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
BehringTM
(Germany) and microparticle EIA (MEIA) from AbbottTM(USA).
Method:
Sera from 1,500 healthy blood donors and 500 patients were obtained to test HBsAg, antiHBs 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 (1.2%) 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.
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