Articles published on quality-control-measures
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- Research Article
- 10.1016/j.humpath.2025.105906
- Aug 1, 2025
- Human pathology
- Liang Cheng + 2 more
Genomic aberration detection by fluorescence in situ hybridization.
- Research Article
1
- 10.1016/j.jconrel.2025.113848
- Aug 1, 2025
- Journal of controlled release : official journal of the Controlled Release Society
- Christoph Wilhelmy + 6 more
Direct structural investigation of pH responsiveness in mRNA lipid nanoparticles: Refining paradigms.
- Research Article
- 10.5194/isprs-archives-xlviii-g-2025-1131-2025
- Jul 30, 2025
- The International Archives of the Photogrammetry, Remote Sensing and Spatial Information Sciences
- Rodolfo Orozco Gálvez + 5 more
Abstract. Mexico, recognized for its exceptional biodiversity, is home to over 58 vegetation types and nearly 30,000 documented plant species. This remarkable ecological variety is influenced by the country’s complex topography, diverse climates, and varying soil conditions. Since 1978, the National Institute of Statistics and Geography (INEGI) has been pivotal in understanding the distribution and condition of Mexico's vegetation. INEGI’s methods have progressed from traditional analogue mapping to sophisticated digital formats, utilizing satellite imagery, other ancillary geospatial data layers and advanced photointerpretation techniques.The data generation process follows rigorous methodologies that are publicly accessible, and dedicated teams across Regional Directorates and State Coordination Offices oversee the mapping of nearly 2 million km2 of territory with a lean workforce of just 30 personnel. This information serves as a National Interest Information, mandated for use by government entities.Recent advancements have underscored the need for innovative modelling and processing capabilities. INEGI are currently exploring artificial intelligence applications, particularly the use of multilayer perceptron neural networks, to enhance vegetation and land-use detection. Robust quality assurance and control measures aligned with ISO-2859 standards are integrated. This article showcases how these initiatives leverage AI to improve data accuracy and processing efficiency, thereby revolutionizing national vegetation mapping and contributing to sustainable land management practices. By highlighting collaborative efforts and outcomes achieved, this work aims to foster a deeper understanding of ecological dynamics and resource management in Mexico.
- Research Article
- 10.53469/wjimt.2025.08(07).18
- Jul 30, 2025
- World Journal of Innovation and Modern Technology
- Chao Li
This article focuses on the research of construction quality control and management in building projects, and explores its key role in ensuring project quality. The article first clarifies the basic concepts and key links of quality control and management. Based on the comprehensive development project of China Communications Future Science and Technology Innovation City, it analyzes the problems faced in practical application and their causes, and puts forward optimization suggestions. Through empirical research design and data analysis, the main factors influencing engineering quality are revealed, and the actual effects of quality control measures are analyzed in combination with cases. The research results show that enhancing the construction technology level, strengthening personnel training and improving the supervision mechanism are important paths to improve the project quality. The conclusion emphasizes the significance of scientific management and strict control, and points out that in the future, attention should be paid to the application of new technologies and the improvement of systems.
- Research Article
- 10.46799/ajesh.v4i7.653
- Jul 29, 2025
- Asian Journal of Engineering, Social and Health
- Slamet Riyadi + 2 more
Abstract The application of the wholesale wage system in construction projects has significant potential for the timeliness of project completion and the work motivation of workers. This research aims to investigate the influence of the wholesale wage system on the timeliness of completion of each project stage, as well as work motivation in the construction of vocational school buildings in Caruban District, Madiun Regency. The main focus of this research is to understand the contribution of the wholesale wage system in improving worker performance and motivation. The method used in this study is quantitative, with multiple linear regression analysis. Data were collected through a questionnaire distributed to 40 project workers. The F-test was applied to evaluate the simultaneous influence of the three independent variables on the dependent variables, while the t-test was used to examine the influence of each independent variable. The results of the analysis showed that, based on the F test, the F value reached 20.108, which is greater than 2.86637 (F value from the table) with a significance of 0.000. Meanwhile, the t-test produced a t-value of 2.0167, which is greater than 2.0167 (table t value) with a significance of 0.011. These findings are particularly relevant for project managers seeking to optimize workforce productivity in similar construction projects. The study highlights the importance of proper system implementation, including adequate supervision and quality control measures, to complement the productivity gains from the wholesale wage system approach.
