Abbott announced it has received CE Marking (Conformité Européenne) in the European Union to market a new, highly sensitive diagnostic test for detection of hepatitis B surface antigen (HBsAg). The test is performed on Abbott's ARCHITECT® system. HBsAg assays may be used to help identify ac ... more
Abbott's New HIV-1 Qualitative Assay Improves Testing Access in Remote Areas for Children and Adults
Abbott announced 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."
Abbott announced the availability of a new molecular test in the European Union and New Zealand designed to identify the presence of gene rearrangements associated with a specific form of non-small-cell lung cancer (NSCLC). These rearrangements in a gene known as ALK (anaplastic lymphoma k ... more
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