Quality Control Measures Research Articles

Amplicon-based sequencing has emerged as an exceptionally powerful tool for the identification and characterization of microorganisms, offering enhanced sensitivity and specificity in molecular diagnostics. In this chapter, we detail the amplification and sequencing protocols for two critical genetic markers: the HSP70 gene, essential for identifying Leishmania species, and the 18S ribosomal RNA gene, a well-established marker for detecting Trypanosoma species. We provide a comprehensive overview of the entire workflow, beginning with the optimization of PCR conditions to ensure robust gene amplification. The subsequent sequencing was performed using Oxford Nanopore Technologies, a platform renowned for generating long reads in real time, which facilitates a detailed analysis of genetic material and supports high-resolution taxonomic assignments. Following sequencing, we describe the bioinformatics pipeline used to process and analyze the data. This pipeline incorporates stringent quality control measures and phylogenetic analysis. Together, these steps not only enhance the accuracy of pathogen detection but also allow for an in-depth assessment of genetic diversity among trypanosomatids.

EPICYCLE: A confirmatory preclinical study of the anti-rhabdomyosarcoma efficacy of BET bromodomain and cyclin-dependent kinase 9 inhibitors.

Ongoing surveillance of analytical platforms in preimplantation genetic testing: phase 4.

Extraction and purification, structural characteristics, biological activities, applications, and quality control of Aloe vera polysaccharides: A review.

Quantifying the impact of beer unit operations (mashing, fermentation, and maturation) on Bacillus thuringiensis behavior.

Expert opinion on extrusion-based pharmaceutical 3D printing from the European Society of Hospital Pharmaceutical Technology (GERPAC).

Abstract: The aggregation of Artificial Intelligence (AI) and Machine Learning (ML) in herbal formulation presents a significant opportunity to improve herbal drug discovery, tailor medicine to individual needs, and expand healthcare access. The growing demand for herbal products high-lights the necessity for robust quality control measures to ensure their safety and efficacy. This study presents an innovative AI-ML-based method for quality control testing in herbal standardi-zation, employing ML algorithms to evaluate complex phytochemical profiles. It emphasizes the potential of an ML-based approach to standardize herbal formulations through advanced quality control testing. The study involves the compilation of various AI-ML-based techniques-or exist-ing techniques integrated with AI-ML systems-for analyzing complex datasets comprising chemi-cal profiles, spectral data, and chromatographic results from various herbal samples. The AI-ML models effectively identify critical bioactive compounds and detect adulteration, thereby improv-ing the accuracy of quality assessment. By training these models on a wide variety of herbal spe-cies, high predictive accuracy can be achieved, underscoring the method's applicability in real-world settings. These novel techniques contribute to enhancing the quality control process, assist in meeting regulatory requirements, and enhance consumer safety. Based on the literature, it is suggested that integrating AI-based methods into herbal standardization can significantly enhance product reliability and promote market confidence.

IntroductionA traditional Chinese herbal decoction, Huoxue-Jiangtang decoction (HXJT), has been clinically prescribed to patients with type 2 diabetes mellitus (T2DM) to improve hyperglycemia and hyperlipidemia for many years. However, the potential mechanisms underlying its anti-diabetic effects remain unclear.MethodsThe aim of this study was to explore the anti-diabetic effects and underlying molecular mechanisms of HXJT in T2DM rats, which were fed with a high-fat diet (HFD) and subsequently induced with streptozotocin (STZ). HPLC-MS analysis was performed to characterize the chemical composition of HXJT and serve as a quality control measure. The T2DM rats were treated with metformin or HXJT for 8 weeks.Results and discussionTreatment with HXJT significantly reduced hyperglycemia and improved insulin resistance in T2DM rats, as revealed by multiple assessments, including fasting blood glucose (FBG), glucose tolerance, fasting insulin levels, homeostasis model assessment of insulin resistance, insulin sensitivity index analysis, and histological examination of pancreas islets. HXJT treatment decreased blood lipid profile, including total cholesterol, low-density lipoprotein cholesterol, and triglycerides, although it did not change the rats’ body weight. The Western blot results indicated that HXJT reversed the downregulation of AKT and PI3K and markedly increased glucose transporter type 4 (GLUT4) in skeletal muscles. Moreover, the levels of glycogen synthetase (GS), hexokinase, superoxide dismutase (SOD), glycogen, and muscle glycogen in the HXJT group significantly increased relative to those in untreated T2DM group, while TNF-α levels decreased observably. In conclusion, HXJT improves insulin resistance, enhances insulin sensitivity, and helps preserve glucose homeostasis. The potential molecular mechanisms are related to the activation of PI3K/AKT and GLUT4 in skeletal muscles, either directly or indirectly.

