Cepheid, Sunnyvale, California 94089, USA.
Clin Infect Dis. 2011 May;52 Suppl 4:S338-45. doi: 10.1093/cid/cir049.
Current diagnostic methods for bacterial respiratory tract infections are slow and often of marginal value for patient management if the adequacy of the specimen is not confirmed before culture. Molecular amplification tests, which are highly sensitive, can provide results in hours rather than days but may not distinguish colonization from infection unless a quantification step is included. Defining the reference method to be used for evaluating a novel molecular assay, with input from the US Food and Drug Administration (FDA), is critical before initiating development of a potential product. Although expectorated sputum may be the clinician's specimen of choice for testing because of ease of collection, the poor quality of such specimens may pose problems for clinical trials of novel amplification tests. There are still many gaps in our understanding of the interplay between colonization and infection and of the role that amplification tests may play in guiding anti-infective therapy. Thus, the performance parameters of a new diagnostic method should be closely matched to a precisely defined intended use statement.
目前的细菌性呼吸道感染诊断方法较为缓慢，如果在培养之前不能确认标本是否充分，其对患者管理的价值往往很有限。高度敏感的分子扩增检测可在数小时内提供结果，而不是数天，但如果不包括定量步骤，可能无法区分定植和感染。在开始开发潜在产品之前，需要由美国食品和药物管理局（FDA）参与，定义用于评估新型分子检测方法的参考方法，这一点至关重要。虽然由于采集方便，咳出的痰液可能是临床医生首选的检测标本，但新型扩增检测的临床试验可能会因这类标本质量较差而出现问题。我们对定植和感染之间的相互作用以及扩增检测可能在指导抗感染治疗方面发挥的作用的理解仍存在许多空白。因此，新诊断方法的性能参数应与明确规定的预期用途声明密切匹配。
