초록 ▼

1. 고속 광학 스캔 방식을 적용한 RT-PCR 및 LAMP-PCR 2종의 제품화
2. 16종의 인플루엔자 관련 진단 키트 제품화
3. 장진단용으로 활용하기 위하여 핵산추출과정을 단순화한 direct RT-PCR 및 real time RT-PCR 진단법을 개발
4. 동물 인플루엔자 바이러스의 항 바이러스제제 내성 유전자 검출용 키트를 개발
5. 고정밀 온도제어 기술 개발
6. 국내 특허 출원 6건, PCT출원 2건, 국내 특허 등록 1건
7. 6편의 논문게재 및 2건의 기술이전 실시

(출

1. 고속 광학 스캔 방식을 적용한 RT-PCR 및 LAMP-PCR 2종의 제품화
2. 16종의 인플루엔자 관련 진단 키트 제품화
3. 장진단용으로 활용하기 위하여 핵산추출과정을 단순화한 direct RT-PCR 및 real time RT-PCR 진단법을 개발
4. 동물 인플루엔자 바이러스의 항 바이러스제제 내성 유전자 검출용 키트를 개발
5. 고정밀 온도제어 기술 개발
6. 국내 특허 출원 6건, PCT출원 2건, 국내 특허 등록 1건
7. 6편의 논문게재 및 2건의 기술이전 실시

(출처 : 요약서 3p)

Abstract ▼

Purpose&Contents
○ Development and commercialization of high-efficiency, cost-saving RT-PCR and real-time RT-PCR diagnostic kit for on-site diagnosis of influenza virus in animals

○ Development and application of developed multi-axis influenza diagnostic kit for early detection of spread o

Purpose&Contents
○ Development and commercialization of high-efficiency, cost-saving RT-PCR and real-time RT-PCR diagnostic kit for on-site diagnosis of influenza virus in animals

○ Development and application of developed multi-axis influenza diagnostic kit for early detection of spread of influenza

○ Development and commercialization of portable high-speed RT-PCR diagnostic device capable of accurate determination of influenza in a short time on site using RT-PCR diagnostic kit

Results
< General Cooperation >
□ Design and development of system equipment for commercialization of RT-PCR, real-time RT-PCR and RT-LAMP PCR
- Build system for multiple analysis (16 ~ 24 sample processing)
- Development of homogeneous temperature maintenance technology between holes for multiple analysis
- Developed precision temperature control module

□ Completed development of prototype of 2 species

□ Firmware and UI development for system operation
- Precision temperature control for temperature modules and relays
- UI development
- PID control algorithm and protocol optimization for precise temperature control

□ Optimize system operation
- Development of board and algorithm optimization for optical module and temperature control
-.Debugging program optimization

□ Develop kit for easy application

□ 5 domestic patent applications, 2 PCT applications, 1 domestic patent registration

< First Cooperation >
□ For development of pan-side diagnosis of animal and avian influenza viruses, RT-PCR, real time RT-PCR and RT-LAMP assays were developed and evaluated in this study, and the research results were as following:
○ RT-PCR and real time RT-PCR assays were developed and evaluated for the detection of animal and avian influenza viruses, and the prototypes of commercial kits that produced by each partner company and provided it to the evaluation agency (QIA).

- RT-PCR and real time RT-PCR kits for the detection of major subtypes of avian influenza viruses and Newcastle disease virus.
- RT-PCR and real time RT-PCR kits for the detection of major subtypes of swine influenza viruses and pandemic H1N1 influenza virus.
- RT-PCR and real time RT-PCR kits for the detection of major subtypes of equine and companion animals (dog and cat) influenza viruses.
- RT-PCR kits for HA　subtyping of influenza A viruses (H1-H16).
- RT-PCR kits for NA subtyping of influenza A viruses (N1-N9).

○ Direct RT-PCR and real time RT-PCR assays without nucleic acid extraction step applicable for pan-side diagnosis of influenza viruses were developed and evaluated, and the prototypes of commercial kits were provided it to the evaluation agency (QIA). As a result of combining the developed pan-side kits with the rapid diagnostic equipment,, the entire test process was completed within 30-40 minutes of original target.

