Interpretation of the World Health Organization’s Catalogue of mutations in Mycobacterium tuberculosis complex and their association with drug resistance (2nd Edition)

doi:10.19982/j.issn.1000-6621.20230450

Abstract

Abstract:

Drug-resistant tuberculosis is a major obstacle to the achievement of the End TB Strategy by 2035. The World Health Organization (WHO) promotes the use of rapid molecular drug susceptibility testing technology for early diagnosis of drug-resistant tuberculosis. Covering comprehensive and reliable drug resistance-related mutations is the key to improving the reliability of molecular drug resistance diagnosis. WHO has released the second edition of the Catalogue of mutations in Mycobacterium tuberculosis complex and their association with drug resistance in November 2023. This catalogue described more comprehensive and accurate drug-resistance-related gene mutations based on the largest collection of multinational Mycobacterium tuberculosis complex isolates, so as to support the development and improvement of the molecular drug susceptibility testing technology. This article provides a detailed interpretation of the updates in the analysis process and drug-resistant mutations in the second edition of the catalogue compared with the first edition, and looks forward to the future direction of improving the catalogue.

Key words: Mycobacterium tuberculosis, Drug resistance, bacterial, Microbial sensitivity tests, Genes, Mutation

CLC Number:

R378.91
R446

Pei Shaojun, Ou Xichao. Interpretation of the World Health Organization’s Catalogue of mutations in Mycobacterium tuberculosis complex and their association with drug resistance (2nd Edition)[J]. Chinese Journal of Antituberculosis, 2024, 46(3): 260-266. doi: 10.19982/j.issn.1000-6621.20230450

