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. 2004 Jan;42(1):286-9.
doi: 10.1128/JCM.42.1.286-289.2004.

Assessment of agreement between the AMPLICOR HIV-1 MONITOR test versions 1.0 and 1.5

Affiliations

Assessment of agreement between the AMPLICOR HIV-1 MONITOR test versions 1.0 and 1.5

Charles E Hill et al. J Clin Microbiol. 2004 Jan.

Abstract

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 log(10) transformed prior to analysis. The 95% limits of agreement for the three tests at the average of 3.66 log(10) copies/ml were +/- 0.28 log(10), +/- 0.34 log(10), and +/- 0.34 log(10) 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 >or=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 log(10) 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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Figures

FIG. 1.
FIG. 1.
Agreement of viral-load values between the MWP 1.0 and MWP 1.5 (A), the MWP 1.0 and COBAS 1.5 (B), and the MWP 1.5 and COBAS 1.5 (C) tests. ○, ultrasensitive test; □, standard test. The solid lines represent the mean differences; the dashed lines represent ±2 standard deviations.

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