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Journal of Clinical Microbiology, January 2004, p. 286-289, Vol. 42, No. 1
0095-1137/04/$08.00+0     DOI: 10.1128/JCM.42.1.286-289.2004
Copyright © 2004, American Society for Microbiology. All Rights Reserved.

Assessment of Agreement between the AMPLICOR HIV-1 MONITOR Test Versions 1.0 and 1.5

Emory University Hospital and Emory University School of Medicine,¹ Biostatistics, Rollins School of Public Health, Emory University, Atlanta, Georgia²

Received 3 April 2003/ Returned for modification 22 June 2003/ Accepted 25 September 2003

The agreement of the microwell plate AMPLICOR HIV-1 MONITOR version 1.0 (MWP 1.0), the microwell plate AMPLICOR HIV-1 MONITOR version 1.5 (MWP 1.5), and the COBAS AMPLICOR HIV-1 MONITOR version 1.5 (COBAS 1.5) tests was evaluated using clinical specimens and well-characterized control material. Two hundred patient plasma specimens and a panel of known human immunodeficiency virus type 1 (HIV-1) subtypes were tested. All data were log₁₀ transformed prior to analysis. The 95% limits of agreement for the three tests at the average of 3.66 log₁₀ copies/ml were ± 0.28 log₁₀, ± 0.34 log₁₀, and ± 0.34 log₁₀ copies/ml for MWP 1.0-MWP 1.5, MWP 1.0-COBAS 1.5, and MWP 1.5-COBAS 1.5, respectively. Ten specimens (6.1%) had differences exceeding the limits of agreement for the MWP 1.0 and MWP 1.5 tests. Correlation coefficients among the three tests were high (r 0.96). The viral-load values obtained with the MWP 1.0 test were only 2.1% higher on average than those measured with the MWP 1.5 test and 1.6% higher than those seen with the COBAS 1.5 test. The MWP 1.5 test values were 0.8% higher than the COBAS 1.5 test values. Overall, there was less agreement among the different tests for viral-load values near the lower limit of quantification. The MWP 1.0 test underquantified subtypes A, E, F, G, and H by 1.0 to 2.0 log₁₀ copies/ml; this problem was not observed with the MWP 1.5 test. The close agreement among the results obtained with the different test versions and formats suggests that it is not necessary to reestablish a baseline viral load when changing AMPLICOR HIV-1 MONITOR tests, unless the patient is known to be infected with a non-B subtype.

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