- Research Article
- 10.1002/hsr2.71107
- Jul 27, 2025
- Health science reports
- Xuewei Fu + 5 more
The increasing prevalence of Crohn's disease (CD) and ulcerative colitis (UC)-the two main forms of inflammatory bowel disease (IBD)-has made these conditions a growing concern in global public health. While IBD primarily impacts the gastrointestinal tract, emerging evidence suggests its extraintestinal effects, especially on the respiratory system. The correlation between the lungs and the gastrointestinal system has drawn attention to the potential pulmonary complications in IBD patients. The causal link between IBD and lung function or related disease remains inconclusive. Leveraging publicly available genome-wide association study (GWAS) data sets, we performed a two-sample Mendelian randomization analysis to investigate potential links between ulcerative colitis, Crohn's disease, and various aspects of lung function or respiratory illness. Through meticulous quality control measures, we pinpointed SNPs with robust associations to UC and CD. The inverse-variance weighted method was our primary analytic approach. Additionally, we evaluated heterogeneity, explored potential pleiotropy, and performed sensitivity tests. We conducted an analysis using GWAS data obtained from the European population, identifying 54 and 77 SNPs for association studies related to lung function and disease in UC and CD, respectively. The results from the MR analysis revealed that neither UC nor CD exhibited a discernible impact on lung function, encompassing metrics such as total lung volume, forced vital capacity, forced expiratory volume in the first second, the forced vital capacity/forced expiratory volume in the first second ratio, and peak expiratory flow. Additionally, neither UC nor CD demonstrated an elevated risk of idiopathic pulmonary fibrosis, chronic obstructive pulmonary disease, or pulmonary cancer. In contrast, CD presented a heightened risk of asthma compared to UC. CD has been associated with a higher risk of developing asthma in the European population.
- Research Article
- 10.1007/s10815-025-03595-2
- Jul 26, 2025
- Journal of assisted reproduction and genetics
- Hong-Lin Li + 3 more
To perform a survey on the semen analysis capabilities and quality control measures of medical institutions conducting male infertility-related testing in Jiangsu, China, by the WeChat, aiming to explore the possibility of mutual recognition of testing results among different laboratories. This study designed a survey questionnaire consisting of 105 questions and investigated and compared semen analysis capabilities and quality control measures between regulated laboratories for assisted reproductive technology (RLART) and non-regulated laboratories for assisted reproductive technology (non-RLART) in Jiangsu, China. RLART had higher percentages of technicians received training on the WHO manual (97.14% [34/35] vs. 57.14% [28/49], P < 0.01), dedicated rooms for semen collection (100% [35/35] vs. 24.49% [12/49], P < 0.01), adherence to the staining methods recommended by the WHO manual (100% [32/32] vs. 33.33% [11/33], P < 0.01), internal quality control for sperm concentration (77.14% [27/35] vs. 6.12% [3/49], P < 0.01), and participation in external quality assessment (74.29% [26/35] vs. 14.29% [7/49], P < 0.01) compared to non-PLART. Establishing unified recognition criteria for semen analysis laboratories and conducting regular supervision can improve semen analysis capabilities and promote mutual recognition of semen testing results.
