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Table. 4.

Table. 4.

Performance evaluation of FDA approved or not approved NTM IVDs in references

AuthorYearSampleSample sizeSpecificityReference
FDA approvedAccuProbe Mycobacterium avium complex identification testTran AC et al.2014Culture3772.9%[29]
Louro AP et al.2001Culture (broth)3482.3%a, 94.1%b[30]
Lebrun L et al.1992Culture13495.2%[31]
FDA not-approvedGenoType Mycobacterium CM/ASMakinen J et al.2006Culture21994.4∼100%[32]
Richter E et al.2006Culture14892.6%c, 89.9%d[33]
INNO-LiPA Mycobacterium V2Lee AS et al.2009Culture (solid)13190.8%[34]
Singh AK et al.2013Culture21998.33%[35]
García-Agudo L et al.2011Culture (broth)19782.0%[36]
Padilla E et al.2004Culture11092.7%[37]
Trueba F et al.2004Culture5494.4%[38]

specificity of M. gordonae from culture bottle;

specificity of M. avium complex;

specificity of GenoType Mycobacterium CM;

specificity of GenoType Mycobacterium AS.

Korean J Clin Lab Sci 2018;50:20-8
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