Standards Development

Scope

This document provides minimum requirements for ensuring reliable and accurate detection of optical signals in photometric methods used for qualitative or quantitative characterization of biological samples.

The optical signal can be generated by bioluminescence, chemiluminescence, fluorescence, and in absorption measurements.

NOTE 1 Several international and domestic standards exist for specific applications involving photometric methods for measurement of biological samples. Consulting these standards can be helpful when working within their scope, particularly regarding points like preanalytical steps and data analysis of measured optical signals.

Purpose

Photometric methods involving bioluminescence, chemiluminescence, fluorescence, and absorption methods are broadly employed for measurements of biological samples in life science and health industries. In many cases, they measure optical signal intensity from samples to evaluate biological aspects qualitatively and quantitatively. These methods are used for purposes such as toxicity testing, environmental risk assessment, drug development, and regenerative medicine.

There are significant needs in the industry for ensuring optical signal quality from photometric methods in measurements, including confidence in the repeatability, intermediate precision, and reproducibility. This is crucial for biological samples. However, points to consider for acquiring reliable data are not well acknowledged. This is because relevant international and domestic standards covering photometric methods are not sufficient. They do not describe the key considerations for measuring optical signal.

This document defines terms and provides general guidance for ensuring optical signal measurement in photometric methods. This includes determination procedures of intended use for instruments qualification. Definition and use of optical references, including reference light sources, are described. This document also provides points to consider regarding biological samples, apparatus, and reagents for ensuring optical signal measurements.

This document can be used for the manufacturers who provide products related to instruments, reagents, measurement kits, and cells to ensure product performance. This document can be used for the users who perform measurements of biological samples by means of photometric methods, increasing the confidence levels in measurement results.