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Xpert® HIV-1 Viral Load
Dual Target Detection for Extended Coverage and Superior Performance
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GXHIV-VL-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
Today, measurement of blood plasma HIV-1 RNA concentration (known as HIV viral load) using nucleic acid- based molecular diagnostic assays has been established as the standard of care in assessing HIV-positive patient prognosis and response to antiretroviral therapy.
Assessment of viral load levels is a strong predictor of the rate of disease progression and, by itself or in combination with CD4 T-cell counts, has great prognostic value.2-7
The need for a rapid HIV viral load test with flexibility to adapt to any throughput requirements and random access for urgent samples is greater than ever because each individual patient deserves better care.
Today, measurement of blood plasma HIV-1 RNA concentration (known as HIV viral load) using nucleic acid- based molecular diagnostic assays has been established as the standard of care in assessing HIV-positive patient prognosis and response to antiretroviral therapy.
Assessment of viral load levels is a strong predictor of the rate of disease progression and, by itself or in combination with CD4 T-cell counts, has great prognostic value.2-7
The need for a rapid HIV viral load test with flexibility to adapt to any throughput requirements and random access for urgent samples is greater than ever because each individual patient deserves better care.
(1) WHO HIV/AIDS Key Fact updates July 2020. Accessed July 2020. https://www.who.int/news-room/fact-sheets/detail/hiv-aids
(2) Katzenstein DA, et all. The relation of virologic and immunologic markers to clinical outcomes after nucleoside therapy in HIV-infected adults with 200 to 500 CD4 cells per cubic millimeter. AIDS Clinical Trials Group Study 175 Virology Study Team. N Engl J Med. 1996 Oct 10;335(15):1091-8.
(3)Mellors JW, et al. Plasma viral load and CD4+ lymphocytes as prognostic markers of HIV-1 infection. Ann Intern Med. 1997 Jun 15;126(12):946-54.
(4)Mellors JW, et al. Prognosis in HIV-1 infection predicted by the quantity of virus in plasma. Science. 1996 May 24;272(5265):1167-70.
(5)O'Brien WA, et al Changes in plasma HIV-1 RNA and CD4+ lymphocyte counts and the risk of progression to AIDS. Veterans Affairs Cooperative Study Group on AIDS. N Engl J Med. 1996 Feb 15;334(7):426-31.
(6) Ruiz L, et al. Quantitative HIV-1 RNA as a marker of clinical stability and survival in a cohort of 302 patients with a mean CD4 cell count of 300 x 10(6)/l. Aids. 1996 Sep;10(11):F39-44.
(7)Saag MS, et al. HIV viral load markers in clinical practice. Nat Med. 1996 Jun;2(6):625-9.
(2) Katzenstein DA, et all. The relation of virologic and immunologic markers to clinical outcomes after nucleoside therapy in HIV-infected adults with 200 to 500 CD4 cells per cubic millimeter. AIDS Clinical Trials Group Study 175 Virology Study Team. N Engl J Med. 1996 Oct 10;335(15):1091-8.
(3)Mellors JW, et al. Plasma viral load and CD4+ lymphocytes as prognostic markers of HIV-1 infection. Ann Intern Med. 1997 Jun 15;126(12):946-54.
(4)Mellors JW, et al. Prognosis in HIV-1 infection predicted by the quantity of virus in plasma. Science. 1996 May 24;272(5265):1167-70.
(5)O'Brien WA, et al Changes in plasma HIV-1 RNA and CD4+ lymphocyte counts and the risk of progression to AIDS. Veterans Affairs Cooperative Study Group on AIDS. N Engl J Med. 1996 Feb 15;334(7):426-31.
(6) Ruiz L, et al. Quantitative HIV-1 RNA as a marker of clinical stability and survival in a cohort of 302 patients with a mean CD4 cell count of 300 x 10(6)/l. Aids. 1996 Sep;10(11):F39-44.
(7)Saag MS, et al. HIV viral load markers in clinical practice. Nat Med. 1996 Jun;2(6):625-9.
The Solution
Xpert HIV-1 Viral Load is a quantitative test that provides on-demand molecular testing.
Based on the GeneXpert® technology, Xpert HIV-1 Viral Load automates the test process including RNA extraction, purification, reverse transcription and cDNA real time quantitation in one fully integrated cartridge.
Redefining Simple:
Easy
Based on the GeneXpert® technology, Xpert HIV-1 Viral Load automates the test process including RNA extraction, purification, reverse transcription and cDNA real time quantitation in one fully integrated cartridge.
Redefining Simple:
Easy
- Run daily or on-demand
- No requirements for PCR room settings
- No daily maintenance or liquid waste management
- 91 minutes run time with a viral load trend report*
- No batch, no delay
- Minimal hands-on time
- Compatible with any lab volume
- Providing up to 403 viral load results per 8 hours^
- Random access 24/7 availability
- Run multiple different tests on the same platform at any time
- Quantification standards run in every test for fixed cost per reportable result independent of daily volume
* Trend report available for patients'™ viral load measured multiple times on the same GeneXpert.
^ Operational throughput on Infinity-80; internal analysis.
^ Operational throughput on Infinity-80; internal analysis.
The Impact
- Increase Efficiency: Simplified workflow and on demand testing reduces hands-on time
- Improve Patient Care: Rapid results enable earlier adjustments to appropriate therapy
- Better for patients: Same day results and treatment decisions reduces anxiety and time for clinical appointments
Move Your Lab Forward
- No Waiting: Run any test any time with 24/7 random access
- Simple & Organised: True 24/7 random access accommodates other urgent test requests
- Flexible: Adapt to any throughput requirement
- Improve Sample Processing: Speed up results turn around time to meet clinical need and deliver better service
Performance
Not available in all countries. New assay version Xpert HIV-1 Viral Load 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 Viral Load 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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