质量保证和PCR在临床试验中的应用。

P S Reichelderfer, J B Jackson
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引用次数: 17

摘要

定性和定量HIV-1 DNA和RNA PCR检测在婴儿HIV-1感染的诊断和临床试验中评估新疗法和方案的体内抗病毒活性方面被证明是有用的。将这些标准化的商业检测方法与外部质量保证程序结合使用,确保了来自不同实验室的结果具有可比性。此外,实时熟练程度监测有可能在患者数据泄露之前立即发现问题。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Quality assurance and use of PCR in clinical trials.

Qualitative and quantitative HIV-1 DNA and RNA PCR assays are proving to be useful in the diagnosis of HIV-1 infection in infants and in assessing the in vivo antiviral activity of new therapies and regimens in clinical trials. The use of these standardized commercial assays in conjunction with an external quality assurance program has ensured that results from different laboratories are comparable. In addition, real-time proficiency monitoring has the potential to detect problems immediately before patient data are compromised.

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