In vitro Diagnostic (IVD) Test kits for clinical laboratory professional and home uses

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:

1. Lateral flow-based assay test kit
2. Immunological-based diagnostic test kits
3. Biomolecular detection for IVD

By providing standardised production facility, the technology provider is able to service the following potential applications: 

• Produce the highest risk class of IVD test kits that professionals require and can be widely used in Clinical Laboratory Analysis or Medical Technology Units for laboratory diagnosis services in hospitals.
• Produce IVD test kits for home use such as Point of Care Testing kits which offers personal care with easy-to-read and yourself analysis.
• Test kits needed for the veterinary and food-supporting industries.

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.