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.

Vicenti, I., Dragoni, F., Giannini, A., Casabianca, A., Lombardi, F., Di Sante, L., et al. (2022). External quality assessment of HIV-1 DNA quantification assays used in the clinical setting in Italy. SCIENTIFIC REPORTS, 12(1), 3291 [10.1038/s41598-022-07196-2].

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

Scutari, Rossana;Ceccherini Silberstein, Francesca
Membro del Collaboration Group
2022-02

Abstract

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.
Pubblicato
Rilevanza internazionale
Articolo
Sì, ma tipo non specificato
Settore MED/07
English
Humans
Italy
Real-Time Polymerase Chain Reaction
HIV Infections
HIV-1
Vicenti, I., Dragoni, F., Giannini, A., Casabianca, A., Lombardi, F., Di Sante, L., et al. (2022). External quality assessment of HIV-1 DNA quantification assays used in the clinical setting in Italy. SCIENTIFIC REPORTS, 12(1), 3291 [10.1038/s41598-022-07196-2].
Vicenti, I; Dragoni, F; Giannini, A; Casabianca, A; Lombardi, F; Di Sante, L; Turriziani, O; Racca, S; Paolucci, S; Lai, A; Bon, I; Abbate, I; Rozera, G; Belmonti, S; Scutari, R; Alteri, C; Saladini, F; Zazzi, M; Ceccherini Silberstein, F
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Utilizza questo identificativo per citare o creare un link a questo documento: http://hdl.handle.net/2108/303935
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