Performance comparison of new Veris and Xpert random access HIV-1 RNA quantification assays

Abstract

Background: Recent systems for Human Immunodeficiency Virus 1 (HIV-1) viral load (VL) monitoring allow one-by-one analysis and fast turn-around-time for results. VL measurement on two rapid recently commercialized systems, GeneXpert (Cepheid) and Veris (Beckman Coulter) was compared to classical methods. Methods: Plasma specimen from HIV-1 (group M) positive patients (n = 129) initially quantified with Abbott RealTime HIV-1 and Generic HIV-VL Biocentric assays were retrospectively tested with GeneXpert and Veris. Results: Valid results on all techniques were obtained for 116/129 specimens composed of 89 Abbott quantifiable VL (38 B, 51 non-B subtypes) [range: 2.09-7.20 log cp/mL] and 27 plasma (9 B, 18 non-B) with Abbott-VL below the limit of quantification (LLQ). All techniques showed good correlation and agreement with a lowest Spearman correlation coefficient of 0.86. Compared to Abbott, the mean bias was 0.35 (95% CI: 0.25-0.45), 0.44 (0.36-0.53) and - 0.04 (- 0.13-0.05) for Biocentric, Beckman and Cepheid, respectively. A difference over 0.5 log cp/mL between VL-quantification of the same sample was observed for 19, 9 and 6 samples with Biocentric, Beckman and Cepheid, respectively. No influence of HIV-1 subtypes on VL was identified. Among 29 samples below LLQ on Abbott, only one was detected and quantified with the Veris assay (38 cp/mL), none with Cepheid. Conclusion: Both random access systems from Cepheid and Beckman appear well designed for quantifying plasma HIV-1 VL, are easy to handle, fast and fully automated. The slight observed differences suggest to follow the current guidelines recommending the use of the same technique over time for patient viral load monitoring.