河南省第二轮结核病耐药监测药敏试验质量控制分析  

Analysis of Quality Control of Drug Susceptibility Testing in the Second Drug Resistant Surveillance on Tuberculosis in He nan Province

作　　者：徐吉英[1] 王国斌[1] 杜长梅[1] 王国杰[1] 李爱华[1] 孙占强[1] 

机构地区：[1]河南省结核病防治研究所,郑州450003

出　　处：《中国初级卫生保健》2005年第7期44-46,共3页Chinese Primary Health Care

摘　　要：目的评价河南省第二轮结核病耐药监测药敏试验工作质量。方法西太区跨国参比室(SRL)--韩国国家结核病研究所参比室对河南省结核防治研究所参比室(PRL)进行了4次药敏试验质量控制。其中3次同时对其他国家参比室(NRL)进行了同步质量控制。试验菌株为含耐药和敏感的结核分支杆菌临床分离菌株。试验的4种药物为链霉素、异烟肼、利福平和乙胺丁醇,采用L-J培养基和比例法。结果4种药一致性均达到95.0%或以上;异烟肼平均敏感性明显高于其平均特异性(100.0%比88.0%,P=0.0298);3次同步质量控制中,河南省PRL利福平平均特异性、一致性明显低于同步质量控制NRL相应平均值(分别为91.0%比98.0%,P=0.0154和93.0%比98.0%,P=0.0298)。结论河南省第二轮结核病耐药监测药敏试验工作质量符合《世界卫生组织(WHO)/国际肺部疾病联合会(IUATLD)结核病耐药监测指南》(1997)及WHO专家要求:以该质量控制结果评价该次耐药监测结果,在某种程度上可能会过高估计异烟肼的耐药率和多耐药率。OBJECTIVE To evaluate the performance of drug susceptibility testing (DST) for M. tuberculosis in the second drug resistant surveillance (DRS) on tuberculosis in Henan. METHOD The supranational reference laboratory (SRL) in the West Pacific Rgeion, the reference lab-oratory of Tuberculosis Research Institute, South Korea, carried out four times of quality control for drug susceptibility testing on the reference laboratory of Henan Province Anti-tuberculosis Institute ( PRL). At the same time, the SRL carried out the same quality control on several national reference laboratories (NRL) in three of the four times. 30 clinical isolated M. tuberculosis strains were tested for resistance to streptomycin (SM), isoniazid (INH), rifampicin (REP) and ethambutol (EMB), each time. Proportion method was used with L-J medium. RESULTS The efficiency of DST for M. tuberculosis for all the fourdrugs is 95.0% or more in PRL.Its mean sensitivity is higher than its mean specifictity for INH ( 100.0% to 88.0%, P=0.0298).Its mean specificity and efficiency are lower than the corresponding values of NRL (91.0% to 98.0%, P=0.015 4 and 93.0% to 98.0%, P= 0.029 8, respectively). CONCLUSIONS It is qualified that the performance of DST for M. tuberculosis of PRL in the second drug resistant surveillance on tuberculosis in Henan. Evaluated with this quality control, the drug resistant rate for INH and multi-drug resistant (MDR) rate for the results of this drug resistant surveillance may be over estimated on some degree.

关 键 词：质量控制 药敏试验 结核分支杆菌 

分 类 号：R52[医药卫生—内科学]