- Research Article
- 10.64063/3049-1630.vol.2.issue7.9
- Jul 24, 2025
- International Journal of Pharmacognosy and Herbal Drug Technology
- Atish Y Sahare + 4 more
Ayurvedic polyherbal formulations are increasingly explored internationally as a budding field of therapeutic potential based on thousands of years of traditional medicinal practice. However, the absence of standardization protocol and stringent quality control measures is a significant barrier, and the adoption of their safe and effective use in western healthcare is a challenge. The goal of this review is to evaluate the standardization and quality control measures related to Ayurvedic polyherbal formulations. The review discusses the complexity of multi-component herbal mixtures, variability of raw material and absence of marker compounds and synergistic effects which make reproducibility more difficult. The review emphasizes the use of modern techniques including High-Performance Thin Layer Chromatography (HPTLC), Liquid Chromatography–Mass Spectrometry (LC-MS) methods, and microbiological analyses, all increasingly common approaches to assess the variance in products. While there have been advances in the use of HPTLC and LC-MS for standardization and quality control, many regulatory frameworks do not exist, and harmonized quality standards are absent. The review indicates a need for the traditional Ayurvedic approach and modern science to work collaboratively to develop standardized strategies. A successful collaborative effort would lead to increased global/consumer recognition, acceptance and contribution to enhanced public safety regarding the quality and efficacy of these established therapeutic preparations.
- Research Article
- 10.1007/s00192-025-06180-4
- Jul 24, 2025
- International urogynecology journal
- Vatche A Minassian + 3 more
The objective was to determine the genetic variants associated with urinary incontinence subtypes using genome-wide association studies (GWAS). We conducted a case-control study of women older than 18 with available genetic data and at least one International Classification of Diseases 10 urinary (stress, urge or mixed) incontinence diagnosis between May 2008 and May 2023. Controls had available genetic data with no urinary incontinence diagnosis. Demographic, health, and genomic data were obtained from our institution's electronic medical records and Biobank. Quality control measures applied to the raw data excluded variants with call rate < 95%, with Hardy-Weinberg equilibrium exact p value < 1 × 10-6, samples with discordant sex, abnormal heterozygote rates, non-European ancestry, or duplicates. The first GWAS run included cases with stress, urge, or mixed incontinence at any point during the study period, whereas the second GWAS run included unique patients with no subtype overlap among the cases. The first GWAS run had 4270 cases with 5 single-nucleotide polymorphisms (SNPs) significantly associated with mixed and 3 SNPs significantly associated with urgency incontinence (p < 5 × 10-8). After controlling for overlapping cases, the second GWAS run included 3352 unique patients with 1055 pure stress, 699 pure urgency, and 1598 mixed incontinence. After applying strict filtering, 1 SNP located near the Myoferlin gene was identified on chromosome 10 for mixed, and 1 SNP located near the COX10 divergent transcript gene on chromosome 17 for stress incontinence. Our study proposes possible new genetic associations in women diagnosed with mixed and stress urinary incontinence that should be validated across other studies.
- Research Article
- 10.32996/jcsts.2025.7.7.99
- Jul 23, 2025
- Journal of Computer Science and Technology Studies
- Pratyush Tewari
The landscape of digital product design has seen major changes as companies increasingly acknowledge the vital importance of structured user experience approaches. Modern software development practices focus on creating core design principles that steer decision-making throughout product lifecycles. This marks a significant shift from conventional development methods that favored technical functionality over user-focused aspects. The Terra design system showcases advanced principle-driven development with its all-encompassing five-attribute framework, which includes Clear, Efficient, Smart, Connected, and Polished traits. Each principle incorporates specific implementation examples, including prioritizing accessibility to support all users, using consistent language that matches users' mental models, addressing ambiguity through tooltips and contextual help, maintaining conciseness for information focus, and writing clear error messages that identify resolution paths. The Clear principle establishes rules for alleviating cognitive load via thoughtful information display and interface streamlining. The Efficient principle focuses on optimizing workflows by systematically removing unnecessary interaction stages. The Smart principle incorporates intelligent system features to offer contextually appropriate support. The Connected principle guarantees smooth data synchronization and cohesive design language application across platforms. The Polished principle highlights careful focus on visual design elements and aesthetic excellence. Comprehensive measurement methodologies, including Customer Effort Score, System Usability Scale, qualitative usability testing, and behavioral metrics, serve as primary evaluation frameworks for analyzing principal effectiveness, complemented by additional metrics such as Net Promoter Score, Customer Satisfaction Score, and Pragmatic Usability Rating by Experts. Implementation demands tactical incorporation into development practices, interdisciplinary cooperation, quality control measures, and management of organizational change. Organizations that adopt structured design frameworks show quantifiable enhancements in user engagement metrics, development efficiency, and overall product quality when compared to those that depend on inconsistent design methods.
