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May 11, 2021

Coronavirus company news summary – FDA approves QUANTA Flash SARS-CoV-2 IgG in the US – Hong Kong approves INDICAID Covid-19 rapid antigen test

By Chloe Kent

Inova Diagnostics has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its QUANTA Flash SARS-CoV-2 IgG to be used on BIO-FLASH random access chemiluminescent analyser. The QUANTA Flash has demonstrated high accuracy in the detection of IgG antibodies to the nucleocapsid and spike proteins of the SARS-CoV-2 virus, with 100% specificity in patients with confounding conditions and 100% sensitivity in patients after 15 days from being tested positive.

Seegene‘s German subsidiary is participating in the government’s Back-to-School programme, the Lolli-Test, in an effort to return to normalcy. The company is expected to deliver Covid-19 diagnostic tests to laboratories in a weekly basis for nine weeks, starting in May until the beginning of the summer break, for about $23.4m. The diagnostic tests will then be delivered to about 400 laboratories in the North Rhine-Westphalia region to test more than 734,000 pupils at 3,764 special and elementary schools.

The Hong Kong government has approved the Covid-19 rapid antigen test INDICAID, developed by biotechnology company PHASE Scientific International, as one of the designated rapid tests after care homes resume visitation from 10 May 2021. The INDICAID Covid-19 rapid antigen test is a CE-marked lateral flow immunoassay that helps detect SARS-CoV-2 antigens in direct nasal swab samples, delivering results in just 20 minutes.

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