scholarly journals A Study on Immunological and Molecular Genetic Test Methods of Bacterial Sexually Transmitted Diseases Reagents

2017 ◽  
Author(s):  
Geun Soo Kim ◽  
San Kim ◽  
Hye Youn Han ◽  
Eunji Kwon
Keyword(s):  
Performance Evaluation ◽  
Sexually Transmitted Diseases ◽  
Medical Device ◽  
Medical Devices ◽  
Test Methods ◽  
Test Method ◽  
Quality And Safety ◽  
Sexually Transmitted ◽  
In Vitro Diagnosis

Chlamydia trachomatis is usally isolated only from humans and is often infected together with other sexually transmitted diseases(STD). C. trachomatis is a serious disease which infects 500 million people per year globally and causes blindness in 7 to 9 million people per year due to continuous infection. Thus, it is urgent to develop (draft) guidelines on the test methods for performance evaluation of medical devices for in vitro diagnosis of bacterial STD(C. trachomatis) based on molecular diagnosis. In this study, in reference to the U.S. FDA Guidance, has derived essential methods for testing performance which are applicable to medical device for in vitro diagnosis of bacterial STD which are used in the field of melecular diagnosis. Because of the establish of the test method for performance evaluation of medical devices, it could provide consistent performance evaluation standards for the approval and examination of products, promote the improvement of the quality and safety of products. This will contribute to the development of the quality and safety of products. This will contribute to the development of medical device for in vitro diagnosis in Korea

scholarly journals A Study on Immunological and Molecular Genetic Test Methods of Bacterial Sexually Transmitted Diseases Reagents

2017 ◽  
Author(s):  
Geun Soo Kim ◽  
San Kim ◽  
Hye Youn Han ◽  
Eunji Kwon
Keyword(s):  
Performance Evaluation ◽  
Sexually Transmitted Diseases ◽  
Medical Device ◽  
Medical Devices ◽  
Test Methods ◽  
Test Method ◽  
Quality And Safety ◽  
Sexually Transmitted ◽  
In Vitro Diagnosis

Chlamydia trachomatis is usally isolated only from humans and is often infected together with other sexually transmitted diseases(STD). C. trachomatis is a serious disease which infects 500 million people per year globally and causes blindness in 7 to 9 million people per year due to continuous infection. Thus, it is urgent to develop (draft) guidelines on the test methods for performance evaluation of medical devices for in vitro diagnosis of bacterial STD(C. trachomatis) based on molecular diagnosis. In this study, in reference to the U.S. FDA Guidance, has derived essential methods for testing performance which are applicable to medical device for in vitro diagnosis of bacterial STD which are used in the field of melecular diagnosis. Because of the establish of the test method for performance evaluation of medical devices, it could provide consistent performance evaluation standards for the approval and examination of products, promote the improvement of the quality and safety of products. This will contribute to the development of the quality and safety of products. This will contribute to the development of medical device for in vitro diagnosis in Korea

Nanostructured Selenium for Preventing Biofilm Formation on Medical Devices

2012 ◽  
Vol 1415 ◽  
Author(s):  
Qi Wang ◽  
Thomas J. Webster
Keyword(s):  
Staphylococcus Aureus ◽  
Medical Device ◽  
Medical Devices ◽  
Biofilm Formation ◽  
In Vitro Study ◽  
Common Cause ◽  
Persistent Infections ◽  
Wide Range ◽  
Novel Material

ABSTRACTBiofilms are a common cause of persistent infections on medical devices as they are easy to form and hard to treat. Selenium and its compounds are considered to be a novel material for a wide range of applications including anticancer applications and antibacterial applications. The objective of this study was to coat selenium nanoparticles on the surface of polycarbonate medical devices and examine their effectiveness at preventing biofilm formation. The results of this in vitro study showed that the selenium coating significantly inhibited Staphylococcus aureus growth on the surface of polycarbonate after 24 hours. Thus, this study suggests that coating polymers with nanostructured selenium is a fast and effective way to reduce bacteria functions leading to medical device infections.

scholarly journals New medical device regulations: the regulator’s view

2019 ◽  
Vol 4 (6) ◽  
pp. 351-356 ◽  
Author(s):  
Tom Melvin ◽  
Marina Torre
Keyword(s):  
Medical Device ◽  
Medical Devices ◽  
Clinical Investigation ◽  
Pool Data ◽  
Critical Function ◽  
Core Dataset ◽  
Medical Device Manufacturers ◽  
In Vitro Diagnostic ◽  
And Performance

Advances in medical device technology have been dramatic in recent years resulting in both an increased number of medical devices and an increase in the invasiveness and critical function which devices perform. Two new regulations entered into force in Europe in May 2017, the Medical Device Regulation (MDR) and the In Vitro Diagnostic Device Regulation (IVDR). These regulations will replace the current directives over the coming years. These regulations, for the first time introduce requirements relating to registries. Medical device manufacturers are required to have systematic methods for examining their devices once available on the market, by systematically gathering, recording and analysing data on safety and performance. Registries can assist public health protection in very practical ways, for example, to help urgently identify patients or devices. Registries can also be powerful tools for collecting and appraising real-world clinical evidence concerning medical devices. Clinical investigations are limited in terms of the sample size and the duration of follow-up which can reasonably be expected. Registries may also be the only available tool to examine rare adverse effects, sub-populations or for time durations which it is not possible or feasible to study in a clinical investigation. By ensuring that a core dataset is collected which can be compared to other registries or trial data, it is possible to pool data to better examine outcomes. There are a range of excellent initiatives which have aimed at ensuring the appropriate regulatory application of registry data. Cite this article: EFORT Open Rev 2019;4 DOI: 10.1302/2058-5241.4.180061

