Close
Enzygnost® HBsAg 6.0 Assay—The Power of Hepatitis Screening
Hepatitis B is the most common serious liver infection in the world.1 Acute (primary) infections of this kind often go unrecognized: About 30% of the infected individuals experience mild symptoms lasting a few weeks, which are commonly mistaken for flu or other mild viral infections.2 Therefore, a secure and reliable blood diagnosis is needed.
Excellent clinical performance
Enzygnost HBsAg 6.0* is an enzyme immunoassay for the qualitative detection of hepatitis B (surface) antigen in serum or plasma suitable for blood donor screening and patient diagnostics—especially in high volume labs.
Built on Siemens Healthcare Diagnostics' experience, the new Enzygnost HBsAg 6.0 offers a significant improvement in hepatitis B testing. The combination of carefully selected raw materials leads to one of the most sensitive assays on the market. Extensive internal and external investigation show excellent performance: All genotypes and subtypes detected were clearly positive with equivalent sensitivity compared to the PEI and WHO standards.
Mutant detection for Hepatitis B
Enzygnost HBsAg 6.0 assay offers excellent detection of HBsAg mutants. During an external investigation, all HBsAg mutant samples were detected positive. This investigation included n = 150 native samples (tested at 3 external sites) and n = 54 recombinant samples (internal). The native mutations involved covered 23 of the 25 known aa positions at which mutations can lead to failure in HBsAg detection.
Specificity and screening
The Enzygnost HBsAg 6.0 assay shows an excellent specificity, proved by external evaluation at different sites. Investigation of several thousand serum samples resulted in an initial specificity of 99.89 %—reducing re-testing which results in less manual work and lower costs.
The micro titer format makes it an ideal fit for high volume screening.
The combination of bar-coded and color-coded reagents, automatic processing on compatible systems and excellent specificity make the Enzygnost HBsAg 6.0 ideal for reliable diagnosis.
Enzygnost HBsAg 6.0 is optimized for the following systems:
References:
1: Hepatitis B Foundation. Hepatitis B: symptoms. http://www.hepb.org/hepb/about_hepatitis_b.htm. Accessed July 2009.
2: Hepatitis B Foundation. Hepatitis B: symptoms. http://www.hepb.org/hepb/symptoms.htm. Accessed July 2009.
* Not available for sale in the US
