{"id":11222,"date":"2003-06-01T09:39:20","date_gmt":"2003-06-01T09:39:20","guid":{"rendered":"http:\/\/i-base.info\/htb\/?p=11222"},"modified":"2014-05-27T12:51:55","modified_gmt":"2014-05-27T12:51:55","slug":"three-minute-hiv-test-wins-approval-in-china-and-the-usa","status":"publish","type":"post","link":"https:\/\/i-base.info\/htb\/11222","title":{"rendered":"Three-minute HIV test wins approval in China and the USA"},"content":{"rendered":"

Graham McKerrow, HIV i-Base<\/strong><\/p>\n

China and the United States have both approved a rapid, portable HIV testing kit that is cheap to produce, easy to use and gives results in three minutes. It is being compared to home pregnancy tests and could revolutionise HIV testing.<\/strong><\/p>\n

After receiving distribution approval from China\u2019s State Drug Administration in February, a small Canadian biotech company is rushing to produce 400,000 rapid HIV tests for the nation. \u201cThe Chinese government has finally acknowledged this is a problem. Now they\u2019re trying to make prevention a priority,\u201d said Daniel Sham of the company MedMira. The US Food and Drug Administration approved the test in April.<\/p>\n

The test, which costs about US$2.25 to manufacture, detects antibodies in the blood and shows two red lines for a positive result. Unlike conventional HIV tests, MedMira\u2019s test produces results in about three minutes. The Chinese order is for 400,000 tests to be distributed to clinics and hospitals.<\/p>\n

The company said in a statement: \u201cWith the FDA approval, MedMira can market the Reveal Rapid HIV-1 Antibody Test for the detection of HIV-1 antibodies in serum or plasma. This test has a one-year shelf life at room temperature, the longest of any rapid HIV tests available in the United States. MedMira\u2019s test also produces highly accurate results substantially faster than any other FDA-approved HIV diagnostic test.\u201d<\/p>\n

Stephen Sham, Chairman and CEO of MedMira, said: \u201cWe are very pleased to enter the United States market with the best rapid HIV test to date. Many countries view the approval to market of a diagnostic test by the FDA to be the gold standard of endorsement. Now that we have obtained this approval, we are very optimistic about the immediate expansion of MedMira\u2019s operations. We look forward to fulfilling the global diagnostic marketplace with our unique diagnostic products.\u201d<\/p>\n

Sham called the earlier approval by China a landmark event for his company, which was founded in a university basement a few years ago. \u201cThis regulatory approval achieves one of the company\u2019s strategic goals of gaining access to large markets where the power of our technology can be used to make a difference in a significant public health campaign,\u201d he said.<\/p>\n

Chinese HIV infection rates have surged, particularly in remote regions where IV drug use, prostitution, migration and blood transfusions have increased. In addition, China\u2019s blood supply was largely unregulated in the 1980s and many private agencies mixed supplies, reused needles and operated without sterilised equipment.<\/p>\n

MedMira – which also manufactures diagnostic tests to detect hepatitis – signed a deal recently to supply 1 million tests to the Democratic Republic of Congo. Health Canada approved the test in 1998.<\/p>\n

http:\/\/www.medmira.ca\/news11.htm<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

Graham McKerrow, HIV i-Base China and the United States have both approved a rapid, portable HIV testing kit that is cheap to produce, easy to use and gives results in three minutes. It is being compared to home pregnancy tests …<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"open","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[21],"tags":[],"class_list":["post-11222","post","type-post","status-publish","format-standard","hentry","category-diagnostic"],"_links":{"self":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/11222","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/comments?post=11222"}],"version-history":[{"count":0,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/posts\/11222\/revisions"}],"wp:attachment":[{"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/media?parent=11222"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/categories?post=11222"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/i-base.info\/htb\/wp-json\/wp\/v2\/tags?post=11222"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}