In Vitro and in Vivo Models for Pathogenic Neisseria gonorrhoeae Infections

2021 ◽  
pp. 111-143
Author(s):  
Karthikeyan Ramalingam ◽  
Sucharithra Ganesh
Keyword(s):  
Neisseria Gonorrhoeae ◽  
Sexually Transmitted Diseases ◽  
Virulence Factors ◽  
Public Awareness ◽  
In Vivo Models ◽  
Sexually Transmitted ◽  
General Aspects ◽  
General Community

The prevalence of gonorrhea has not discontinued in several countries and still remains as one of the top sexually transmitted diseases (STD) and it's caused by Neisseria gonorrhoeae. This bacterium gains entry into the human host via receptors, and by the usage of several virulence factors, it manages to spread through the cells and leads to severe complications. The study of these bacteria in various in vitro and in vivo models have paved the way for gaining insights on various aspects of bacterial infection, such as the study of pathogenesis of the organism in the host. It also drove the development of more appropriate drugs for the treatment of the gonorrhea illness caused by this ‘superbug'. This chapter focuses on providing a concise overview on the general aspects of N. gonorrhoeaeas an update and the in vitro and in vivo models used for understanding this bacterium over the years. Despite gonorrhea not being a rare STD, it is still a big challenge for researchers, healthcare professionals, and communicators with public awareness to communicate effectively with the general community.

scholarly journals In Vitro Evaluation of Enteric-Coated HPMC Capsules—Effect of Formulation Factors on Product Performance

Pharmaceutics ◽  
2020 ◽  
Vol 12 (8) ◽  
pp. 696
Author(s):  
Maoqi Fu ◽  
Johannes Andreas Blechar ◽  
Andreas Sauer ◽  
Jozef Al-Gousous ◽  
Peter Langguth
Keyword(s):  
Acid Resistance ◽  
Test Methods ◽  
Test Method ◽  
Disintegration Time ◽  
Sealing Performance ◽  
Hpmc Capsules ◽  
Enteric Polymer ◽  
Formulation Factors ◽  
Enteric Coated

A comparative study on different enteric-coated hard capsules was performed. The influence of different formulation factors like choice of enteric polymer, triethyl citrate (TEC) concentration (plasticizer), talc concentrations (anti-tacking agent), and different coating process parameters on the sealing performance of the capsule and the disintegration time were investigated. Furthermore, the influence of different disintegration test methods (with disc vs. without disc and 50 mM U.S. Pharmacopoeia (USP) buffer pH 6.8 vs. biopredictive 15 mM phosphate buffer pH 6.5) was evaluated. All formulations showed sufficient but not equivalent acid resistance when tested. Polymer type was the main factor influencing the capsule sealing and disintegration time. In addition, TEC and talc could affect the performance of the formulation. Regarding the choice of the disintegration test method, the presence of a disc had for the most part only limited influence on the results. The choice of disintegration buffer was found to be important in identifying differences between the formulations.

Fluconazole, caspofungin, voriconazole in combination with amphotericin B

Open Medicine ◽  
2010 ◽  
Vol 5 (2) ◽  
pp. 194-197 ◽  
Author(s):  
Ayse Kalkanci ◽  
Murat Dizbay ◽  
Nuran Sari ◽  
Burce Yalcin ◽  
Isil Fidan ◽  
...  
Keyword(s):  
Amphotericin B ◽  
Combination Treatment ◽  
Antifungal Agents ◽  
Candida Parapsilosis ◽  
Test Methods ◽  
Antagonistic Activity ◽  
Test Method ◽  
Synergistic Activity ◽  
Combination Test

AbstractCombined antifungal therapy has been suggested to enhance the efficacy and reduce the toxicity of antifungal agents. The aim of the study was to investigate the in vitro synergistic activity of caspofungin, voriconazole, and fluconazole with amphotericin B against ten isolates of Candida parapsilosis and Candida albicans strains which were resistant to azoles or amphotericin B. Three different antifungal combinations (amphotericin B [AP] — caspofungin [CS], amphotericin B — fluconazole [FL], and AP — voriconazole [VO]) were evaluated for in vitro synergistic effect by the microdilution checkerboard and E-test methods. For the majority of strains, the combination test showed indifferent activity. Via the E-test method, synergistic activity was seen in 3 strains in response to AP-CS combination treatment and in one strain after administration of AP-FL; however, no synergy was observed in response to combination treatment with P-VO. Antagonistic activity was the result in 1 strain treated with AP-CS as well as in 6 strains treated with AP-FL and AP-VO combinations. Via the microdilution test, no synergistic activity was seen after treatment with all 3 combinations. Antagonistic activity was the result in 2 strains with AP-CS, in 6 strains with AP-VO and in 5 strains with AP-FL combinations. Agreement between the checkerboard and E-test methods was observed to be approximately 72%. These combinations may be used in the case of antifungal resistance.

Sign in / Sign up

Export Citation Format

Share Document