Evaluation of Indigenously Manufactured Immunochromatographic Assay Systems for Rapid Detection of Hepatitis B Surface Antigen and Antibody / 대한진단검사의학회지

BACKGROUND: We evaluated three indigenously produced immunochromatography (ICA) kits for the rapid detection of hepatitis B surface antigen (HBsAg) and antibody to HBsAg (anti-HBs) by comparing them with a microparticle enzyme immunoassay (MEIA). METHODS: HBsAg and anti-HBs were tested by the ICA kits manufactured by three domestic companies, SD HBsAg and Anti-HBs (Standard Diagnostics, Inc., Yongin, Korea); Asan Easy Test(R) HBsAg and Anti-HBs (Asan Pharm Co., Ltd., Whasung, Korea); and GENEDIA(R) HBsAg Rapid Device and Anti-HBs Rapid Device (Green Cross MS, Inc., Yongin, Korea). RESULTS: Results by ICA agreed completely with those of MEIA in all the 20 HBsAg-negative sera and in all the anti-HBs-negative sera except one sample. Among the 20 HBsAg-positive sera by MEIA, 17 were positive by ICA using Green Cross MS, 16 using Asan Pharm Co., and 13 using SD and reverse passive hemagglutination. Among the 20 anti-HBs-positive sera by MEIA, 19 were positive by ICA using Green Cross MS and Asan Pharm Co., 17 using SD, and 18 by passive hemagglutination. Elapsed time for the control and test line to be visualized in ICA might be longer and the color of the lines lighter when using SD than Green Cross MS or Asan Pharm Co. CONCLUSIONS: Three indigenously produced ICA kits are as sensitive as MEIA for the detection of anti-HBs, but are less sensitive than MEIA for HBsAg. The ICA kits for the rapid detection of HBsAg might be recommended for a limited use in the clinical laboratory.

Annual Report on External Quality Assessment in Immunoserology in Korea (2005) / 임상검사와정도관리

The followings are the results for external quality assessment (EQA) in immunoserology for 2005: 1.Evaluation of EQA was done in 2 trials in May and December, about 99% of laboratories participating average 8.4 items. The results were collected via internet for the first time and 66~78% of laboratories have sent their results via internet. 2.Commercial controls, MASR Immunology Control from Medical Analysis Systems (Camarillo, CA, USA) and Immunology Control (Immuno-Q-sera I, SEIKEN, Japan) were used to assure the quality of quantitative results of C-reactive protein (CRP), rheumatoid factor (RF) and anti-streptolysin O (ASO) tests. All the specimens for Immunoserology in EQA were delivered refrigerated, being received within 48 hours after sending. 3.Commercial control for serologic tests for syphilis, Syphilis Control (Mediace RPR con, Sekisui, Japan) was newly introduced in 2005. 4.The laboratories using immunochromatography assay (ICA) were increased, however, many laboratories using ICA reported falsely negative for the positive specimens. The sensitivity of ICA test kits as well as various factors influencing the ICA results should be evaluated. 5.Standardization of methods including calibrators for quantitative results should be required for the harmonization of results.

Annual Report on External Quality Assessment in Immunoserology in Korea (2004) / 임상검사와정도관리

The followings are the results for external quality assessment (EQA) in immunoserology for 2004: 1. Evaluation of EQA was done in 2 trials in May and November, about 99% of laboratories participating average 8.4 items. EQA for anti-HBc test was newly started in 2004. 2. Commercial control, MASR Immunology Control from Medical Analysis Systems (Camarillo, CA, USA) was used to assure the quality of quantitative results of C-reactive protein (CRP), rheumatoid factor (RF) and anti-streptolysin O (ASO) tests in 2004. All the specimens for Immunoserology in EQA were delivered refrigerated for the first time, being received within 48 hours after sending. 3. EQA for detection of HBsAg mutants was tried for the first time, using the recombinant HBsAg mutant (Gly/Arg 145) kindly provided by Abbott Laboratories, USA. 4. The laboratories using immunochromatography assay (ICA) were increased, however, many laboratories using ICA reported falsely negative for the positive specimens. The sensitivity of ICA test kits as well as various factors influencing the ICA results should be evaluated. 5. Standardization of methods including calibrators for quantitative results should be required for the harmonization of results.

Annual Report on External Quality Assessment in Immunoserology in Korea (2003) / 임상검사와정도관리

The followings are the results for external quality assessment (EQA) in immunoserology for 2003: 1.Evaluation of EQA was done in 2 trials in May and November, about 99% of laboratories participating average 8.2 items. 2.In C-reactive protein (CRP), rheumatoid factor (RF) and anti-streptolysin O (ASO) tests, about 63%, 49% and 44% of the participating laboratories respectively have used quantitative assays. Because the laboratories using quanitiative assays were on the increase annually, commercial control, Liquicheck(TM) Immunology Contol from Bio-Rad Laboratories (Irvine, CA, USA) was used to assure the quality of quantitiavie results in 2003. A few laboratories reproted the outlier results, comparing with the reference ranges presented by the company. 3.Over 92% of participating laboratoreis have used imunoassays including enzyme immunoassay (EIA), microparticle EIA (MEIA), chemiluminescence immunoassay (CIA), immunochromatography assay (ICA) or radioimmunoassay (RIA) for detedting viral antigens or antibodies. Especially for anti-HCV, over 98% of participating laboratoreis have used various kind of imunoassays. Laboratories using ICA increased and about 24% of participating laboratoreis have used ICA for anti-HCV and anti-HIV. However, many laboratories using ICA for detecting anti-HCV reported false negative results, suggesting lower sensitivity of ICA than those of other immunoassays. 4.The criteria of interpretation were considered to be evaluated in Widal test and laboratories using ICA increased in serological tests for syphilis.

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

The followings are the results for external quality assessment (EQA) in immunoserology for 2002: 1. Evaluation of EQA was done in 2 trials in May and November, about 96% of laboratories participating average 8.3 items. 2. In C-reactive protein (CRP), rheumatoid factor (RF) and anti-streptolysin O (ASO) tests, about 40%, 53% and 52% of the participating laboratories respectively have used qualitative assays, mainly latex agglutination. And about 55%, 43% and 40% of the participating laboratories have used quantitative assays, turbidimetric immunoassay (TIA) or nephelometry in CRP, RF and ASO tests respectively. Laboratories using TIA increased and those using nephelometry decreased. The instruments which were the most frequently used in nephelometry were BN series (Dade Behring Inc., Germany). The instruments of Hitachi series (Hitachi Ltd., Japan), Cobas Integra and Mira series (Roche Diagnostics GmbH, Germany), Toshiba series (Toshiba Corporation, Japan) and Olympus AU series (Olympus Optical Co., Ltd., Japan) were frequently used in TIA. The quantitative results were quite variable according to the methods or reagents, especially in RF and ASO. 3. Over 90% of participating laboratoreis have used imunoassay including enzyme immunoassay (EIA), microparticle EIA (MEIA), chemiluminescence immunoassay (CIA), immunochromatography assay (ICA) or radioimmunoassay (RIA). Laboratories using CIA and ICA increased. Sensitivities of ICA were lower than those of other immunoassays in the results of HBsAg and anti-HCV. The sensitivity of SD HCV (Standard Diagnostics, Inc., Korea) was especially lower in anti-HCV results. Sensitivities of CIA and ICA were also lower than those of EIA including MEIA in the results of anti-HIV. 4. The criteria of interpretation were considered to be evaluated in Widal test and laboratories using ICA increased in serological tests for syphilis.