pecifications HBsAg Elisa test kit: 
1) Hbsag test (serum or plasma ) (detection limit: 0.5ng/ml) 
2) Sensitivity and specificity: above 99% 

HBsAg ELISA Test Kit

Intended Use:

The Genelisa HBsAg Test Kit is an enzyme-linked immunosorbent assay (ELISA) for the qualitative determination of Hepatitis B Surface Antigen (HBsAg) in human serum or plasma.

 

Specimen Collection and Storage:

1. Collect serum or plasma specimens following regular clinical laboratory procedures. Separate the serum from the clot or plasma from the red cells as soon as possible to avoid hemolysis.

2. Specimens containing sodium azide or particulate matter may give erroneous results.

3. Specimens should be refrigerated if not used within 3 days of collecting. Avoid freezing and thawing the specimens more than 2-3 times before using.

 

Performance Characteristics:

Sensitivity:

The following results were obtained on evaluating analytical sensitivity of the Genelisa HBsAg Elisa test kit

 

Concentration in	ng/ml
HBsAg adr	0.5
HBsAg adw	0.5
HBsAg ay	0.5

 

Specificity:

The specificity of the Genelis HBsAg elisa test kit was investigated in an independent laboratory of 4259 serum samples from healthy blood donors tested, 4 samples were found be reactive(99.9%).

In this study the specificity obtained was 99.9%.