INDICAID™妥析™新冠病毒快速抗原检测试剂盒获缅甸紧急授权使用
新闻稿2021年9月7日
(只有英文版本)
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.
News Source: PHASE Scientific
