This Article Full Text Full Text (PDF) Alert me when this article is cited Alert me if a correction is posted Services Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Copyright Information Books from ASM Press MicrobeWorld Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Michael, N. L. Articles by Robb, M. L. Search for Related Content PubMed PubMed Citation Articles by Michael, N. L. Articles by Robb, M. L.

Journal of Clinical Microbiology, August 1999, p. 2557-2563, Vol. 37, No. 8
0095-1137/99/$04.00+0
Copyright © 1999, American Society for Microbiology. All rights reserved.

Development of Calibrated Viral Load Standards for Group M Subtypes of Human Immunodeficiency Virus Type 1 and Performance of an Improved AMPLICOR HIV-1 MONITOR Test with Isolates of Diverse Subtypes

Nelson L. Michael,^1,* Steven A. Herman,² Shirley Kwok,³ Kimberly Dreyer,^2, June Wang,² Cindy Christopherson,³ Joanne P. Spadoro,² Karen K. Y. Young,² Victoria Polonis,⁴ Francine E. McCutchan,⁴ Jean Carr,⁴ John R. Mascola,^1,5 Linda L. Jagodzinski,⁴ and Merlin L. Robb¹

Division of Retrovirology, Walter Reed Army Institute of Research,¹ and Henry M. Jackson Foundation,⁴ Rockville, Maryland 20850; Diagnostics Development, Roche Molecular Systems, Somerville, New Jersey 08876²; Discovery Research, Roche Molecular Systems, Alameda, California 94501³; and Department of Infectious Diseases, Naval Medical Research Institute, Bethesda, Maryland 20889⁵

Received 28 December 1998/Returned for modification 15 March 1999/Accepted 10 May 1999

Accurate determination of plasma human immunodeficiency virus type 1 (HIV-1) RNA levels is critical for the effective management of HIV-1 disease. The AMPLICOR HIV-1 MONITOR Test, a reverse transcription-PCR-based test for quantification of HIV-1 RNA in plasma, was developed when little sequence information on HIV-1 isolates from outside North America was available. It has since become apparent that many non-subtype B isolates, particularly subtypes A and E, are detected inefficiently by the test. We describe here the AMPLICOR HIV-1 MONITOR Test, version 1.5, an upgraded test developed to minimize subtype-related variation. We also developed a panel of HIV-1 standards containing 30 HIV-1 isolates of subtypes A through G. The virus particle concentration of each cultured viral stock was standardized by electron microscopic virus particle counting. We used this panel to determine the performance of the original AMPLICOR HIV-1 MONITOR Test and version 1.5 of the test with HIV-1 subtypes A through G. The original test underestimated the concentration of HIV-1 subtype A, E, F, and G RNA by 10-fold or more, whereas version of the 1.5 test yielded equivalent quantification of HIV-1 RNA regardless of the subtype. In light of the increasing intermixing of HIV-1 subtypes worldwide, standardization of PCR-based tests against well-characterized viral isolates representing the full range of HIV-1 diversity will be essential for the continued utility of these important clinical management tools.

---

^* Corresponding author. Mailing address: Department of Molecular Diagnostics and Pathogenesis, Division of Retrovirology, Walter Reed Army Institute of Research, 1600 E. Gude Dr., Rockville, MD 20850. Phone: (301) 762-0089, ext. 1081. Fax: (301) 762-7460. E-mail: nmichael{at}pasteur.hjf.org.

Present address: Department of Infectious Diseases, University of Rochester Medical Center, Rochester, NY 14627.

---

Journal of Clinical Microbiology, August 1999, p. 2557-2563, Vol. 37, No. 8
0095-1137/99/$04.00+0
Copyright © 1999, American Society for Microbiology. All rights reserved.

This article has been cited by other articles:

