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Xpert® HIV-1 Qual
Detection of Human Immunodeficiency Virus Type 1 (HIV-1) in around 90 minutes
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10 Tests
GXHIV-QA-CE-10
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The Need
The World Health Organization estimated that 38 million people worldwide were living with HIV at the end of 2019.1
Infected individuals generally develop an acute infection characterized by flu-like symptoms in a period of days to weeks after initial exposure.2 Acute HIV infections typically last less than 14 days3 and are associated with high levels of viremia prior to a detectable immune response.4-6 Therefore, HIV-1 nucleic acid testing can be more sensitive than standard serologic testing in detection of acute infection.
The need for a highly sensitive HIV qualitative test to detect HIV infection early in high risk and vulnerable populations is greater than ever. To improve patient care for all patients and reduce viral transmission in communities, a rapid answer on a whole blood (WB) or dried blood spot (DBS) sample is necessary.
Infected individuals generally develop an acute infection characterized by flu-like symptoms in a period of days to weeks after initial exposure.2 Acute HIV infections typically last less than 14 days3 and are associated with high levels of viremia prior to a detectable immune response.4-6 Therefore, HIV-1 nucleic acid testing can be more sensitive than standard serologic testing in detection of acute infection.
The need for a highly sensitive HIV qualitative test to detect HIV infection early in high risk and vulnerable populations is greater than ever. To improve patient care for all patients and reduce viral transmission in communities, a rapid answer on a whole blood (WB) or dried blood spot (DBS) sample is necessary.
(1) WHO HIV/AIDs Key Facts updates 6th July 2020 Accessed July 2020. https://www.who.int/news-room/fact-sheets/detail/hiv-aids
(2) Aids.gov. Aids Signs and Symptoms. Accessed May 2015. https://www.aids.gov/hiv-aids-basics/hiv-aids-101/signs-and-symptoms/
(3) O'Brien M, et al. Should we treat acute HIV infection? Curr HIV/AIDS Rep. 2012 Jun;9(2):101-10.
(4) Kahn JO, et al. Acute human immunodeficiency virus type 1 infection. N Engl J Med. 1998 Jul 2;339(1):33-9.9.
(5) Daar ES, et al. Transient high levels of viremia in patients with primary human immunodeficiency virus type 1 infection. N Engl J Med. 1991 Apr 4;324(14):961-4.
(6) Clark SJ, et al. High titers of cytopathic virus in plasma of patients with symptomatic primary HIV-1 infection. N Engl J Med. 1991 Apr 4;324(14):954-60.
(2) Aids.gov. Aids Signs and Symptoms. Accessed May 2015. https://www.aids.gov/hiv-aids-basics/hiv-aids-101/signs-and-symptoms/
(3) O'Brien M, et al. Should we treat acute HIV infection? Curr HIV/AIDS Rep. 2012 Jun;9(2):101-10.
(4) Kahn JO, et al. Acute human immunodeficiency virus type 1 infection. N Engl J Med. 1998 Jul 2;339(1):33-9.9.
(5) Daar ES, et al. Transient high levels of viremia in patients with primary human immunodeficiency virus type 1 infection. N Engl J Med. 1991 Apr 4;324(14):961-4.
(6) Clark SJ, et al. High titers of cytopathic virus in plasma of patients with symptomatic primary HIV-1 infection. N Engl J Med. 1991 Apr 4;324(14):954-60.
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:
Easy
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:
Easy
- 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
- 93 minutes run time
- No batch, no delay
- Minimal hands-on time
- Providing up to 394 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 per 8-hr shift based on HIV-1 Qual testing, internal analysis.
The Impact
- 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.
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.
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