Automated Multiplex Assay System for Simultaneous Detection of Hepatitis B Virus DNA, Hepatitis C Virus RNA, and Human Immunodeficiency Virus Type 1 RNA

We have developed an automated multiplex system for simultaneously screening hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus type 1 (HIV-1) in blood donations. The assay, designated AMPLINAT MPX HBV/HCV/HIV-1 Test (AMPLINAT MPX), consists of virus extraction and ta...

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Main Authors: Meng, Q., Wong, C., Rangachari, A., Tamatsukuri, S., Sasaki, M., Fiss, E., Cheng, L., Ramankutty, T., Clarke, D., Yawata, H., Sakakura, Y., Hirose, T., Impraim, C.
Formato: Artigo
Idioma:en
Publicado em: American Society for Microbiology 2001
Assuntos:
Virology
Acesso em linha:https://ncbi.nlm.nih.gov/pmc/articles/PMC88264/
https://ncbi.nlm.nih.gov/pubmed/11474017
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1128/JCM.39.8.2937-2945.2001
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spelling pubmed-882642002-05-02 Automated Multiplex Assay System for Simultaneous Detection of Hepatitis B Virus DNA, Hepatitis C Virus RNA, and Human Immunodeficiency Virus Type 1 RNA Meng, Q. Wong, C. Rangachari, A. Tamatsukuri, S. Sasaki, M. Fiss, E. Cheng, L. Ramankutty, T. Clarke, D. Yawata, H. Sakakura, Y. Hirose, T. Impraim, C. J Clin Microbiol Virology We have developed an automated multiplex system for simultaneously screening hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus type 1 (HIV-1) in blood donations. The assay, designated AMPLINAT MPX HBV/HCV/HIV-1 Test (AMPLINAT MPX), consists of virus extraction and target sequence-specific probe capture on specimen preparation workstation GT-X (Roche Diagnostics K.K., Tokyo, Japan) and amplification and detection by TaqMan PCR on the ABI PRISM 7700 Analyzer (Perkin-Elmer Applied Biosystems, Foster City, Calif.). An internal control (IC) is incorporated in the assay to monitor the extraction, target amplification, and detection processes. The assay yields qualitative results without discrimination of the three targets. Detection limits (95% confidence interval) are 22 to 60 copies/ml for HBV, 61 to 112 IU/ml for HCV, and 33 to 66 copies/ml for HIV-1, using a specimen input volume of 0.2 ml. The AMPLINAT MPX assay detects a broad range of genotypes or subtypes for all three viruses and has a specificity of 99.6% for all three viruses with seronegative specimens. In an evaluation of seroconversion panels, the AMPLINAT MPX assay detects HBV infection an average of 24 days before the detection of HBsAg by enzyme immunoassay. HCV RNA was detected an average of 31 days before HCV antibody. HIV-1 RNA was detected an average of 14 days before HIV-1 antibody and an average of 9 days before p24 antigen. The Japanese Red Cross has been evaluating the AMPLINAT MPX system since October 1999. The clinical performance indicates that the AMPLINAT MPX system is robust, sensitive, and reproducible, with a high percentage of valid assay runs (96.8%), a low false-positive rate (0.34%), and a low IC failure rate (0.24%). American Society for Microbiology 2001-08 /pmc/articles/PMC88264/ /pubmed/11474017 http://dx.doi.org/10.1128/JCM.39.8.2937-2945.2001 Text en Copyright © 2001, American Society for Microbiology
institution US National Library of Medicine
collection PubMed Central
language en
format Article
topic Virology
spellingShingle Virology
Meng, Q.
Wong, C.
Rangachari, A.
Tamatsukuri, S.
Sasaki, M.
Fiss, E.
Cheng, L.
Ramankutty, T.
Clarke, D.
Yawata, H.
Sakakura, Y.
Hirose, T.
Impraim, C.
