaceutical products. The review also discusses analytical considerations for measuring genotoxic pollutants at trace levels and concludes with several examples of measuring several important classes of genotoxic pollutants. We will also explain our results. The article provides detailed information on genotoxicity studies of waste solutions, metal wastes, and isolated pollutants.

Filling the void: Expanding the role of PAs in palliative care.

Palliative care, which focuses on symptom management, quality of life, and communication, is appropriate for patients at any age and any stage in the disease process. Because of increased patient demand, the United States faces a shortage of palliative care specialists. Expansion of palliative care curriculum in physician associate/assistant (PA) programs, on-the-job training, and improvement of regulatory practice guidelines can help PAs alleviate the shortage of palliative care professionals.

Pharmacokinetics and ADME Profiling of Tanimilast Following an Intravenous 14C-Microtracer co-administered with an Inhaled Dose in Healthy Male Individuals.

Tanimilast is an inhaled phosphodiesterase-4 inhibitor currently in phase 3 clinical development for treating chronic obstructive pulmonary disease (COPD) and asthma. This trial aimed to characterize the pharmacokinetics, mass balance, and metabolite profiling of tanimilast. Eight healthy male volunteers received a single dose of non-radiolabeled tanimilast via powder inhaler (NEXThaler® (3200μg)), followed by a concomitant intravenous (IV) infusion of a microtracer ([14C]-tanimilast: 18.5μg and 500nCi). Plasma, whole blood, urine, and feces samples were collected up to 240 hours post-dose to quantify non-radiolabeled tanimilast, [14C]-tanimilast, and total-[14C]. The inhaled absolute bioavailability of tanimilast was found to be approximately 50%. Following IV administration of [14C]-tanimilast, plasma clearance was 22 L/h, the steady-state volume of distribution was 201 L, and the half-life was shorter compared to inhaled administration (14 vs. 39 hours, respectively), suggesting that plasma elimination is limited by the absorption rate from the lungs. 79% (71% in feces; 8% in urine) of the IV dose was recovered in excreta as total-[14C]. [14C]-tanimilast was the major radioactive compound in plasma, while no recovery was observed in urine and only 0.3% was recovered in feces, indicating predominant elimination through metabolic route. Importantly, as far as no metabolites accounting for more than 10% of the circulating drug-related exposure in plasma or the administered dose in excreta were detected, no further qualification is required according to regulatory guidelines. This study design successfully characterized the absorption, distribution, and elimination of tanimilast, providing key pharmacokinetic parameters to support its clinical development and regulatory application. Significance Statement This trial investigates PK and ADME profile of tanimilast, an inhaled PDE4 inhibitor for COPD and asthma. Eight male volunteers received a dose of non-radiolabeled tanimilast via NEXThaler® and a microtracer IV dose. Results show pivotal PK results for the characterization of tanimilast, excretion route and quantification of significant metabolites, facilitating streamlined clinical development and regulatory approval.

Presence and concentration of lead in keys and keyring items.

Environmental lead is a persistent hazard that disproportionately affects children. Keys are known sources of lead exposure in children, but little is known about the specific lead content or frequency of lead in keys. We identified differences in lead concentration and frequency across items with different physical characteristics. This study tested a convenience sample of keys and keychain objects using an X-ray Fluorescence (XRF) analyzer. The mean lead concentration across 362 objects tested was 1722 ppm (SD 3657 ppm; range 95.5-44 400 ppm). Lead was present in the majority (64%) of objects tested. Door keys had the highest concentration of lead (mean 2646 ppm; SD 3701 ppm). Door keys had significantly more lead than both vehicle keys (p<0.0001) and electronic fobs (p=0.0004). Gold-coloured keys contained significantly more lead than silver-coloured keys (p<0.0001). Copied keys were significantly more likely to contain detectable levels of lead compared with original keys (p<0.0001); however, this relationship was not significant when controlling for key type. There was a positive association between key age and lead concentration (p=0.009). Keys were less likely to contain lead if they were silver-coloured; car keys or electronic fobs; and newer. However, several categories of keys with less lead contained high lead levels, and the majority of items tested (64%) contained more lead than limits on lead in keys that were implemented in Minnesota after data collection (90 ppm). The levels of lead identified highlight the need for public education and potential additional regulatory guidelines for keys.

