April 8, 2024- Cepheid announced that Xpert® HIV-1 Qual XC has been awarded World Health Organization (WHO) prequalification. Inclusion on the prequalification list signifies that Xpert HIV-1 Qual XC meets WHO’s stringent performance, quality, safety and reliability standards. Xpert HIV-1 Qual XC (extended coverage) is an in vitro nucleic acid amplification test for the qualitative detection of HIV-1 total nucleic acids directly from human dried blood spots and capillary or venous whole blood specimens.
Xpert HIV-1 Qual XC provides extended strain coverage by including two gene targets for the identification of HIV-1 infections – delivering results up to seven to ten days before seroconversion. The test has been cleared for use in early diagnosis of infants, adolescents, and adults at the point of care and in laboratories.
Prompt diagnosis and treatment are critical for survival of infants with HIV. Untreated, around 50% of infants infected with HIV during or around the time of birth will die before the age of two years. Although efforts have been made to scale up diagnosis, only around 60% of exposed infants are given an HIV test within the first two months of life.