Standardization of diagnostic materials. 4. Diagnostic immunofluorescence.

Abstract 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.