Τίτλος:
Analytical and clinical sensitivity of the Procleix Ultrio HIV-1/HCV/HBV
assay in samples with a low viral load
Γλώσσες Τεκμηρίου:
Αγγλικά
Περίληψη:
Background and Objectives The Procleix Ultrio human immunodeficiency
virus type 1 (HIV-1)/hepatitis C virus (HCV)/hepatitis B virus (HBV)
(Ultrio) assay simultaneously detects HIV-1 RNA, HCV RNA and HBV DNA in
individual blood donations. The main objective of the study was to
assess the analytical and clinical sensitivity of the multiplex and
discriminatory probe assays in samples with a low viral load.
Material and Methods The VQC HIV RNA genotype B, HCV RNA genotype 1 and
HBV DNA genotype A standard dilutions were tested in 26 repeats. The
probability of detection by Ultrio was compared with previously obtained
data of the Procleix Duplex HIV-1/HCV assay on the same reference
panels. A selection of 121 anti-HIV-1, 138 anti-HCV and 190 HBsAg
positive samples from patients receiving antiviral therapy were tested.
The majority of patient samples had a viral load below the detection
limit of the diagnostic nucleic acid test assays, which made them
suitable to evaluate the performance of the multiplex and discriminatory
assays on yield cases with a similar low viral load.
Results The 95% and 50% detection end-points of the Ultrio assay along
with the corresponding 95% confidence intervals are 53.7 (32.9-117.2)
and 8.6 (6.2-12.1) geq/ml for HIV-1 RNA, 30.3 (19.0-62.4) and 5.2
(3.7-7.2) geq/ml for HCV RNA and 393.7 (147.9-6978) and 54.5
(22.4-143.8) geq/ml for HBV DNA. The analytical sensitivity of Ultrio
expressed as a potency factor relative to previously obtained Duplex
results on the same HIV-1 RNA and HCV-RNA standard dilutions was 1.09
(0.20-6.10) and 1.11 (0.21-5.89), respectively. The assay detected all
22 HIV-1 infected patients with viral load > 50 copies/ml, and 41 of 99
patients (41%) with viral load < 50 copies/ml, of which 23 (56%) were
detected by the discriminatory assay. All 47 patients with HCV RNA load
> 521 IU/ml and 10/91 polymerase chain reaction-negative patients with
viral load < 50 IU/ml tested positive in Ultrio assay of which five were
missed in the discriminatory test. The assay detected 53/55 HBV infected
patients (96%) with viral load > 250 copies/ml and 108/135 patients
(80%) with viral load < 250 copies/ml of which 17 (16%) were missed by
the discriminatory test.
Conclusions The new Procleix Ultrio assay is as sensitive as the
Procleix Duplex assay for HIV-1 and HCV detection meeting the
requirements of universal guidelines. The ability of the assay to detect
HBV DNA in low viral load samples could be useful for screening blood.
Inevitable negative results of discriminatory probe assays caused by
stochastic sample variation will reduce the chance of recognizing low
viraemic blood donors detected by individual donation nucleic acid test.
Συγγραφείς:
Katsoulidou, A.
Moschidis, Z.
Sypsa, V.
Chini, M. and
Papatheodoridis, G. V.
Tassopoulos, N. C.
Mimidis, K. and
Karafoulidou, A.
Hatzakis, A.
Λέξεις-κλειδιά:
blood screening; HBV DNA; HCV RNA; HIV-1 RNA; nucleic acid testing;
transcription-mediated amplification
DOI:
10.1111/j.1423-0410.2006.00857.x
