There is a high demand for invitro diagnosis (IVD) test kits for various diseases in ASEAN and this technology is suited to provide product support to commercialise IVD test kits especially for public health problems faced in ASEAN. Produced under ISO13485 certified production, the IVD tests have high sensitivity and specificity, especially supporting the specific types of local ASEAN microorganisms detection. The technology services have supported the production of test kits for infectious disease for specific conditions such as Covid-19 and Leptospirosis.
There are varieties of detection platforms which has been used in clinical laboratory system in hospital and clinic in remote areas. However, to improve the quality of produced IVD test kits, standarised production process under the ISO13485 requirements are provided. Until now, the IVD test technologies that the technology provider can support include:
By providing standardised production facility, the technology provider is able to service the following potential applications:
Supported under the Center of Excellent in Medical Innovative Development and Accelerating Support for Commercialization (MIDAS Center), the Technology Acelerator specifically designed to empower resarchers in advancing their medical IVD test kits. The technology provider focuses on taking research and innovation to IVD product development, ensuring all kits meet the international standards and can gain FDA approval worldwide.