Abbott receives CE-Mark for new qualitative PCR-based HIV-1 test

Abbott (NYSE: ABT) announced today that it has received CE-Mark for a new qualitative PCR-based HIV-1 test that produces highly accurate results from dried blood spot and plasma specimens. The new assay is a long-awaited diagnostic tool for health officials in African nations and other resource-limited areas to detect HIV-1 infected infants at early stages and begin treatment when success is more likely.

Abbott's RealTime HIV-1 Qualitative Assay is performed on Abbott's automated, high-throughput m2000 system, which is used in laboratories worldwide. The highly sensitive assay detects both DNA and RNA of HIV-1. Dried blood spot samples are more convenient for testing infants because only a small volume of sample is needed and the sample remains stable under various environmental conditions.

The new RealTime HIV-1 Qualitative Assay will be available for diagnostic laboratories and supplied to non-governmental organizations and health agencies collaborating with the Ministries of Health in countries most affected by the epidemic.

"This test is a welcome advancement in the ongoing effort to detect pediatric HIV infections in Africa," said Kristina Rodnikova, divisional vice president and general manager of Abbott's molecular diagnostics business in Europe. "Early detection of infants with HIV is now more practical and possible in remote areas because a drop of blood can be applied to a paper card for HIV testing, which allows for easy collection, transport, and storage. The sample can be stored at room temperature and will remain stable for three months."

Early detection of HIV infection – four to six weeks after exposure – in infants and young children is critical for successful treatment. According to the World Health Organization (WHO), of the estimated 33 million individuals living with HIV, about 2.5 million are children and more than 90 percent reside in sub-Saharan Africa.

Nearly 50 percent of pediatric HIV infections are transmitted by the mother at birth when there is no intervention. Early testing and treatment of infants has been shown to decrease mortality associated with HIV-1 infections.

The Abbott RealTime HIV-1 Qualitative Assay reports qualitative results of HIV-1 total nucleic acids from human plasma and dried blood spots. The assay is highly sensitive for detecting HIV in pediatric and adult specimens. The test is designed to aid in diagnosing HIV infection in children and adults and is not intended for screening blood donors.