Annual Report on External Quality Assessment in Immunoassay in Korea (2009) / 임상검사와정도관리

Two trials with 15 test items of external quality assessment survey were performed in 2009. The test items were constituted three immunoassay categories, i.e., tumor markers, thyroid hormones and immunoproteins (IgG, IgM, IgA, C3 and C4). Fifteen test items commonly used in clinical laboratories and performed by immunoassay method were surveyed as scheduled. The number of participated laboratory of external quality assessment for Immunoassay Subcommittee were 494 institutions in the first trial survey and 519 institutions in the second survey. All of the fourteen control materials consisted of 12 home-made pooled sera and 2 commercial control sera (Liquimmune(R), Liquid Assayed Immunoassay Control, Microgenics Co, USA) were used for the two trials in 2009 survey. The results are summarized as follows. 1. Laboratories participating in external quality control program of immunoassay were 494 and 519 laboratories and the response rate were 97.6% and 98.3% in 2009. 2. Chemiluminiscence immunoassay autoanalyzers were most commonly used for immunoassay testing in the clinical laboratories for detecting tumor markers and hormones. 3. Stability tests of home-made control materials were performed and confirmed the CV values were in acceptable ranges. 4. Workshops titled "National health examination for tumors" and "Standardization and harmonization of laboratory tests" were held on September 4, 2009 and December 16, 2009 in cooperation with Annual Autumn Academic Conferences of Clinical Laboratory and Quality Control, and Immunoserology Subcommittee, respectively. The quality of the participating laboratories seems to be continuously improved. And, this year, new sixty eight laboratories were participated to our Immunoassay Subcommittee.

Annual Report on External Quality Assessment of Immunoassay Subcommittee in Korean Clinical Laboratory Survey (2008) / 임상검사와정도관리

Two trials of external quality assessment were performed in 2008. The first and the second trials assessed by three test categories, i.e., tumor markers, thyroid hormones and immunoproteins (IgG, IgM, IgA, C3 and C4). Fifteen test items using immunoassay method were surveyed as scheduled. The number of participated laboratory of external quality assessment for Immunoassay Subcommittee were 437 institutions in the first trial survey and 476 institutions in the second survey.Fourteen control materials consisted of 12 home-made pooled sera and 2 commercial control sera (Liquimmune(R), Liquid Assayed Immunoassay Control, Microgenics Co, USA) were used. The results are summarized as follows. 1. Laboratories participating in external quality control program of immunoassay were 437 and 476 laboratories and the response rate were 94.6% and 98.7% in 2008. 2. Chemiluminiscence immunoassay autoanalyzers were most commonly used for immunoassay testing in the clinical laboratories for detecting tumor markers and hormones. 3. Some analyzers of a few test items showed variations of the test results of the same control material probably due to personal factors of the institution. 4. Workshops titled "Quality control of Immunoassay" and " Quality control of tumor markers" were held on September 5, 2008 and December 3, 2008 in cooperation with Annual Autumn Academic Conferences of Clinical laboratory and Quality Control and Immunoserology Subcommittee. The quality of the participating laboratories seems to be thought being continuously improved. And, this year, about 51 laboratories are newly participated to our Immunoassay Subcommittee.

Annual Report on External Quality Assessment of Immunoassay Subcommittee in Korean Clinical Laboratory Survey (2007) / 임상검사와정도관리

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.

Annual Report on External Quality Assessment of Immunoassay Subcommittee in Korean Clinical Laboratory Survey (2007) / 임상검사와정도관리

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.

Annual Report on External Quality Assessment of Immunoassay Subcommittee in Korean Clinical Laboratory Survey (2005) / 임상검사와정도관리

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.

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

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.

Annual Report on External Quality Assessment of Immunoassay Subcommittee in Korea (2003) / 임상검사와정도관리

Two trials of external quality assessment were performed in 2003. Thirteen test items of immunoassay with ten control materials were surveyed. The response rate of external quality assessment for Immunoassay Subcommittee were 93.8% and 92.8%. Ten control materials were consisted of 8 home-made pooled sera and 2 commercial control sera. The results are summarized as follows. 1. Laboratories participating in external quality control program of immunoassay were 259 laboratories and the response rate were 93.8% and 92.8% in 2003. 2. Chemiluminiscence immunoassay autoanalyzer was now widely introduced comparing to previous years and now it is the most popular analyzer in the field of immunoassay testing. 3. Still some test items show big variations of the test results of the same control material according to autoanalyzer. Generally the quality of the participating laboratories seems to be thought being improved. And in the following years, new planning of the statistic analysis and some standardization protocols could be introduced.

Annual Report on External Quality Assessment in Immunoassay in Korea (2002) / 임상검사와정도관리

Two trials of external quality assessment were performed in 2002. Thirteen test items of immunoassay with eight control materials were surveyed. The response rate of external quality assessment for Immunoassay Subcommitee were 94.3% and 94.5% in each trial. Eight control materials were consisted of 6 home-made pooled sera and 2 commercial control sera. The results are summarized as follows. 1. Laboratories participating in external quality control program of immunoassay were 233 to 241 laboratories and the response rate were 94.3% and 94.5% in 2002. 2. Chemiluminiscence immunoassay autoanalyzer was widely introduced comparing to previous years and now it is the most popular analyzer in the field of immunoassay testing. 3. Still some test items show wide variations of the test results of the same control material. But, generally the quality of the participating laboratories seems to be thought being improved.