定量病毒二次标准的准确性:重新审查
R T Hayden1, Y Su2, L Tang2
1Department of Pathology, St. Jude Children's Research Hospital, Memphis, Tennessee, USA.
Journal of clinical microbiology
|February 21, 2024
概括
细胞巨血病毒 (CMV) 和BK病毒 (BKV) 的定量病毒载荷标准显示了提高的准确性. 数字PCR (dPCR) 和国际单位 (IU) 提高了对标值的一致性,减少了病毒载荷测试中的偏差.
科学领域:
- 病毒学 病毒学
- 分子生物学分子生物学
- 临床诊断 临床诊断 临床诊断
背景情况:
- 病毒载荷测定中的实验室间协议依赖于准确的定量校准器.
- 之前的研究表明,对细胞巨乳病毒 (CMV) 二次标准的一致性不佳.
- 对BK病毒 (BKV) 和CMV的商业二次标准需要重新评估.
研究的目的:
- 重新评估BKV和CMV的商业生产二次标准的协议.
- 使用数字PCR (dPCR) 来比较三家不同制造商的材料.
- 评估标准化对国际单位 (IU) 和dPCR分配对准确性的影响.
主要方法:
- 使用数字PCR (dPCR) 来进行BKV和CMV二次标准的定量比较.
- 评估了三家商业制造商的二次标准.
- 结果与log10副本/毫升和log10 IU/毫升的面值进行了比较.
主要成果:
- 与之前的工作相比,标准显示了与名义价值的更好的一致性.
- 来自制造商指定的标称值的偏差在0.0-0.9log10单位之间.
- 以IU规范化的标准和dPCR分配的标准显示出更好的一致性.
结论:
- 商业定量病毒载量标准有了显著的改善.
- 数字PCR (dPCR) 对于对参考材料进行定量值赋值非常有价值.
- 对dPCR进行值赋值的普遍实施,将其规范化为IU,可以进一步减少偏差.
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