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Vision & Mission Statement

Vision & Mission Statement

Vision & Mission Statement

Value
Striving for people’s happiness,
Contributing to enhancement of public health & welfare
Creativity
Introducing superior products quickly to market, Developing products with high social demand
Public Benefit
Undertaking research projects to promote healthy lives of people

Vision & Mission Statement 1.

ValueStriving for people’s happiness, Contributing to enhancement of public health & welfare: Contributed to early testing of HCV & HIV; Contributed to new health technology research and development (Please refer to reimbursement/non-reimbursement notice by Ministry of Health and Welfare); Contributed to transformation of social perceptions regarding infectious diseases; Contributed to development of innovative testing system for infection management

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Rapid Point-of-Care HIV Antibody Test
Health Insurance Service Reimbursement Item
HCV Antibody Test
Health Insurance Service Reimbursement Item

Enactment 2008.06.10 Notice 2008-53

Notice on Result for Safety · Efficacy Evaluation of New Health Technology

1. Rapid HIV (Human immunodeficiency Virus) Antibody Point-of-Care Test

A. Name of Technology: Korean Name : 신속 HIV(Human immunodeficiency Virus) 항체 현장검사; English Name : Rapid HIV Antibody Point of Care

B. Purpose of Use: Rapidly evaluating the presence of Human Immunodeficiency Virus (HIV) infection

C. Intended Users: Those with suspected Human Immunodeficiency Virus (HIV) infection

D. Test Method: A qualitative test employing a single-use diagnostic test device to detect the presence of Human Immunodeficiency Virus-1/2 (HIV-1/2) antibodies in such specimens as fingerstick whole blood, oral fluid, venipuncture whole blood, and plasma within 30 minutes

E. Safety · Efficacy Evaluation Result: Since the rapid point-of-care HIV antibody test is conducted in vitro and its specimen collection process does not pose any direct risk to a testee’s body, the test is considered safe.; Large-scale diagnostics evaluation research showed that the rapid point-of-care HIV antibody test demonstrates excellent diagnostic accuracy.; Considering the extremely low HIV prevalence in South Korea, the relatively high false positive rate in clinical tests, the social outlook on HIV, and the seriousness of the disease, the rapid point-of-care HIV antibody test cannot be used to confirm the HIV infection.; Accordingly, the test is recommended for use in a specific group or region having high susceptibility to HIV infection or for those patients with suspected HIV infection based on medical history.; Even if the rapid point-of-care HIV antibody test shows “positive” reactivity, the presence or absence of HIV infection should be officially reported to a testee only after the result is validated by Western blot.

F. Notes: The rapid point-of-care HIV antibody test was evaluated by literature-based evidences of more than 60 types of the rapid point-of-care HIV antibody test and OraQuick Rapid HIV-1/2 Antibody Test. Accordingly, if the test of the same intended use and method is to be introduced to Korea in the future, the decision can be made based on evaluation results stated above.; The rapid point-of-care HIV antibody test was evaluated by a total of 20 literature-based evidences (7 review articles, 2 systematic reviews, and 11 observational studies).

Ministry of Health and Welfare Notice 2019-310

Health Insurance Service Reimbursement · Non-Reimbursement Item List and Relative Value Score Revision for Reimbursement

Part 2 Chapter 2 Test Fee Section 1 Specimen Test Fee [Infection Test] <Acquired Immunodeficiency> 누-720 General Immunity Test 나. HIV Antibody-Simple Test has been revised as follows:

Classification Number



누-720

Code




D7202


D7203

Classification
Section 1. Specimen Test Fee
[Infection Test]
<Acquired Immunodeficiency>
General Immunity Test
나. HIV Antibody - Simple Test HIV Ab
Notes:
1. Application of Reimbursement according to Attachment 2 of 「Standard for Selected Reimbursement Designation and Implementation」
2. When test is performed using OraQuick

Score



61.56



183.60

Enactment 2008.6.10 Notice 2008-53

Notice on Results for Safety · Efficacy Evaluation of New Health Technology

175. HCV Antibody Test [Simple Test]

Name of Technology: Korean Name : HCV 항체검사 [간이검사]; English Name : HCV Rapid Antibody Test