• Read, J. S., and the Committee on Pediatric AIDS, (2007). Diagnosis of HIV-1 Infection in Children Younger Than 18 Months in the United States. Pediatrics 120: e1547-e1562 [Abstract] [Full Text]  
• Chen, P., Hubner, W., Spinelli, M. A., Chen, B. K. (2007). Predominant Mode of Human Immunodeficiency Virus Transfer between T Cells Is Mediated by Sustained Env-Dependent Neutralization-Resistant Virological Synapses. J. Virol. 81: 12582-12595 [Abstract] [Full Text]  
• Oliver, A. R., Pereira, S. F., Clark, D. A. (2007). Comparative Evaluation of the Automated Roche TaqMan Real-Time Quantitative Human Immunodeficiency Virus Type 1 RNA PCR Assay and the Roche AMPLICOR Version 1.5 Conventional PCR Assay. J. Clin. Microbiol. 45: 3616-3619 [Abstract] [Full Text]  
• Apetrei, C., Gautam, R., Sumpter, B., Carter, A. C., Gaufin, T., Staprans, S. I., Else, J., Barnes, M., Cao, R. Jr., Garg, S., Milush, J. M., Sodora, D. L., Pandrea, I., Silvestri, G. (2007). Virus Subtype-Specific Features of Natural Simian Immunodeficiency Virus SIVsmm Infection in Sooty Mangabeys. J. Virol. 81: 7913-7923 [Abstract] [Full Text]  
• Drexler, J. F., de Souza Luna, L. K., Pedroso, C., Pedral-Sampaio, D. B., Queiroz, A. T. L., Brites, C., Netto, E. M., Drosten, C. (2007). Rates of and Reasons for Failure of Commercial Human Immunodeficiency Virus Type 1 Viral Load Assays in Brazil. J. Clin. Microbiol. 45: 2061-2063 [Abstract] [Full Text]  
• Garcia-Diaz, A., Clewley, G. S., Booth, C. L., Labett, W., McAllister, N., Geretti, A. M. (2006). Comparative Evaluation of the Performance of the Abbott Real-Time Human Immunodeficiency Virus Type 1 (HIV-1) Assay for Measurement of HIV-1 Plasma Viral Load following Automated Specimen Preparation.. J. Clin. Microbiol. 44: 1788-1791 [Abstract] [Full Text]  
• Patton, J. C., Sherman, G. G., Coovadia, A. H., Stevens, W. S., Meyers, T. M. (2006). Ultrasensitive Human Immunodeficiency Virus Type 1 p24 Antigen Assay Modified for Use on Dried Whole-Blood Spots as a Reliable, Affordable Test for Infant Diagnosis. CVI 13: 152-155 [Abstract] [Full Text]  
• Swanson, P., de Mendoza, C., Joshi, Y., Golden, A., Hodinka, R. L., Soriano, V., Devare, S. G., Hackett, J. Jr. (2005). Impact of Human Immunodeficiency Virus Type 1 (HIV-1) Genetic Diversity on Performance of Four Commercial Viral Load Assays: LCx HIV RNA Quantitative, AMPLICOR HIV-1 MONITOR v1.5, VERSANT HIV-1 RNA 3.0, and NucliSens HIV-1 QT. J. Clin. Microbiol. 43: 3860-3868 [Abstract] [Full Text]  
• Respess, R. A., Cachafeiro, A., Withum, D., Fiscus, S. A., Newman, D., Branson, B., Varnier, O. E., Lewis, K., Dondero, T. J. (2005). Evaluation of an Ultrasensitive p24 Antigen Assay as a Potential Alternative to Human Immunodeficiency Virus Type 1 RNA Viral Load Assay in Resource-Limited Settings. J. Clin. Microbiol. 43: 506-508 [Abstract] [Full Text]  
• Marozsan, A. J., Fraundorf, E., Abraha, A., Baird, H., Moore, D., Troyer, R., Nankja, I., Arts, E. J. (2004). Relationships between Infectious Titer, Capsid Protein Levels, and Reverse Transcriptase Activities of Diverse Human Immunodeficiency Virus Type 1 Isolates. J. Virol. 78: 11130-11141 [Abstract] [Full Text]  
• Brambilla, D. J., Jennings, C., Morack, R., Granger, S., Bremer, J. W. (2004). Comparison of the Sensitivities of the Version 1.5 and Version 1.0 Ultrasensitive Roche AMPLICOR HIV-1 MONITOR Kits at Low Concentrations of Human Immunodeficiency Virus RNA. J. Clin. Microbiol. 42: 2819-2820 [Abstract] [Full Text]  
• Li, F., Goila-Gaur, R., Salzwedel, K., Kilgore, N. R., Reddick, M., Matallana, C., Castillo, A., Zoumplis, D., Martin, D. E., Orenstein, J. M., Allaway, G. P., Freed, E. O., Wild, C. T. (2003). PA-457: A potent HIV inhibitor that disrupts core condensation by targeting a late step in Gag processing. Proc. Natl. Acad. Sci. USA 100: 13555-13560 [Abstract] [Full Text]  
• Treadwell, T. L, Fleisher, J. (2003). Underestimation of HIV-1 Plasma Viral Burden in Patients Who Acquire Infection Abroad: The Experience in a Community Hospital Clinic. Arch Intern Med 163: 1613-1614 [Abstract] [Full Text]  
• Jagodzinski, L. L., Cooley, J. D., Weber, M., Michael, N. L. (2003). Performance Characteristics of Human Immunodeficiency Virus Type 1 (HIV-1) Genotyping Systems in Sequence-Based Analysis of Subtypes Other than HIV-1 Subtype B. J. Clin. Microbiol. 41: 998-1003 [Abstract] [Full Text]  
