Marie Gueudin1, Adeline Baron, Elodie Alessandri-Gradt, Véronique Lemée, Thomas Mourez, Manuel Etienne, Jean-Christophe Plantier. 1. *Laboratoire de Virologie Associé au Centre National de Référence du VIH, Département de Microbiologie, Hôpital Charles Nicolle, CHU de Rouen, Rouen, France; †GRAM, Equipe d'Accueil 2656, Faculté de Médecine-Pharmacie, Institut de Recherche et d'Innovation en Biomédecine, Université de Rouen, Rouen, France; and ‡COREVIH Haute-Normandie, Hôpital Charles Nicolle, CHU de Rouen, Rouen, France.
Abstract
OBJECTIVE: To evaluate the quantification performance of the new Cepheid GeneXpert HIV-1 viral load assay, on a wide panel of HIV-1 variants. METHODS: Clinical performance was evaluated relative to the Abbott RealTime HIV-1 assay on 285 HIV-1 seropositive samples selected to cover the assays quantification range (40 copies/mL-10,000,000 copies/mL), and included RNA undetectable or detected seropositive samples. The panel comprised 120 subtype B, 150 non-B, and 15 nontypable clinical samples; serial dilutions of 18 viral supernatants representative of the divergent viruses of HIV-1 groups N, O, and P were also tested. RESULTS: Based on samples selected according to the Abbott assay viral loads (VL), the Cepheid assay detected or quantified 222/285 (78%) samples and the Abbott assay 240/285 (84%). Xpert yielded VLs for 162 (76%) of the 213 quantifiable samples with Abbott. This difference corresponded to 51 samples with VL >40 copies/mL by the Abbott assay (all below 200 copies/mL) but detected (n = 40) or undetectable (n = 11) by the Cepheid assay. VL of samples quantifiable by both assays (n = 162) showed very strong correlation, with a Spearman correlation coefficient of 0.985 and a Bland-Altman's mean of differences of -0.01. Performance for quantification of the non-M samples showed very good correlation, with significantly higher values with Cepheid for the group N and 2 group O samples. CONCLUSIONS: Our study showed that the Xpert HIV-1 VL assay offered very good performance for detection and quantification of the current HIV-1 genetic diversity; differences reported at the threshold could be an issue and requires further evaluations. The practicability of this new assay makes it suitable for low-income countries, where it could facilitate and improve follow-up of patients, as well as for high-income regions.
OBJECTIVE: To evaluate the quantification performance of the new Cepheid GeneXpert HIV-1 viral load assay, on a wide panel of HIV-1 variants. METHODS:Clinical performance was evaluated relative to the Abbott RealTime HIV-1 assay on 285 HIV-1 seropositive samples selected to cover the assays quantification range (40 copies/mL-10,000,000 copies/mL), and included RNA undetectable or detected seropositive samples. The panel comprised 120 subtype B, 150 non-B, and 15 nontypable clinical samples; serial dilutions of 18 viral supernatants representative of the divergent viruses of HIV-1 groups N, O, and P were also tested. RESULTS: Based on samples selected according to the Abbott assay viral loads (VL), the Cepheid assay detected or quantified 222/285 (78%) samples and the Abbott assay 240/285 (84%). Xpert yielded VLs for 162 (76%) of the 213 quantifiable samples with Abbott. This difference corresponded to 51 samples with VL >40 copies/mL by the Abbott assay (all below 200 copies/mL) but detected (n = 40) or undetectable (n = 11) by the Cepheid assay. VL of samples quantifiable by both assays (n = 162) showed very strong correlation, with a Spearman correlation coefficient of 0.985 and a Bland-Altman's mean of differences of -0.01. Performance for quantification of the non-M samples showed very good correlation, with significantly higher values with Cepheid for the group N and 2 group O samples. CONCLUSIONS: Our study showed that the Xpert HIV-1 VL assay offered very good performance for detection and quantification of the current HIV-1 genetic diversity; differences reported at the threshold could be an issue and requires further evaluations. The practicability of this new assay makes it suitable for low-income countries, where it could facilitate and improve follow-up of patients, as well as for high-income regions.
Authors: Sikhulile Moyo; Terence Mohammed; Kathleen E Wirth; Melanie Prague; Kara Bennett; Molly Pretorius Holme; Lucy Mupfumi; Philemon Sebogodi; Natasha O Moraka; Corretah Boleo; Comfort N Maphorisa; Boitumelo Seraise; Simani Gaseitsiwe; Rosemary M Musonda; Erik van Widenfelt; Kathleen M Powis; Tendani Gaolathe; Eric J Tchetgen Tchetgen; Joseph M Makhema; Max Essex; Shahin Lockman; Vladimir Novitsky Journal: J Clin Microbiol Date: 2016-10-12 Impact factor: 5.948
Authors: Paul K Drain; Jienchi Dorward; Andrew Bender; Lorraine Lillis; Francesco Marinucci; Jilian Sacks; Anna Bershteyn; David S Boyle; Jonathan D Posner; Nigel Garrett Journal: Clin Microbiol Rev Date: 2019-05-15 Impact factor: 26.132
Authors: Lindsey K Reif; Marie Elmase Belizaire; Vanessa Rouzier; Grace Seo; Patrice Severe; Joseph-Marie Bajo Joseph; Bernadette Joseph; Sandra Apollon; Jean W Pape; Margaret L McNairy; Batya Elul; Daniel W Fitzgerald; Stephen M Arpadi; Elaine J Abrams; Louise Kuhn Journal: AIDS Care Date: 2021-10-06
Authors: A Hahn; R Hinz; T Meyer; U Loderstädt; O Herchenröder; C G Meyer; N G Schwarz; H Frickmann Journal: Epidemiol Infect Date: 2018-04-15 Impact factor: 4.434