Obesity is a chronic disease with a rising global prevalence, representing a significant public health burden. Patients increasingly utilize short-video platforms such as TikTok and Bilibili to obtain health information regarding bariatric surgery. The quality and reliability of this content have not been thoroughly evaluated, raising concerns about the potential for misinformation to influence patient decision-making. A cross-sectional content analysis was conducted on the top 100 videos retrieved from both TikTok and Bilibili using the keyword "bariatric surgery" in Chinese. After excluding irrelevant and duplicate content, a total of 200 videos were included for analysis. Videos were systematically categorized by uploader type and content. Two senior bariatric surgeons independently assessed the videos for quality and reliability using the Global Quality Score (GQS) and a modified DISCERN instrument. TikTok videos demonstrated significantly higher user engagement, with greater median likes, collections, shares, and comments compared to Bilibili (p < 0.001). Conversely, Bilibili videos had a significantly longer median duration (p < 0.001). The overall quality of videos on both platforms was suboptimal. However, TikTok videos received modestly higher GQS and DISCERN scores from both reviewers (p < 0.05). Content uploaded by professional institutions achieved the highest quality scores across both platforms (p < 0.001). Professional individuals were the predominant uploaders, accounting for 79.0% of the videos. A strong positive correlation was observed among user engagement metrics (likes, saves, shares, comments; r > 0.9), but these metrics showed no significant correlation with GQS or DISCERN quality scores. The quality and reliability of bariatric surgery-related educational content on both TikTok and Bilibili are largely inadequate. While TikTok videos demonstrated slightly superior quality scores, professional institutions represent the most reliable source of information. User engagement metrics are poor indicators of video quality. These findings underscore the need for healthcare professionals to guide patients in navigating online health information and for platforms to implement more stringent quality control measures.

Essential Oils are innovative products of vegetable origin, whose use can find multifunctional applications in food supplements, aquaculture as a complementary feed, agriculture as plant protection products, topical disinfectants and wellness products. The aims of this study are the development of a multiresidue method to be used with essential oils, the determination of contaminant pesticide levels in twelve different products randomly taken from the Italian market and a preliminary human risk assessment. By using the developed method, fulfilling the EU criteria for pesticide control activity, we found that Citrus EOs showed the highest contamination among the investigated products. Inter-batches variability was also evident. Considering the oral and dermal exposure to different pesticide residues contaminating the analysed EO, based on combined exposure to multiple pesticides, and their hazard potential, no risk for consumers’ health seems to be present. However, these preliminary findings underscore the importance of monitoring and quality control measures in the production and distribution of EOs to ensure consumer safety.

This guide outlines a step-by-step methodology for utilizing Nucleic Acid Programmable Protein Arrays (NAPPA) to identify and characterize novel autoantibody biomarkers for specific diseases. The guide starts with a detailed description of the discovery phase design, including target antigens, sample selection, and experimental controls. It further describes the protein microarray fabrication, emphasizing quality control measures to ensure protein expression and reliable array performance. The third section describes the autoantibody discovery and validation process, including sample preparation, data acquisition, and processing. Finally, it offers a range of data analysis strategies for identifying biomarkers using the NAPPA for further investigation.

Background: Histopathology and cytology are pivotal diagnostic disciplines that utilize microscopic analysis of tissues and cells to detect diseases, including cancers and inflammatory conditions. Aim: This article aims to provide a comprehensive overview of the techniques, processes, and quality control measures employed in histopathology and cytology laboratories. Methods: A detailed review of histopathological and cytological procedures, including specimen preparation, fixation, processing, processing embedding, sectioning, staining, and quality assurance protocols, was conducted based on established guidelines and literature. Results: The study outlines key techniques such as routine histopathology, frozen section analysis, immunohistochemistry, special staining, and cytology, emphasizing their role in accurate diagnosis. Fixation with 10% neutral buffered formalin, tissue processing with automated systems, and precise sectioning (3–5 μm) ensure high-quality slides. Quality control measures, including proper labeling and standardized protocols, minimize errors. Conclusion: Histopathology and cytology laboratories are essential for precise disease diagnosis, leveraging advanced techniques and rigorous quality control to enhance patient outcomes.