Risk sharing framework and systemic tolerance in Indian banks: Double layer network approach

Interconnectedness spreads systemic risk and is critical in enhancing banks’ systemic tolerance through interbank liquidity and lines of credit. Literature on systemic risk has not considered the importance of interconnectedness in providing liquidity to improve banks’ systemic tolerance. As a bank’s resistivity towards systemic disruption depends on its tolerance, the current article develops a model to measure the systemic tolerance of individual banks in a two-layer interbank network using ΔCoVaR. It estimates systemic tolerance distance through a risk-sharing framework and analyzes the significance of macroeconomic and bank-specific factors in explaining systemic tolerance. The results support that systemic tolerance values are higher during the down-cycle than the up-cycle, signaling the importance of interconnectedness in protecting against systemic crises. The empirics further substantiate that risk-sharing distance is lower, and structure is complex with clusters during economic down-cycle. This highlights that banks couple with each other during stressful environments and empirically validate the importance of interbank and lines of credit in enhancing systemic tolerance and, therefore, possess the regulator to develop a robust interbank market through regulatory guidelines.

ProtAct-Us from serious injuries with long-term consequences

Abstract Battling serious injuries and long-term consequences in road traffic remains one important issue in the overall goal of resilient future road transport and its Vision Zero. Challenges of increasing personal transport in urban areas coupled with autonomous vehicles and shuttles, new mobility devices and the overall need to ensure the safety of vulnerable road users as well as all types of vehicle occupants’ require solid medical background knowledge paired with innovative engineering approaches. EU Horizon Europe is currently funding the ProtAct-Us consortium (2024-2027) that aims at protecting all Road User Groups from serious injury and long-term physical, cognitive and mental health consequences related to road crashes through innovatively interlinked research action between medical and engineering methods and approaches. ProtAct-Us works on the following goals and challenges: i) Medical data correlation, standardisation and classification of long-term consequences of road crashes; ii) Robust and reliable medical, epidemiological and engineering tools like agreed methods to collect information on long-term consequences, upgraded Human Body Models and virtual assessment methods for the extremities, head, neck and face allowing for effective countermeasure development for all road users; iii) Reduction of long-term consequences and related socio-economic cost of road crash related injuries for all road users. The ProtAct-Us solutions will influence new standards in respect of extending current injury codification system with relevant long-term aspects, allowing new physical as well as virtual safety assessment procedures and adaption of rules and regulations to be implemented. Finally, scientifically well-founded suggestion for future implementation into policy, regulatory, and standardization guidelines for an inclusive safety improvement approach for in- as well as post-crash will be provided.

Impact of Temperature on Reaction Rate in Catalytic Reactions

Purpose: The aim of the study was to assess the impact of temperature on reaction rate in catalytic reactions. Methodology: This study adopted a desk methodology. A desk study research design is commonly known as secondary data collection. This is basically collecting data from existing resources preferably because of its low cost advantage as compared to a field research. Our current study looked into already published studies and reports as the data was easily accessed through online journals and libraries. Findings: The study indicated that as higher temperatures generally increase the rate at which reactions occur. This is due to the fact that elevated temperatures provide the reactant molecules with more kinetic energy, enabling them to collide more frequently and with greater force, which is necessary to overcome the activation energy barrier. In catalytic reactions, temperature not only accelerates the intrinsic rate of the reaction but can also affect the activity and selectivity of the catalyst. However, too high a temperature can lead to catalyst deactivation through processes such as sintering or coke formation, where the catalyst surface is altered or blocked. Thus, an optimal temperature range is crucial to balance enhanced reaction rates while maintaining catalyst integrity and performance. Implications to Theory, Practice and Policy: Arrhenius equation, transition state theory and collision theory may be used to anchor future studies on the impact of temperature on reaction rate in catalytic reactions. In practical applications, industries should implement advanced temperature control systems to maintain optimal reaction conditions during catalytic processes. Policymakers have a critical role in shaping the landscape of catalytic reactions by developing regulatory guidelines focused on temperature management.

Alternative Method for Glyphosate Determination in Unroasted Green Coffee Beans by Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS).