Automated Multiplex Assay System for Simultaneous Detection of Hepatitis B Virus DNA, Hepatitis C Virus RNA, and Human Immunodeficiency Virus Type 1 RNA
description We have developed an automated multiplex system for simultaneously screening hepatitis B virus (HBV), hepatitis C virus (HCV), and human immunodeficiency virus type 1 (HIV-1) in blood donations. The assay, designated AMPLINAT MPX HBV/HCV/HIV-1 Test (AMPLINAT MPX), consists of virus extraction and target sequence-specific probe capture on specimen preparation workstation GT-X (Roche Diagnostics K.K., Tokyo, Japan) and amplification and detection by TaqMan PCR on the ABI PRISM 7700 Analyzer (Perkin-Elmer Applied Biosystems, Foster City, Calif.). An internal control (IC) is incorporated in the assay to monitor the extraction, target amplification, and detection processes. The assay yields qualitative results without discrimination of the three targets. Detection limits (95% confidence interval) are 22 to 60 copies/ml for HBV, 61 to 112 IU/ml for HCV, and 33 to 66 copies/ml for HIV-1, using a specimen input volume of 0.2 ml. The AMPLINAT MPX assay detects a broad range of genotypes or subtypes for all three viruses and has a specificity of 99.6% for all three viruses with seronegative specimens. In an evaluation of seroconversion panels, the AMPLINAT MPX assay detects HBV infection an average of 24 days before the detection of HBsAg by enzyme immunoassay. HCV RNA was detected an average of 31 days before HCV antibody. HIV-1 RNA was detected an average of 14 days before HIV-1 antibody and an average of 9 days before p24 antigen. The Japanese Red Cross has been evaluating the AMPLINAT MPX system since October 1999. The clinical performance indicates that the AMPLINAT MPX system is robust, sensitive, and reproducible, with a high percentage of valid assay runs (96.8%), a low false-positive rate (0.34%), and a low IC failure rate (0.24%).
author Meng, Q.
Wong, C.
Rangachari, A.
Tamatsukuri, S.
Sasaki, M.
Fiss, E.
Cheng, L.
Ramankutty, T.
Clarke, D.
Yawata, H.
Sakakura, Y.
Hirose, T.
Impraim, C.
author_facet Meng, Q.
Wong, C.
Rangachari, A.
Tamatsukuri, S.
Sasaki, M.
Fiss, E.
Cheng, L.
Ramankutty, T.
Clarke, D.
Yawata, H.
Sakakura, Y.
Hirose, T.
Impraim, C.
author_sort Meng, Q.
title Automated Multiplex Assay System for Simultaneous Detection of Hepatitis B Virus DNA, Hepatitis C Virus RNA, and Human Immunodeficiency Virus Type 1 RNA
title_short Automated Multiplex Assay System for Simultaneous Detection of Hepatitis B Virus DNA, Hepatitis C Virus RNA, and Human Immunodeficiency Virus Type 1 RNA
title_full Automated Multiplex Assay System for Simultaneous Detection of Hepatitis B Virus DNA, Hepatitis C Virus RNA, and Human Immunodeficiency Virus Type 1 RNA
title_fullStr Automated Multiplex Assay System for Simultaneous Detection of Hepatitis B Virus DNA, Hepatitis C Virus RNA, and Human Immunodeficiency Virus Type 1 RNA
title_full_unstemmed Automated Multiplex Assay System for Simultaneous Detection of Hepatitis B Virus DNA, Hepatitis C Virus RNA, and Human Immunodeficiency Virus Type 1 RNA
title_sort automated multiplex assay system for simultaneous detection of hepatitis b virus dna, hepatitis c virus rna, and human immunodeficiency virus type 1 rna
publisher American Society for Microbiology
publisher_facet American Society for Microbiology
publishDate 2001
url https://ncbi.nlm.nih.gov/pmc/articles/PMC88264/
https://ncbi.nlm.nih.gov/pubmed/11474017
https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1128/JCM.39.8.2937-2945.2001
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