Cherry W B, Reimer C B
Bull World Health Organ. 1973 Jun;48(6):737-46.
The standardization of diagnostic immunofluorescence is a complex problem because diagnostic results are greatly influenced by interacting factors, such as the equipment, materials, and techniques for expressing and recording fluorescence. Furthermore, the characteristics of immunofluorescence reagents depend on how they are manufactured and used. The adoption of stable reference preparations of such reagents appears to be the only practicable way of standardizing laboratory test results. Several professional and regulatory organizations are actively promoting this objective. Consensus evaluation may be the best method of introducing proposed standards. Basic and applied research must provide the information needed to improve reagents and tests.Material fluorescent standards are proving helpful in standardizing fluorescence emission, but the most promising development is the use of insolubilized antigens to provide standards for more relevant immunological-fluorescence comparisons.Several important direct and indirect diagnostic immunofluorescence tests and reagents currently used in microbiological, histological, and pathological examinations require standardization. The medical profession should insist that commercial reagents be adequately characterized and that manufacturers supply the data necessary for their safe and informed use.
诊断免疫荧光的标准化是一个复杂的问题，因为诊断结果会受到多种相互作用因素的极大影响，比如用于表达和记录荧光的设备、材料及技术。此外，免疫荧光试剂的特性取决于其生产和使用方式。采用此类试剂的稳定参考制剂似乎是使实验室检测结果标准化的唯一可行方法。几个专业和监管组织正在积极推动这一目标。共识评估可能是引入拟议标准的最佳方法。基础研究和应用研究必须提供改进试剂和检测所需的信息。物质荧光标准在使荧光发射标准化方面已证明很有帮助，但最有前景的进展是使用固定化抗原为更相关的免疫荧光比较提供标准。目前在微生物学、组织学和病理学检查中使用的几种重要的直接和间接诊断免疫荧光检测及试剂需要标准化。医学界应坚持要求对商业试剂进行充分表征，并要求制造商提供安全、明智使用所需的数据。
