• Proceedings of the PSK Conference
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• 2003.04a
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• pp.291.1-291.1
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• 2003

The purpose of this study is to provide KFDA's guidance for premarket notification submission and labeling for prescription use drugs of abuse in vitro diagnostic devices. To evaluate in vitro diagnostic devices the following performance characteristics should be described in detail within the submission: analytical sensitivity or minimum detection limit, cutoff concentration, specificity and cross reactivity, interference, precision, method comparison and stability. (omitted)

• Journal of Microbiology and Biotechnology
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• v.29 no.2
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• pp.230-234
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• 2019

Currently, the genetic modification of Aspergillus oryzae is mainly dependent on protoplast-mediated transformation (PMT). In this study, we established a dual selection marker system in an industrial A. oryzae 3.042 strain by using Agrobacterium tumefaciens-mediated transformation (ATMT). We first constructed a uridine/uracil auxotrophic A. oryzae 3.042 strain and a pyrithiamine (PT)-resistance binary vector. Then, we established the ATMT system by using uridine/uracil auxotrophy and PT-resistance genes as selection markers. Finally, a dual selection marker ATMT system was developed. This study demonstrates a useful dual selection marker transformation system for genetic manipulations of A. oryzae 3.042.

• Korean Journal of Clinical Laboratory Science
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• v.50 no.1
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• pp.20-28
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• 2018

Tuberculosis (TB) is a bacterial infection disease caused by members of the species Mycobacterium tuberculosis (MTB) complex. Approximately one third of the world's population is infected with TB. In Korea, approximately 40,000 new patients are identified each year. Moreover, infections from non-tuberculous mycobacteria (NTM) have also increased. In the diagnosis of TB and NTM, traditional bacterial cultures are required for 3 to 4 weeks. Therefore, rapid and accurate diagnostic tests for TB and NTM are needed. To distinguish between TB and NTM, a range of diagnostic methods have been developed worldwide. In vitro diagnostic assays are constantly being developed to meet the increasing need for the rapid and accurate identification for TB and NTM. On the other hand, the performance evaluations of in vitro diagnostic reagents for TB and NTM are lacking. Recently, the Korea Food and Drug Administration (KFDA) issued a guideline for in vitro diagnostic reagents for MTB and NTM. Here, this study analyzed the performance of currently developed in vitro diagnostic reagents for TB and NTM in the US FDA. This analysis of US FDA approved molecular assays could serve as a useful reference for an evaluation of the reagent performance of TB and NTM.

• Journal of Veterinary Clinics
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• v.35 no.4
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• pp.119-125
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• 2018

In vitro diagnostic veterinary medical reagents (IVDVMRs) were diverted the medical devices from medicine by the revision of the pharmaceutical affairs act enforcement regulations in 2015 in Korea. It classified into class I-IV according to risks of individual and public health. However, good manufacturing practices requirements on IVDVMRs were exempted from the current system. The registration of IVDVMRs by the Animal and Plant Quarantine Agency has gradually increased since 2012, and total of 584 products from 68 companies were registered from 1978 to 2017. Most of these items are clinical immunochemistry (infection disease), clinical immunochemistry (non-infection disease), molecular genetics, endocrinology, blood gas analysis, clinical microbiology, toxin, heavy metal and drug of abuse, other etc. The market size of IVDVMRs reported from the Korea Animal Health Products Association was estimated to be approximately 51.9 billion won in 2017. The domestic consumption and the export sales were approximately 31.2 and 20.7 billion won, respectively. They are increasing 23.9% (CAGR) in domestic consumption and 40.4% (CAGR) in export from 2011 to 2017.

• Proceedings of the KOSOMBE Conference
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• v.1997 no.05
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• pp.439-442
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• 1997

For the treatment of arteriovenous malformations (AVM), we developed a new liquid embolic material and named it Embol. The material was pre-tested in an in vitro AVM model and tested in rete mirabile of pigs that is similar in structure with the AVM in human. We report on the construction of the in vitro AVM model, the pre-test results of Embol in the AVM model, and the animal test result in pig rete mirabile.

