Patrick Braun1, Allison Glass2, Leana Maree2, Maria Krügel2, Monia Pacenti3, Francesco Onelia4, Rory Gunson5, Emily Goldstein5, Laura Martínez-García6, Juan-Carlos Galán6, Alba Vilas7, Jodie D'costa8, Rizmina Sameer8, Robert Ehret9, Heribert Knechten10, Gudrun Naeth10, Magali Bouvier-Alias11, Natalia Marlowe12, Michael J Palm12, Ajith M Joseph12, Jens Dhein13, Birgit Reinhardt13, Karin Pfeifer13, Danijela Lucic12, Martin Obermeier9. 1. Laboratory Dr. Knechten, Medical Center for HIV and Hepatitis, Aachen, Germany. Electronic address: pab@pzb.de. 2. Lancet Laboratories, Johannesburg, South Africa. 3. Azienda Ospedaliera di Padova, Padua, Italy. 4. Università di Padova, Padua, Italy. 5. West of Scotland Specialist Virology Center, Glasgow, United Kingdom. 6. Servicio de Microbiología, Hospital Universitario Ramón y Cajal and Instituto Ramón y Cajal de Investigación Sanitaria (IRYCIS) and CIBER en Epidemiología y Salud Pública (CIBERESP), Madrid, Spain. 7. Laboratori de Referència de Catalunya, El Prat de Llobregat, Spain. 8. Victorian Infectious Diseases Reference Laboratory, Royal Melbourne Hospital, At the Peter Doherty Institute for Infection and Immunity, Victoria, 3000, Australia. 9. Medizinisches Infektiologiezentrum Berlin, Germany. 10. Laboratory Dr. Knechten, Medical Center for HIV and Hepatitis, Aachen, Germany. 11. Hôpital Henri Mondor, Université Paris-Est, Créteil, France. 12. Abbott Molecular Inc. Des Plaines, IL, USA. 13. Abbott GmbH, Wiesbaden, Germany.
Abstract
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.
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.