Niesters Hubert G M
Department of Virology, Erasmus MC, University Medical Center Rotterdam, Dr Molewaterplein 40, 3015 GD Rotterdam, The Netherlands.
J Clin Virol. 2002 Dec;25 Suppl 3:S3-12. doi: 10.1016/s1386-6532(02)00197-x.
The ability to detect nucleic acids has had and still has a major impact on diagnostics in clinical virology. Both quantitative and qualitative techniques, whether signal or target amplification based systems, are currently used routinely in most if not all virology laboratories. Technological improvements, from automated sample isolation to real time amplification technology, have given the ability to develop and introduce systems for most viruses of clinical interest, and to obtain clinical relevant information needed for optimal antiviral treatment options. Both polymerase chain reaction (PCR) and nucleic acid sequence-based amplification (NASBA) can currently be used together with real time detection to generate results in a short turn-around time and to determine whether variants relevant for antiviral resistance are present. These new technologies enable the introduction of an individual patient disease management concept. Within our clinical setting, we have introduced this e.g. for quantitative detection of Epstein-Barr Virus (EBV) in T-dell depleted allogeneic stem cell transplant patients. This enabled us to develop models for pre-emptive anti B-cell immunotherapy for EBV reactivation, thereby effectively reducing not the incidence of EBV-lymphoproliferative disease but the virus related mortality. Furthermore, additional clinically relevant viruses can now easily be detected simultaneously. It also becomes more feasible to introduce molecular testing for those viruses that can easily be detected using classical virological methods, like culture techniques or antigen detection. Prospective studies are needed to evaluate the clinical importance of the additional positive samples detected. It should however be made clear that a complete exchange of technologies is unlikely to occur, and that some complementary technologies should stay operational enabling the discovery of new viruses. The implementation of these molecular diagnostic technologies furthermore warrants the use and introduction of standardized materials as well as participation in international quality control programs. Finally, the use of an internal control throughout the whole procedure not only ensures the accuracy of the results generated, but also is necessary to enable precise quantification of these results and to determine detection thresholds more accurately. Since so many targets do have clinical implications, laboratories might prefer to use universal internal controls before the in-house developed assays should be introduced in clinical virology.
核酸检测能力过去和现在都对临床病毒学诊断产生了重大影响。无论是基于信号扩增还是基于靶标扩增的系统,定量和定性技术目前在大多数(即便不是全部)病毒学实验室中都有常规应用。从自动化样本分离到实时扩增技术的技术改进,使得能够开发并引入针对大多数具有临床意义的病毒的检测系统,并获取最佳抗病毒治疗方案所需的临床相关信息。目前,聚合酶链反应(PCR)和基于核酸序列的扩增(NASBA)都可与实时检测一起使用,以在短时间内得出结果,并确定是否存在与抗病毒耐药性相关的变体。这些新技术促成了个体患者疾病管理概念的引入。在我们的临床环境中,我们已将此应用于例如T细胞去除的异基因干细胞移植患者中爱泼斯坦 - 巴尔病毒(EBV)的定量检测。这使我们能够开发针对EBV再激活的抢先抗B细胞免疫疗法模型,从而有效降低的不是EBV淋巴增殖性疾病的发病率,而是病毒相关死亡率。此外,现在可以轻松同时检测其他临床相关病毒。对于那些使用经典病毒学方法(如培养技术或抗原检测)就能轻松检测的病毒,引入分子检测也变得更加可行。需要进行前瞻性研究来评估检测到的额外阳性样本的临床重要性。然而,应该明确的是技术不太可能完全相互替代,并且一些互补技术应继续运行以发现新病毒。这些分子诊断技术的实施还需要使用和引入标准化材料,并参与国际质量控制计划。最后 在整个过程中使用内部对照不仅能确保所产生结果的准确性,而且对于精确量化这些结果以及更准确地确定检测阈值也是必要的。由于如此多的靶标都具有临床意义,在临床病毒学中引入内部开发的检测方法之前,实验室可能更倾向于使用通用内部对照。