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Sysmex Obtains Japan Marketing Approval for Use of Saliva With Coronavirus Kit

NEW YORK ─ Sysmex said Tuesday it has obtained marketing approval in Japan for the use of saliva with BGI Genomics' 2019-nCoV Fluorescence Detection Real-Time RT-PCR Kit.

In March, Kobe, Japan-based Sysmex had obtained marketing approval in the country for the distribution of the kit to detect the RNA of SARS-CoV-2 extracted from upper respiratory tract swabs or lower respiratory tract sputum or bronchoalveolar lavage fluids.

Sysmex said it subsequently filed a change request for the marketing approval to enable the use of saliva as a sample type, which was approved on June 2, and the use of saliva for testing was also included in health insurance coverage.

Shenzhen, China-based BGI received US Food and Drug Administration Emergency Use Authorization for the test in March.

Sysmex noted that the Japanese Ministry of Health, Labour, and Welfare this month announced that saliva obtained within nine days of the onset of symptoms could be used in PCR testing for the novel coronavirus, in addition to nasopharyngeal swabs from the upper respiratory and sputum or alveolar fluid samples from the lower respiratory tract.

Compared with sampling mucus from deep in the nose and throat, saliva samples enable safer, faster, and simpler PCR testing for the novel coronavirus, Sysmex said.

The 2019-nCoV Fluorescence Detection Real-Time RT-PCR Kit runs on the Thermo Fisher Scientific Applied Biosystems 7500 Fast Dx Real-Time PCR Instrument or an equivalent analyzer.