Intestinal Tuberculosis (ITB) presents a significant diagnostic challenge due to its nonspecific clinical presentation and the lack of comprehensive local data to guide diagnostic strategies. This study aims to fill the gap by conducting a twelve-year retrospective cross-sectional analysis at a tertiary hospital in Cebu, Philippines. Electronic records of 209 patients aged 18 years old and above were first reviewed, focusing on clinical features, laboratory results, endoscopic findings, and CT scan of the abdomen. Initial screening identified 54 patients meeting the predefined criteria for gastrointestinal tuberculosis (GITB). In addition, statistical analyses, including logistic regression models, were employed to identify significant predictors of ITB which can further enhance the ITB diagnosis and management in the region.

Clinical manifestations observed include: symptoms and signs resembling those observed in malignancies and inflammatory bowel diseases, such as abdominal pain (92.6%), ascites (57.4%), fever (51.9%), hematochezia (25.9%), abdominal mass (24.1%) and intestinal obstruction (5.6%). The findings from CT scans of the abdomen were consistent with other studies, including the presence of matted mesenteric lymph nodes (79.6%), concentric mural thickening (57.4%), ileocecal involvement (44.4%). However, dilated bowel loops (20.4%), intestinal perforation (5.4%) and strictures (3.7%) were observed in only a few cases. Ileocecal involvement was found to be a dependable predictor among all the variables when logistic regression analysis was employed, emphasizing its diagnostic utility.

Our findings highlight the importance of local epidemiological insights in improving diagnostic strategies and patient outcomes. Consolidating the clinical profiles and diagnostic markers contributes to evidence-based strategies tailored to the Philippine context. This localized approach can further help medical professionals in making more informed decisions. Future studies could validate these findings to develop region-specific predictive tools, for a more time sensitive management of ITB.

On March 19, 2021, the National Medical Products Administration(NMPA) issued the Regulations on the Supervision and Administration of Medical Devices (Order No. 739 of the State Council of the People's Republic of China), which clearly stipulated in Article 53 the basic definition and scope of use of in vitro diagnostic reagents developed by medical institutions. It also pointed out that the relevant administrative measures shall be formulated by the Drug Regulatory Department of the State Council in conjunction with the Health Department of the State Council. This initiative marks the re-incorporation of in vitro diagnostic reagents developed by medical institutions into China's regulatory system. This study reviewed the development of regulatory policies for self-developed in vitro diagnostic reagents at home and abroad, combined with the Key Points of On-site Verification of Self-developed In Vitro Diagnostic Reagents in Shanghai Medical Institutions issued by the Shanghai Municipal Drug Administration, in conjunction with the Shanghai Municipal Health Commission, and the specific verification work of pre-record evaluation, and sorted out the general requirements for the quality management system of self-developed in vitro diagnostic reagents. The purpose is to provide some references for the further development of this pilot work and its nationwide promotion.
China ; Quality Control ; Indicators and Reagents/standards* ; Reagent Kits, Diagnostic/standards*

Representative models of instruments for in vitro diagnostic (IVD) reagents simplify the performance evaluation of registration. Different from the concept of the US FDA instrument family, the domestic identification of representative models focuses on the risk analysis of instrument differences. However, there are problems such as unclear requirements for the identification of instruments, difficulties in the identification of new technology and high-risk instruments. The performance evaluation of the detection system can be partially simplified by representative models, and representative models can evaluate the performance of non-detection systems. Meanwhile, the comprehensive performance should be evaluated by representative models as conditions. Therefore, according to the analysis, performance evaluations using representative models can guarantee the safety and effectiveness of in vitro diagnostic reagents while promoting the high-quality development of the IVD industry.
Indicators and Reagents ; Reagent Kits, Diagnostic

A molecular diagnostic assay which could be stored at room temperature was developed to rapidly detect Mycobacterium tuberculosis (MTB) based on loop-mediated isothermal amplification (LAMP) technology and dry-reagent process. LAMP uses 4 or 6 primers and Bst DNA polymerase to amplify DNA at a constant temperature. The results showed that the LAMP assay could detect the amplification of IS6110 target gene within 20 min using real-time fluorescence signal detection. The sensitive of LAMP assay was similar to the PCR technology while the precision of PCR was better than LAMP (coefficient of variation, LAMP 18.9%, PCR 3.4%), meaning LAMP was more suitable for qualitative detection. The LAMP assay did not amplify DNA of other 10 types of pathogens, including Neisseria meningitidis, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pneumoniae, Rubivirus, mumps virus, adenovirus (type 3), adenovirus (type 7), respiratory syncytial virus B and parainfluenza virus type 2, indicating a good specificity. Furthermore, a dry-reagent assay was developed using air-drying and freeze-drying process. The performance of dried reagents did not change after 10 days storage at 50 ℃, meaning the dried reagents could be stored at room temperature (25 ℃) for more than six months. The dry-reagent LAMP assay also successfully amplified MTB DNA from several clinical samples within 20 min. In conclusion, the developed LAMP assay together with isothermal amplifier could rapidly detection MTB.
Humans ; Mycobacterium tuberculosis/genetics* ; Indicators and Reagents ; Sensitivity and Specificity ; Nucleic Acid Amplification Techniques/methods* ; DNA

