WHO prequalification for Cepheid’s point-of-care HIV test

Cepheid’s 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.

The test 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.

In high-burden regions, centralised laboratory-based infant diagnosis often results in only about half of infants and children living with HIV being linked to and initiated on antiretroviral therapy (ART). Simple point-of-care molecular tests can deliver results to the care giver on the same day, enable earlier linkage to care and initiation of ART, and improve retention in care.

"Xpert HIV-1 Qual XC leverages dual-target technology to improve detection while maintaining the flexibility to be performed on-demand with results in as little as 91 minutes," said David Persing MD PhD, EVP Chief Medical and Scientific Officer at Cepheid. "The combination of peripartum determination of HIV viral load in mothers along with early qualitative HIV detection in newborns facilitates same-day treatment decisions, which will result in improved outcomes for babies, mothers, and entire communities."

The test is designed for use on any of Cepheid's GeneXpert systems, which provide simple, reference lab-quality PCR testing on location at medical centres and hospitals or near-patient testing in community health clinics and physician offices.


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