QAS Complement Standardization Committee – update report

September 19, 2018

Michael Kirschfink

Institute of Immunology

University of Heidelberg

At the 2008 International Complement Workshop in Basel, Switzerland, a group of interested members of the International Complement Society (ICS) met to discuss the formation of a standardization committee and to define the major aims of this quality management initiative (https://www.complement.org/committee).
In 2010, the International Union of Immunological Societies established the initiative officially as Subcommittee for the Standardization of Complement Analysis. Michael Kirschfink (Heidelberg, Germany) is the Chairman and Zoltán Prohászka (Budapest, Hungary), Bo Nilsson (Uppsala, Sweden) and Ashley Frazer-Abel (Denver, USA) serve as Co-Chairs.
The subcommittee with its associated laboratories aims at:
– initiating and organizing actions to improve the quality of complement analysis;
– making available various standard materials to academic and clinical laboratories;
– defining standardized methods of modern complement analysis;
– organizing national and international workshops and training courses on modern complement analysis;
– developing guidelines for high quality standardized complement analysis.
On January 22–23, 2016, the Complement Standardization Committee met in Budapest for a strategy workshop, with 31 participants representing 21 complement laboratories (Figure 1). The group reviewed the accomplishments of the first five years of the Committee and discussed the path forward. Participants critically assessed their achievements and defined the next steps for improvement. In addition, the group focused on developing recommendations on most appropriate methods, calibration strategies, and on how to interpret and report results.
In the past 12 months, the 7th and 8th complement external quality assessment programs (EQA) have been conducted with the help of INSTAND e.V. (Düsseldorf, Germany), a WHO accredited institution for quality control in laboratory analysis. In October 2017, 96 laboratories (from multiple countries, including several European countries, US, Australia, Japan, South Africa, Israel and Iceland) participated in the full EQA program, which consisted in determination of 20 complement parameters including multiple autoantibodies and activation products.

In March 2018, 102 laboratories (the majority from Europe, mainly Germany) participated on another EQA round, consisting of 11 parameters, restricted to the most commonly used complement parameters and anti-C1q antibodies.
These EQA programs were successful in terms of organization, evaluation of results, and high success rates for the different evaluated parameters. A detailed analysis (beyond calculating success rates) is currently going on during the summer 2018, and the EQA group will meet and have in-depth discussions during the next International Complement Workshop (ICW), to be held in Santa Fe, September 2018.

A summary of the Committee’s activities is included in a recent manuscript, accepted for publication in Immunobiology, by occasion of the Special Issue to be released in the frame of the upcoming ICW in Santa Fe. (Prohászka Z, Kirschfink M, Frazer-Abel A. Complement analysis in the era of targeted therapeutics. Mol Immunol. 2018 Jun 19. pii: S0161-5890(18)30184-6. doi: 10.1016/j.molimm.2018.06.001. [Epub ahead of print])

On request and invitation by the European Society of Immunodeficiencies (ESID), a panel of international authors currently prepares the ESID Complement Guidelines, to be published by end of this year.
On behalf of Chair Michael Kirschfink, who was not able to join the IUIS Quality Assessment and Standardization Committee Meeting, Cancun, Mexico, May 12th 2018), Dr. Ashley Frazer-Abel attended and presented a report on the activities of the Complement Standardization Committee.

Figure 1 – Members of the Complement Standardization Committee at the Strategy Meeting in Budapest

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