Routine use of the gen-probe MTD2 amplification test for detection of Mycobacterium tuberculosis in clinical specimens in a large public health mycobacteriology laboratory1 1 The MTD2 kit “for export,” as used in Canada and this study does not have an indeterminate cut-off value. The recently FDA approved (1998) MTD2 kit for use in the United States, recommends an indeterminate cut-off level of 500,000 RLUs. Our experience with the first MTD1 kit was that some results gave a low amplification of 30,000 to 300,000 RLUs, which were subsequently negative on repeat testing. On discussion wth Gen-Probe Inc., San Diego, in 1997, it was agreed that we would interpret results in the range of 30,000 to 300,000 RLUs as indeterminate.
Titel:
Routine use of the gen-probe MTD2 amplification test for detection of Mycobacterium tuberculosis in clinical specimens in a large public health mycobacteriology laboratory1 1 The MTD2 kit “for export,” as used in Canada and this study does not have an indeterminate cut-off value. The recently FDA approved (1998) MTD2 kit for use in the United States, recommends an indeterminate cut-off level of 500,000 RLUs. Our experience with the first MTD1 kit was that some results gave a low amplification of 30,000 to 300,000 RLUs, which were subsequently negative on repeat testing. On discussion wth Gen-Probe Inc., San Diego, in 1997, it was agreed that we would interpret results in the range of 30,000 to 300,000 RLUs as indeterminate.
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