Figures/Tables 3

药物	1组(耐药相关突变)	2组(暂定与耐药相关)	1组+2组
利福平
敏感度(%,95%CI)	92.1(91.7~92.5)	1.1(1.0~1.3)	93.3(92.9~93.7)
特异度(%,95%CI)	97.1(96.9~97.3)	99.8(99.8~99.9)	96.9(96.7~97.1)
阳性预测值(%,95%CI)	94.5(94.2~94.9)	76.5(70.8~81.6)	94.2(93.9~94.6)
异烟肼
敏感度(%,95%CI)	89.6(89.2~90.0)	2.0(1.8~2.2)	91.6(91.2~92.0)
特异度(%,95%CI)	98.2(98.1~98.4)	99.7(99.6~99.7)	97.9(97.8~98.1)
阳性预测值(%,95%CI)	97.5(97.2~97.7)	82.5(78.9~85.7)	97.1(96.8~97.3)
乙胺丁醇
敏感度(%,95%CI)	81.1(80.3~81.9)	0.0	81.1(80.3~81.9)
特异度(%,95%CI)	91.6(91.3~91.9)	100.0(100.0~100.0)	91.6(91.3~91.9)
阳性预测值(%,95%CI)	71.9(71.0~72.8)	0.0	71.9(71.0~72.8)
吡嗪酰胺
敏感度(%,95%CI)	63.5(62.0~64.9)	14.6(13.5~15.6)	78.0(76.8~79.2)
特异度(%,95%CI)	98.6(98.5~98.8)	99.2(99.1~99.3)	97.9(97.6~98.1)
阳性预测值(%,95%CI)	92.4(91.4~93.4)	82.9(80.1~85.5)	90.5(89.5~91.4)
左氧氟沙星
敏感度(%,95%CI)	83.6(82.6~84.5)	1.2(1.0~1.6)	84.8(83.9~85.7)
特异度(%,95%CI)	97.3(97.0~97.5)	99.6(99.6~99.7)	96.9(96.7~97.1)
阳性预测值(%,95%CI)	89.2(88.4~90.0)	48.3(40.1~56.6)	88.1(87.3~89.0)
莫西沙星
敏感度(%,95%CI)	84.8(83.7~85.9)	0.9(0.6~1.2)	85.7(84.6~86.8)
特异度(%,95%CI)	94.0(93.6~94.3)	99.5(99.4~99.6)	93.5(93.2~93.9)
阳性预测值(%,95%CI)	75.2(73.9~76.4)	29.5(21.6~38.4)	74.0(72.7~75.2)
贝达喹啉
敏感度(%,95%CI)	26.3(23.7~29.1)	23.0(20.5~25.7)	49.4(46.3~52.5)
特异度(%,95%CI)	99.4(99.3~99.5)	99.3(99.1~99.4)	98.7(98.5~98.9)
阳性预测值(%,95%CI)	78.2(73.5~82.4)	72.0(66.8~76.8)	75.2(71.8~78.4)
利奈唑胺
敏感度(%,95%CI)	27.3(22.8~32.1)	6.7(4.4~9.7)	34.0(29.2~39.0)
特异度(%,95%CI)	99.8(99.8~99.9)	100.0(99.9~100.0)	99.8(99.7~99.9)
阳性预测值(%,95%CI)	78.5(70.4~85.2)	78.1(60.0~90.7)	78.4(71.3~84.5)
氯法齐明
敏感度(%,95%CI)	4.3(2.9~6.1)	12.7(10.3~15.4)	17.0(14.2~20.0)
特异度(%,95%CI)	99.8(99.7~99.8)	98.9(98.7~99.1)	98.7(98.5~98.9)
阳性预测值(%,95%CI)	46.0(33.4~59.1)	36.0(29.9~42.4)	38.1(32.6~43.8)
德拉马尼
敏感度(%,95%CI)	0.0(0.0~1.5)	14.7(10.6~19.7)	14.7(10.6~19.7)
特异度(%,95%CI)	100.0(100.0~100.0)	99.9(99.8~99.9)	99.9(99.8~99.9)
阳性预测值(%,95%CI)	0.0	72.5(58.3~84.1)	72.5(58.3~84.1)
阿米卡星
敏感度(%,95%CI)	68.9(67.0~70.7)	4.0(3.2~4.8)	72.8(71.0~74.6)
特异度(%,95%CI)	99.2(99.0~99.3)	99.2(99.0~99.3)	98.3(98.1~98.5)
阳性预测值(%,95%CI)	90.1(88.7~91.4)	34.3(28.8~40.1)	82.8(81.2~84.4)
链霉素
敏感度(%,95%CI)	72.1(71.2~72.9)	7.6(7.1~8.1)	79.7(78.9~80.5)
特异度(%,95%CI)	97.6(97.4~97.8)	96.5(96.2~96.8)	94.1(93.7~94.4)
阳性预测值(%,95%CI)	95.2(94.7~95.7)	58.8(56.1~61.4)	89.9(89.3~90.5)
乙硫异烟胺
敏感度(%,95%CI)	45.8(44.4~47.1)	29.1(27.8~30.3)	74.8(73.6~76.0)
特异度(%,95%CI)	94.0(93.6~94.3)	91.9(91.5~92.3)	85.9(85.3~86.4)
阳性预测值(%,95%CI)	71.7(70.1~73.2)	54.6(52.7~56.4)	63.9(62.7~65.1)
卡那霉素^a
敏感度(%,95%CI)	74.4(73.0~75.9)	0.4(0.3~0.7)	74.9(73.4~76.3)
特异度(%,95%CI)	96.7(96.5~97.0)	100.0(99.9~100.0)	96.7(96.4~96.9)
阳性预测值(%,95%CI)	79.4(78.0~80.8)	66.7(44.7~84.4)	79.3(77.9~80.7)
卷曲霉素^a
敏感度(%,95%CI)	61.2(59.1~63.3)	4.9(4.0~6.0)	66.2(64.1~68.2)
特异度(%,95%CI)	98.0(97.8~98.2)	99.8(99.7~99.9)	97.8(97.6~98.1)
阳性预测值(%,95%CI)	80.4(78.4~82.3)	76.1(68.0~83.1)	80.1(78.1~81.9)

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第2版	第1版
第2版	1组	2组	3组	4组	5组	无
1组	167	53	18	0	0	8
2组	9	880	107	0	0	126
3组	4	7(98)^a	12581	3	8	21178
4组	0	(1)^a	7	20	29	1(12358)^b
5组	0	0	36	5	136	182(126)^b