- Detect Acute Infections: Early identification of HIV infections up to 7-10 days before seroconversion
- Improve Patient Care: Same day detection and confirmation enables fast linkage to care and treatment
- Reduce Patient Anxiety: Fast lab quality results that can be delivered on- site in a single visit
The limit of detection (LOD) of the HIV-1 Qual test was determined for both WB and DBS procedures by testing two different HIV-1 subtype B reference standards including the Viral Quality Assurance Laboratory (VQA) reference material of the AIDS Clinical Trials Group and the WHO 3rd International Standard NIBSC code 10/152 diluted in HIV-1 negative EDTA WB.
The HIV-1 Qual test LOD is 278 cp/mL for WB samples and the LOD for the DBS samples is 668 cp/mL (using WHO 3rd International Standards).
- LOD WB samples with VQA reference material: 203 cp/mL (95%CI 181-225)
- LOD DBS samples with VQA reference material: 531 cp/mL (95%CI 474-587)
Performance characteristics of Xpert HIV-1 Qual were evaluated at two institutions in Africa. Subjects included individuals whose routine care called for collection of WB or DBS specimens for HIV-1 testing. The CE-marked comparator assay was validated for DBS and not for WB therefore Xpert HIV-1 Qual WB results were compared to the DBS comparator method.
New assay version Xpert HIV-1 Qual XC is available in the European Union and the countries accepting the CE-mark registration only (link to new product page).
For other countries where product registration is on-going, Xpert HIV-1 Qual assay is available.
Please reach out to your Local Cepheid Representative for more information regarding the availability of the new product.