To address the urgent testing demands arising from the COVID-19 pandemic, the Taiwan Food and Drug Administration (TFDA) established a platform for the preparation and distribution of SARS-CoV-2 reference standards and respiratory virus nucleic acid panels. These materials were developed to support domestic manufacturers in product development, performance evaluation, and quality management, thereby strengthening Taiwan’s diagnostic capacity and pandemic preparedness. Under TFDA regulations, in vitro diagnostic (IVD) medical devices are required to use appropriate viral reference materials for product registration and performance evaluation. During the pandemic, however, many of these materials were difficult to obtain. To meet this need, TFDA rapidly established and supplied SARS-CoV-2 reference standards and respiratory virus panels to domestic manufacturers, medical institutions, and research organizations. The panels include SARS-CoV-2 and other respiratory viral nucleic acid reference materials for evaluating analytical sensitivity, specificity, cross-reactivity, and overall assay performance. They serve as important tools for quality control and assay validation of IVD medical devices. The products and related services have received positive user feedback and contributed significantly to improving diagnostic quality and supporting the development of Taiwan’s biotechnology and diagnostic industries.

Taiwan Food and Drug Administration, Ministry of Health and Welfare

The product complies with the principles outlined in WHO technical guidelines for the preparation of biological reference standards.

The TFDA’s SARS-CoV-2 reference standards and respiratory virus panels are prepared and supplied in accordance with WHO guidelines for biological reference materials. Quality control and collaborative calibration studies are implemented to ensure product consistency and reliability. Stability studies are conducted based on ICH guidelines, while laboratory management follows ISO/IEC 17025 principles. In addition, all handling, storage, and transportation procedures comply with regulations governing infectious biological materials to ensure biosafety and biosecurity.

Following preparation, the product undergoes collaborative calibration studies in accordance with WHO guidelines for biological reference standards. Participating laboratories include WHO collaborating centers and national laboratories such as the U.S. FDA, the U.K. NIBSC, Germany’s PEI, Japan’s NIID, Australia’s NRL, and Taiwan CDC, as well as leading domestic and international diagnostic manufacturers and professional laboratories. Test results are traceable to international reference standards and are statistically analyzed to ensure the consistency and reliability of product quality. In addition, long-term and accelerated stability studies are conducted in accordance with the principles outlined in ICH technical guidelines for stability testing. Product stability is evaluated under different temperature and storage conditions to verify product quality and environmental tolerance during transportation, storage, and use.

To ensure the continued quality, stability, and suitability of respiratory virus nucleic acid reference kits after distribution, the TFDA continuously monitors product usage and collects feedback from users. Any abnormalities related to testing results, product performance, or operational procedures can be promptly reported and investigated by the Agency for root cause analysis and follow-up actions. In addition, periodic stability evaluations and quality assessments are conducted to continuously ensure the consistency and stability of the reference standards.

Po-Lin Lin, Ming-Sian Wu, Po-Chi Wu, Hsin-Mei Chen, Yi-Hsuan Peng, Jia-Chuan Hsu, Der-Yuan Wang. A collaborative study to establish the national standard for SARS-CoV-2 RNA nucleic acid amplification techniques (NAAT) in Taiwan. Biologicals. 2022, 79, 31-37.