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Journal of Clinical Microbiology, July 2000, p. 2665-2669, Vol. 38, No. 7
0095-1137/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.

Comparison of Two Amplification Technologies for Detection and Quantitation of Human Immunodeficiency Virus Type 1 RNA in the Female Genital Tract

James Bremer,1,* Marek Nowicki,2 Suzanne Beckner,3 Donald Brambilla,4 Mike Cronin,5 Steven Herman,6 Andrea Kovacs,2 and Patricia Reichelderfer7 for the Division of Aids Treatment Research Initiative 009 Study Team

Rush Medical College, Chicago, Illinois 606121; University of Southern California, Los Angeles, California 900332; Westat, Rockville, Maryland 208503; New England Research Institutes, Watertown, Massachusetts 024724; Organon Teknika Corporation, Durham, North Carolina 277125; Department of Infectious Diseases, Roche Molecular Systems, Inc., Alameda, California 945016; and National Institute of Child Health and Human Development, Bethesda, Maryland 208927

Received 28 January 2000/Returned for modification 3 April 2000/Accepted 9 May 2000

Human immunodeficiency virus type 1 (HIV-1) RNA levels in female genital tract and peripheral blood samples were compared using two commercial amplification technologies: the Roche AMPLICOR HIV-1 MONITOR test and either the Organon Teknika nucleic acid sequence-based amplification (NASBA-QT) assay or the NucliSens assay. Estimates of HIV-1 RNA copy number were derived from internal kit standards and analyzed unadjusted and adjusted to a common set of external standards. We found a discordance rate of approximately 18% between the two technologies for the detection of HIV-1 in either the genital tract or peripheral blood samples. Detection discordance was not consistent among specimens or among women. There were no significant differences in adjusted or unadjusted estimates of HIV-1 RNA copy number in the genital tract samples using the AMPLICOR HIV-1 MONITOR test and either the NASBA-QT assay or the NucliSens assay. In addition, the estimated HIV-1 RNA copy number in peripheral blood samples did not differ when tested with the NucliSens assay and the AMPLICOR HIV-1 MONITOR test using kit standards. However, there was a significant difference in estimated RNA copy number between the NASBA-QT assay and the AMPLICOR HIV-1 MONITOR test for internal kit standards, which, as we have previously shown, was eliminated after adjustment with the external standards. Our results suggest that the Roche and Organon Teknika assays are equivalent for quantifying HIV-1 RNA in female genital tract specimens, although variation in detection does exist.

* Corresponding author. Mailing address: Rush Medical College, Chicago, IL 60612. Phone: (312) 942-3308. Fax: (312) 942-6787. E-mail: jbremer{at}rush.edu.

Journal of Clinical Microbiology, July 2000, p. 2665-2669, Vol. 38, No. 7
0095-1137/00/$04.00+0
Copyright © 2000, American Society for Microbiology. All rights reserved.


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