• Proceedings of the Korean Society of Applied Entomolohy Conference
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• 2002.05a
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• pp.96-96
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• 2002

• KIPS Transactions on Computer and Communication Systems
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• v.12 no.2
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• pp.77-84
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• 2023

Dengue virus transmission is a viral infection disease between humans and Aedes mosquitoes. Dengue is ubiquitous throughout the tropics and subtropical zones, where 1/3 of the global population live. The weather in Korea is also changing to subtropical weather, resulting in increased vulnerable Korean population to dengue virus transmission. It is important to control and prevent the dengue risk with track-recording & monitoring system. It is also required to have the control system to treat and monitor dengue patients with various cases such as regions, ages, genders according to the track-record of the disease. In this paper, we developed a Dengue Control & Prevention System, which can monitor and control dengue outbreaks in real-time with in-vitro diagnostic devices. Dengue Control & Prevention System is composed of in-vitro diagnostic device, which is a fluorescent immunoassay, and real-time monitoring system. In the future, we expect that our Dengue Control & Prevention System can be upgraded to have various disease information from Korea Disease Control and Prevention Agency for government policies and diseases control in Korea.

• BMB Reports
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• v.48 no.9
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• pp.489-494
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• 2015

The in vitro antibody discovery technologies revolutionized the generation of target-specific antibodies that traditionally relied on the humoral response of immunized animals. An antibody library, a large collection of diverse, pre-constructed antibodies, can be rapidly screened using in vitro display technologies such as phage display. One of the keys to successful in vitro antibody discovery is the quality of the library diversity. Antibody diversity can be obtained either from natural B-cell sources or by the synthetic methods that combinatorially generate random nucleotide sequences. While the functionality of a natural antibody library depends largely upon the library size, various other factors can affect the quality of a synthetic antibody library, making the design and construction of synthetic antibody libraries complicated and challenging. In this review, we present various library designs and diversification methods for synthetic antibody library. From simple degenerate oligonucleotide synthesis to trinucleotide synthesis to physicochemically optimized library design, the synthetic approach is evolving beyond the simple emulation of natural antibodies, into a highly sophisticated method that is capable of producing high quality antibodies suitable for therapeutic, diagnostic, and other demanding applications. [BMB Reports 2015; 48(9): 489-494]

• Health Policy and Management
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• v.33 no.2
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• pp.173-184
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• 2023

Background: The coronavirus disease 2019 pandemic has been challenging the healthcare service, i.e., the vitalization of the point of care accompanying self-testing in vitro diagnostic medical devices (IVDs). This study aims to suggest priority criteria to classify self-testing IVDs using the analytic hierarchy process technique. Methods: Two dimensions of the characteristics embedded in the IVDs and the diseases to be diagnosed with self-testing IVDs were parallelly considered and independently investigated. In addition, three expert panels consisting of laboratory medical doctors (n=11), clinicians (n=10), and citizens (n=11) who have an interest in the selection of self-testing IVDs were asked to answer to questionnaires. Priorities were derived and compared among each expert panel. Results: First of all, ease of specimen collection (0.241), urgency of the situation (0.224), and simplicity of device operation (0.214) were found to be the most important criteria in light of the functional characteristics of self-testing IVDs. Medical doctors valued the ease of specimen collection, but the citizen's panel valued self-management of the disease more. Second, considering the characteristics of the diseases, the priority criteria were shown in the order of prevalence of diseases (0.421), fatality of disease (0.378), and disease with stigma (0.201). Third, medical doctors responded that self-testing IVDs were more than twice as suitable for non-communicable diseases as compared to communicable diseases (0.688 vs. 0.312), but the citizen's group responded that self-testing IVDs were slightly more suitable for infectious diseases (0.511 vs. 0.489). Conclusion: Our findings suggested that self-testing IVDs could be primarily classified as the items for diagnosis of non-communicable diseases for the purpose of self-management with easy specimen collection and simple operation of devices, taking into account the urgency of the situation as well as prevalence and fatality of the disease.

• The Korean Journal of Mycology
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• v.21 no.2
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• pp.140-145
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• 1993

Yeast strains were isolated from healthy women(36 isolates), infertile women(15 isolates) and women suffering from local morbidity(82 isolates). On the basis of 37 different physiological and morphological characteristics, the isolated 133 yeast strains were assigned to 10 species belonging to 5 genera. Four pathogenic species were identified. They were Candida albicans, Candida parapsilosis, Candida tropicalis and Trichosporon beigelii. Candida albicans was the dominant species, whereas Saccharomyces cerevisiae prevailed among the saprophytic species. The percentage occurrence as well as the pattern of yeast species differed in the diagnostic groups. It was higher in the women suffering from local morbidity than in the healthy and infertile women. Moreover, a wider spectrum of species was isolated from this group. Women with intrauterine contraceptive devices showed the highest percentage of yeast occurrence which reached 50% of those tested. Five different antifungal agents were tested fro their effects on the growth of the isolated yeast species in vitro. Nystatin was the most effective against the isolated yeast species, followed by pyrithion zink and ciclopiroxolamine, whereas micronazole and clotrimazole, showed a lesser effect.