Immunoassay검사 신빙도조사 결과보고 (2007)

Abstract

Two trials of external quality assessment were performed in 2007. The first and the second trials assessed by three test categories, tumor markers, thyroid hormones and immunoproteins(IgG, IgM, IgA, C3 and C4). All of fifteen test items using immunoassay method were surveyed. The response rates of external quality assessment for Immunoassay Subcommittee were 98.3%in first trial and 98.8% in second trial in 2007. Fourteen control materials consisted of 12 home-made pooled sera and 2 commercial control sera (LyphoCheck, BioRad, USA) were used for external survey. The results are summarized as follows. 1. Laboratories participating in external quality control program of immunoassay were 400 laboratories and the response rates were 95.4% and 98.8% in 2007. 2. Recently chemiluminescence immunoassay autoanalyzers were most commonly used for immunoassay testing in the clinical laboratories. 3. Still some test items show big variations of the test results of the same control material according to reagents and autoanalyzers. 4. A workshop for "Quality control practices of Immunoassay" was held on September 7th, 2007 in cooperation with Annual Autumn Academic Conferences of Clinical Laboratory and Quality Control. The quality of the participating laboratories seems to be continuously improved. And, this year, many laboratories are newly participated to Immunoassay Subcommittee. A new surveillance system for the individual laboratory according to its performance by method and analyzer is on scheduling for special performance-based QC.