Evaluation of the QIAsymphony™ SP and Artus™ RealTime extraction-quantification systems for measuring HIV-1 virus load.

Background: Automated HIV-1 RNA extraction and its quantification by real-time PCR assays provide improved sample processing and better analytical performances. The new Artus HIV-1 RealTime assay can be performed after automated extraction with the Qiagen Qiasymphony robot.

Objectives And Study Design: To evaluate the sensitivity, reproducibility, linearity, ability to detect HIV-1 subtypes of the Qiagen Qiasymphony and RealTime Artus HIV-1 assay system and to compare with the Roche Cobas Ampliprep Cobas TaqMan assay, vs 2.0 (CAP/CTM; Roche Molecular Systems).

Results: The detection limit calculated by probit analysis was 65 c/ml using dilutions of a NIBSC. Assays of serially diluted clinical samples gave very good inter-assay and intra-assay reproducibilities (<10% CV) and linearity (2.2-6.5 log copies/ml). The results Artus™ HIV-1 and CAP/CTM assays provided very similar results: average difference=0.11 log copies/ml. The Artus™ titers for 18 (22%) of the 114 HIV-1 group M samples tested differed by over 0.5 log copies/ml from the CAP/CTM titers. The Artus™ values were lower than the CAP/CTM values in 83% of cases. Discrepant results were not associated with particular subtypes.

Conclusion: The Artus™ HIV-1 assay reliably quantified the HIV RNA in clinical specimens. Analytical performances were good and it integrated well with the Qiasymphony automated RNA extraction procedure. It appears to be appropriate for monitoring therapy and the routine management of HIV-1 infections.