The kits will run on a high-throughput multiplex PCR platform which allows processing of large numbers of samples and detecting multiple pathogens in one single run. The highly automated platform – which includes an advanced control system based on biosafe viruses developed and patented by Bio-Manguinhos – has demonstrated excellent screening results in the field test. The partnership between Qiagen and Bio-Manguinhos also involves technical advice for implementation of the production of enzymes and buffers in Brazil, but excludes the delivery of primers and probes. These integral test components, essentially needed to make virus sequences visible, are developed and provided by Bio-Manguinhos.

Brazil’s new national screening program is scheduled to start in 2010. It marks the largest initiative in the country’s history of blood donations safety. Every year, five million blood donations are performed in Brazil (with a population of 190 million South America’s largest country), of which 70% are conducted by public blood banks. About 0.1% and 0.3% of these donations are tested positive for HIV and HCV, respectively. Since most of these tests are performed with older, less sensitive serological methods, experts believe that the actual number of positive cases could be higher than officially reported. The new program marks the effort to complement these traditional, immunodiagnostic tests with nucleic-acid-based, molecular assays that are considered significantly more sensitive in detecting infection. They help close the diagnostic window between the time of an infection and laboratory diagnosis by enabling faster treatment and reducing the ability of an infection to spread – thereby further increasing the safety of the blood supply.

Nucleic-acid testing is the premium public health option to help prevent often transfusion-transmitted diseases such as AIDS or Hepatitis C, said Dr. Akira Homma, director of Bio-Manguinhos. Furthermore, the increased quality of screened blood from donations will also allow the public health system to gain high quality and safer plasma products in sufficient volumes. Therefore, the new screening program will also reduce the country’s demand for costly imports of plasma products which are needed to treat patients suffering from Hemophilia and other blood disorders.

Molecular diagnostic methods are key to making blood donations safer, and it is our goal to make these life saving technologies available to governments and their people throughout the world, said Peer M. Schatz, chief executive officer of Qiagen. We are proud to team up with the Brazilian authorities in a combined effort to significantly reduce the number of blood-borne transmissions of HIV and HCV and the resulting disease burden.