• Pascual, A., Cachafeiro, A., Funk, M. L., Fiscus, S. A. (2002). Comparison of an Assay Using Signal Amplification of the Heat-Dissociated p24 Antigen with the Roche Monitor Human Immunodeficiency Virus RNA Assay. J. Clin. Microbiol. 40: 2472-2475 [Abstract] [Full Text]  
• Holguín, A., Aracil, B., Álvarez, A., Barros, C., Soriano, V. (2001). Prevalence of Human Immunodeficiency Virus Type 1 (HIV-1) Non-B Subtypes in Foreigners Living in Madrid, Spain, and Comparison of the Performances of the AMPLICOR HIV-1 MONITOR Version 1.0 and the New Automated Version 1.5. J. Clin. Microbiol. 39: 1850-1854 [Abstract] [Full Text]  
• de Baar, M. P., Timmermans, E. C., Bakker, M., de Rooij, E., van Gemen, B., Goudsmit, J. (2001). One-Tube Real-Time Isothermal Amplification Assay To Identify and Distinguish Human Immunodeficiency Virus Type 1 Subtypes A, B, and C and Circulating Recombinant Forms AE and AG. J. Clin. Microbiol. 39: 1895-1902 [Abstract] [Full Text]  
• de Baar, M. P., van Dooren, M. W., de Rooij, E., Bakker, M., van Gemen, B., Goudsmit, J., de Ronde, A. (2001). Single Rapid Real-Time Monitored Isothermal RNA Amplification Assay for Quantification of Human Immunodeficiency Virus Type 1 Isolates from Groups M, N, and O. J. Clin. Microbiol. 39: 1378-1384 [Abstract] [Full Text]  
• Swanson, P., Soriano, V., Devare, S. G., Hackett, J. Jr. (2001). Comparative Performance of Three Viral Load Assays on Human Immunodeficiency Virus Type 1 (HIV-1) Isolates Representing Group M (Subtypes A to G) and Group O: LCx HIV RNA Quantitative, AMPLICOR HIV-1 MONITOR Version 1.5, and Quantiplex HIV-1 RNA Version 3.0. J. Clin. Microbiol. 39: 862-870 [Abstract] [Full Text]  
• Andersson, S., Norrgren, H., da Silva, Z., Biague, A., Bamba, S., Kwok, S., Christopherson, C., Biberfeld, G., Albert, J. (2000). Plasma Viral Load in HIV-1 and HIV-2 Singly and Dually Infected Individuals in Guinea-Bissau, West Africa: Significantly Lower Plasma Virus Set Point in HIV-2 Infection Than in HIV-1 Infection. Arch Intern Med 160: 3286-3293 [Abstract] [Full Text]  
• Murphy, D. G., Côté, L., Fauvel, M., René, P., Vincelette, J. (2000). Multicenter Comparison of Roche COBAS AMPLICOR MONITOR Version 1.5, Organon Teknika NucliSens QT with Extractor, and Bayer Quantiplex Version 3.0 for Quantification of Human Immunodeficiency Virus Type 1 RNA in Plasma. J. Clin. Microbiol. 38: 4034-4041 [Abstract] [Full Text]  
• Emery, S., Bodrug, S., Richardson, B. A., Giachetti, C., Bott, M. A., Panteleeff, D., Jagodzinski, L. L., Michael, N. L., Nduati, R., Bwayo, J., Kreiss, J. K., Overbaugh, J. (2000). Evaluation of Performance of the Gen-Probe Human Immunodeficiency Virus Type 1 Viral Load Assay Using Primary Subtype A, C, and D Isolates from Kenya. J. Clin. Microbiol. 38: 2688-2695 [Abstract] [Full Text]  
• Quinn, T. C., Wawer, M. J., Sewankambo, N., Serwadda, D., Li, C., Wabwire-Mangen, F., Meehan, M. O., Lutalo, T., Gray, R. H., The Rakai Project Study Group, (2000). Viral Load and Heterosexual Transmission of Human Immunodeficiency Virus Type 1. NEJM 342: 921-929 [Abstract] [Full Text]  
• Jagodzinski, L. L., Wiggins, D. L., McManis, J. L., Emery, S., Overbaugh, J., Robb, M., Bodrug, S., Michael, N. L. (2000). Use of Calibrated Viral Load Standards for Group M Subtypes of Human Immunodeficiency Virus Type 1 To Assess the Performance of Viral RNA Quantitation Tests. J. Clin. Microbiol. 38: 1247-1249 [Abstract] [Full Text]  
• Christopherson, C., Kidane, Y., Conway, B., Krowka, J., Sheppard, H., Kwok, S. (2000). PCR-Based Assay To Quantify Human Immunodeficiency Virus Type 1 DNA in Peripheral Blood Mononuclear Cells. J. Clin. Microbiol. 38: 630-634 [Abstract] [Full Text]  
• Vahey, M., Nau, M. E., Barrick, S., Cooley, J. D., Sawyer, R., Sleeker, A. A., Vickerman, P., Bloor, S., Larder, B., Michael, N. L., Wegner, S. A. (1999). Performance of the Affymetrix GeneChip HIV PRT 440 Platform for Antiretroviral Drug Resistance Genotyping of Human Immunodeficiency Virus Type 1 Clades and Viral Isolates with Length Polymorphisms. J. Clin. Microbiol. 37: 2533-2537 [Abstract] [Full Text]