J Clin Pathol Qual Control.  1997 Dec;19(2):393-397.

Evaluation of Relatively Unknown HBsAg Screening Kits

• Kim DA
• Kim HS
• Kim TY
• Lee HR
• Park IK
• Kang JO
• Choi TY

Abstract

BACKGROUND: Hepatitis B infection is still the main cause of chronic liver disease in Korea, and so the reagents used for screening of hepatitis B surface antigen (HBsAg) must state proven sensitivity and specificity. Recently, not only are products that have international credibility being used, but products of relatively low cost which have been brought in from abroad have entered the market. However, there is little information on their evaluation. The authors set out to determine the diagnostic performance of two products from Spain and Italy that are being used rather frequently in Korea.
METHODS
One hundred one positive and 296 negative specimens tested for HBsAg at the Department of Clinical Pathology at Hanyang University Hospital with the Abbott AUSRIA II-125 were included in this study. The products evaluated were the bioelisa HBsAg (Biokit, Spain : bioelisa) and the HBsAg IEMA WELL (Radim, Italy: IEMA WELL). The tests were performed according to the manufacturer's instructions.
RESULTS
Of the 101 positive sera, bioelisa showed 99 positive and 2 negative results. IEMA WELL showed 99 positive and 2 negative results. On testing the 296 negative sera, bioelisa was negative in all tests, but IEMA WELL was positive in 5 tests. The sensitivity, specificity, positive predictive value and negative predictive value of bioelisa were 98.0%, 100%, 100% and 99.3% while those of IEMA WELL were 98.0%, 98.3%, 95.2% and 99.3%, respectively.
CONCLUSIONS
The relatively unknown products for HBsAg screening from Spain and Italy showed a concordance of 99.5% (395/397) for bioelisa and 98.2% (390/397) for IEMA WELL compared with AUSRIA II-125. The present study shows that there is no clear difference between the products used for HBsAg screening.

MeSH Terms

Hepatitis B
Hepatitis B Surface Antigens*
Indicators and Reagents
Italy
Korea
Liver Diseases
Mass Screening*
Pathology, Clinical
Sensitivity and Specificity
Spain
Hepatitis B Surface Antigens
Indicators and Reagents