This research proposes an alternative method to detect and quantify glyphosate residues in unroasted green coffee beans by LC-MS/MS. The sample preparation was conducted without derivatization steps, with integrated cleanup, which improves the analytical method's frequency. Validation results were consistent with the requirements of the regulatory guidelines employed. Specificity, linearity (r2 = 0.9991), precision (RSD ≤ 9%), and recovery (92-112%) were ensured, with a satisfactory limit of quantification (LOQ = 0.48 mg kg-1). These data demonstrate that the method is suitable for monitoring glyphosate residues in unroasted coffee beans while offering simplicity and speed in sample preparation. The method was applied to analyze authentic unroasted coffee bean samples, in which two of them were contaminated with glyphosate (<LOQ). These results exhibit the importance of glyphosate monitoring in coffee samples and enhance that the method can be successfully implemented as a tool to guarantee food quality and safety.

Pedigree tracing to determine the origins of the modern Palomino Horse Breeders of America stock-type horse

Registration numbers for the Palomino Horse Breeders of America (PHBA) have risen with the assistance of new registration guidelines. These changes in guidelines allowed for registration of any horse with a palomino body color, including those with unknown pedigrees. While this promoted registry growth, documenting the breed's orgins from those known pedigrees making up the breed's foundation is important with the introduction of unknown pedigrees. This can be accomplished using pedigree tracing, which is of particular value for color registries as the study of coat color patterns is plagued with misunderstandings due to pedigrees with inaccurate color designations. Thus, the objective of this study was to develop an understanding of the historical origins of the modern PHBA stock-type horse through pedigree tracing. Horses (n = 460) were randomly sampled from published entries from 10 years (2012-2022) of the PHBA World Show Championship Horse Show. The All-Breed Database was utilized to obtain documentation of extended pedigrees that included uninterrupted generation-to-generation inheritance patterns of a cream dilution allele-influenced coat color. Pedigrees were traced back to the earliest recorded relative. We observed six foundation sires contributed to the modern PHBA stock-type horse with the majority (58%) tracing back to a sire named Old Fred. Two identified sires, Yellow Jacket (4%) and Cotton Eyed Joe (3%), have conflicts concerning color designation. While these results assist in documenting the breed's origins, genetic testing is required to accurately identify the cream dilution allele within the horses registered to ensure a phenotype-based solely on the cream dilution allele.

Influence of Asparaginase on Acrylamide Content, Color, and Texture in Oat, Corn, and Rice Cookies.

The safety of cereal-based baked goods can be compromised by acrylamide, a processing contaminant and class 2A carcinogen. One method to prevent acrylamide formation is by converting asparagine to aspartic acid using asparaginases. Four different asparaginases were tested using two dough incubation temperatures and dosages for oat, corn, and rice cookies. To evaluate the impact of asparaginases on product quality, color and texture were measured. Acrylamide was reduced by up to 97, 95, and 92% for oat, corn, and rice cookies, respectively, compared to the control. Asparaginase treatment resulted in minor changes in color and texture. There was a strong correlation between acrylamide concentrations in cookies and the free asparagine content of the flour. By minimizing the formation of acrylamide while maintaining product quality, the use of asparaginases offers a promising approach to enhancing food safety standards and protecting public health, potentially influencing regulatory guidelines and consumer preferences.

Creating a specialized dataset for enhanced noise compliance in live concert environments

Regulatory guidelines mandate strict noise levels during concerts, specially for night leisure soundscapes, yet accurate compliance assessment is hindered by the presence of extraneous noises. This paper presents a methodology focused on creating a specialized dataset tailored to address this challenge. We have captured several live concerts, ensuring the dataset's relevance and applicability in noise compliance assessments. This paper exposes the methodology followed since the deployment of the sensors until the labeling of the most relevant parts of it by using the LAeq levels to select the most prominent sound sources. The dataset has been used to use a PANN and incorporate a classification mechanism into a noise monitoring platform for live concerts. By leveraging LAeq levels to identify prominent sound sources, our methodology ensures the inclusion of key acoustic events in the dataset, facilitating subsequent analysis and classification tasks. The integration of a PANN (Pretrained Audio Neural Network) enables the development of a robust classification mechanism tailored to the intricacies of live concert environments. This work underscores the importance of specialized datasets in addressing the challenges of noise compliance in concert settings, offering a modest resource for advancing research and practical applications in this field.

