Point of Care HIV Test Enables Early Infection Diagnosis for Infants

Early diagnosis and initiation of treatment are crucial for the survival of infants infected with HIV (human immunodeficiency virus). Without treatment, approximately 50% of infants who acquire HIV during or near birth will not survive past their second year. Despite efforts to improve early diagnosis rates, only about 60% of infants exposed to HIV are tested within the first two months of life. In regions with a high burden of the disease, the reliance on centralized laboratory-based diagnosis means that only about half of the infants and children living with HIV are linked to and start antiretroviral therapy (ART). Point-of-care molecular tests that provide same-day results can significantly enhance early care linkage, prompt ART initiation, and increase care retention. Now, a point-of-care HIV diagnostic test leverages dual-target technology for the early detection of HIV infection in infants.

Cepheid’s (Sunnyvale, CA, USA) Xpert HIV-1 Qual XC 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. By targeting two genes, this test extends strain coverage and can detect HIV-1 infections up to seven to ten days before seroconversion, making it a critical tool for the early diagnosis of infants, adolescents, and adults, whether at the point of care or in laboratory settings.

The test is designed for use on any of Cepheid's GeneXpert systems, which facilitate on-site, reference lab-quality PCR testing across a variety of settings, from medical centers and hospitals to community health clinics and physicians' offices. Xpert HIV-1 Qual XC has been awarded World Health Organization (WHO) prequalification, indicating that the test meets the WHO's stringent performance, quality, safety, and reliability standards. This test is part of Cepheid's extensive range of WHO pre-qualified Xpert tests available internationally, which also includes tests for HIV-1 viral load, HBV and HCV viral load, HPV, and WHO-endorsed tests for tuberculosis and drug-resistant TB.

"Timing is critical for infants born to mothers living with HIV. When accurate and sensitive test results are provided to clinicians quickly, they can immediately initiate the highly effective therapies that are now available to babies with HIV," said Devasena Gnanashanmugam, M.D. and VP of Medical Affairs at Cepheid. "Mothers and families also benefit from the test's quick turnaround time since they have fewer days of anxiety waiting for answers."

"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," added David Persing, M.D., Ph.D., 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."

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