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