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Xpert ® HIV-1 Qual XC

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HIV-1 Qual XC computer generated depiction.
A molecular point-of-care test that delivers results in around 90 minutes

The Need

an ill woman listens to a physician
  • Acute HIV infections are characterized by the lack of anti-HIV antibodies and the presence of high levels of virus in the blood and a risk of transmission.1
  • Maternal HIV antibodies can persist in a child up to 18 months preventing the use of serological testing for diagnosis. HIV infection in infants can be definitively confirmed only with HIV NAT2 (e.g. PCR) testing.
  • A highly sensitive HIV qualitative PCR test is needed for early diagnosis of HIV infections in high-risk populations and infants.
1 National Institute of Health, Fact Sheet: The stages of HIV Infection. https://clinicalinfo.hiv.gov/en/guidelines/hiv-clinical-guidelines-adult-and-adolescent-arv/early-acuteand-recent-hiv-infection#:~:text=Acute%20HIV%20infection%20occurs%20soon%20after%20transmission%20and,after%20infection%2C%20during%20which%20anti-HIV%20antibodies%20become%20detectable. Accessed Sept 2023.
2 World Health Organization. (2021). Guidelines: updated recommendations on HIV prevention, infant diagnosis, antiretroviral initiation and monitoring. World Health Organization. https://apps.who.int/iris/handle/10665/340190.

The Solution

a male and a female researchers scanning cepheid test cartridges
  • The Xpert HIV-1 Qual XC (extended coverage) test is a nucleic acid amplification test for the qualitative detection of HIV-1 total nucleic acids, on the automated GeneXpert® system and directly from whole blood or dried blood spot samples.
  • It is intended to aid in the diagnosis of HIV-1 infection in infant, adolescent, and adult populations that can be performed in a laboratory or at the point of care.

The Impact

a smiling female doctor attends an elderly woman
  • Improve access to HIV testing: Designed for near-patient testing in any setting allowing faster delivery of results and medical follow up. Simple sample collection, testing, and results in ~90 minutes.3,4
  • Accurate results for infant diagnosis and acute infections: Earlier detection provides an important opportunity to improve management in all age groups.3,4
  • Reduce time from testing to treatment: Fast track initiation of treatment, reduce risk of transmission and increase retention in care with point-of-care HIV-1 nucleic acid tests.3,4
3 Meulbroek, et al. 2018 HIV Medicine BCN Checkpoint: same-day confirmation of reactive HIV rapid test with Point Of Care HIV-RNA accelerates linkage to care and reduces anxietyDOI: 10.1111/hiv.12595
4 Bianchi et al, 2019 Lanvet HIV Evaluation of a routine point-of-care intervention for early infant diagnosis of HIV: an observational study in eight African countries.

CE 2797-IVD. Medical Devices for in vitro Diagnosis. May not be available in all countries. Xpert® tests are molecular biology tests intended for use by healthcare professionals with the GeneXpert® Systems. Carefully read the instructions in the package insert and in the systems user manual. Manufacturer: Cepheid AB, Distributor: Cepheid Europe SAS. Classe D. 2797 BSI. Updating date: 03/2025.
ANSM number for France: 25/01/CEPHEID/PM/002

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