External quality assessment of HIV-1 DNA quantification assays used in the clinical setting in Italy.

Autor: Vicenti I; Department of Medical Biotechnologies, University of Siena, Siena, Italy. vicenti@unisi.it., Dragoni F; Department of Medical Biotechnologies, University of Siena, Siena, Italy., Giannini A; Department of Medical Biotechnologies, University of Siena, Siena, Italy., Casabianca A; Department of Biomolecular Sciences, University of Urbino 'Carlo Bo', Urbino, PU, Italy., Lombardi F; Fondazione Policlinico Universitario A. Gemelli IRCCS, UOC Malattie Infettive, Rome, Italy., Di Sante L; Virology Unit, Department of Biomedical Sciences and Public Health, Polytechnic University of Marche, Ancona, Italy., Turriziani O; Department of Molecular Medicine, Sapienza University of Rome, Rome, Italy., Racca S; Laboratory of Microbiology and Virology, IRCCS San Raffaele Scientific Institute, Milan, Italy., Paolucci S; Molecular Virology Unit, Microbiology and Virology Department, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy., Lai A; Department of Biomedical and Clinical Sciences Luigi Sacco, University of Milan, Milan, Italy., Bon I; UO Microbiologia, IRCSS Azienda Ospedaliero Universitaria di Bologna, Policlinico S. Orsola, Bologna, Italy., Abbate I; Virology and Biosafety Laboratories Unit, National Institute for Infectious Diseases IRCCS L. Spallanzani, Rome, Italy., Rozera G; Virology and Biosafety Laboratories Unit, National Institute for Infectious Diseases IRCCS L. Spallanzani, Rome, Italy., Belmonti S; Dipartimento di Sicurezza e Bioetica, Sezione Malattie Infettive, Università Cattolica del Sacro Cuore, Rome, Italy., Scutari R; Department of Experimental Medicine, University of Rome 'Tor Vergata', Rome, Italy., Alteri C; Department of Oncology and Hemato-Oncology, University of Milan, Milan, Italy.; Multimodal Medicine Research Area, Bambino Gesù Children's Hospital, IRCCS, Rome, Italy., Saladini F; Department of Medical Biotechnologies, University of Siena, Siena, Italy., Zazzi M; Department of Medical Biotechnologies, University of Siena, Siena, Italy.
Jazyk: angličtina
Zdroj: Scientific reports [Sci Rep] 2022 Feb 28; Vol. 12 (1), pp. 3291. Date of Electronic Publication: 2022 Feb 28.
DOI: 10.1038/s41598-022-07196-2
Abstrakt: Total cell-associated HIV-1 DNA is a surrogate marker of the HIV-1 reservoir, however, certified systems for its quantification are not available. The Italian HIV DNA Network was launched to validate HIV-1 DNA quantification methods in use at University and Hospital labs. A quality control panel including HIV-1 DNA standards, reconstructed blood samples (RBSs) and DNA from different HIV-1 subtypes was blindly tested by 12 participating labs by quantitative real-time PCR (n = 6), droplet digital PCR (n = 3) or both (n = 3). The median 95% hit rate was 4.6 (3.7-5.5) copies per test and linearity in the tested range was excellent (R 2  = 1.000 [1.000-1.000]). The median values obtained across labs were 3,370 (2,287-4,245), 445 (299-498), 59 (40-81) and 7 (6-11) HIV-1 DNA copies, for the 3,584, 448, 56 and 7-copy standards, respectively. With RBSs, measured values were within twofold with respect to the median in two thirds of cases. HIV-1 subtypes were missed (CRF01_AE by 3 labs) or underestimated by > 1 log (subtypes A, C, D, F by one lab; CRF01_AE by one lab; CRF02_AG by one lab). The overall performance was excellent with HIV-1 DNA standards, however detection of different HIV-1 subtypes must be improved.
(© 2022. The Author(s).)
Databáze: MEDLINE
Externí odkaz:
Nepřihlášeným uživatelům se plný text nezobrazuje