James Vivienne
Quality Assurance Laboratory, Health Protection Agency Centre for Infections, 61 Colindale Avenue, London NW9 5EQ, UK.
Rev Med Virol. 2008 Mar-Apr;18(2):77-80. doi: 10.1002/rmv.562.
There are no differences inherent in the design of commercial or in-house assays and their early development is similar. The same principles apply and it is on the same criteria of accuracy, reproducibility and clinical relevance of results that all assays are judged. However, if there is sufficient uptake of a commercial assay, its strengths and any flaws soon become apparent and it will only be the best commercial assays that remain in the market. For the in-house assays it is through comparability studies and external quality assessment (EQA) schemes that the best can be demonstrated, albeit this information is only accessible initially to the EQA provider and the laboratories using the assays. The EQA results described here support my supposition that, for the diagnosis of viral infections, commercial assays do not provide more reliable results than do in-house assays.
商业检测方法和内部检测方法在设计上并无本质区别，且它们的早期开发过程相似。同样的原则适用，并且所有检测方法都是依据准确性、可重复性和结果的临床相关性这些相同标准来评判的。然而，如果一种商业检测方法得到足够广泛的应用，其优点和任何缺陷很快就会显现出来，留在市场上的将只会是最好的商业检测方法。对于内部检测方法，只有通过可比性研究和外部质量评估（EQA）计划才能证明其最佳性能，尽管这些信息最初只有EQA提供者和使用这些检测方法的实验室能够获取。这里描述的EQA结果支持了我的推测，即对于病毒感染的诊断，商业检测方法并不比内部检测方法提供更可靠的结果。
