TY - JOUR
T1 - External quality assessment of HIV-1 DNA quantification assays used in the clinical setting in Italy
AU - Vicenti, I.
AU - Dragoni, F.
AU - Giannini, A.
AU - Casabianca, A.
AU - Lombardi, F.
AU - Di, Sante L.
AU - Turriziani, O.
AU - Racca, S.
AU - Paolucci, S.
AU - Lai, A.
AU - Bon, I.
AU - Abbate, I.
AU - Rozera, G.
AU - Belmonti, S.
AU - Scutari, R.
AU - Alteri, C.
AU - Saladini, F.
AU - Zazzi, M.
AU - Orlandi, C.
AU - Magnani, M.
AU - Di Giambenedetto, Simona
AU - Longo, R.
AU - Menzo, S.
AU - Di, Carlo D.
AU - Mazzuti, L.
AU - Ardemagni, A.
AU - Clementi, M.
AU - Baldanti, F.
AU - Giardina, F.
AU - Bergna, A.
AU - Balotta, C.
AU - Bertoldi, A.
AU - Capobianchi, M. R.
AU - Ceccherini-Silberstein, F.
AU - Antonello, M.
AU - Perno, C. F.
AU - Andreoni, M.
PY - 2022
Y1 - 2022
N2 - 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 (R2 = 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.
AB - 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 (R2 = 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.
KW - Diagnostic markers
KW - Retrovirus
KW - Viral reservoirs
KW - Diagnostic markers
KW - Retrovirus
KW - Viral reservoirs
UR - https://publicatt.unicatt.it/handle/10807/211045
UR - https://www.scopus.com/inward/citedby.uri?partnerID=HzOxMe3b&scp=85125572560&origin=inward
UR - https://www.scopus.com/inward/record.uri?partnerID=HzOxMe3b&scp=85125572560&origin=inward
U2 - 10.1038/s41598-022-07196-2
DO - 10.1038/s41598-022-07196-2
M3 - Article
SN - 2045-2322
VL - 12
SP - 1
EP - 11
JO - Scientific Reports
JF - Scientific Reports
IS - 1
ER -