B. Purpose of Use: Hepatitis C screening

C. Intended Users: Those for whom hepatitis C screening is necessary

D. Test Method: The test qualitatively detects HCV antibodies in oral fluid using an immunochromatographic assay (via OraQuick kit)

E. Safety · Efficacy Evaluation Result: Since the HCV antibody test [simple test] is conducted in vitro using a testee’s blood or oral fluid, it is considered a safe test which does not cause any direct harm to the testee.; The diagnostic accuracy of the HCV antibody test [simple test] is high with sensitivity of 0.83-1.00 and specificity of 0.99-1.00.; Accordingly, the evidence is present that the HCV antibody test [simple test] is safe and effective in rapidly evaluating HCV infection using serum, plasma, whole blood, and oral fluid specimens of a testee for whom hepatitis C screening is necessary.

F. Notes: The HCV antibody test [simple test] was evaluated by a total of 14 literature-based evidences (10 diagnostic method evaluation research articles and 4 other research articles).

Ministry of Health and Welfare Notice 2019-156

Health Insurance Service Reimbursement · Non-Reimbursement Item List and Relative Value Score Revision for Reimbursement

[Infection Test] <Liver Infection> 누-700 바. Hepatitis C Antibody-Simple Test (1) Type I & (2) Type II (after 마. Hepatitis C Antibody) has been newly established as follows:

Classification Number



누-700

Code




D7007

Classification
Section 1. Specimen Test Fee
[Liver Infection Test]
<Liver Infection>
General Immunity Test
바. Hepatitis C Antibody-Simple Test HCV Ab
(2) Type II
※ Only when test is performed using OraQuick kit.
Note: Application of Reimbursement according to Attachment 2 of 「Standard for Selected Reimbursement Designation and Implementation」

Score




296.19

Vision & Mission Statement 2.

CreativityIntroducing superior products quickly to market, Developing products with high social demand: Introducing superior products quickly to market, Developing products with high social demand; Established online business via eSTIM; Developed Oraquick Autotransmission system

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QraQuick Autotransmission System: Diagnostic Kit & Smartphone Stand

Vision & Mission Statement 3.

Public BenefitUndertaking research projects to promote healthy lives of people: Completed academic research project offered by Korea Disease Control and Prevention Agency (KDCPA)
[Project Title: “Development and Simulation of Routine HIV Testing System in Dental Clinic”]; Conducted business in collaboration with Seoul Association of University, Research Institute and Industry (SAURI)
[Project Title: “Supporting Development of Techniques for Patented Technology Commercialization”]; Founded “The Korean Academy of Dental Clinic Infection

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Academic Research Project Business Final Report: Project # 2009E0067800

Development and Simulation of Routine HIV Testing System in Dental Clinic

Project ManagerYeongju ChaCollege of Medicine, Chung-Ang University (Laboratory Medicine)
Co-ResearcherHuijeong KangCollege of Medicine, Hallym University Medical School (Laboratory Medicine)
Co-ResearcherSeungcheol ShinCollege of Dentistry, Dankook University (Preventive Dentistry)
Co-ResearcherJongho LeeCollege of Dentistry, Yonsei University (Periodontology)
Co-ResearcherSeongho ChoiCollege of Dentistry, Yonsei University (Periodontology)
Co-ResearcherSeonjong KimEwha Womans University (Dentistry / Graduate School of Clinical Dentistry)

Declare Possible Conflict-of-Interest The researchers have no conflicts of interest to declare that are relevant to the company and the product affiliated with this project.

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Project # PA100026

Year 2010 Collaborative Business with Seoul Association of University, Research Institute and Industry Final Report: Supporting Development of Techniques for Patented Technology Commercialization

Development of Highly Sensitive AIDS Diagnostic Kit Based on Antibody Detection in Oral Mucosa / Saliva

2012.11 Korea University / Chung-Ang University / Innovative Medical Solutions Co., LTD. Seoul

Insol D-836~843, Hyundai Knowledge Industry Center Hangangmisa 2-cha, 520, Misa-daero, Hanam-si, Gyeonggi-do, 12925, Republic of Korea Company Registration Number : 220-87-02544 Phone: +82-2-404-7990,1 Fax: +82-2-6499-2660

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