Urinary benzyl alcohol and hippuric acid in workers exposed to benzyl alcohol during paint stripping work.

This research aimed to develop a reliable gas chromatography-mass spectrometry (GC-MS) method for detecting urinary benzyl alcohol (BeOH) concentrations and assess its suitability as a biomarker for occupational BeOH exposure. Thirteen male participants exposed to BeOH during paint stripping work provided preshift and postshift urine samples, and their personal exposure concentrations were measured. Meanwhile, a control group of 10 nonexposed workers contributed urine samples. The newly developed GC-MS method met regulatory guidelines. The personal exposure concentrations of BeOH ranged from 8.4 to 45.2mg/m3. Postshift urine samples from exposed participants showed significant BeOH and hippuric acid (HA) concentration increases compared to preshift samples (BeOH, post-/pre-shift geometric mean (GM) ratio = 7.5-7.8, p < 0.001; HA, post-/pre-shift GM ratio = 4.3-4.5, p < 0.001). These levels were considerably higher than those in postshift samples from the nonexposed control group (BeOH, exposed-/nonexposed-workers GM ratio = 14.8-19.0, p < 0.001; HA, exposed-/nonexposed-workers GM ratio = 12.1-15.3, p < 0.001), even after urine density correction. Urinary BeOH and HA can serve as potential biomarkers of occupational exposure to BeOH. More specifically, BeOH might serve as a superior biomarker than HA because it is apparently less influenced by confounding factors such as dietary intake and genetic polymorphism of low-Km aldehyde dehydrogenase (ALDH2). The findings will improve workplace safety measures and protocols, assisting healthcare professionals in diagnosing and managing exposure-related health issues, thereby potentially reducing the risk of occupational exposure to BeOH.

Pharmaceutical industry promotional activities on social media: a scoping review

Abstract Objectives The rise of social media has broadened the reach and impact of pharmaceutical promotion across countries. This scoping review synthesizes available literature on the nature, extent, and impacts of such promotion, with a particular focus on public health implications. Methods Using a systematic strategy, we searched six multidisciplinary scholarly databases for empirical studies, both peer-reviewed and grey, published since 2004, which had collected data on pharmaceutical promotion via social media. Data were synthesized qualitatively into outcome domains. Key findings We included 45 studies, primarily conducted in the USA (20/45, 44%) and multi-nationally (15/45, 33%), and published after 2013 (40/45, 89%). Studies used content analyses, surveys, and interviews to measure pharmaceutical industry presence or impacts on the following indicators: social media, social media strategy, consumer reach and engagement, health information quality, ethical and regulatory guideline adherence, and consumer attitudes and behaviours. Taken together, these studies indicate a gradual increase in industry use of social media, notably including the development of novel consumer engagement strategies, such as targeted promotion and influencer sponsorship. Studies also showed that, in some cases, health information provided on social media is of low quality, ethically and legally questionable, and potentially harmful to public health. Conclusions Appreciating the regulatory and reputational risks of consumer engagement on social media, the pharmaceutical industry has gradually increased promotional activities on social media since its inception. Evidence of harmful content and promotional activities that have become more covert and targeted suggests the need for regulatory development.

B-099 Validation and Clinical Implementation of Organ Procurement Serology Testing: Our Analytical and Regulatory Experience in Implementing a New Donor Testing Program

