Malakhov V N, Irtuganova O A, Khaĭdukova I L, Levi D T, Golyshevskaia V I, Erokhin V V
Probl Tuberk Bolezn Legk. 2005(4):6-11.
The paper presents the results of the assessment of the quality of cultural detection and determination of Mycobacterium tuberculosis (MBT) sensitivity at Russia's public health laboratories, which has been made by the Federal System for External Assessment of the Quality of Clinical Laboratory Studies in 2002-2003. The "Bacteriological Detection" Section involved 102 laboratories, of them 57 laboratories also participated in the section "Detection of Drug Resistance". Sixty-three laboratories operated as part of specialized tuberculosis-controlling service facilities and 39 laboratories worked as part of general medical care therapeutic-and-prophylactic institutions. A set of 5 lyophilized samples containing 2.5 x 10(6) M. tuberculosis H37Rv (n = 1); 2.5 x 10(4) M. tuberculosis H37Rv (n = 2); M. fortuitum (n = 1); E. coli in the mixture with autoclaving-killed M. tuberculosis H37Rv (n = 1). 77% of the laboratories could detect in the cultural sample with a high content of M. tuberculosis, by obtaining a correct result; 85% revealed MBT if only in every three MBT-containing samples; 15% of the laboratories could not find MBT in none of the three positive samples. 12% of the laboratories took the growth of microorganisms in the M. fortuitum-containing sample for that of M. tuberculosis. 58% of the laboratories obtained correct results if only in one sample containing M. tuberculosis H37Rv; 42% reported the detection of resistance to one or several antituberculous drugs in the samples containing the drug-sensitive strain H37Rv (a false drug resistance). All the results of determination of drug resistance (DR) in the M. fortium-containing sample were correct. The findings suggest that it is necessary to increase the professional competence of laboratory personnel to the level that ensures the adequate of fulfillment of the standard protocols for detecting MTB and determining DR, which have been introduced by the Ministry of Health of the Russian Federation through its order No. 109 on March 21, 2003.
本文展示了俄罗斯公共卫生实验室对结核分枝杆菌(MBT)培养检测质量及药敏测定结果的评估情况,该评估由联邦临床实验室研究质量外部评估系统于2002 - 2003年开展。“细菌学检测”部分涉及102家实验室,其中57家实验室还参与了“耐药性检测”部分。63家实验室作为专门的结核病防控服务机构的一部分开展工作,39家实验室作为普通医疗保健治疗与预防机构的一部分开展工作。一套5份冻干样本,其中包含2.5×10(6)结核分枝杆菌H37Rv(n = 1);2.5×10(4)结核分枝杆菌H37Rv(n = 2);偶然分枝杆菌(n = 1);大肠杆菌与经高压灭菌灭活的结核分枝杆菌H37Rv的混合物(n = 1)。77%的实验室能够在结核分枝杆菌含量高的培养样本中检测到并得出正确结果;85%的实验室仅在每三份含MBT的样本中能检测出MBT;15%的实验室在三份阳性样本中均未检测到MBT。12%的实验室将含偶然分枝杆菌样本中的微生物生长误判为结核分枝杆菌。若仅在一份含结核分枝杆菌H37Rv的样本中,58%的实验室得出了正确结果;42%的实验室报告在含药物敏感菌株H37Rv的样本中检测到对一种或几种抗结核药物耐药(假耐药)。在含偶然分枝杆菌样本中所有耐药性测定结果均正确。研究结果表明,有必要将实验室人员的专业能力提升至确保能充分按照俄罗斯联邦卫生部2003年3月21日第109号令引入的检测MTB和测定耐药性的标准方案来执行的水平。