{"id":44648,"date":"2020-05-23T00:38:38","date_gmt":"2020-05-23T00:38:38","guid":{"rendered":"https:\/\/websitedesigns.com.au\/elankanew\/?p=44648"},"modified":"2021-12-19T06:51:21","modified_gmt":"2021-12-19T06:51:21","slug":"asx-announcement-tbg-biotechnology-corp-confirms-ce-mark-approval-of-covid-19-nucleic-acid-and-antibody-rapid-test-kits-authorised-by-the-board-of-directors-jitto-arulampalam-chairman","status":"publish","type":"post","link":"https:\/\/websitedesigns.com.au\/elankanew\/asx-announcement-tbg-biotechnology-corp-confirms-ce-mark-approval-of-covid-19-nucleic-acid-and-antibody-rapid-test-kits-authorised-by-the-board-of-directors-jitto-arulampalam-chairman\/","title":{"rendered":"ASX Announcement TBG Biotechnology Corp. Confirms CE Mark approval of COVID-19 Nucleic Acid and Antibody Rapid Test Kits &#8211; Authorised by the Board of Directors Jitto Arulampalam Chairman"},"content":{"rendered":"<h1><span style=\"font-size: 20px;\"><strong><span style=\"font-size: 28px;\"><span style=\"color: #3366ff;\">ASX Announcement TBG Biotechnology Corp. Confirms CE Mark approval of COVID-19 Nucleic Acid and Antibody Rapid Test Kits &#8211;<\/span> <span style=\"color: #3366ff;\">Authorised by the Board of Directors Jitto Arulampalam Chairman<\/span><\/span><span style=\"color: #3366ff;\">\u00a0<\/span><br \/>\n<img loading=\"lazy\" loading=\"lazy\" decoding=\"async\" class=\"size-full wp-image-44650 alignleft\" src=\"https:\/\/websitedesigns.com.au\/elankanew\/wp-content\/uploads\/2020\/05\/TBG_Diagnostics.jpg\" alt=\"TBG_Diagnostics\" width=\"280\" height=\"175\" \/> <\/strong><\/span><\/h1>\n<p><span style=\"font-size: 20px;\">TBG Diagnostics Limited (\u201cTDL\u201d or \u201cCompany\u201d) is pleased to announce that its wholly owned subsidiary TBG Biotechnology Corp. (\u201cTBG Taiwan\u201d) has received the CE Mark approval for its ExProbe<sup>TM <\/sup>SARS-CoV-2 Testing Kit and SARS-CoV-2 IgG \/ IgM Rapid Test Kit.<\/span><\/p>\n<p><span style=\"font-size: 20px;\">CE Mark certification indicates that the ExProbe<sup>TM <\/sup>SARS-CoV-2 Testing Kit and SARS-CoV-2 IgG \/ IgM Rapid Test Kit meet the essential health, safety, and environmental protection requirements of the applicable European regulations to allow the sale of the kit throughout the European Economic Area as well as any country that accepts CE-mark, subject to satisfying regulatory requirements and obtaining import permits for individual countries. Both tests are manufactured by TBG Biotechnology Corp. in Taiwan and will be exported from Taiwan subject to meeting the regulatory requirements of the destination country.<\/span><\/p>\n<p><span style=\"font-size: 20px;\">The ExProbe<sup>TM <\/sup>SARS-CoV-2 Testing Kit is a RNA based diagnostic kit that uses real time PCR technology with multiplex design to detect distinctive segments within RdRP, N and E genes of the SARS-CoV-2 virus in a single reaction. It is commonly used to confirm active infection of the SARS-CoV-2 virus.<\/span><\/p>\n<p><span style=\"font-size: 20px;\">The SARS-CoV-2 IgG \/ IgM Rapid Test Kit test is a lateral flow assay that is able to detect IgG and IgM antibodies against specific protein epitopes on the N and S proteins of the SARS-CoV-2.<\/span><\/p>\n<p><span style=\"font-size: 20px;\">The Company expects the test to take 15 minutes to complete and detect the presence of SARS- CoV-2 specific IgM and IgG antibodies in the blood, serum and plasma. IgM and IgG antibodies usually generated in the body 7-10 days after SARS-CoV-2 infection and can last for weeks. This test is often used to confirm if he\/she has been infected with the COVID-19 virus. This rapid test uses droplet of blood, serum or plasma as testing sample. Together, these two test products are expected to be able to confirm symptomatic individuals with an active SARS-CoV-2 viral infection and those who have been infected by SARS-CoV-2 and generated a specific antibody response.<\/span><\/p>\n<p><span style=\"font-size: 20px;\">Authorised by the Board of Directors <\/span><\/p>\n<p><span style=\"font-size: 20px;\"><strong><img loading=\"lazy\" loading=\"lazy\" decoding=\"async\" class=\"alignnone size-full wp-image-44649\" src=\"https:\/\/websitedesigns.com.au\/elankanew\/wp-content\/uploads\/2020\/05\/Jitto-Arulampalam.png\" alt=\"Jitto Arulampalam\" width=\"137\" height=\"136\" \/><\/strong><\/span><\/p>\n<p><span style=\"font-size: 20px;\">Jitto Arulampalam : Chairman\u00a0<\/span><\/p>\n<p>Photo Source: <a href=\"http:\/\/www.tbgbio.com\/en\/about\/our_board_of_directors\" target=\"_blank\" rel=\"noopener noreferrer\">TBG Diagnostics<\/a><\/p>\n<p><span style=\"font-size: 20px;\">ABN 82 010 975 612<\/span><\/p>\n<p><span style=\"font-size: 20px;\">Level 18, 101 Collins Street Victoria 3000 Australia Telephone: + 61 7 3273 9133 Facsimile: + 61 7 3375 1168 <\/span><strong><span style=\"font-size: 20px;\">www.tbgbio.com<\/span> <\/strong><\/p>\n<p>&nbsp;<\/p>\n","protected":false},"excerpt":{"rendered":"<p>ASX Announcement TBG Biotechnology Corp. Confirms CE Mark approval of COVID-19 Nucleic Acid and Antibody Rapid Test Kits &#8211; Authorised by the Board of Directors Jitto Arulampalam Chairman\u00a0 TBG Diagnostics Limited (\u201cTDL\u201d or \u201cCompany\u201d) is pleased to announce that its wholly owned subsidiary TBG Biotechnology Corp. (\u201cTBG Taiwan\u201d) has received the CE Mark approval for [&hellip;]<\/p>\n","protected":false},"author":3,"featured_media":44649,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"aside","meta":{"footnotes":""},"categories":[20],"tags":[19804,19806,19805],"class_list":{"0":"post-44648","1":"post","2":"type-post","3":"status-publish","4":"format-aside","5":"has-post-thumbnail","7":"category-articles","8":"tag-jitto-arulampalam","9":"tag-tbg-biotechnology-corp","10":"tag-tbg-diagnostics","11":"post_format-post-format-aside"},"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.7.1 (Yoast SEO v25.9) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>ASX Announcement TBG Biotechnology Corp. 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