- Research Article
- 10.36348/sjmps.2025.v11i07.020
- Jul 23, 2025
- Saudi Journal of Medical and Pharmaceutical Sciences
- Abdulaziz Abdullah Felemban + 7 more
Clinical laboratory professionals and diabetes educators play pivotal roles in improving diagnostic accuracy and patient outcomes in diabetes management. Laboratory professionals are responsible for conducting precise and reliable laboratory tests, such as fasting blood glucose, HbA1c, and oral glucose tolerance tests, which are crucial for diagnosing diabetes and assessing glycemic control. Their expertise ensures that test results are accurate, timely, and interpret correctly to aid clinicians in making informed treatment decisions. Additionally, they maintain strict quality control measures and stay updated with advancements in diagnostic technologies to minimize errors and improve the overall quality of laboratory data used in diabetes care, Diabetes educators complement this by empowering patients through education about disease management, medication adherence, lifestyle modifications, and self-monitoring techniques. They help interpret test results and translate complex medical information into understandable advice, enhancing patient compliance and engagement. This collaborative approach between laboratory professionals and educators ensures that diabetes is managed effectively, reducing the risk of complications and enhancing patient outcomes. Together, they create a comprehensive support system that promotes accurate diagnosis, personalized treatment plans, and sustained disease control.
- Research Article
- 10.30560/sdr.v7n3p16
- Jul 22, 2025
- Sustainable Development Research
- Gaoyuan Qi + 1 more
In this paper, the research on the foundation treatment technology of sand cushion is carried out, and its basic principle, design method, construction technology and quality control measures are discussed in depth. By analyzing the mechanism and application scope of sand cushion foundation treatment, the scientific design method and construction process are put forward. The research shows that the foundation treatment of sand cushion can effectively improve the bearing capacity of foundation, reduce settlement and improve drainage performance, which has a wide application prospect in engineering. In this paper, the foundation treatment measures of sand cushion are verified by practical engineering cases, which provides theoretical basis and technical guidance for related engineering practice.
- Research Article
- 10.1038/s41598-025-12748-3
- Jul 22, 2025
- Scientific reports
- S Kavery Chengappa + 6 more
The regular use of toothpastes containing metals has been shown to be a formidable threat because of their ability to bioaccumulate and reach toxic proportions, affecting people's health and the environment. While studies have evaluated the presence of metals in toothpaste across different countries, a paucity of studies in India fostered a need to identify the presence of the metals arsenic, lead, copper and zinc in over-the-counter toothpastes. The 20 most sold toothpastes were selected from Indian e-commerce platforms and prepared following quality control measures. The samples were then subjected to flame atomic absorption spectroscopy (AAS) to determine the presence and concentrations of these metals. The individual toothpaste samples presented the highest concentrations of 0.5371mg/L arsenic, 0.0620mg/L copper, 0.0544mg/L lead and 7.4224mg/L zinc. Although the concentrations of lead, copper and zinc were found to be below the permissible limits in all the toothpaste samples, the arsenic concentration of one sample exceeded the European Union (EU) standard. Arsenic, which has the potential to cause neural and gastrointestinal disorders, needs to be strictly monitored in toothpaste samples. Considering these findings, there is a need for consistent global guidelines on permissible amounts of metals in toothpastes, with a determined intention toward their implementation.
