COBAS® AmpliPrep/COBAS® TaqMan® HLA-B*5701 Screening Test 

 
Registration Status

CE-IVD
Confidently identify patients who have a hypersensitivity to abacavir
Use PCR technology to facilitate HLA-B*5701 screening and better manage HIV patients who could potentially have hypersensitivity reactions to abacavir
Allergic hypersensitivity to the HIV reverse nucleoside transcriptase inhibitor, abacavir, is highly associated with a specific allele at the HLA-B locus, HLA-B*5701.*† The COBAS® AmpliPrep / COBAS® TaqMan® HLA-B*5701 Screening Test‡ uses PCR technology to facilitate HLA-B*5701 screening in the routine clinical setting for managing HIV patients. HLA-B*5701 screening promotes more informed patient treatment and facilitates safer disease management as recommended by the US Department of Health and Human Services (DHHS), European AIDS Clinical Society (EACS) and the International AIDS Society-USA Panel (IAS).§**
Benefits
  • Help improve HIV-1 patient care by allowing for a more informed use of abacavir treatment.
  • Screen for the presence or absence of the HLA B*5701 allele to avoid prescribing abacavir, which can cause a potentially dangerous hypersensitivity reaction in patients who carry the HLA-B*5701 allele.
  • Reliable results for quick decisions with an easy-to-operate system and fully automated walk-away technology that simplifies your workload.
Features
  • The correlation of the COBAS® AmpliPrep/COBAS® TaqMan® HLA-B*5701 Screening Test when compared to Sanger sequencing demonstrated 100% correlation, 100% Sensitivity, 100% Specificity, 100% positive agreement, and 100% negative agreement.
  • Limit of detection with a PROBIT 95% hit rate for 429ng input DNA for the HLA-B*5701 positive genomic DNAs and 151ng input DNA for the HLA-B*5701 negative genomic DNAs.
  • The COBAS® AmpliPrep/COBAS® TaqMan® HLA-B*5701 Screening Test permits automated specimen preparation followed by automated PCR amplification and detection of the HLA-B*5701 allele.
Intended Use

The COBAS® AmpliPrep/COBAS® TaqMan® HLA-B*5701 Screening Test is an in vitro nucleic acid amplification test for the presence or absence of the HLA-B*5701 allele in peripheral EDTA human whole blood using the COBAS® AmpliPrep Instrument for automated specimen processing and the COBAS® TaqMan® Analyzer or the COBAS® TaqMan® 48 Analyzer for automated amplification and detection. When prescribing treatment, information about the presence or absence of the HLA B*5701 allele may be used by clinicians to avoid prescribing abacavir, which can cause a potentially dangerous hypersensitivity reaction in patients who carry the HLA-B*5701 allele.
*1. Mallal, S.A., et. al. 2008. HLA-B*5701 Screening for Hypersensitivity to Abacavir. NEJM 358;6:568-579.
†Hughes, A.R., et. al. 2008. Pharmacogenetics of hypersensitivity to abacavir: from PGx hypothesis to confirmation to clinical utility. The Pharmacogenomics Journal 8:365-374.
‡ Not available in the United States
§ Department of Health and Human Services. Panel on Antiretroviral Guidelines for Adult and Adolescents. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. December 1, 2009; 1-146. Available at http://www.aidsinfo.nih.gov/. Accessed December 1, 2009.
** Hammer SM, Eron JJ, Jr., Reiss P, Schooley RT, Thompson MA, Walmsley S, et al. Antiretroviral treatment of adult HIV infection: 2008 recommendations of the International AIDS Society-USA panel. JAMA 2008, 300:555-570.
More Information
 
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