The international standard for interleukin-6. Evaluation in an international collaborative study

Area of Science:

• Biotechnology
• Immunology
• Biochemistry

Background:

• Interleukin-6 (IL-6) is a critical cytokine involved in immune responses and inflammation.
• Standardization of biological materials like IL-6 is essential for reproducible scientific research and reliable clinical diagnostics.
• Previous international standards for IL-6 were lacking, necessitating the establishment of a new reference material.

Purpose of the Study:

• To evaluate three ampouled preparations of interleukin-6 (IL-6) for their suitability as an international standard.
• To establish a WHO-authorized international standard for IL-6 to ensure global consistency.

Main Methods:

• Multi-laboratory evaluation of three IL-6 preparations coded 89/548, 89/549, and 89/550.
• Assays included a range of in vitro bioassays and immunoassays performed by 12 laboratories across seven countries.
• Statistical analysis of results to determine the most suitable candidate for the international standard.

Main Results:

• Preparation 89/548 demonstrated consistent performance across various bioassays and immunoassays.
• The collaborative study involved 12 laboratories, indicating a robust and widely accepted evaluation process.
• Agreement among participants and authorization by the Expert Committee on Biological Standardization (ECBS) supported the selection.

Conclusions:

• Ampouled preparation 89/548 was successfully established as the international standard for IL-6.
• This new standard will facilitate improved comparability and reliability in IL-6 research and diagnostics worldwide.
• The collaborative effort highlights the importance of international cooperation in standardizing biologicals.