Evaluation of Diagnostic Kits for Hepatitis B Developed by LG Chemical Ltd / 대한수혈학회지

ABSTRACT

BACKGROUND: Infection of hepatitis B virus(HBV) is one of the most important cause of the liver diseases in Korea, although HBV infection tends to be decreased. Diagnostic kits more accurately detecting HBV infection have been required'in order to diagnose and prevent the HBV infection. Recently LG Chemical Ltd. developed new diagnostic kits for HBsAg, anti-HBs and anti-HBc, using HBV from Korean patients. We evaluated these new kits by comparing them with microplate enzyme immunoassay (EIA) from BehringTU(Germany) and microparticle EIA (MEIA) from AbbottTM(USA). METHOD: Sera from 1,500 healthy blood donors and 500 patients were obtained to test HBsAg, anti- HBs and anti-HBc using diagnostic kits from AbbottTM, BehringTM and LG Chemical Ltd. We analyzed the results of 3 manufacturers and confirmed the discordant results of HBsAg by Southern hybridization after HBV PCR and those of anti-HBs by neutralization assay with HBsAg from LGTM. We also evaluated the reproducibility and detection limit. RESULTS: Of 1,500 healthy blood donors, HBsAg was positive in 34 (2.3%), representing completely the same results from 3 manufacturers. However, of 500 patients, 7 (1.4%) had discordant results; HBsAg was positive in all 7 sera tested with BehringTM and positive in only one tested with AbbottTM and LGTM, respectively. HBV DNA was not detected in all 7 discordant results of HBsAg, so false positive results totaled 7 (1.4%) with BehringTM and 1 (0.2%) with AbbottTM and LGTM, respectively. Of 2,000 sera, the results of anti-HBs and anti-HBc from 3 manufacturers were same in 1,876 (93.8%) and in 1,949 (97.5%), respectively. Results of HBsAg, anti-HBs and anti-HBc from 3 manufacturers were constant on repeating tests. When testing the detection limit, BehringTM kits for HBsAg and anti-HBs retained significantly higher sensitivity than AbbottTM and LGTM. On the other hand, BehringTM kit for anti-HBc showed significantly lower sensitivity than AbbottTM and LGTM. CONCLUSION: The diagnostic kits for HBV developed by LG Chemical Ltd. showed comparable results with those by AbbottTM or BehringTM and will be useful as screening blood donors or detecting patients with HBV infection.