Immunoassay분과 외부신빙도 조사 결과보고 (2005)

Abstract

Three trials of external quality assessment were performed in 2005. The first and the second trials were assessed by 14 test items including tumor markers, hormones and immunoproteins and the third trial was intended only for five items of immunoproteins, i.e. Immunoglobulin G (IgG), IgM, IgA, Complement 3 (C3) and C4. Fourteen test items of immunoassay method including 5 tumor markers, 4 hormones and 5 imunoproteins were surveyed. The response rate of external quality assessment for Immunoassay Subcommittee were 94.4% ～ 95.0% in this year. Ten control materials of the first and second trials were consisted of 8 home-made pooled sera and 2 commercial control sera (LyphoCheck, BioRad, USA and Randox, Randox Ltd., UK). And, for the third trial we used the 05-S-4 specimen of the Immunoserology Subcommittee control material. The results are summarized as follows. 1. Laboratories participating in external quality control program of Immunoassay Subcommittee were 305 laboratories and the response rate were 94.4% and 95.0% in 2005. 2. Autoanalyzers based on enhanced or improved enzyme/chemiluminiscence imunoassay were mostly used in the field of immunoassay testing. 3. A new reporting system which uses the internet web site was introduced in this year from the second trial of external quality survey. 4. Some test items show big variations of the test results of the same control material according to autoanalyzer and reagents. The quality of the participating laboratories seems to be improved step by step. And, the new methods of reporting system and statistic analyses introduced this year were considered to get a good reputation from the member institutes for the surveillance systems.