Xpert ® HIV-1 Viral Load XC

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Next Generation Molecular Testing for Monitoring Viral Load and HIV-1 Infection

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10 Tests

GXHIV-VL-XC-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 Less than 30% of HIV patients have access to viral load testing, representing severe market shortcomings and a large opportunity for intervention.² 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.³

The HIV Cascade to Ending AIDS by 2030
Initiated by WHO, The HIV Cascade to Ending AIDS by 2030, can only be achieved through multisectoral partnerships that provide access to diagnosis and care and bring HIV treatment to all who need it.

(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.

The Solution

Xpert HIV-1 Viral Load XC is a quantitative test that provides on-demand molecular testing.
Based on the GeneXpert^® technology, Xpert HIV-1 Viral Load XC automates the test process including RNA extraction, purification, reverse transcription and real-time quantification in one fully integrated cartridge.

Dual Target Detection for Extended Coverage and Superior Performance
Easy

No requirements for separate PCR room settings
No daily maintenance or liquid waste management

Fast

Approximately 90 minutes run time with a viral load trend report*
No batching required^*

Flexible

Compatible with any lab volume
Provides 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

* Trend report available for patients' viral load measured multiple times on the same GeneXpert.
^ Operational throughput on Infinity-80; internal analysis.

The Impact

Improve Patient Care: Optimize better treatment options by reducing loss to follow up wiht shorter turn-around times between sample collection and reporting results to patients
Increase Efficiency: Fast results enable earlier interventions with counseling and therapy
Strengthen Communities: Quick decisions can help reduce drug resistance and lower transmission

Designed for High-Throughput Labs and Decentralized Testing in a Laboratory Setting

Simple & Organised: True 24/7 random access accommodates other urgent test requests (e.g. TB, HCV, HBV, HPV)
Flexible: Modular system can adapt to any throughput requirement from health clinics to national reference laboratories

Performance
The performance of the Xpert HIV-1 VL XC test was compared to a nucleic acid amplification test (NAAT) comparator in a multi-site study using fresh and frozen human plasma specimens collected from known HIV-1 infected individuals. Of the 362 specimens, each from unique individuals, 206 (56.9%) were collected from male subjects. Most individuals (94.5%; 342/362) were in the age range of 22 to 59 years. Classification of specimens by HIV-1 Group M subtypes in this study population were shown to be 25.1% subtype B, 16.1% non-B subtype and 58.8% subtype unknown. There were 21 indeterminate results of which 14 were resolved after retesting. The final indeterminate rate was 1.93% (7/362). Of the 362 specimens, 328 were within the quantitation range of Xpert HIV-1 VL XC and the comparator test. The Deming regression shows high correlation between the Xpert HIV-1 VL XC test and the comparator method with a slope of 0.9625 and intercept of 0.0198. The R2 was 0.9561.

Correlation between Xpert HIV-1 Viral Load XC Relative to a Comparator Method⁴

CE-IVD In Vitro Diagnostic Medical Device. Not available in all countries.
(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.
Not available in all countries. Xpert HIV-1 Viral Load 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 Viral Load assay is available.Please reach out to your Local Cepheid Representative for more information regarding the availability of the new product.