A molecular diagnostic assay which could be stored at room temperature was developed to rapidly detect Mycobacterium tuberculosis (MTB) based on loop-mediated isothermal amplification (LAMP) technology and dry-reagent process. LAMP uses 4 or 6 primers and Bst DNA polymerase to amplify DNA at a constant temperature. The results showed that the LAMP assay could detect the amplification of IS6110 target gene within 20 min using real-time fluorescence signal detection. The sensitive of LAMP assay was similar to the PCR technology while the precision of PCR was better than LAMP (coefficient of variation, LAMP 18.9%, PCR 3.4%), meaning LAMP was more suitable for qualitative detection. The LAMP assay did not amplify DNA of other 10 types of pathogens, including Neisseria meningitidis, Haemophilus influenzae, Staphylococcus aureus, Streptococcus pneumoniae, Rubivirus, mumps virus, adenovirus (type 3), adenovirus (type 7), respiratory syncytial virus B and parainfluenza virus type 2, indicating a good specificity. Furthermore, a dry-reagent assay was developed using air-drying and freeze-drying process. The performance of dried reagents did not change after 10 days storage at 50 ℃, meaning the dried reagents could be stored at room temperature (25 ℃) for more than six months. The dry-reagent LAMP assay also successfully amplified MTB DNA from several clinical samples within 20 min. In conclusion, the developed LAMP assay together with isothermal amplifier could rapidly detection MTB.
Humans ; Mycobacterium tuberculosis/genetics* ; Indicators and Reagents ; Sensitivity and Specificity ; Nucleic Acid Amplification Techniques/methods* ; DNA

Design and development process of molecular diagnostic reagents is critical to quality management system of in vitro diagnostic reagent. Based on the technical characteristics of molecular diagnostic reagents, the study analyzed the concerned key control points and common problems in the process of design and development from the view of registration quality management system. It aimed at offering technical guidance on design and development process of molecular reagents and registration quality management system to enterprises, thus improving the product development efficiency, optimizing the quality management system, and increasing the efficiency and quality of registration and declaration.
Indicators and Reagents ; Pathology, Molecular

OBJECTIVE: The national requirements for the fund management of scientific research projects are becoming more stringent, so that it is convenient to carry out scientific research work and can strengthen the regulation of scientific research reagent procurement, so this study explores the standardization of the whole process of the procurement of scientific research reagent supplies in hospitals and new modes of management. METHODS: By exploring the implementation of the centralized procurement management platform, we engage in full process supervision before, during, and after the event. RESULTS: Introduction of centralized procurement management platform for scientific research reagent supplies can normalize the procurement process, ensure the quality of procurement and improve the procurement efficiency on the basis of ensuring the quality of scientific research. CONCLUSIONS The new model of centralized procurement of full process management based on one-stop service for scientific research reagent supplies is an important part of improving the fine scale management of public hospitals, and it is of great significance in improving the level of scientific research in China and avoiding scientific research corruption.
Indicators and Reagents ; Hospitals, Public ; China

OBJECTIVE: This paper puts forward suggestions on the development of in vitro diagnostic reagents and supervision measures for the post-marketing products, so as to further improve the quality of in vitro diagnostic reagents and ensure the safety use of medical device. METHODS: This paper summarizes the quality of in vitro diagnostic reagents and analyzes the causes of the problems, according to the results of the national medical device supervision and inspection in 2020. RESULTS: The overall quality of in vitro diagnostic reagents for national medical device supervision and inspection in 2020 is stable and the unqualified detection rate is 1.6%. However, there are some problems. For example, the management of raw materials is unscientific, the faultiness in the preparation of reference materials, the understanding of standards is unthorough, and the management of instructions is unimportance. CONCLUSIONS It is suggested that manufacturers of in vitro diagnostic reagents should improve the binding force of the quality management system, strengthen the awareness of risk management, attach importance to communicate with regulatory authorities, study standards sufficiently and strengthen the management of instructions. It is also suggested that the regulatory authorities should strengthen supervision and inspection, and further complete the evaluation guidance and standard publicity and implementation.
Indicators and Reagents ; Marketing ; Reference Standards

The management of in vitro diagnostic reagents has always been a concern. This paper describes the application of SPD medical consumables fine management system in our hospital. Relying on the brand-new management mode, the whole process from supplier qualification certificate management, in vitro diagnostic reagent procurement management, secondary warehouse management, and then to the use process traceability was realized. The monthly cost of in vitro diagnostic reagents can be accurately counted, which effectively controls the cost of in vitro diagnostic reagents.
Hospitals ; Indicators and Reagents

In the perspective of technical evaluation, the pre-marketing regulatory requirements of allergen detection reagents in China, America, European Union were compared, and the regulatory risks and performance requirements of this product were analyzed based on the monitoring of post-marketing adverse events, reference standards and domestic and foreign regulatory documents. In view of the "neck-stuck" problems such as the difficulty of clinical trials, the difficulty of finding comparable contrast reagents and the lack of clinical diagnostic gold standards, this paper discusses and gives regulatory suggestions, with a view to providing technical reference for product R&D, production, evaluation, approval and supervision in this field.
Allergens ; European Union ; Indicators and Reagents ; Marketing ; Reference Standards