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Table 1.

Specificity of RLEP TaqMan for Mycobacterium leprae detection.

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Figure 1.

RLEP TaqMan PCR results from titration of nude mouse-derived M. leprae.

Serial 2-fold dilutions of M. leprae were made from 2×106 to 1.56×104/ml. Ten microliters of each dilution were tested in triplicate representing 2×104 to 156 M. leprae in the test sample, respectively. The ordinate is PCR cycle number at threshold and the abscissa is number of M. leprae (log10). Standard deviations did not exceed 0.5% of mean at any dilution.

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Figure 2.

Comparison of direct microscopic counting of AFB per standard volume with enumeration of M. leprae by RLEP TaqMan PCR from tissues originating from a variety of host animals.

Symbols identify individual samples from sets of conventional, TNFR1 knock-out (KO), and congentially athymic nude mice, as well as from nine-banded armadillos. Pearson's coefficient (r2) is calculated for each tissue set. Enumeration estimates for all tissues combined showed high correlation (r2 = 0.96) between the “gold standard' direct microscopic counting and estimates based on RLEP TaqMan PCR.

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Table 2.

The number and percent of bacilli recovered from conventional mouse foot pads within 4 hours and 1 week post inoculation with varying doses of M. leprae as measured by RLEP PCR.

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Figure 3.

A comparison of RLEP TaqMan PCR and M. leprae counting results from a vaccine trial using conventional C57/B mice.

Bars represent mean plus the standard deviation for each group. ** = probability of statistical significance (p)<0.01, and *** = probability of statistical significance (p)<0.001.

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