V Saludes1, A Antuori2, J V Lazarus3, C Folch4, S González-Gómez2, N González5, N Ibáñez6, J Colom7, L Matas1, J Casabona4, E Martró8. 1. Microbiology Department, Laboratori Clínic Metropolitana Nord, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Genetics and Microbiology Department, Universitat Autònoma de Barcelona, Badalona, Spain; Germans Trias i Pujol Research Institute (IGTP), Badalona, Spain; Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III, Madrid, Spain. 2. Microbiology Department, Laboratori Clínic Metropolitana Nord, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Genetics and Microbiology Department, Universitat Autònoma de Barcelona, Badalona, Spain; Germans Trias i Pujol Research Institute (IGTP), Badalona, Spain. 3. Barcelona Institute for Global Health (ISGlobal), Hospital Clínic, University of Barcelona, Barcelona, Spain. 4. Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III, Madrid, Spain; Centre for Epidemiological Studies on Sexually Transmitted Infections and HIV/AIDS of Catalonia (CEEISCAT), Public Health Agency of Catalonia (ASPCAT), Badalona, Spain. 5. Drug consumption room "El Local", IPSS Foundation, Sant Adrià del Besòs, Barcelona, Spain. 6. Program on Substance Abuse, ASPCAT, Barcelona, Spain. 7. Program for the Prevention, Control and Treatment of HIV, Sexually Transmitted Infections and Viral Hepatitis, ASPCAT, Barcelona, Spain. 8. Microbiology Department, Laboratori Clínic Metropolitana Nord, Hospital Universitari Germans Trias i Pujol, Badalona, Spain; Genetics and Microbiology Department, Universitat Autònoma de Barcelona, Badalona, Spain; Germans Trias i Pujol Research Institute (IGTP), Badalona, Spain; Centro de Investigación Biomédica en Red en Epidemiología y Salud Pública (CIBERESP), Instituto de Salud Carlos III, Madrid, Spain. Electronic address: emartro@igtp.cat.
Abstract
BACKGROUND: Catalonia requires decentralized and simplified strategies for the diagnosis of viremic HCV infection among people who inject drugs (PWID). We aimed to perform a direct comparison of the diagnostic performance between two, single-step strategies for the screening and diagnosis of viremic HCV infection in PWID attending a drug consumption room (DCR) in Barcelona: i) on-site HCV-RNA testing using the point-of-care test (PoCT) Xpert HCV VL Fingerstick; and ii) on-site dried blood spots (DBS) collection for HCV-RNA testing at the laboratory (in-house assay). Additionally, we aimed to assess participants' preferences in receiving HCV-RNA testing results and feasibility of same-day delivery of PoCT results. METHODS: The real-world, clinical performance of these two strategies was established in comparison with the reference method (HCV viral load testing with the Xpert HCV Viral Load assay at the laboratory from venous plasma collected at the DCR). HCV genotypes/subtypes and HIV status were also determined by sequencing and serology, respectively. A questionnaire including preferences regarding the delivery of test results was administered. RESULTS: The prevalence of HCV-RNA was 63.0% (of which 25.8% were co-infected with HIV). The RNA-PoCT showed a sensitivity of 98.4% for detectable viral loads (>4 IU/mL) and of 100% for quantifiable viral loads (≥10, ≥1000 and ≥3000 IU/mL). For the DBS-based assay, a sensitivity of 93.7% was obtained for detectable viral loads, 96.7% for the quantifiable ≥10 IU/mL threshold, and 98.3% for both the quantifiable ≥1000 and ≥3000 IU/mL thresholds. No significant differences were detected between the sensitivity values of these two strategies, and the specificity was 100% in both cases. Half of the participants preferred to receive the HCV-RNA result on the same day, and 80% of participants received their RNA-PoCT results on the same day. CONCLUSIONS: Both the HCV-RNA PoCT and the DBS-based assay are highly reliable tools for the simplified diagnosis of viremic HCV infection among current PWID. These strategies allow for on-site sample collection and delivery of test results, facilitating decentralized care in harm reduction services.
BACKGROUND: Catalonia requires decentralized and simplified strategies for the diagnosis of viremic HCV infection among people who inject drugs (PWID). We aimed to perform a direct comparison of the diagnostic performance between two, single-step strategies for the screening and diagnosis of viremic HCV infection in PWID attending a drug consumption room (DCR) in Barcelona: i) on-site HCV-RNA testing using the point-of-care test (PoCT) Xpert HCV VL Fingerstick; and ii) on-site dried blood spots (DBS) collection for HCV-RNA testing at the laboratory (in-house assay). Additionally, we aimed to assess participants' preferences in receiving HCV-RNA testing results and feasibility of same-day delivery of PoCT results. METHODS: The real-world, clinical performance of these two strategies was established in comparison with the reference method (HCV viral load testing with the Xpert HCV Viral Load assay at the laboratory from venous plasma collected at the DCR). HCV genotypes/subtypes and HIV status were also determined by sequencing and serology, respectively. A questionnaire including preferences regarding the delivery of test results was administered. RESULTS: The prevalence of HCV-RNA was 63.0% (of which 25.8% were co-infected with HIV). The RNA-PoCT showed a sensitivity of 98.4% for detectable viral loads (>4 IU/mL) and of 100% for quantifiable viral loads (≥10, ≥1000 and ≥3000 IU/mL). For the DBS-based assay, a sensitivity of 93.7% was obtained for detectable viral loads, 96.7% for the quantifiable ≥10 IU/mL threshold, and 98.3% for both the quantifiable ≥1000 and ≥3000 IU/mL thresholds. No significant differences were detected between the sensitivity values of these two strategies, and the specificity was 100% in both cases. Half of the participants preferred to receive the HCV-RNA result on the same day, and 80% of participants received their RNA-PoCT results on the same day. CONCLUSIONS: Both the HCV-RNA PoCT and the DBS-based assay are highly reliable tools for the simplified diagnosis of viremic HCV infection among current PWID. These strategies allow for on-site sample collection and delivery of test results, facilitating decentralized care in harm reduction services.
Authors: Maria Buti; Jeffrey V Lazarus; Camila A Picchio; Sabela Lens; Manuel Hernandez-Guerra; Juan Arenas; Raúl J Andrade; Javier Crespo; Javier García-Samaniego; Manuel Romero-Gómez; Juan Turnes; José Luis Calleja; Miguel Ángel Simón; Trenton M White; Mar Riveiro-Barciela; Anna Pocurull; Dalia Morales-Arraez; Alexandra Gómez Journal: Sci Rep Date: 2021-12-17 Impact factor: 4.996
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