印度国家结核病控制规划下TrueNat MTB/Rif的影响及操作可行性
Impact and operational feasibility of TrueNat MTB/Rif under India's RNTCP.
作者信息
Jeyashree K, Shanmugasundaram D, Rade K, Gangakhedkar R R, Murhekar M V
机构信息
Indian Council of Medical Research (ICMR)-National Institute of Epidemiology, Chennai, India.
World Health Organization India Country Office, New Delhi, India.
出版信息
Public Health Action. 2020 Sep 21;10(3):87-91. doi: 10.5588/pha.20.0004.
BACKGROUND
The Revised National Tuberculosis Control Programme (RNTCP) in Andhra Pradesh, India, introduced TrueNat MTB/Rif, a rapid molecular test for detecting (MTB) and rifampicin (RIF) resistance at 193 TB units (TUs) in October 2018. We evaluated its impact on TB diagnosis and assessed the operational feasibility of its deployment at point-of-care (POC) settings.
METHODS
We compared the number of presumptive TB cases tested and the number (proportion) of microbiologically positive before (January-August 2018) and after (January-August 2019) the deployment of TrueNat. We interviewed laboratory technicians and Senior TB Laboratory Supervisor from 25 randomly selected TUs to assess operational feasibility.
RESULTS
In 2018, 10.5% (range 8.9-13.1) of 245,989 presumptive cases tested were positive. In 2019, of the 185,435 presumptive cases tested, 13.7% (range 9.6-18.9) were positive. The proportion of presumptive TB cases in whom MTB was detected using TrueNat was 14.4% (range 10.0-21.2). TrueNat significantly increased case detection (incidence rate ratio [IRR] 1.30; 95%CI 1.15-1.46), yielding an additional 18 TB cases per 100 000 population. Laboratory technicians became comfortable in performing TrueNat after a median of 10 tests (interquartile range 5-17.5). Invalid reports declined from 6.8% to 3.6%.
CONCLUSION
The deployment of TrueNat as POC diagnostic test improved case detection and was operationally feasible under RNTCP.
背景
印度安得拉邦的修订版国家结核病控制规划（RNTCP）于2018年10月在193个结核病防治单位（TUs）引入了TrueNat MTB/Rif，这是一种用于检测结核分枝杆菌（MTB）和利福平（RIF）耐药性的快速分子检测方法。我们评估了其对结核病诊断的影响，并评估了在即时检测（POC）环境中部署该检测方法的操作可行性。
方法
我们比较了TrueNat部署前后（2018年1月至8月和2019年1月至8月）检测的疑似结核病病例数以及微生物学阳性的病例数（比例）。我们采访了25个随机选择的结核病防治单位的实验室技术人员和高级结核病实验室主管，以评估操作可行性。
结果
2018年，在检测的245,989例疑似病例中，10.5%（范围8.9 - 13.1%）呈阳性。2019年，在检测的185,435例疑似病例中，13.7%（范围9.6 - 18.9%）呈阳性。使用TrueNat检测出MTB的疑似结核病病例比例为14.4%（范围10.0 - 21.2%）。TrueNat显著提高了病例检出率（发病率比[IRR] 1.30；95%置信区间1.15 - 1.46），每10万人口中额外增加了18例结核病病例。实验室技术人员在进行中位数为10次检测（四分位间距5 - 17.5）后对操作TrueNat变得得心应手。无效报告从6.8%降至3.6%。
结论
将TrueNat作为即时检测诊断方法进行部署可提高病例检出率，并且在RNTCP下操作可行。
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