Moringa (Moringa oleifera) is a salinity-resistant tree known for its high nutritional and medicinal value. In recent years, interest in Moringa has grown as a cash crop in developing countries due to its potential to address food insecurity, malnutrition, and poverty. However, development of Moringa value chains faces significant challenges, including accessing quality seeds, processing skills, pest and fungal issues, and market access barriers. This study uses a mixed-methods approach, combining stakeholder interviews based on participatory co-inquiry and co-research process, to identify key activities and challenges in Pakistan's Moringa value chain. These findings underscore the critical need for improved hygiene management and the establishment of formal value chains to unlock Moringa's economic potential for smallholders. Despite these, study identifies significant opportunities for value-added products, e-commerce integration, and value chain development through improved processing techniques and establishing robust downstream market linkages that led to improved farmer returns. Leveraging the community's indigenous knowledge about Moringa's benefits proved instrumental in encouraging the development of value-added products. Assessment of consumer preferences and concerns revealed a need for better quality control measures to meet market needs. Overall, the study emphasizes the importance of both forward and backward market linkages to promote sustainable development, ultimately improving livelihoods of smallholder farmers, and maximizing economic potential. The findings conclude that although enormous potential exists for moringa based products, the gaps in communication among actors and lack of awareness among local consumers hinder the sector growth. Keywords: Moringa oleifera, Value chain, Market access, Smallholder farmers, Co-inquiry.

Patient-derived organoids (PDOs) have emerged as powerful tools in personalized medicine applicable to both non-malignant conditions and to cancer, where they are increasingly used for personalized drug screening and precision treatment strategies in part due to their ability to replicate tumor heterogeneity. They also serve as study model systems to understand disease mechanisms, pathways, and the impact of ex vivo exposures. We present a detailed step-by-step protocol for generating organoids from normal crypts, polyps, and tumors, including methods for tissue processing, crypt isolation, culture establishment, and the transition from basolateral to apical-out polarity for co-culture and exposure-based studies. The protocol also includes immunofluorescence staining procedures for cellular characterization and quality control measures. Our standardized approach successfully generates organoids from diverse colorectal tissues with high efficiency and reproducibility. This comprehensive guide addresses common technical challenges and provides troubleshooting strategies to improve success rates across different sample types. We believe that this resource will enhance reproducibility in organoid research and expand their utility in translational applications, particularly for personalized medicine approaches in colorectal cancer.

The success of targeted therapy in non-small cell lung cancer (NSCLC) hinges on the precise identification of driver alterations, including mutations, gene fusions, and amplifications. Next-generation sequencing (NGS) has emerged as a comprehensive molecular diagnostic tool, capable of detecting both known and novel genomic aberrations, providing critical support for personalized NSCLC treatment. However, NGS remains a complex and technically challenging method. Despite its widespread adoption, NGS still faces some challenges, including technical complexity and prolonged turnaround times. Here, the ISO15189-certified NGS workflow implemented in the clinical laboratory is introduced. The standardized protocol encompassed tumor cellularity assessment (≥20 %), DNA extraction from formalin-fixed paraffin-embedded (FFPE) tissues (DNA input ≥ 50 ng), automated library preparation, and bioinformatics analysis. By integrating stringent quality control (QC) measures at each step, the workflow ensures high data reliability. Besides, the key innovation in workflow was the automation of NGS library construction. The automated system of NGS library construction included end repair, A-tailing, adapter ligation, hybridization capture, and purification, effectively minimizing human error, enhancing experimental reproducibility, reducing hands-on time, and thus improving efficiency. Together, experience demonstrates that rigorous QC and automated library preparation are essential for maintaining accuracy and scalability in clinical NGS testing. This optimized approach not only ensures compliance with ISO15189 standards but also supports the growing demand for precision oncology in NSCLC management.

Local livestock genetic resources are crucial for sustainable agriculture and biodiversity conservation. Dengchuan cattle, a nationally protected dairy breed in China, are esteemed for their high milk fat content and cultural significance. However, they have been threatened by crossbreeding with exotic high-yielding breeds, resulting in a decline in purebred resources. In this study, we evaluated the genetic diversity and structure of a conserved population using 100K SNP microarray data from 74 individuals. After implementing strict quality control measures, 78,460 loci were retained for principal component analysis (PCA), which identified 100 SNPs most associated with PC1. After calculating high-consistency loci using PLINK, based on allelic consistency, we selected 61 high-stability markers to represent 60 individuals for further analysis. Genetic diversity parameters indicated moderate polymorphism, with an effective population size (Ne) of 2.293, observed heterozygosity (Ho) of 0.300, expected heterozygosity (He) of 0.326, and an average polymorphic information content (PIC) of 0.261. A paired t-test confirmed a highly significant difference between Ho and He (p < 0.001). Runs of homozygosity (ROH) revealed a moderate level of inbreeding (FROH = 0.0928), with bulls exhibiting slightly higher values than females. Neighbor-joining (NJ) clustering further indicated clear lineage distinctions among bulls, but lower kinship among females. Overall, Dengchuan cattle exhibit moderate genetic diversity but face risks due to a small Ne and an unbalanced family structure. Targeted breeding strategies and genetic monitoring are recommended to ensure sustainable conservation and utilization.