○ Real time RT-PCR assays for the detection of anti-influenza virus agent (amantadine or oseltamivur)-resistant viruses were developed and evaluated for tested influenza viruses and in need further studies for clinical evaluation.

○ Through these studies, six papers were published and 2 cases of technical transfer were completed as a quantitative research achievement.

< Second Cooperation >
□ Development of high-speed scan type module through development of small optical system

□ Development and commercialization of optical module for RT-PCR and LAMP-PCR (system integration)

□ High speed scanning method for 24 wells and the algorithm for minimizing deviation between measurement holes is completed.

□ Complete fluorescence data acquisition algorithm

< Third Cooperation >
□ Influenza A virus HA subtype (HA1 ~ HA16) standard virus security

□ Evaluation of development kit

□ Development Diagnosis Kit completed assessment of whether influenza virus is highly pathogenic

□ Evaluation of development kit applied outdoor

Expected Contribution
< General Cooperation >
□ A new business model will be created including commercialization of two kinds of PCR systems (RT-PCR and LAMP-PCR)

□ Expect to expand into in vitro diagnostics based on gene analysis

□ Expect to generate sales through diagnostic kit (OEM type) including PCR diagnosis system

□ Establish win-win relationship between organizations

< First Cooperation >
□ RT-PCR, real time RT-PCR and RT-LAMP assays for the detection of animal and avian influenza viruses were applicable for rapid and differential diagnostic methods contributing to prevention of animal infection and spresd of influenza viruses. And it is expected that sales of the diagnostic kits will be increased by commercialization by the partner companies.

< Second Cooperation >
□ Based on the developed products, we will continue to apply to POC testing and verification to help you become a competitive product.

< Third Cooperation >
□ Expect to increase sales by creating a new business model by delivering optical modules to its main agency or by making its own products

(출처 : SUMMARY 7p)

목차 Contents

• 표지 ... 1
• 제 출 문 ... 2
• 보고서 요약서 ... 3
• 요약문 ... 4
• SUMMARY ... 7
• CONTENTS ... 10
• 목차 ... 12
• 제 1장 연구개발과제의 개요 ... 13
• 제 1절. 연구개발 목적 ... 13
• 제 2절. 연구개발의 필요성 및 범위 ... 13
• 제 2장 국내외 기술개발 현황 ... 15
• 제 1절. 논문, 특허, 시장 분석을 통한 국내외 기술 및 시장 현황 ... 15
• 제 3장 연구수행 내용 및 결과 ... 23
• 제 1절. 다축종 (산업동물 및 반려동물 포함) 적용 가능한 신속, 정확한 인플루엔자 검출 기법 개발 및 상용화 ... 23
• 제 2절. 동물 인플루엔자 바이러스 현장감별용 Pan-side RT-PCR 및 real time RT-PCR 키트 개발 ... 69
• 제 3절. 동물 인플루엔자 현장 진단을 위한 RT-PCR 분석 광학계 및 분석 SW개발 ... 122
• 제 4절. 현장에서 적용 가능한 인플루엔자 진단 키트 및 휴대용 기기의 유효성 평가 ... 144
• 제 4장 목표 달성도 및 관련 분야에의 기여도 ... 165
• 4-1. 목표달성도 ... 166
• 4-2. 관련 분야 기여도 ... 168
• 제 5장 연구결과의 활용 계획 ... 169
• 제 6장 연구과정에서 수집한 해외과학기술정보 ... 170
• 제 7장 연구개발 결과의 보안등급 ... 170
• 제 8장 국가과학기술종합정보시스템에 등록한 연구시설·장비현황 ... 170
• 제 9장 연구개발과제 수행에 따른 연구실 등의 안전조치 이행실적 ... 170
• 제 10장 연구개발과제의 대표적 연구실적 ... 171
• 제 11장 기타사항 ... 171
• 제 12장 참고문헌 ... 171
• 별첨 1 연구개발보고서 초록 ... 174
• 끝페이지 ... 176