噬菌体法同时检测四种一线抗结核药物耐药性

Study on simultaneous detection of four drugs resistance anti-tuberculosis front line by phage amplified biologically assay

目的探讨噬菌体检测技术(PhaB)同时快速检测四种一线抗结核药物耐药性的可能性,分析其临床应用价值。方法应用PhaB同时测定139株结核分枝杆菌(MTB)临床分离株对链霉素(S)、异烟肼(H)、利福平(R)和乙胺丁醇(E)的耐药性,并与Bactec-960药敏结果比较,对两法检测结果不符的菌株进行最低抑菌浓度(MIC)测定。结果PhaB检测S、H、R、E药敏结果与Bactec-960药敏结果符合率分别为97.1%、99.3%、95.7%和95.0%。如以Bactec-960药敏结果为判断标准,则PhaB检测S的敏感性、特异性、阳性和阴性预测值(PPV、NPV)及准确性分别为90.0%、99.1%、96.4%、98.2%和97.1%;检测H的敏感性、特异性、PPV、NPV及准确性为97.9%、98.9%、97.9%、98.9%和95.0%;检测R的敏感性、特异性、PPV、NPV及准确性为86.2%、97.3%、89.3%、96.4%和95.0%;检测E的敏感性、特异性、PPV、NPV及准确性为81.0%、97.5%、85.0%、96.6%和95.0%。共有13株菌株19个药敏结果PhaB与Bactec-960检测结果不符。MIC检测结果有12株18个药敏结果支持PhaB结果,1株1个药敏结果支持Bactec-960结果。结论PhaB同时检测S、H、R、E药敏结果与Bactec-960结果有较高的符合率,可作为MTB耐药性的快速筛选方法。

Objective Evaluating possibility of phage amplified biologically（PhaB） assay in detecting susceptibility of Mycobacterium tuberculosis（MTB） to four first-anti-tuberculosis drugs on the same time and of 139 clinical isolates to streptomycin（S）, isoniazid（H）, rifampin（R） and ethambatal （E） at the same time, comparing with the results of Bactec-960 and determining the minimal inhibitory eoneentrations（MiC） of isolates which results were not consistent. Results Concordance rates of the susceptibility to S, H, R and E in 139 clinical isolates detected by PhaB and Baetee-960 are 97.1%, 99.3%, 95.7% and 95.0% respectively. If the results of Bactee-960 system is the golden standard, the sensitivity, speeifieity, positive and negative predictive value （PPV and NPV） as well as accuracy of susceptibility test to S detected by Phag assay was 90.0%, 99. 1%, 96.4%, 98.2% and 97.1% respectively, to H 97.9%, 98.9%, 97.9%, 98.9% and 95.0% , to R 86.2%, 97.3%, 89.3%, 96.4%and95.0%, to E 81.0%, 97.5%, 85.0%, 96.6% and 95.0%. There are 19 inconsistent results of 13 isolates in comparing PhaB with Bactee-960. 18 results of 12 isolates by MIC are identical with the results of PhaB assay. 1 result of 1 isolate is identical with Bactec-960. Conclusions The results of susceptibility to S, H, R and E detected by PhaB were highly concordance rate with the results of Bactec-960. PhaB assay can be used for rapid screening of susceptibility test for MTB.