SARS-CoV-2 Test Development Information

Xpert HIV-1 Qual

Xpert® HIV-1 Qual

Urgent results for early intervention

Ordering Info
  • The Need

    The World Health Organization estimates that 35 million people worldwide are currently living with HIV/AIDS.1

    Of those infected, 2.1 million represent new infections and an estimated 240,000 are children.2 One-third of all people living with HIV reside in nine countries in southern Africa, which only account for 2% of the global population.3 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 reaching two years old.2

    Early diagnosis of HIV infection in infants is a necessity; however, many patients are lost to follow-up while waiting for an early test.

    A highly sensitive HIV qualitative test is needed for detecting HIV infection in pediatric patients 18 months of age or younger. To reduce loss to patient follow up, a near-patient, same-day HIV PCR test is critical to expand access for high risk patients and infants.

    (1) WHO. HIV/AIDS Fact sheet N°360. Updated November 2014. (2) UNAIDS. Gap Report 2014 Jul. Updated Sep 2014. Accessed Mar 2015. (3) Hankins C. Overview of the Current State of the Epidemic. Curr HIV/AIDS Rep 2013

    The Solution

    Xpert HIV-1 Qual is a qualitative test that provides on-demand molecular testing for early diagnosis.
    Based on the GeneXpert technology, Xpert HIV-1 Qual provides a total nucleic acid based test for RNA and proviral DNA in one fully integrated cartridge.

    Redefining Simple:


    • 100 μl of WB or 1 DBS (60-70 μL)
    • Simple near-patient workflow
    • No requirements for PCR room settings
    • No daily maintenance or liquid waste management


    • 90 minutes run time
    • No batch, no delay
    • 1 minute hands-on time


    • Providing up to 403 results per 8 hours*
    • Random access 24/7 availability
    • Run multiple different tests on the same platform at any time
    • Fixed cost per reportable result independent of daily volume

    *   Operational throughput on Infinity-80; internal analysis.

    The Impact

    • Greater Sensitivity: Detect HIV infections up to 7-10 days before seroconversion
    • Improve Patient Care: Same day results support better clinical decisions
    • Increase Efficiency: Rapid results enable immediate intervention to save lives at birth
    • Strengthen Communities: Quick decisions can help reduce morbidity or mortality in HIV-infected infants

    Get Answers Earlier

    Xpert HIV-1 Qual detected HIV-1 on average nine days earlier than a panel of HIV-1 antibody tests and five days earlier than a panel of HIV-1 antigen p24 tests.*

    *   Data in Xpert HIV-1 Qual Package Insert. Internal Analysis. Antibody tests: Abbott HIV 1/2 EIA, Abbott PRISM HIV-1/2, Abbott Murex HIV 1.2.O HIV,  Bio-Rad GS HIV-1/HIV-2 Plus O EIA, Siemens HIV 1/O/2 Enhanced ADVIA Centaur. Antigen p24-tests: Abbott, Coulter HIV-1 p24 Antigen, Innogenetics RL29, Perkin Elmer Alliance HIV-1 p24 ELISA


    • Cepheid - Our Vision for a Better Way
    • Catalog #:

      Xpert HIV-1 Qual
      Number of Tests: 10