Abstract Background The Mount Sinai Hospital recently implemented a comprehensive organ donor testing program to service the clinical needs of transplant services in the New York City metro area. Conventional serology testing is not approved by the FDA for donor testing. To support this program, the MSH Chemistry Laboratory implemented and validated a comprehensive donor testing panel on the Abbott Alinity S donor testing platform. We validated donor serology testing for the following assays: HIV-1/2 (HIV), Anti-Hepatitis B Core (Anti-HBc), Hepatitis B Surface Antigen (HBsAg), Human T-lymphotropic virus I and II (HTLV-I/II), Anti-Hepatitis C (Anti-HCV), and Trypanosoma cruzi antibodies (T.Cruzi). The Alinity S System is an automated immunoassay-based analyzer FDA-approved for donor testing. The analyzer consists of two distinct sample ‘paths’ and is effectively two instruments combined in one analyzer. The analyzer is approved for use in living donor serum and plasma and in cadaveric serum. Prior to going live, we found that there was limited guidance on laboratory quality assurance programs related to donor testing. In addition to confirming assay analytical performance, we designed and implemented a comprehensive quality assurance program prior to satisfy compliance with regulatory guidelines, addressing proficiency compliance, sample TAT, and control ranges, amongst other quality indicators. Methods Inter and Intraday precision was assessed through replicate analysis of positive and negative controls, where 10 replicates of both controls were assayed on a single day, and one replicate of each control was assayed daily for 7 distinct days, results were represented as %CV. Result accuracy was assessed through split sample analysis of known serologically positive (n=20) and negative samples (n=40). Each sample was assayed on two distinct lots of reagents, each with its own unique calibration curve. Accuracy was confirmed in both living donor (n=30), and cadaveric samples (n=10). In addition, split sample analysis was performed between the Alinity S and FDA-approved donor testing assays in a reference laboratory (N=7). A carryover study was performed through the analysis of triplicate replicates of low, high, and then low controls. These analyses were performed for all 6 assays. Results Intraday precision using assay general controls afforded the following %CV: HIV: 3.1%, 6.5%; Anti-HBc: 1.3%, 2.6%; Anti-HCV: 3.3%, 11.7%; HTLV-I,II: 2.5%, 5.9%; T.Cruzi: 2.8%, 0%; HBsAg: 3.2%, 11.6%. Interday precision yielded the following in %CV: HIV: 2.9%, 10.0%; Anti-HBc: 3.0%, 5.6%; Anti-HCV: 3.3%, 3.4%; HTLV-I,II: 2.8%, 4.6%; T.Cruzi: 2.4%, 0%; HBsAg: 4.7%, 7.8%. Accuracy studies yielded 100% positive and negative correlation for all 6 assays in both living donor and cadaveric samples. In addition, there was a 100% serological correlation for samples compared to reference laboratories. Carryover studies showed no evidence of sample carryover. Conclusions The Abbott Alinity S shows acceptable assay precision on all 6 validated assays. The assays are serologically accurate in both cadaveric and living donor samples. As such, the assays and platform are acceptable for use in donor screening. We designed a unique quality assurance program including a comprehensive self-proficiency and instrument crosscheck program to ensure analyzer accuracy, as well as adherence to regulatory guidelines.

Comparative Analysis Of Ai Governance In Africa Relative To Global Standards And Practices

Africa as a continent recognizes the need for Artificial Intelligence (AI) governance frameworks. However, despite initiatives like the African Union's Continental AI Strategy, African nations grappled with challenges in formulating comprehensive AI policies, while established global frameworks provided advanced benchmarks for comparison. To address this disparity, this study conducted a comparative analysis of AI governance in Africa relative to global standards and practices. Employing a comprehensive document analysis methodology, the research examined key policy documents, strategic frameworks, and regulatory guidelines across African, European, American, and Asian contexts. The findings revealed that while the African Union demonstrated commitment to coordinated AI governance, African approaches generally lagged behind global benchmarks in comprehensiveness, formalization, and ethical integration. The study identified a notable fragmentation in AI governance across African nations, contrasting with more unified approaches in other regions. African frameworks emphasized leveraging AI for socio-economic development, diverging from the risk mitigation focus seen in EU regulations. The integration of indigenous African ethical perspectives in AI governance frameworks was limited, presenting both challenges and opportunities. Significant disparities in digital infrastructure and AI capacity between Africa and other regions were found to affect governance implementation. The study concluded that despite these challenges, there was potential for Africa to develop innovative, context-specific AI governance models that could contribute valuable insights to the global discourse on responsible AI development. Recommendations included accelerating the implementation of the Continental AI Strategy, prioritizing investment in digital infrastructure, developing Africa-centric AI ethics frameworks, establishing mechanisms for regular benchmarking against global standards, fostering increased collaboration, and implementing AI literacy programs across the continent.