RE:HiThanks rewko1, you are the keeper of our approvals again. Right as DM announced this kit, the FDA took another look at their E-Use approvals and decided to reset their whole system making manufacturers to go through the whole process again. One day people will learn not to trust "NOTHING, I MEAN NOTHING" that comes out of China.
https://www.fda.gov/media/138300/download 2020-05-06 07:54 ET - News Release
Mr. Marshall Gunter reports
DATAMETREX OBTAINS RIGHTS TO SELL COVID-19 TESTS FROM TWO ADDITIONAL SOUTH KOREAN MANUFACTURERS
Datametrex AI Ltd. has secured non-exclusive rights to sell COVID-19 test kits from two additional South Korean manufacturers, including a kit that is U.S. Food & Drug Administration approved under Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices (EUA) for the United States, and CE marking certification (CE) for European Economic Area (EEA) countries, which covers the 27 member states of the EU, the four members of EFTA, plus Turkey and the United Kingdom under Brexit.
According to each of the manufacturers, these test kits made are both nucleic acid based, which Health Canada is prioritizing the review of. Each of the manufacturers' test kits have been submitted to Health Canada approval on a fast-track basis and, until such approval is granted, these tests may not be sold or used in Canada. The company is currently working closely with Health Canada to have the approval of the test kits fast tracked. An interim order request for Health Canada has been submitted for 300,000 kits immediately and an additional 100,000 weekly thereafter.
One of the test kits, manufactured by Seasun Biomaterials Inc. of South Korea, was authorized on April 27, 2020, by the FDA in the United States for emergency use under the EUA by authorized laboratories and has also been approved for use in the EEA with CE marking certification. With regard to the FDA authorization: (1) This test has not been FDA cleared or approved; (2) this test has been authorized by the FDA only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and (3) this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the act, 21 U.S.C. paragraph 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
Seasun claims that the average number of specimens that can be tested in a 12-hour period with its U-TOP COVID-19 Real-Time Detection Kit is 3,400. Seasun advises this is the equivalent of approximately 283 tests per hour, and the kit uses dual-labelled peptide nucleic acid probes to detect two distinct regions in ORF1ab and one region in N gene of the SARS-CoV-2 genome in oropharyngeal and nasopharyngeal swab specimens, anterior nasal and mid-turbinate nasal swabs, nasopharyngeal wash/aspirate or nasal aspirate specimens and sputum. The test runs on any authorized RT-PCR instrument and can be performed by any lab CLIA-certified to perform high-complexity tests.