REMEMBER ELISA LAM?
A spooky coincidence was that a TB outbreak happened in the same area of the Cecil Hotel where Elisa Lam died, and a test kit they use for TB is a LAM-ELISA test kit.
Maybe it gets worse.
FIND annual report for 2009: http://www.finddx.org/wp-content/uploads/2016/02/Annual-report_2009.pdf
>In 2009, the Expanding Access to New Diagnostics for TB (EXPANDx-TB) project extended its activities to cover an additional 11 high burden countries. EXPANDx-TB is a UNITAID-funded joint collaboration between the WHO, the Global Laboratory Initiative and the Stop TB Partnership’s Global Drug Facility. This initiative aims to diagnose 15% of the global MDR-TB burden, by ensuring that (i) countries have access to new and effective diagnostic technologies; (ii) these technologies are properly integrated into TB control programmes; (iii) the laboratories which need to support these efforts have the requisite capacity for implementation; and (iv) technology transfer efforts promote local know-how and sustainability. With additional funding of almost US$ 61.5 million, the number of high burden TB countries to be covered by this project will increase from 16 to 27.
>FIND has been working with the Swedish Institute for Infectious Diseases (now at the Karolinska Institute), Genovac (Germany), and Future Diagnostics BV (The Netherlands) to develop a new LAM-based assay using monoclonal antibodies. By June 2009, an ELISA prototype assay was developed which showed very high analytic sensitivity (low nmol/l range) for the detection of the LAM antigen.
>Below are some of the key highlights and activities from 2009 in each of the 16 countries:
>Intra-laboratory validation showed 100% proficiency in performance of the introduced assays by laboratory
technicians, and thus a scale-up plan was drafted to cover all districts in Lesotho by December 2010. This would allow the country to take over testing completely from the National Institute for Communicable Diseases (NICD) in Johannesburg, where many samples were still being sent for analysis. FIND, the NICD and the Clinton Health Access Initiative (USA) have partnered to contribute supplies and logistics to this scale-up project;
USAID involvement: http://pdf.usaid.gov/pdf_docs/Pnadf424.pdf
>Comprehensive national HIV/AIDS programs are relative newcomers to public health programs in resource poor settings. Recent global initiatives such as the President’s Emergency Plan for AIDS Relief; the Global Fund for HIV/AIDS, Tuberculosis, and Malaria; the Clinton Foundation’s HIV/AIDS Initiative; and WHO’s 3 by 5 Strategy have fostered an environment of rapid expansion of HIV/AIDS programs in countries by focusing financial, human, and technical resources toward achieving global prevention, care, and treatment goals. As a result, in many countries, the life cycle of these HIV/AIDS programs is somewhat distorted by the political, multilateral, bilateral, and social pressure to rapidly scale up these services, and program implementation is not as systematic as managers would prefer.
>Rapid Test Devices (RTDs) are also ELISAs, but are listed as a separate type because of the nearly immediate results provided and because of other characteristics of the tests. Traditional ELISAs are sometimes referred to as long ELISAs because they take up to three hours to produce a test result.
PEPFAR 1000+ pages on work in Nigeria: http://www.pepfar.gov/documents/organization/113015.pdf
>Since COP05, USG-Nigeria has reached 44,736 OVC in 20 states. Major accomplishments include the launch of the 2006-2010 National Plan of Action for OVC (NPA) developed with USG and other donor support. Guidelines, standards of practice for care of OVC, and legal support resources have been produced for distribution and use by PEPFAR-Nigeria partners and other stakeholders. The Government of Nigeria (GON) has demonstrated political will to mitigate the plight of OVC with the launch of the NPA by the previous President, the decision to utilize debt relief funds for a collaborative program with the Clinton Foundation to accelerate pediatric HIV diagnosis, treatment and care, and the decision to conduct the National Situation Analysis on OVC in 2007.
>PEPFAR has been the largest donor supporting Nigeria’s OVC programs to date. Now, the Global Fund (GF) will increase its role with the implementation of the Round 5 OVC grants. GF has facilitated the development of an OVC Vulnerability Index and continues to support skills development in psychosocial support for civil society organizations implementing OVC activities in 12 focal states. USG/Nigeria has provided and will continue to provide OVC technical assistance to the GF recipients. Other development partners include UNICEF, World Bank DFID and the Clinton Foundation; USG-Nigeria will continue its involvement in the Development Partners Group thereby collaborating with these other partners on OVC program planning and implementation.
Tulip Group: http://www.tulipgroup.com/ProductEvaluations/Retrocheck.pdf
>The 4 rapid tests were provided by the Clinton Foundation.
>Serum samples were obtained from individuals after signing an informed consent. All sera samples were processed using each of the 4 rapid tests and their results were compared against the reference test, Determine TM (2503). All positive results for HIV were confirmed by an ELISA test and, if needed, by Western Blot. The data was analyzed with Epi Info 2000 with a 5% alpha. All tests were performed in doubleblind with an individual code to avoid any bias. Quality controls were run for positive and negative tests.