Diagnostic reagent development is one of the two central pillars which support the developing of the institute, it also recognized as one of the four major research fields in the institute. Systemic researches and series research achievement of diagnostic reagent had been achieved before the forming of the institute. The establishment of the institute provided a better platform for the development of diagnostic reagent, it also enriched the techniques and productions for diagnostic reagent.
1, The diagnostics platform in the institute
Diagnostic reagents which developed previously based on immune-assay techniques, and our team achieved outstanding production in HIV, HCV and Syphilis. After the establishment of the institute, with the evolving of new techniques in diagnostics, we have successfully developed many new diagnostics platforms such as rapid immunoassay, Immune colloidal gold technique, Enzyme linked Immunofiltration assay. Some special diagnostic method achieved great break-through at the same time, such as recombinated immunoblotting used for infectious disease confirm and IGRA technique for TB infection testing. Facing the future research trend, the institute is building new platforms which were based on chemiluminescent immunoassay, enzyme-linked immunochromatography assay, fluorescence immunochromatography assay for diagnostic reagent development and made great progression. At the other hand, with the rapid development of immune-assay technique, we also initiated our research work in nucleic acid diagnostic field which was based on RT-PCR and capillary convective PCR(CCPCR).
As the integration research of reagent and instrument becoming the major trend in diagnostics field, the application of diagnostic reagents limited by instruments more and more significantly. In order to breaking the limitation caused by the diagnostic instrument, the institute initiated the research for automatic chemiluminescent immunoassay analyzer, fluorescence meter and CPCR to achieve a higher level of diagnostic reagent development.
Bio-active materials research plays an important role in the development of institute’s diagnostic reagent developing. We use the recombinant antigen platform and monoclonal antibody platform to develop bio-active antigen and antibody for diagnostic reagent researching and support the diagnostics technique developing in the institute.
2, Achievements in diagnostic reagent area
By using our own diagnostic reagent developing platform, 37 diagnostic assay kits including HIV, viral Hepatitis (HBV, HCV, HDV, HEV) were developed.
In HIV area, we developed the third generation HIV antibody diagnostic kit which based on the high bio-activity HIV recombinant antigen which was firstly prepared nationally by ourself. This achievement broke the monopoly of foreign technology and promoted the upgrading of HIV diagnostic reagents in China, it also placed second in the National Science and Technology Progress Award at 2001. The institute then developed the fourth generation HIV antigen diagnostic assay kit which shortened the HIV testing window for 6-9 days and kept the quality of Chinese HIV testing assay in the international advanced level. To fulfill the different requirement for HIV diagnosis, the institute developed HIV rapid testing reagent using salvia sample, HIV POCT test using blood sample, the first HIV antibody confirming test in China and a HIV chemiluminescent immunoassay reagent which compatible with automatic instrument. We totally get 6 CFDA registration and 1 CE certification.
For HEV research, we found HEV virus capsid protein’s dominant conformational epitope and a method to produce recombinant antigen which can keep the epitope’s conformation. According to this new technique, we have succeeded in developing HEV antibody, IgM antibody and antigen diagnosis kits which have reached the international leading level and placed second in the National Science and Technology Progress Award at 2010. We also got 4 CFDA registration certificate and 2 CE certification totally for our HEV production.
We also built efficient testing kit for HBsAg mutant preS1 and core antigen. At the same time, we also developed a brand new double antigen sandwich method for quantitative detection of HBcAb by using a HBV core antigen virus like particle which can keep its natural epitope conformation. By using this new diagnosis assay, we found the level of HbcAb showed significant relationship with HBV patient’s prognosis after treatment. We totally got 6 CFDA registration certificate and 1 CE certification in this researching field.
For HCV diagnosis, we have successfully developed HCV antibody diagnostic assay and HCV antibody confirming assay kit and get 2 CFDA registration certificate and 1 CE certification.
For HDV research, we have developed HDV IgM antibody testing kit and HDV IgG antibody testing kit and got 2 CFDA registration certificate while collaborating with University of Taiwan.
Other than HIV and viral Hepatitis, we also got 17 CFDA registration certificate, 1 EU certification and 1 Taiwan DoH approval for diagnosis production like Syphilis, HFMD (EV71 and CA16), RV, HCV, HTLV, TV and Type A Influenza.
For bio-active materials, depending on the technical platform of recombinant antigen and monoclonal antibody, we have developed materials for more than 20 testing assay kits such as HIV, HBV, HCV, HDV, HEV, HGV, EBV, TB, TP, HELV, Influenza, Tsutsugamushi Disease and HFMD, which supported the research requirement of different diagnostic reagents in the institute.
3, Achievement transformation in Diagnostic reagent
The 37 diagnostic reagents developed has be successfully introduced into commercial market by Beijing Wantai biological pharmacy Limited by Share Ltd and achieved significant economic benefit—the cumulative total sales have exceeded 1 billion RMB. The third and fourth generation HIV diagnostic reagents successfully broke the international monopoly for twice and kept the quality of Chinese HIV diagnostic reagents advanced internationally. The product ranked one in domestic market and exported to more than 30 countries, such as England, France. In the other hand, HEV diagnostic reagents in China occupy the market dominant position, market share of more than 80%, and exports to the EU and other 23 countries and regions. Our bio-active materials also support serval enterprises and institutes such as Wan Tai, Ai Bo, Da An, Northwestern University.
4, The institute’s influence in the area of diagnostics
The institute is a national platform for leading domestic diagnostic reagents research. In 2009, guiding by the Ministry of science and Technology Commission, the institute started to form a combination of advantage unites in diagnosis of industry chain "production, education, research, application, management" which now recognized as “China Infectious Disease Diagnostics Alliance”, and the institute served as the chairman of the alliance, our member also served as the Council and the Secretary General. Depending on the alliance, the institute help Xiamen to build “Fujian diagnostic product innovation park". “National Kay Laboratory for Molecular Vaccine and Molecular Diagnostics” approved by the Ministry of Science and Technology has been built by School of Public Health, Xiamen University at 2013, and the institute is one of the core team in this project. With the help of different level of technical platform, the institute is enhancing its international influence in the field of diagnosis.