荧光PCR探针熔解曲线技术检测MTB耐药性的成本分析

doi:10.3969/j.issn.1000-6621.2020.07.013

摘要/Abstract

摘要：

目的通过将荧光PCR探针熔解曲线技术(简称“熔解曲线技术”)与BACTEC MGIT 960技术(简称“MGIT 960”)对MTB耐药性检测的成本进行比较,评估熔解曲线技术在中国不同地区、不同层级结核病防治机构检测MTB耐药性的可行性。方法选择西安市胸科医院、新疆维吾尔自治区胸科医院、沈阳市胸科医院、南阳市第六人民医院、遵义医学院附属医院和杭州市红十字会医院6家结核病定点医院,按照高、中、低3种工作量收集3次MGIT 960和熔解曲线技术的成本数据,采用“要素法(包括管理费、建筑费、设备费、人员费、试剂费、耗材费)”计算每种方法的单位检测成本,计算不同检测方法检出每例患者的检测成本。结果使用MGIT 960、熔解曲线技术平均每例患者的检测成本分别为702.6(4215.8/6)和440.7(2644.3/6)元。当熔解曲线技术检测敏感度超过70%,在结核病人群MDR-TB患病率≤50%的情况下,使用熔解曲线技术进行耐药MTB检测的每例患者检测成本(熔解曲线技术检测敏感度为70.0%时,结核病患者MDR-TB的患病率在1.0%、5.0%、10.0%、15.0%、20.0%、30.0%、50.0%时,熔解曲线技术检出1例MDR-TB患者的平均成本分别为62957.1、12591.4、6295.7、4197.1、3147.9、2098.6、1259.1元;熔解曲线技术检测敏感度为80.0%时,上述患病率情况下平均成本分别为55087.5、11017.5、5508.8、3672.5、2754.3、1836.3、1101.8元)均低于MGIT 960(平均成本分别为70260.0、14052.0、7026.0、4684.0、3513.0、2342.0、1405.2元)。结论与MGIT 960相比,熔解曲线技术更具成本-效益,具备在中国不同地区、不同层级结核病防治机构检测MTB耐药性的价值。

关键词: 分枝杆菌,结核, 分子诊断技术, 微生物敏感性试验, 成本及成本分析

Abstract:

Objective Through the comparison of the cost of MGIT 960 and melting curve technology, to evaluate the feasibility of melting curve technology in detection of MTB drug resistance at tuberculosis control and prevention institutions in different regions and levels in China. Methods Six TB designated hospitals were selected, including Xi’an Chest Hospital, Xinjiang Uygur Autonomous Region Chest Hospital, Shenyang Chest Hospital, Nanyang Sixth People’s Hospital, Zunyi Medical College Affiliated Hospital and Hangzhou Red Cross Hospital. Cost data of MGIT 960 and melting curve techniques were collected for three times, according to three workloads of high, medium and low. The unit detection cost of each method and the unit cost of one MDR-TB patient detection were calculated by “element method”. Results The average unit detection costs of MGIT 960 and melting curve technique were 702.6 yuan (4215.8/6) and 440.7 yuan (2644.3/6), respectively. When the sensitivity of the melting curve technique was greater than 70% and the prevalence of MDR-TB was ≤50% in TB patients, the average cost of one MDR-TB patient detected by the melting curve technique (when the sensitivity of the melting curve technique was 70.0%, the prevalence of MDR-TB in TB patients were 1.0%, 5.0%, 10.0%, 15.0%, 20.0%, 30.0%, 50.0%) were 62957.1, 12591.4, 6295.7, 4197.1, 3147.9, 2098.6, and 1259.1 yuan. When the sensitivity of the melting curve technology was 80.0%, the average cost were 55087.5, 11017.5, 5508.8, 3672.5, 2754.3, 1836.3, 1101.8 yuan respectively, which was lower than that of MGIT 960 (the average cost were 70260.0, 14052.0, 7026.0, 4684.0, 3513.0, 2342.0, and 1405.2 yuan). Conclusion Compared with MGIT 960, melting curve technology is a more cost-effective diagnostic method, and has the value of detecting MTB resistance in TB control institutions with different levels in different regions in China.

Key words: Mycobacterium tuberculosis, Molecular diagnostic techniques, Microbial sensitivity tests, Costs and cost analysis

宋怡蒙, 李远春, 贺文从, 何萍, 包晶晶, 刘春法, 刘东鑫, 王鑫洋, 赵雁林, 李燕明. 荧光PCR探针熔解曲线技术检测MTB耐药性的成本分析[J]. 中国防痨杂志, 2020, 42(7): 712-717. doi: 10.3969/j.issn.1000-6621.2020.07.013

SONG Yi-meng, LI Yuan-chun, HE Wen-cong, HE Ping, BAO Jing-jing, LIU Chun-fa, LIU Dong-xin, WANG Xin-yang, ZHAO Yan-lin, LI Yan-ming. Cost analysis of fluorescence PCR probe melting curve technique for the detection of Mycobacterium tuberculosis resistance in China[J]. Chinese Journal of Antituberculosis, 2020, 42(7): 712-717. doi: 10.3969/j.issn.1000-6621.2020.07.013

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项目地点	管理费	建筑费	设备费	人员费	试剂费	耗材费	合计
遵义	48.5	14.3	7.8	49.8	537.3	38.5	707.1
杭州	59.4	14.3	7.5	49.8	537.3	27.4	695.7
乌鲁木齐	59.3	16.1	16.5	19.5	539.7	83.3	734.3
南阳	47.1	13.7	9.0	13.8	532.4	27.5	643.3
西安	58.1	14.3	7.8	49.8	537.3	38.5	707.1
沈阳	92.1	18.6	10.2	28.2	541.8	37.4	728.4
平均费用	60.7	15.2	9.8	35.2	537.6	42.1	702.6

项目地点	管理费	建筑费	设备费	人员费	试剂费	耗材费	合计
遵义	19.7	0.1	2.5	8.6	391.2	19.1	441.2
杭州	11.4	0.0	1.4	17.2	390.7	18.0	438.7
乌鲁木齐	22.3	0.1	1.8	8.8	391.4	23.1	447.5
南阳	23.2	0.1	1.9	8.9	391.5	12.7	438.3
西安	10.0	0.0	1.0	15.1	391.2	15.9	433.2
沈阳	22.6	0.1	1.8	9.0	391.3	20.3	445.1
平均费用	18.2	0.1	1.7	11.3	391.2	18.2	440.7

项目地点	MGIT 960			熔解曲线技术
项目地点	检出率 (%)	单位成本 (元)	检出MDR-TB成本 (元)	检出率 (%)	单位成本 (元)	检出MDR-TB成本 (元)
遵义	17.4	707.1	4063.8	15.1	441.2	2921.9
杭州	9.0	695.7	7730.0	8.1	438.7	5416.0
乌鲁木齐	12.9	734.3	5692.2	15.8	447.5	2832.3
南阳	3.6	643.3	17869.4	4.1	438.3	10690.2
西安	16.9	707.1	4184.0	15.8	433.2	2741.8
沈阳	17.9	728.4	4069.3	19.7	445.1	2259.4
合计	13.0	702.6	5404.6	13.1	440.7	3364.1