- Research Article
- 10.1007/s44313-025-00090-6
- Jul 22, 2025
- Blood research
- Soo-Kyung Kim + 10 more
Processing methods for hematopoietic stem cells vary significantly across institutions, with no standardized guidelines currently in place. This lack of standardization presents challenges in ensuring consistent quality and outcomes of stem cell transplantation procedures. This study investigated current practices in peripheral blood stem cell (PBSC) processing and storage among transplant centers in Korea to establish a foundation for the development of standardized guidelines. A comprehensive questionnaire was distributed to 46 hematopoietic stem cell transplantation centers in Korea, examining five key areas: PBSC collection procedures, use of cryopreservatives, cryopreservation protocols, quality control measures, and thawing protocols. Analysis of the 29 responses revealed significant variations across different stages of PBSC handling. All centers used controlled-rate freezers, and 92.9% stored cells at temperatures below -150 . However, other practices varied widely. Additional post-collection processing was performed by 53.8% of respondents. DMSO concentrations ranged from 5 to 15%, with diverse combinations of supplementary media. Notably, 28.6% of patients did not undergo post-thaw quality assessment tests. This study identified significant heterogeneity in PBSC processing practices across Korean transplant centers. These findings underscore the need for evidence-based standardized guidelines to ensure consistent product quality and improve transplantation outcomes.
- Research Article
- 10.59882/1859-364x/296
- Jul 21, 2025
- Tạp chí Nghiên cứu Dược và Thông tin Thuốc
- Trần Thu Hằng + 3 more
Citrulline malate (CM) is a widely sought-after ingredient in the dietary supplement industry due to its ability to enhance exercise performance and promote muscle recovery. With the rising demand for CM, stringent quality control measures are essential, particularly in monitoring residual impurities in raw materials. An HPLC method was developed for the determination of fumaric acid (FA) and maleic acid (MA) impurities in CM raw material using a Shim-pack GIST C18 column (250 × 4.6 mm, 5 µm), detection at 210 nm, injection volume of 10 µL, and flow rate of 0.8 mL/min with a mobile phase consisting of acetonitrile and 3.3 mM potassium dihydrogen phosphate buffer (pH 2.0) (gradient). Another HPLC method was developed for the determination of N-acetylornithine (AO) impurity using the same C18 column, but with a detection wavelength of 200 nm, injection volume of 20 µL, flow rate of 1.0 mL/min, and a mobile phase consisting of 10 mM octane sulfonic acid sodium salt (pH 2.5) and acetonitrile under gradient condition. The methods were validated following AOAC International, confirming their accuracy and reliability (recovery not over than 100.0 ± 5.0% for all; RSD ≤ 1.1, 2.6, 3.0 % for FA, MA, AO respectively) in the range of concentration from 0.1 to 70 µg/mL (FA); 0.1 to 3.5 µg/mL (MA); 0.7 to 5.0 µg/mL (AO) with the coefficients very close of 1 (0.9999 for FA and MA, 0.9994 for AO). LOD, LOQ were established at 0.03, 0.1 for both FA, MA, and 0.5, 0.7 for AO.
- Research Article
2
- 10.1002/jcla.70080
- Jul 18, 2025
- Journal of clinical laboratory analysis
- Ming Hu + 6 more
This study applied the six sigma model to evaluate plasma protein testing performance in six laboratories, with customized quality control programs and targeted improvements introduced where necessary. Internal quality control (IQC) and external quality assessment (EQA) data for plasma proteins were gathered from six laboratories. Sigma values for each analyte were determined based on the coefficient of variation (CV), bias, and total allowable error (TEa). Using six sigma performance verification charts, we calibrated analyte performance and, guided by Westgard sigma rules, batch length, and quality goal index (QGI), developed laboratory-specific quality control schemes and improvement plans. Despite standardized platforms and reagents, sigma values showed significant inter-laboratory variation, with some differences also observed within labs at varying analyte concentrations. For projects with sigma < 6, tailored quality control measures were implemented, leading to marked performance improvements. The six sigma model provides an objective framework for evaluating plasma protein test performance and enhancing quality. It enables quantitative assessment of laboratory management and supports the development and implementation of customized, risk-based statistical quality control (SQC) strategies and improvement measures across multiple laboratory systems.
