Abbott's New HIV-1 Qualitative Assay Improves Testing Access in Remote Areas for Children and AdultsBy Abbott, PRNE
Sunday, March 20, 2011
WIESBADEN, Germany, March 21, 2011 - 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
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.
About the Abbott m2000 System
Abbott's automated molecular diagnostics system, the m2000, utilizes
real-time polymerase chain reaction (PCR) technology for detecting and
monitoring infectious diseases and is designed to provide clinical
laboratories a unique system that fully automates all of the complex and
heavily manual steps often associated with molecular diagnostics. The Abbott
m2000 system offers a broad menu of assays outside the United States,
including tests for HIV-1 viral load, hepatitis B and C viral loads,
hepatitis C genotyping, human papillomavirus, cytomegalovirus, Epstein-Barr
virus, chlamydia, gonorrhea, colorectal cancer detection, and KIF6, a test to
identify patients at risk for coronary heart disease. Tests approved in the
United States are HIV, HBV, chlamydia, and gonorrhea.
About Abbott Molecular
Abbott Molecular, www.abbottmolecular.com, is an emerging leader
in molecular diagnostics - the analysis of DNA, RNA, and proteins at the
molecular level. Some of Abbott Molecular's tests are designed to detect
subtle but key changes in human genes and chromosomes. The results of these
tests may aid in the earlier detection or diagnosis of disease, may influence
the selection of appropriate therapies, and may improve monitoring of disease
Abbott is a global, broad-based health care company devoted to the
discovery, development, manufacture and marketing of pharmaceuticals and
medical products, including nutritionals, devices and diagnostics. The
company employs nearly 90,000 people and markets its products in more than
Abbott's news releases and other information are available on the
company's Web site at www.abbott.com.
Media, Cheryl Dodd of Abbott, +1-847-937-6570
Tags: Abbott, Germany, March 21, Wiesbaden