TREK Sensititre MYCOTB检测结核分枝杆菌对一、二线抗结核药物的敏感性研究

Evaluation of the TREK Sensititre MYCOTB for susceptibility testing of the Mycobacterium tuberculosis to first-line and second-line anti-tuberculosis drugs

目的本研究旨在评价TREKSensititre MYCOTB（简称“MYCOTB”；一种含有一、二线抗结核药物冻干粉的商品化药敏板）检测一、二线抗结核药物的敏感性的效能。方法采用随机数字表法选取来自国家结核病参比实验室的151株结核分枝杆菌临床分离株，采用MYCOTB方法对一、二线抗结核药物[包括氧氟沙星（ofloxacin，Ofx）、莫西沙星（moxifloxacin，Mfx）、利福平（rifampin，RFP）、阿米卡星（amikacin，Am）、链霉素（streptomycin，Sm）、利福布汀（rifabutin，Rfb）、对氨基水杨酸（para-aminosalicylic acid，PAS）、乙硫异烟胺（ethionamide，Eto）、环丝氨酸（cycloserine，Cs）、异烟肼（isoniazid，INH）、卡那霉素（kanamycin，Km）、乙胺丁醇（ethambutol，EMB）]进行药物敏感性试验（简称“药敏试验”）。并使用Middlebrook7H10琼脂比例法（APM）作为对照，研究评估MYCOTB的敏感度、特异度、可行性及两种药敏试验方法的一致率。结果8／12种药物（Ofx、Mfx、RFP、Sm、Rfb、Eto、Km及EMB）的敏感度≥90％，其余4种药物除cs外，敏感度均≥80％。另外，除Rfb的特异度为86．8％外，其余药物的特异度均≥90％。9／12种药物（Ofx、Mfx、RFP、Am、Sm、PAS、Eto、Cs及Km）MYCOTB和APM的绝对一致率≥94％。10／12种药物（Ofx、Mfx、RFP、Am、Sm、PAS、Eto、Cs、Km及EMB）的MYCOTB和APM的条件一致率≥96％。MYCOTB的平均判读时间为10d，lO／12种药物（Ofx、Mfx、RFP、Am、Sm、Rfb、PAS、Eto及EMB）双人判读的一致率≥94％。结论MYCOTB方法检测Mtb对一、二线抗结核药物的敏感性试验是可行、可靠的。

Objective To evaluate the performance of Sensititre MYCOTB MIC plate to detecting the sus- ceptibility of Mycobacterium tuberculosis （M. tuberculosis） to twelve first-line and second-line anti-tuberculosis （TB） drugs （MYCOTB, a dry microdilution plate containing 12 lyophilized antibiotics）. Methods A total of 151 isolates were randomly selected from China National Tuberculosis Reference Laboratory. Drug susceptibility testing （DST） was conducted to 12 first-line and second-line anti-tuberculosis （TB） drugs, including ofloxacin （Ofx）, moxifloxacin （Mfx）, rifampin （RFP）, amikacin （Am）, streptomycin （Sin）, rifabutin （Rfb）, para-aminosalicylic acid （PAS）, ethionamide （Eto）, cycloserine （Cs）, isoniazid （INH）, kanamycin （Kin）, ethambutol （EMB）. We used the Middlebrook 7H10 agar proportion method （APM） as the reference method to evaluate the sensitivity, specificity and feasibility of MYCOTB. The agreement between two methods was also evaluated. Results The sensitivity was ≥90% for 8/12 drugs （Ofx, Mfx, RFP, Sin, Rfb, Eto, Km and EMB）, and was ≥80% for other three drugs except for Cs. The specificity was ≥90% for all drugs except for Rifabutin （86.8%）. Categorical agreement between MYCOTB and APM was ≥94% for 9/12 drugs （Ofx, Mfx, RFP, Am, Sm, PAS, Eto, Cs and Kin） and conditional agreement was ≥96% for 10/12 drugs （Ofx, Mfx, RFP, Am, Sin, PAS, Eto, Cs, Km and EMB）. For MYCOTB, the median time to plate interpretation was 10 days and inter-reader agreement was ≥94% for 10/12 drugs （Ofx, Mfx, RFP, Am, Sin, Rfb, PAS, Eto and EMB）. Conclusion MYCOTB can provide reliable results for susceptibility testing of M. tuberculosis to first-line and second-line drugs.