Multicenter clinical comparative evaluation of Alinity m HIV-1 assay performance
| Autor: | Natalia Marlowe, Jens Dhein, Monia Pacenti, Ajith M. Joseph, Alba Vilas, Gudrun Naeth, Laura Martínez-García, Rory N. Gunson, Martin Obermeier, Jodie D’costa, Maria Krügel, Patrick Braun, Michael J. Palm, Danijela Lucic, Rizmina Sameer, Karin Pfeifer, Magali Bouvier-Alias, Juan Carlos Galán, Francesco Onelia, Emily Goldstein, Allison Glass, Robert Ehret, Leana Maree, Heribert Knechten, Birgit Reinhardt |
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| Rok vydání: | 2020 |
| Předmět: |
RealTime HIV-1
0301 basic medicine Dual target 030106 microbiology Human immunodeficiency virus (HIV) HIV Infections Diagnostic accuracy Biology Alinity m HIV-1 medicine.disease_cause Sensitivity and Specificity Rapid detection Comparative evaluation 03 medical and health sciences 0302 clinical medicine Virology Viral load monitoring medicine Humans HIV-1 RNA Hologic Aptima HIV-1 030212 general & internal medicine Clinical decision Reproducibility Chromatography Reproducibility of Results virus diseases Viral Load Infectious Diseases HIV-1 Dual probe RNA Viral Reagent Kits Diagnostic |
| Zdroj: | Journal of Clinical Virology. 129:104530 |
| ISSN: | 1386-6532 |
| DOI: | 10.1016/j.jcv.2020.104530 |
| Popis: | Background Accurate, rapid detection of HIV-1 RNA is critical for early diagnosis, treatment decision making, and long-term management of HIV-1 infection. Objective We evaluated the diagnostic performance of the Alinity m HIV-1 assay, which uses a dual target/dual probe design against highly conserved target regions of the HIV-1 genome and is run on the fully automated Alinity m platform. Study design This was an international, multisite study that compared the diagnostic performance of the Alinity m HIV-1 assay to four commercially available HIV-1 assays routinely used in nine independent clinical laboratories. Alinity m HIV-1 assay precision, detectability, and reproducibility was compared across four study sites. Results The Alinity m HIV-1 assay produced comparable results to currently available HIV-1 assays (correlation coefficient >0.995), with an overall bias of -0.1 to 0.10 Log10 copies/mL. The Alinity m HIV-1 assay and its predecessor m2000 HIV-1 assay demonstrated comparable detection of 16 different HIV-1 subtypes (R2 = 0.956). A high level of agreement (>88 %) between all HIV-1 assays was seen near clinical decision points of 1.7 Log10 copies/mL (50 copies/mL) and 2.0 Log10 copies/mL (200 copies/mL). Alinity m HIV-1 assay precision was 0.08 and 0.21 Log10 copies/mL at VLs of 1000 and 50 copies/mL, respectively, with a high level of detectability (≥97 % hit rate) and reproducibility across sites. Conclusions The Alinity m HIV-1 assay provides comparable diagnostic accuracy to current HIV-1 assays, and when run on the Alinity m system, has the capacity to shorten the time between diagnosis and treatment. |
| Databáze: | OpenAIRE |
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