- Research Article
- 10.1038/s41598-025-06764-6
- Jul 15, 2025
- Scientific reports
- Eliana Wendland + 10 more
This study explores HIV prevalence and its social determinants in the southernmost state in Brazil, where the HIV epidemic has historically been more severe. A population-based serological household survey was conducted in 56 sampled municipalities between 2020 and 2022. Adult residents completed electronic questionnaires and provided blood samples for HIV testing, following Brazilian guidelines. Statistical analysis employed survey-weighted methods and hierarchical robust Poisson regression models to investigate factors associated with HIV prevalence. Quality control measures and sensitivity analyses were included to ensure result robustness. Among 7978 analyzed participants, 81 HIV cases were serologically detected (51 also self-reported), resulting in an estimated overall HIV prevalence of 0.99% (95% CI 0.56-1.75). A generalized HIV epidemic was confirmed in the metropolitan health macro-region of Rio Grande do Sul, where HIV prevalence was 1.64% (95% CI 1.59-1.70). Socioeconomic position was the most important factor associated with HIV prevalence, even after adjustments. Disparities in HIV distribution across regions and subpopulations, combined with rising prevalence trends in other Brazilian states, support implementing a national serology household survey to create evidence-based policies addressing systemic social inequities. The high proportion of unknown HIV cases highlights the need for improved community-based testing strategies.
- Research Article
- 10.25077/amar.9.1.104-124.2025
- Jul 15, 2025
- AMAR (Andalas Management Review)
- Thida Cho Lwin + 1 more
Background – Europe & Asia Beverages Co., Ltd. is a top beverage manufacturer in Myanmar, offering soft drinks, energy drinks, and bottled water. As the industry grows, employees face rising job stress due to production demands and quality control measures. Psychological well-being and training are crucial for improving performance, yet often overlooked. This study examines how these factors impact employee outcomes at Europe & Asia Beverages Co., Ltd. Aim – This study aims to examine the effects of job stress, psychological well-being, and employee training on job performance in Myanmar’s beverage industry, with a specific focus on Europe & Asia Beverages Co., Ltd. Design / methodology / approach – This study employs a quantitative research approach to examine the impact of job stress, psychological well-being, and employee training on job performance at Europe & Asia Beverages Co., Ltd. in Myanmar. Data were collected using structured questionnaires distributed to 150 employees, including managers, supervisors, and laborers. The study utilized a cross-sectional design and analyzed the data using descriptive statistics, reliability tests, and SmartPLS software to test hypotheses and assess relationships between variables. Findings – The findings reveal that psychological well-being and employee training significantly and positively influence job performance. Employees with higher psychological well-being exhibit better focus, motivation, and job satisfaction, leading to improved performance. Research Implication – This research highlights the importance of fostering psychological well-being and investing in employee training to enhance job performance. Organizations should prioritize mental health initiatives, such as counselling and mindfulness programs, and implement structured training programs tailored to employees' needs. Limitations – The study's reliance on self-reported data introduces potential biases, such as social desirability bias. The cross-sectional design limits the ability to establish causal relationships between variables. Furthermore, the sample is restricted to a single organization in Myanmar's beverage industry, which may limit the generalizability of the findings to other industries or cultural contexts.