Acyclovir (AVR), an antiviral drug often used to treat herpes simplex and varicella-zoster infections, necessitates precise and repeatable measurement for quality control, pharmacokinetic investigations, and therapeutic monitoring. This review examines both developing and known analytical approaches for determining AVR. Chromatography, spectrophotometry, electrochemical methods, and newer approaches, such as hyphenated and sensor-based methods, are critically evaluated as to sensitivity, accuracy, economical, and applicability across a wide range of dimensions. Analytical researchers often employ quality by design or design by expert techniques for improve method validation. Which make quick review that can help analysts select and validate the optimum analytical procedure. Recent innovations, such as nanotechnology-based sensors and green analytical techniques, are highlighted for their potential to improve detection capacities while also addressing environmental problems. The paper also looks at the limitations of established approaches and potential future paths for innovative analytical tools. This effort intends to help researchers and practitioners choose acceptable methodologies for AVR quantification, supporting improvements in antiviral medication analysis.

Breed management and genomic evaluation rely on understanding population structure and genetic diversity. The primary objective of this study was to evaluate genetic diversity in Rambouillet enrolled in the National Sheep Improvement Program (NSIP) in comparison to other U.S. and international sheep breeds. We considered genotypes of 667 NSIP Rambouillet from a 50K single nucleotide polymorphism (SNP) array and 600K SNP genotypes on 64 each of NSIP Rambouillet, Suffolk, and Katahdin sheep. Pedigree analyses were also conducted on the NSIP Rambouillet. International comparisons incorporated 50K SNP data from 9 international breeds. After genomic quality control measures to reduce bias in analyses, the NSIP Rambouillet had the greatest diversity among the 3 NSIP breeds (expected heterozygosity: 0.404; average individual inbreeding: 9.94%). Conversely, the NSIP Rambouillet had the lowest genetic diversity when compared to the international breeds. Based on principal component analyses, NSIP Rambouillet were divergent from the international populations except for evidence of connectivity between the NSIP and European Rambouillet. Population structure within the NSIP Rambouillet, demonstrated by cluster analysis and a significant loss of heterozygosity (FIS) was driven primarily by one flock. Using complete pedigrees of the NSIP population, effective population size, effective number of founders, and average generation interval was 87 to 218, 95, and 3.4 yr, respectively. This pedigree and genomic assessment of genetic diversity provides the basis for genomic selection and monitoring of the NSIP Rambouillet.

Abstract Background Accurate and timely patient results requires efficient quality control (QC) measures. Conventional Bio-Rad Multiqual Assayed (Multiqual) QC materials come in glass vials that necessitate several manual steps prior to analysis. Bio-Rad’s InteliQ Multiqual Assayed (InteliQ) QC is a plastic tube-based material that recently became available. The InteliQ design allows direct analyzer loading straight from the refrigerator. This study investigated if the new tube-based QC could improve technologist time, reduce QC laboratory waste and minimize handling errors. Methods Two levels of conventional Multiqual and InteliQ tube-based QC materials were analyzed in parallel, twice a day on an Abbott Alinity c analyzer for 21 days. Several chemistry analytes (n=23) were selected to compare percent coefficient of variation (CV) and false rejections between the two materials (rejection flags resolved after repeating QC only) (Table). Waste from the two QC formats was collected, including packaging, pipets, sample cups, QC vials, and QC tubes. A time study was conducted over the initial 5 days of the 21-day study to determine the total time and preparation touch points to analyze both materials. Results Conventional Multiqual QC had comparable performance characteristics to the InteliQ QC material. Several analytes (n=3) were noted with CVs greater than 5% with InteliQ compared to 1 analyte for Multiqual. Assays with false rejections were three-fold lower with Multiqual than InteliQ (2 vs 5 assays). Total waste generated from InteliQ (110.5 g) was 67% lower than the conventional material (331.5 g). The time study determined a total time savings of 60% when using the tube-based QC material (1.72 vs 2.85 mins) from initial preparation point to first analysis (8 vs 17 points). Conclusion InteliQ tube-based QC demonstrates similar performance characteristics when comparing to the conventional material with noted false rejection differences. The new material offers improvements in total preparation time and total waste generated.

Traditional Uses, Phytochemical Constituents, Pharmacological Activities, Toxicity, and Quality Control of Senecio cannabifolius Less.: A Review.