Cepheid gets WHO prequalification for Xpert HIV-1 qualitative test
June 14, 2016 – SUNNYVALE. Cepheid announced that its Xpert® HIV-1 Qual (Qualitative) test has been awarded World Health Organization (WHO) prequalification, making it one of the first molecular point of care tests designed for HIV to be given this designation. The test can detect HIV-1 in whole blood and dried blood spots from individuals suspected of HIV infection, including infants. Inclusion in the prequalification list signifies that Xpert HIV-1 Qual meets WHO’s stringent performance, quality, safety and reliability standards, and fulfills a performance measure established for many developing countries and global health participants before they can allow broad deployment of a new technology.
Without timely HIV testing and therapy initiation, one-third of HIV-infected infants will die before their first birthday, and more than 50% will die before their second birthday.1 Globally, an estimated 110,000 children died of AIDS-related causes in 2015.2 HIV infection in infants can only be diagnosed by molecular testing since immunoassay tests can be ambiguous given the presence of maternal HIV antibodies in the infant’s bloodstream up to 18 months of age.3
“Early detection of HIV in infants can be life-saving, particularly if these children are placed on antiretroviral therapy (ART) in the first twelve weeks of life,” said David Persing, M.D., Ph.D., Cepheid’s Chief Medical and Technology Officer. “Current central laboratory testing methods are slow, delays in initiation of ART for HIV-positive infants are all too common, and many patients are lost to follow up. In fact, for as many as half the infants tested for HIV, results are never received.”4
“Having rapid quantitative results available for assessment of maternal transmission risk on the day of delivery, along with a sensitive qualitative test to determine neonatal infection status, could together represent significant leaps forward in HIV prevention strategies,” said Jeanne Jordan, Ph.D., Professor, School of Public Health at The George Washington University.
Xpert HIV-1 Qual is part of a comprehensive portfolio of Xpert tests available internationally, including Xpert HIV-1 VL, Xpert CT/NG, Xpert Ebola and Xpert MTB/RIF, which run on the GeneXpert® System, the world’s most prevalent molecular diagnostics platform.
Xpert HIV-1 Qual is available outside the United States. For more information on Cepheid’s GeneXpert Systems or the complete menu of Xpert tests, visit www.cepheidinternational.com.
1http://www.unaids.org/sites/default/files/media_asset/09_ChildrenandpregnantwomenlivingwithHIV.pdf 2 UNAIDS aidsINFO. http://aidsinfo.unaids.org/ |3 WHO Consolidated Guidelines on HIV Testing Services. July 2015.4http://www.pedaids.org/page/-/uploads/resources/UNITAID_FS_Nov21.pdf