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News items for the in vitro diagnostics industry for the week of August 10, 2020.
To enable the use of saliva in addition to other types of samples, Sysmex requested a change to a marketing approval it obtained in March.
BGI will establish six so-called Huo-Yan COVID-19 testing labs in Saudi Arabia, based on the emergency lab the firm set up in Wuhan, China in February.
Both the Israeli and Palestinian authorities have granted approval for the lab to perform 3,000 COVID-19 tests per day for Gaza residents.
Sysmex anticipates delivering the kit to Japanese medical institutions this month for diagnosis of the SARS-CoV-2 infection.
The BGI Real-Time Fluorescent RT-PCR Kit for detecting SARS-2019-nCoV runs in approximately three hours and can be manufactured in large volumes, the firm has said.
The qualitative in vitro nucleic acid amplification assay detects 2019-mCoV using RT-PCR from throat swab and bronchoalveolar lavage fluid samples.
The Shenzhen Mammoth Public Welfare Foundation, which BGI sponsors, has also raised funding to purchase PCR and automate sample preparation instruments.
The new laboratory, which began trial operations this week, is designed to test 10,000 samples per day for the 2019-nCoV coronavirus.