Comparative evaluation of a triplex nucleic acid test for detection of HBV DNA, HCV RNA, and HIV-1 RNA, with the Procleix Tigris System

Research Center of Food Safety and Detection, College of Light Industry and Food Sciences, South China University of Technology, Guangzhou 510640, China.
Journal of virological methods (Impact Factor: 1.78). 11/2012; 187(2). DOI: 10.1016/j.jviromet.2012.10.015
Source: PubMed


Nucleic acid testing (NAT) is valuable for screening blood donors for occult hepatitis B virus (HBV) infection and infection during the window period in countries where HBV is endemic, such as China. An "in-house" NAT (Triplex NAT) was developed for screening for HBV DNA, hepatitis C virus (HCV) RNA, and the human immunodeficiency virus type 1 (HIV-1) RNA. Using the Triplex NAT, a head-to-head comparative clinical evaluation was carried out against the most common commercial NAT used for blood screening in China: the Procleix Tigris System. A total of 33025 specimens which were negative for Hepatitis B surface antigen, HCV antibody and HIV-1 antibody/antigen from potential blood donors were tested for HBV DNA, HCV RNA, and HIV-1 RNA by both the in-house Triplex assay and the commercially available Procleix Tigris System. Eleven specimens were detected as HBV positive by both NATs. Twelve specimens were detected as HBV positive by the Procleix Ultrio assay and the discriminatory assays, and not the Triplex. Twenty-eight specimens were detected as HBV positive by the Triplex and not the Procleix Ultrio. This study, combined with other data obtained in China, suggest that at least 50% HBV surface antigen negative but DNA-positive blood donations would be undetected using the current commercial NATs because of their insufficient sensitivity and/or Mini-Pool formatting strategies.

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  • R Zhang · Y Sun · L Wang · K Zhang · J Xie · J Li ·
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    ABSTRACT: Objectives The objectives to this study were to evaluate the performance of an anti-human immunodeficiency virus (HIV) blood screening test and propose a new screening algorithm for blood banks routinely using nucleic acid amplification testing (NAT) to reduce false-positive results. Background Most anti-HIV enzyme-linked immunosorbent assay (ELISA) results are false-positive because of the low prevalence of HIV infection and high sensitivity of the ELISAs. Methods/MaterialsA total of 281 588 voluntary donations were collected and sera reactive on one or both anti-HIV ELISAs were confirmed by Western blot (WB) testing. All samples with nonreactive results for the two ELISAs underwent NAT. A confirmed HIV-1-positive result was defined by a reactive result on NAT or WB testing. Correlations between signal-to-cutoff ratios and the confirmed HIV-1 infection rate were analysed for each enzyme immunoassay and two-enzyme immunoassay combination. The positive predictive values (PPVs) of the current and proposed algorithms were calculated. ResultsSeventy-nine donations (13 9 %) were positive on WB analysis and one donation negative for anti-HIV antibody was reactive on NAT and confirmed to be a window period donation on additional follow-up testing. The PPV of the 567 donations reactive on one or two ELISAs was 13 9 %. However, using the new screening algorithm, 457 donations underwent NAT immediately instead of WB testing. Only 110 donations were tested with WB and the PPV was 71 8 %. Conclusion Screening for HIV is sensitive, specific and time saving for donors with this algorithm, which is suitable for HIV screening in low prevalence settings.
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    ABSTRACT: The ability of a new generation commercial, multiplex, multi-dye test from Roche, the cobas TaqScreen MPX test, version 2.0, to detect and identify occult HBV infections was evaluated using routine donor samples from Kaohsiung Blood Bank, Taiwan. A total of 5973 samples were tested by nucleic acid amplification technology (NAT); 5898 in pools of six, 66 in pools of less than six and nine samples individually. NAT-reactive samples were retested with alternative NAT tests, and follow-up samples from the donors were tested individually by NAT and for all the HBV serological markers. Eight NAT-only-reactive donors were identified, and follow-up samples were obtained from six of the donors. The results indicated that all eight donors had an occult HBV infection with viral loads <12 IU/ml. The cobas(®) TaqScreen MPX test, version 2.0, has an advantage over the current Roche blood screening test, the cobas TaqScreen MPX test, for screening donations in countries with a high prevalence of occult HBV infections since the uncertainty associated with identifying samples with very low viremia is removed by the ability of the test to identify the viral target in samples that are reactive with the cobas TaqScreen MPX test, version 2.0.
    Vox Sanguinis 08/2013; 106(2). DOI:10.1111/vox.12075 · 2.80 Impact Factor
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    ABSTRACT: The detection of acute human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) infection is vital for controlling the spread of HIV, HBV, and HCV to uninfected individuals. Considering that these viruses have high replication rates and are undetectable by serological markers, early detection upon transmission is crucial. Various nucleic acid assays have been developed for diagnostics and therapeutic monitoring of infections. In the past decade, rapid and sensitive molecular techniques such as PCR have revolutionized the detection of a variety of infectious viruses, including HIV, HCV, and HBV. Here, we describe two of the most commonly used licensed methods for the detection and quantification of HIV, HCV, and HBV: the cobas TaqScreen MPX (PCR) test and the Tigris System. We used transcription-mediated amplification to review and compare the development and efficiency of these technologies.
    International Journal of Infectious Diseases 08/2014; 25. DOI:10.1016/j.ijid.2014.04.007 · 1.86 Impact Factor

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