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Journal of Clinical Microbiology, August 2001, p. 2937-2945, Vol. 39, No. 8
0095-1137/01/$04.00+0   DOI: 10.1128/JCM.39.8.2937-2945.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.

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

Q. Meng,1,* C. Wong,1 A. Rangachari,1 S. Tamatsukuri,2 M. Sasaki,2 E. Fiss,1 L. Cheng,1 T. Ramankutty,1 D. Clarke,1 H. Yawata,2 Y. Sakakura,2 T. Hirose,2 and C. Impraim1,dagger

Roche Molecular Systems, Inc., Pleasanton, California 94588,1 and Roche Diagnostics, K. K., Tokyo, Japan2

Received 10 April 2001/Returned for modification 16 May 2001/Accepted 11 June 2001

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%).

* Corresponding author. Mailing address: Roche Molecular Systems, Inc., 4300 Hacienda Dr., Pleasanton, CA 94588. Phone: (925) 730-8150. Fax: (925) 225-0760. E-mail: qi.meng{at}roche.com.

dagger Present address: Applera, Inc., Alameda, Calif.

Journal of Clinical Microbiology, August 2001, p. 2937-2945, Vol. 39, No. 8
0095-1137/01/$04.00+0   DOI: 10.1128/JCM.39.8.2937-2945.2001
Copyright © 2001, American Society for Microbiology. All rights reserved.


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Copyright © 2001 by the American Society for Microbiology. All rights reserved.