Abstract
Implementation of Xpert MTB/RIF requires quality assessment. A pilot program using dried culture spots (DCSs) of inactivated Mycobacterium tuberculosis is described. Of 274 DCS results received, 2.19% generated errors; the remainder yielded 100% correct Mycobacterium tuberculosis detection. The probe A cycle threshold (C(T)) variability of three DCS batches was ≤ 3.47. The study of longer-term DCS stability is ongoing.
Publication types
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Research Support, N.I.H., Extramural
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Research Support, Non-U.S. Gov't
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Research Support, U.S. Gov't, Non-P.H.S.
MeSH terms
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Diagnostic Errors / statistics & numerical data
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Humans
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Molecular Diagnostic Techniques / methods*
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Molecular Diagnostic Techniques / standards*
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Mycobacterium tuberculosis / drug effects*
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Mycobacterium tuberculosis / isolation & purification*
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Pilot Projects
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Quality Assurance, Health Care / methods*
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Reference Standards*
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South Africa
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Tuberculosis / diagnosis*