Currently, there is no requirement in Brazil to use molecular tests for blood screening, but it is recommended and the country is in the process of incorporating molecular tests, complementing serological tests in order to increase blood transfusion safety.
The initial HIV positive rate of blood donations in Brazil is between 0.3-0.4% but only about a fifth of these are later confirmed. In addition to earlier detection, another motivation for moving to molecular blood screening is to eliminate these false positives. Roche and Novartis/Gen-Probe are currently in the market with triple molecular screening tests; Roche was first in this segment, and is selling tests to five private blood banks. The local distributor REM introduced the ULTRIO test from Novartis/Gen-Probe more recently and is selling to two private blood banks. They are using Gen-Probe’s Tigris instruments. The price for either of these triple screening tests is between $12 and $20 per blood unit.
But the big news is in the public sector.
Bio-Manguinhos received regulatory approval from Brazil’s Agéncia Nacional de Vigiláncia Sanitária (ANVISA) for its molecular HIV and HCV screening tests in December, 2010. Bio-Manguinhos is the vaccine, diagnostic and pharmaceutical manufacturer for the Oswaldo Cruz Foundation, which has been providing these blood screening tests to public institutions since 2011. Public sector blood screening takes place at 15 large centers around the country and at many smaller testing sites, as well. At this point, about half of the large centers are using the Bio-Manguinhos screening tests and they expect to have all 15 operational by the end of 2012. They do not plan to sell tests to the private market.
Changing the location of blood screening is a major logistical challenge, particularly in the more remote parts of Brazil where transportation is difficult. There is some skepticism in the market about the ability of Bio-Manguinhos to overcome that difficulty and to manage the supply chain to get the tests out to all of the testing centers. But Bio-Manguinhos is moving forward and is also working on molecular tests for HBV, CMV and dengue.
We understand that during the incorporation of molecular tests, both public and private blood banks will continue to use their current screening regimes. The only change is that if molecular tests are being used, the blood bank can switch from the current antibody/antigen tests for HCV and HIV to antibody-only tests. We are not sure when this duplicate screening will be suspended but expect overlapping testing to be done through 2012
Carl McEvoy started his international career with the Program for Appropriate Technology in Health (PATH), a nonprofit organization based in Seattle. PATH is a Collaborating Center for the World Health Organization (WHO) in the areas of human reproduction, AIDS and hepatitis B vaccination and the leading recipient of Gates Foundation funding. McEvoy joined Michael Farmer 21 years ago in a consulting partnership that provides information on in vitro diagnostics in emerging markets around the world. The company publishes reports on the volume, type and brand of diagnostics used in Asia and Latin America. While the company has reported on 26 countries over the past two decades, the current focus of McEvoy & Farmer is China, India, Brazil and Mexico. He can be reached via e-mail at firstname.lastname@example.org.