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

Abstract

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). 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 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. 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.