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Xpert® HIV-1 Qual

Same day detection of HIV-1 infection to support early infant diagnosis and identification of acute infection in 92 minutes

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

Ordering Info

Xpert® HIV-1 Qual

Number of Tests: 10

Catalog #: GXHIV-QA-CE-10

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