J Lab Med Qual Assur.  2005 Jun;27(1):91-110.

Annual Report on External Quality Assessment of Immunoassay Subcommittee in Korean Clinical Laboratory Survey (2004)

• Kim HS
• Lim HS
• Kim YR
• Cho HS
• Chun HS
• Shin S
• Jung YS
• Kwon OH
• Kim DA
• Kim YK
• Kim JQ
• Sun YK

Abstract

Two trials of external quality assessment were performed in 2004 as previous year. Thirteen test items of immunoassay with ten control materials were surveyed. The response rate of external quality assessment for Immunoassay Subcommittee were 94.4% and 98.6%. Ten control materials were consisted of 8 home-made pooled sera and 2 commercial control sera (LyphoCheck, BioRad, USA). The results are summarized as follows. 1. Laboratories participating in external quality control program of immunoassay were 259 laboratories and the response rate were 94.4% and 98.6% in 2004. 2. Chemiluminiscence immunoassay autoanalyzers were most widely used in the field of immunoassay testing. 3. A new test item CA125 was introduced in this year from the second trial of external quality survey. 4. Still some test items show big variations of the test results of the same control material according to autoanalyzers. The quality of the participating laboratories seems to be thought being continuously improved. And, some new methods of the statistic analysis and some standardization protocols were considered to be introduced in the surveillance systems.

Keyword

Quality assurance; External quality assessment; Survey; Immunoassay

MeSH Terms

Immunoassay*
Quality Control