Drugdu.com expert's response:

The naming of in vitro diagnostic reagents must follow a series of clear requirements to ensure the standardization, accuracy, and ease of understanding of the names. These requirements mainly include the following points:

Ⅰ. Naming Structure

The product name of in vitro diagnostic reagents typically consists of three parts: Name of the Substance Being Tested: This is the target substance that the reagent detects, and the name should accurately reflect the characteristics of the substance being tested.

Purpose: Describes the purpose of the reagent, such as "assay kit," "quality control material," etc. This part helps users understand the specific application of the reagent.

Method or Principle: Explains the method or principle of the reagent's detection, such as "magnetic bead-based chemiluminescent immunoassay," "fluorescent PCR method," "fluorescent in situ hybridization," etc. This information is usually listed in parentheses to provide additional technical details.

Ⅱ. Specific Naming Rules

Quantitative vs. Qualitative Distinction: The product names of clinical chemistry in vitro diagnostic reagents (kits) for quantitative testing should be described as "assay reagents (kits)." For qualitative products, the names should be described as "detection reagents (kits)."

Handling of Special Cases: If the tested substance has multiple components or other special circumstances, alternative names related to the product's indication or other names can be used. For Class I products, calibrators, and quality control materials, naming should be based on their intended use.

Ⅲ.  General Principles

Clarity and Simplicity: The name of the reagent should clearly express its function, facilitating user understanding and use. Keywords or professional terminology related to the reagent's function are usually used as the name.

Standardized Naming: The naming of reagents should comply with relevant norms and standards, avoiding the use of non-standard, vague, or misleading names.

Distinctive Naming: The name of the reagent should be clearly distinguishable from other reagents to avoid confusion or ambiguity. Unique combinations of words, abbreviations, or numbers can be used for distinction.

Prefixes and Suffixes: Prefixes and suffixes can be used in reagent names to identify their type, attributes, or uses. For example, the prefix "anti-" can indicate an antibody reagent, and the suffix "-enzyme" can indicate an enzyme-labeled reagent.

Readability and Pronunciation: The name of the reagent should have good readability and pronunciation, facilitating user use and identification in verbal communication and written records.

Ⅳ. Internationalization and Universalization

Additionally, the internationalization and universalization of reagent naming should be considered to facilitate global use and communication. This helps promote international technical exchanges and cooperation, driving the healthy development of the in vitro diagnostic reagent industry.

In summary, the naming of in vitro diagnostic reagents must follow certain structures and principles to ensure the standardization, accuracy, and ease of understanding of the names. At the same time, internationalization and universalization requirements should also be considered to adapt to the needs of the global market.