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INSTI HIV self-test
Prequalification of WHO: first and only blood-based HIV test
bioLytical Laboratories Inc.
VANCOUVER, British Columbia, November 28, 2018 (GLOBE NEWSWIRE) – BioLytical Laboratories, the world leader in rapid infectious disease tests, is pleased to announce that its INSTI® HIV self-test has been prequalified by the World Health Organization (WHO). INSTI, the world's fastest home-based test providing results in one minute, is becoming the first and only blood-based HIV self-test to be prequalified by WHO.
the INSTI HIV self-test allows people to discreetly track HIV in the comfort of their own home with easy-to-understand, field-tested graphic instructions. The product is based on the INSTI HIV-1 / HIV-2 test, which is the only rapid HIV test approved by the US FDA, Health Canada, WHO, and the European Union (CE Marked) . For this reason, healthcare professionals around the world rely on INSTI with more than 15 million rapid tests used in more than 60 countries. The ease of use, reliability and convenience of a one minute blood test were adapted from the product to the place of treatment to a carefully prepared test for home use.
Prequalification of the WHO means that the product meets the highest global standards of quality, safety and performance. The strict evaluation includes a review of the technical performance of the product, a site inspection and a laboratory evaluation of the product. Data in support of the INSTI HIV Self Test Screening show that the baday has sensitivity and specificity up to 100% compared to a fourth generation HIV ELISA / HIV antibody test. Rigorous field studies showed that more than 95% of participants found the INSTI HIV self-test easy to use, that they used it again and recommended it to partners and family members. The focus is on the suitability of a product for use in resource-constrained environments. Only when the product has pbaded each step and meets the prequalification requirements is it eligible for inclusion by the United Nations and other contracting agencies, such as UNITAIDPEPFAR and / or the Global Fund.
"Unitaid is pleased that WHO has for the first time prequalified a safe and reliable blood self-diagnosis for HIV. It is now a crucial step in achieving Unitaid's strategic investment objective of creating a healthy global marketplace for these key devices, "he said. Executive Director of Unitaid, Lelio Marmora.
Based on its performance and usability, the INSTI HIV self-test has been selected for use in the UNITAID / PSI system. HIV Self-Screening Initiative in Africa (STAR), which is the world's largest self-testing demonstration of HIV to date. The multi-year STAR project is an initiative to catalyze the HIV self-test market by generating information on how to distribute HIV testing at home in an effective and ethical way, as well as developing models of HIV testing. successful distribution.
"We will continue to badist countries to develop and launch their self-badessment policies, guidelines and programs, with planned launches in South Africa, Zimbabwe, Zambia, Malawi, Rwanda and Nigeria in early 2019, then at the global level as national policies in effect ", said Ryan Bennett, Vice President of Global Business Solutions at bioLytical.
"Our portfolio of on-site tests and self-tests has become a recognized market leader in Europe and North America. We are proud to have this certification as we continue to offer this long-awaited and highly anticipated one-minute test in Africa, as well as in North America, Asia and Latin America. Over the last year, countries and consumers have been actively calling for a quick, easy-to-use blood test and, thanks to obtaining prequalified status by the WHO, we are now able to respond to this request. "
the INSTI HIV self-test is already available in retail outlets and online in France, the United Kingdom, Germany, Spain, Portugal, Ireland, the Netherlands, Belgium, Austria, Estonia, Finland, Italy , Switzerland and Kenya. Pilot programs are underway in Armenia, Ukraine and Taiwan, and innovative self-test studies using INSTI are being conducted on a global scale. The INSTI home test approval also facilitates the early detection of HIV infection and facilitates more effective interventions through one-minute results and detection capabilities. IgM.
About bioLytical Laboratories Inc.
bioLytical Laboratories Inc. is a privately held Canadian company engaged in the research, development and commercialization of rapid in-vitro medical in-patient diagnostics using its proprietary INSTI technology platform. With a global footprint of regulatory approvals including US FDA approval, Health Canada approval and CE marking, bioLytical markets and markets its INSTI HIV test worldwide and its INSTI HIV / Syphilis Multiplex Test. in Europe. The INSTI product line provides very accurate test results in 60 seconds or less, much faster than the 15-20 minutes required for competitor tests based on side-flow technology. bioLytical has an active R & D program including tests for diseases such as Zika, Hepatitis C, Hepatitis B and Ebola, among others. The company also provides contract services to adapt the INSTI platform to the requirements of customized functional and technical diagnostic tests. For more information, please visit www.biolytical.com.
Eva Siu
Marketing Manager
+1 604 204 6784
[email protected]
A photo accompanying this announcement is available at http://www.globenewswire.com/NewsRoom/AttachmentNg/cea4e105-55a2-40d1-be7e-8538e236f003.
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