Myanmar’s Food and Drug Administration (FDA) has authorised an Emergency Use Authorization (EUA) for the sale and use of the INDICAID COVID-19 Rapid Antigen Test in Myanmar on 27 August 2021. The EUA authorises the sale and usage of the test in Myanmar for both professional and home COVID-19 testing, helping to facilitate early isolation, diagnosis, and treatment of patients.
The INDICAID™ COVID-19 Rapid Antigen Test is a lateral flow immunoassay designed for qualitative detection of SARS-CoV-2 antigens. Unlike other testing methods that use nasopharyngeal swab specimens, INDICAID™ uses nasal swab specimens to provide fast results within 20 minutes without need of any special equipment or facilities.
INDICAID™ has been validated in the world’s largest clinical trial for a product of its kind, results from which have been published in Microbiology Spectrum on 4 August 2021. In this Dual-Track testing trial, 22,994 asymptomatic subjects were tested using both INDICAID™ and a confirmatory RT-PCR test at COVID-19 community testing centers in Hong Kong. Results show that INDICAID™ has excellent sensitivity and specificity and is effective for fast population screening.
INDICAID™ COVID-19 Rapid Antigen Test has received Emergency Use Authorization from the US Food & Drug Administration (FDA) and the European CE Mark. The kit has been widely adopted in COVID-19 testing centers, hospitals, government and private corporations, supermarkets, hotels and schools in Hong Kong and overseas. INDICAID™ is currently available in 33 countries, and is the best-selling rapid test kit in Hong Kong.
EUA authorization issued to INDICAID from Myanmar’s FDA
About Phase Scientific International LTD: PHASE Scientific is a high-growth biotech company founded by a team of bioengineers from UCLA. The organization is focused on building tools that empower people by giving them better information about their health. Headquartered in Hong Kong, its footprint includes research and development, manufacturing and distribution in Hong Kong, mainland China and Southern California. For more information: https://phasescientific.com/.