INDICAID™妥析™新冠病毒快速抗原檢測試劑盒獲肯尼亞緊急授權使用
新聞稿2021年8月30日
(只有英文版本)
PHASE Scientific announces that its INDICAID™ COVID-19 Rapid Antigen Test (INDICAID™) has received Emergency Use Authorization from the Ministry of Health (MOH) of the Republic of Kenya on 17 August 2021. The authorization enables the test to be used in Kenya for the identification of COVID-19 cases, facilitating 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.
"The authorization of INDICAID™ from various countries indicates our technology and quality are well-recognized globally," says Dr. Ricky Chiu Yin-to, Founder and CEO of PHASE Scientific. "Thanks to INDICAID's high sensitivity, not only can the product help detect symptomatic positive cases, it can also be used for screening in asymptomatic populations." Dr. Chiu has also mentioned that Kenya is the first market in Africa the Company enters, and that it will continue expanding to other African countries to help combat COVID-19.
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: CISION
