Drobniewski F A, Hoffner S, Rusch-Gerdes S, Skenders G, Thomsen V
HPA National Mycobacterium Reference Unit and Clinical TB and HIV Group, London, UK.
Eur Respir J. 2006 Nov;28(5):903-9. doi: 10.1183/09031936.06.00084906. Epub 2006 Aug 9.
The principles underpinning these standards are that any tuberculosis laboratory-based diagnostic procedure should be performed by appropriately trained staff, working to standardised operating procedures in appropriately equipped and safe laboratories, against clear national and international proficiency and quality standards. Quality should be the pre-eminent criteria, not cost. The standards are technologically feasible, but initially may not be within the financial capacity of all laboratories. There is a requirement for government and international donors to adequately fund an appropriate safe infrastructure to enable staff to deliver accurate and timely results at whatever level of activity they are performing. There is a need for national reference laboratories to train a new cadre of mycobacterial laboratory experts. This will require the funding of appropriate individuals at these centres to train and assist in the implementation of good laboratory practice and evaluation to build sustainable capacity. Further operational research is needed to establish the optimal configuration of new technologies to determine isoniazid, rifampicin and second-line drug susceptibility in mycobacterial cultures and also, increasingly, directly on specimens. Improved integration of laboratory medicine as a core part of all tuberculosis programmes is needed to achieve and maximise the potential of new developments.
这些标准所依据的原则是，任何基于实验室的结核病诊断程序都应由经过适当培训的人员在配备适当、安全的实验室中按照标准化操作程序进行，且要符合明确的国家和国际能力验证及质量标准。质量应是首要标准，而非成本。这些标准在技术上是可行的，但最初可能并非所有实验室都有财力达到。政府和国际捐助方需要提供充足资金，以建立合适的安全基础设施，使工作人员无论在何种工作水平下都能提供准确、及时的结果。国家参考实验室需要培养一批新的分枝杆菌实验室专家。这将需要为这些中心的合适人员提供资金，以培训并协助实施良好实验室规范及评估，从而建立可持续的能力。还需要进一步开展运筹学研究，以确定用于检测分枝杆菌培养物中异烟肼、利福平及二线药物敏感性的新技术的最佳配置，而且越来越需要直接针对标本进行检测。需要更好地将检验医学整合为所有结核病防治规划的核心部分，以实现并最大化新进展的潜力。