- Research Article
- 10.1038/s41598-025-08311-9
- Jul 15, 2025
- Scientific reports
- Halizah Mat Rifin + 2 more
The National Health and Morbidity Survey (NHMS), which focuses on non-communicable diseases (NCDs), their risk factors and healthcare demand, is a cross-sectional,nationwide, population-based survey conducted every four-year cycle since 2011. NHMS 2023 was the 7th cycle of NCDs, their risk factors and healthcare demand, which aimed to monitor trends in diseases and healthcare utilisation. This article outlines the methodology, sociodemographic characteristics, and overall findings from the population surveyed in 2023 regarding NCDs, their risk factors, and various health-related topics. This survey utilised a two-stage stratified random sampling design and encompassed fifteen main scopes, with sample sizes calculated to meet the specific requirements of each scope. Conducted from July to September 2023, it involved the random selection of 499 enumeration blocks(EBs) by the Department of Statistics Malaysia (DOSM) across all states and federal territories in Malaysia. The step resulted in the selection of 5,988 living quarters(LQs). Data collection methods included validated questionnaires administered through face-to-face interviews and self-administered questionnaires, alongside clinical assessments and blood investigations using calibrated devices. To ensure the high quality of the collected data, we implemented stringent quality control measures. Furthermore, we applied complex sampling analyses to ensure that the findings accurately represented the population in Malaysia. The survey received responses from 13,616 individuals out of the 5,006 LQs that were successfully visited, resulting in an overall response rate of the survey of 83.2%, which includes individuals aged 5 years and above. A substantial segment of the population lived in urban regions, comprising 77.6% of the total. About half of the population consisted of males (51.9%), Malay (54.6%), and individuals who had attained secondary education (54.2%). Additionally, 20.0% of the population were within the age range of 30 to 39 years. The weighted prevalence of diabetes was 15.6%, hypertension 29.2%, hypercholesterolaemia 33.3%, overweight and obesity 54.4%.Depression among adults was4.6%, while mental health problems among children were reported at 16.5%. The current tobacco smokers prevalence was 19.0%, and 29.9%of adults in Malaysia were physically inactive. The known asthma prevalence among adults was 6.2%, while the current asthma among children was 3.4%. Additionally, 37.7% of adults experienced sleep insufficiency.The results indicate that the higher proportion of diabetes, hypertension,and hypercholesterolaemia, particularly among the young age group, and the high prevalence of overweight and obesity, as well as mental health problems, are making the healthcare system deal with more non-communicable diseases, complications, and problems. The methodology of this survey is robust for a population-based study. We took comprehensive steps to ensure the validity and reliability of the findings. The findings indicate an urgent need for targeted public health interventions to address the escalating health issues. By focusing on prevention and early intervention strategies, we can mitigate the impact of NCDs on the healthcare system and improve overall population health.
- Research Article
1
- 10.1128/aem.00589-25
- Jul 14, 2025
- Applied and Environmental Microbiology
- Hiroki Ozawa + 2 more
Wastewater surveillance for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA is a valuable tool for monitoring coronavirus disease prevalence. However, the dynamics of SARS-CoV-2 and its RNA in wastewater remain largely uncharacterized, leading to uncertainties in viral RNA quantification. This study aimed to improve a recently developed solid-based viral RNA extraction method used in wastewater surveillance programs in Japan. Eighty-four RNA samples extracted from the solid fractions of influent and sludge from two wastewater treatment plants from January to December 2022 were analyzed using reverse transcription quantitative PCR (RT-qPCR) for SARS-CoV-2 and control RNAs. Spiking experiments with a processing control demonstrated that PCR inhibition significantly affected RNA samples from the solid fractions. Contrary to expectations, the commercially available PCR inhibitor removal kit was ineffective, whereas a simple dilution mitigated the inhibitory effect, suggesting the presence of uncharacterized inhibitory factor(s) in the solid fraction. Furthermore, the emergence of the Omicron variant decreased the sensitivity of the CDC N1 RT-qPCR assay. This study demonstrates the improvement of the solid-based method by addressing PCR inhibition and variant emergence and emphasizes the importance of continuous quality control measurements in wastewater surveillance for the effective management of outbreaks caused by evolving viruses, such as SARS-CoV-2.IMPORTANCEThe standardization of methodologies for SARS-CoV-2 wastewater surveillance has not yet been achieved because of the heterogeneous characteristics of wastewater, even within the same country or sewer system. Studies have demonstrated efficient detection of SARS-CoV-2 RNA in the solid fraction of influent wastewater and sludge. A solid-based methodology has recently been developed for the detection of SARS-CoV-2 RNA; however, there remains potential for further refinement. We assessed the effect of RT-qPCR inhibition in samples from the solid fraction of wastewater using virus-like particles (VLPs) as a processing control. This study emphasizes that the methodology for wastewater surveillance should be regularly evaluated with appropriate quality control (QC) measures and refined based on prevailing circumstances.