Multicenter Evaluation of Two Next-Generation HIV-1 Quantitation Assays, Aptima Quant Dx and Cobas 6800, in Comparison to the RealTi m e HIV-1 Reference Assay

Author:

Wiesmann Frank1,Ehret Robert2,Naeth Gudrun1,Däumer Martin3,Fuhrmann Jörg4,Kaiser Rolf5,Noah Christian6,Obermeier Martin2,Schalasta Gunnar7,Tiemann Carsten8,Wolf Eva9,Knechten Heribert1,Braun Patrick1

Affiliation:

1. PZB Aachen, Medical Center for Infectious Diseases, Aachen, Germany

2. MVZmib AG, Medical Center for Infectious Diseases, Berlin, Germany

3. IIG-Institute of Immunology and Genetics, Kaiserslautern, Germany

4. Labor 28, Berlin, Germany

5. University of Cologne, Institute of Virology, Cologne, Germany

6. MVZ Labor Lademannbogen, Hamburg, Germany

7. Labor Enders, Laboratory for Medical Diagnostics, Stuttgart, Germany

8. Labor Krone, Laboratory for Medical Diagnostics, Bad Salzuflen, Germany

9. MUC Research, Munich, Germany

Abstract

High accuracy and precision at the lower end of quantification are crucial requirements of a modern HIV viral load (VL) assay, since some clinically relevant thresholds are located at 50 and 200 copies/ml. In this study, we compared the performance of two new fully automated HIV-1 VL assays, Aptima HIV-1 Quant Dx and Cobas HIV-1 (Cobas 6800), with the established RealTi m e m 2000 assay.

Publisher

American Society for Microbiology

Subject

Microbiology (medical)

Reference32 articles.

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2. Department of Health and Human Services (DHHS). 2018. Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents. Department of Health and Human Services, Washington, DC. http://aidsinfo.nih.gov/contentfiles/lvguidelines/AdultandAdolescentGL.pdf.

3. Antiretroviral Treatment of Adult HIV Infection

4. European AIDS Clinical Society (EACS). 2013. Guidelines, version 7.0, October 2013. European AIDS Clinical Society, Brussels, Belgium. http://www.eacsociety.org/files/guidelines_9.0-english.pdf.

5. Ribaudo H, Lennox J, Currier J. 2009. Virologic failure endpoint definition in clinical trials: is using HIV-1 RNA threshold <200 copies/mL better than <50 copies/mL? An analysis of ACTG studies. 16th Conference on Retroviruses and Opportunistic Infections, 8 to 11 February 2009, Montreal, Canada.

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