Comparison of the bioMérieux NucliSENS EasyQ HIV-1 v2.0–HIV-1 RNA quantification assay versus Abbott RealTime HIV-1 and Roche Cobas TaqMan HIV-1 v2.0 on current epidemic HIV-1 variants
Section snippets
Background
The choice of viral RNA quantification technique for determination of HIV-1 plasma viral load (pVL) is crucial and hence the main marker of antiretroviral treatment efficacy and a major endpoint in clinical trials. Automated techniques such as Abbott RealTime HIV-1 (Abbott RT HIV-1, Abbott Molecular, Rungis, France), Cobas® AmpliPrep/Cobas® TaqMan® HIV-1 v2.0 (CA/CTM v2.0, Roche Diagnostics, Meylan, France), and NucliSENS® EasyMAG®/NucliSENS® EasyQ® HIV-1 v2.0 (EM/EQ v2.0, bioMérieux) allow
Objectives
To evaluate the performance of the bioMérieux EM/EQ v2.0 assay, we compared its analytical and clinical sensitivity to that of Roche CA/CTM v2.0 and Abbott RT HIV-1 on samples representative of different HIV-M subtypes. As the diversity of HIV-1, in many African and European countries, is not limited to HIV-M, and since the bioMérieux is not recommended for the quantification of HIV-1 non-M strains, we also evaluated its clinical specificity against these divergent strains.
Study design
Frozen plasma (n = 103), from patients infected with HIV-M, were used to quantify the pVL with the 3 different assays. The freeze/thaw cycles on the split specimens were the same for each assay. These routine samples, sampled on EDTA anticoagulant, were previously centrifuged at 3000 × g for 20 min, decanted directly after centrifugation, and stored at –80 °C for batch testing. Registered leftover collection was used so that no additional blood samples were collected for this study. Subtypes were
Analysis of results below the quantification threshold
We first analyzed the false-negative results of each technique, compared to the other assay results (Table 1). A false negative result was defined as a result below the lower limit of quantification (LLQ) of the considered test, while at least one of the other tests quantified the viral load above this limit.
Overall, Roche gave the lowest rate of false negative results (0.97%; 1/103); it corresponded to a unique sample, only quantified with the bioMérieux kit at a low level of 54 copies/mL.
Discussion
We compared the performance of the NASBA® based bioMérieux V2.0 assay to the 2 more widely used techniques: the RT-PCR based Roche TaqMan® CA/CTM v2.0, and the Abbott RT HIV-1 assays. We used samples representative of a wide range of viral loads and of the current epidemic strains of HIV-1 [1]. Values obtained with the 3 different techniques showed good overall correlation.
First, we analyzed the occurrence of false negative results using the different techniques. As others have done [9], and
Funding
We are indebted to the Institut de Veille Sanitaire (InVS), the Agence National de Recherche contre le Sida et les hépatites virales (ANRS), and the Rouen University Hospital for financial support.
Competing interest
None declared.
Ethical approval
Not required.
Authors contribution
T.M., C.D., M.V., V.L., F.S., J.C.P. contributed to the conception and design of the work or analysis and interpretation of data. T.M., C.D., F.S., J.C.P. contributed to the drafting of the article. All authors have approved the manuscript to be submitted.
Acknowledgment
We thank the teams of the Virology Laboratories at Rouen University Hospital and St Louis University Hospital for their involvement in the study.
We are also grateful to Nikki Sabourin-Gibbs, Rouen University Hospital, for writing assistance and review of the manuscript in English.
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Equal contribution to the work.