Standards Development

Scope

This document specifies the requirements for screening, optimization and evaluation of the aptamers. This document specifies the evaluation parameters and methods for the aptamer.

This document is applicable to aptamer targets at different levels, such as metal ions, small molecules, macromolecules, cells and particles, tissues, and mixed targets.

This document is intended to be used by researchers, manufacturers and customs involved in the design, screening, optimization, and evaluation of nucleic acid aptamers for various applications.

Purpose

Nucleic acid aptamers are short oligonucleotide fragments (DNA or RNA) known for their high affinity and specificity in binding to specific targets, often referred to as 'chemical antibodies'. They undergo adaptive folding into specific three-dimensional structures, through nucleotide base pairing, hydrogen bonding, - stacking, electrostatic interactions, and other forces, to ensure their functionality and stability. Mainly as bionic recognition elements, they can target a wide range of molecules, including metal ions, small molecules, proteins, viruses, cells, and even living tissues, showcasing their unique functionalities. Their applications span a diverse range of fields, including but not limited to: molecular sensors, where they can be utilized in monitoring, inspection and detection for the precise identification and quantification of analytes, even at trace levels; molecular drugs, where they enable targeted therapeutic interventions, such as cancer treatments and antiviral therapies; molecular delivery, where they facilitate the transport of active agents, such as drugs or imaging molecules, to specific cellular or tissue targets; and molecular capture, where they are employed for the selective isolation and enrichment of specific targets, such as biomarkers, pathogens, or environmental pollutants. The development and implementation of this standard are imperative to establish a robust and universal protocol for the preparation of nucleic acid aptamers. It ensures that the aptamers produced across different laboratories and for diverse applications maintain a high standard of consistency, reproducibility, and reliability. This is crucial for the credibility and effectiveness of aptamer-based technologies in research and commercial settings. By establishing a standardized framework, this standard facilitates the translation of aptamer research from the bench to the market, enabling the development of innovative diagnostic tools, environmental sensors and therapeutic agents. It also aids in reducing variability in aptamer performance, which is essential for their acceptance and integration into regulatory frameworks, ultimately contributing to the advancement of biological research and environmental science.