Market penetration of Xpert MTB/RIF in high tuberculosis burden countries: A trend analysis from 2014 - 2016.
Market penetration of Xpert MTB/RIF in high tuberculosis burden countries: A trend analysis from 2014 - 2016.
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DOI：
10.12688/gatesopenres.12842.2
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发表时间：
2018-01-01
影响因子：
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通讯作者：
Pai, Madhukar
中科院分区：
文献类型：
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作者：
Cazabon, Danielle;Pande, Tripti;Pai, Madhukar
背景：Xpert MTB/RIF是一种快速结核病(TB)分子检测方法，于2010年获得世界卫生组织认可。自那时以来，已以优惠价格采购了3440万发子弹。尽管这种诊断方法的推出前景看好，但之前的研究表明，市场渗透率很低。方法：为评估Xpert MTB/RIF在公共部门的三年市场渗透率趋势，评估了2016年的涂抹量和Xpert MTB/RIF量，并研究了22个高负担国家(HBC)2014-2016年的政策。向22个重债穷国的代表发出了一份结构化问卷。问卷调查评估了国家结核病计划(NTP)中GeneXpert机器的涂片和Xpert MTB/RIF总量、模块数量和运行天数。收集了有关NTP GeneXpert机器用于其他疾病和其他疾病控制计划采购GeneXpert的数据。市场渗透率是通过初始诊断的总痰涂片量除以公共部门采购的Xpert结核分枝杆菌/RIF检测次数的比率来估计的。结果：调查应答率为95%(21/22)。自2014年以来，涂片/Xpert比率在17/21个国家下降，在4个国家上升。中位数比率从2014年的32.6(IQR：44.6)下降到2016年的6.0(IQR：15.4)。2016年，GeneXpert的使用率中值为20%，但2017年有7个国家(7/19；37%)在其NTP采购的GeneXpert系统上运行了其他疾病的测试，如艾滋病毒、丙型肝炎病毒(丙型肝炎病毒)、沙眼衣原体和淋病奈瑟菌。五个国家(5/15；33%)报告了2016年和/或2017年通过艾滋病毒或丙型肝炎病毒计划进行的GeneXpert采购。结论：我们的结果显示Xpert MTB/RIF在21个HBC公共部门的市场渗透率呈积极趋势。然而，基因Xpert机器在结核病方面没有得到充分利用，作为一项多病技术也没有得到充分利用。
Background: Xpert MTB/RIF, a rapid tuberculosis (TB) molecular test, was endorsed by the World Health Organization in 2010. Since then, 34.4 million cartridges have been procured under concessional pricing. Although the roll out of this diagnostic is promising, previous studies showed low market penetration. Methods: To assess 3-year trends of market penetration of Xpert MTB/RIF in the public sector, smear and Xpert MTB/RIF volumes for the year 2016 were evaluated and policies from 2014-2016 within 22 high-burden countries (HBCs) were studied. A structured questionnaire was sent to representatives of 22 HBCs. The questionnaires assessed the total smear and Xpert MTB/RIF volumes, number of modules and days of operation of GeneXpert machines in National TB Programs (NTPs). Data regarding the use of NTP GeneXpert machines for other diseases and GeneXpert procurement by other disease control programs were collected. Market penetration was estimated by the ratio of total sputum smear volume for initial diagnosis divided by the number of Xpert MTB/RIF tests procured in the public sector. Results: The survey response rate was 21/22 (95%). Smear/Xpert ratios decreased in 17/21 countries and increased in four countries, since 2014. The median ratio decreased from 32.6 (IQR: 44.6) in 2014 to 6.0 (IQR: 15.4) in 2016. In 2016, the median GeneXpert utilization was 20%, however seven countries (7/19; 37%) were running tests for other diseases on their NTP-procured GeneXpert systems in 2017, such as HIV, hepatitis-C virus (HCV), Chlamydia trachomatis, and Neisseria gonorrhoeae. Five (5/15; 33%) countries reported GeneXpert procurement by HIV or HCV programs in 2016 and/or 2017. Conclusions: Our results show a positive trend for Xpert MTB/RIF market penetration in 21 HBC public sectors. However, GeneXpert machines were under-utilized for TB, and inadequately exploited as a multi disease technology.