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Xpert ® HIV-1 Qual XC
A molecular point-of-care test that delivers actionable results in around 90 minutes
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10 Tests
GXHIV-QA-XC-CE-10
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Collection devices
Sarstedt Minivette POCT 100 μl(Pack of 100)
MINIVETTE100E-100
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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 is 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 is 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
(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
(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 XC (extended coverage) is an in vitro nucleic acid amplification test for the qualitative detection of HIV-1 total nucleic acids, on the automated GeneXpert® System.
Xpert HIV-1 Qual XC is intended to aid in the diagnosis of HIV-1 infection in conjunction with clinical presentation and other laboratory markers in infant, adolescent, and adult populations..
Now Improved:
Xpert HIV-1 Qual XC is intended to aid in the diagnosis of HIV-1 infection in conjunction with clinical presentation and other laboratory markers in infant, adolescent, and adult populations..
Now Improved:
- Extended coverage for HIV-1 strains with dual target detection
- 2 protocols; Only 100ul capillary/EDTA venous WB or a single DBS
- Simply load the sample and run the test. No additional preparation required for WB or DBS
- Includes point-of-care testing
- Improved cartridge chemistry with addition of sample adequacy control (SAC) to verify human specimen and removal of guanidinium thiocyanate (GTC) for safer cartridge disposal
The Impact
- Improve access for HIV testing: Designed for near patient testing in any setting allowing faster delivery of results and medical follow up. Simple sample collection and testing with results in ~90 minutes
- Detect acute Infections:Earlier detection than serology based methods provides an important opportunity to improve management of those at risk of recent infections and prior to initiating PrEP
- Reduce time from testing to treat: Fast track initiation of treatment with point-of-care HIV-1 nucleic acid test confirmation
Source: Molecular Point-of-Care Testing as Part of an Integrated Approach to Achieve Earlier Diagnosis and Treatment of HIV, presented at IAS2020, M Meulbroek.
Source: Molecular Point-of-Care Testing as Part of an Integrated Approach to Achieve Earlier Diagnosis and Treatment of HIV, presented at IAS2020, M Meulbroek.
(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
(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.
(7) Fonner VA, Denison J, Kennedy CE, et al. Voluntary counseling and testing (VCT) for changing HIV-related risk behavior in developing countries. Cochrane Database Syst Rev 2012;9:CD001224.
(8) Steward WT, Remien RH, Higgins JA, et al. Behavior change following diagnosis with acute/early HIV infection-a move to serosorting with other HIV-infected individuals. The NIMH Multisite Acute HIV Infection Study: III. AIDS Behav 2009;13:1054-1060.
(9) Metsch LR, Pereyra M, Messinger S, et al. HIV transmission risk behaviors among HIV-infected persons who are successfully linked to care. Clin Infect Dis 2008;47:577-584.
Xpert HIV-1 Qual XC assay is only available in the European Union and the countries accepting the CE-mark registration.
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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