About the product
The Elecsys HBsAg Confirmatory Test (Roche code CPS_000717) is an immunoassay used for the in vitro qualitative confirmation of the presence of hepatitis B surface antigen (HBsAg). According to the Roche product page, the test is defined for samples that give a repeatedly reactive result with Elecsys HBsAg II and is used on cobas e immunoassay analyzers.
Measured parameter and clinical significance
According to the CDC document on interpreting hepatitis B serologic tests, HBsAg is a protein on the surface of the hepatitis B virus. It can be detected at high levels in serum during acute or chronic hepatitis B virus infection. The CDC states that the presence of HBsAg indicates that the person is infectious. According to the same document, the body produces antibody to HBsAg as part of the normal immune response, and HBsAg is the antigen used to make hepatitis B vaccine.
The same document generally interprets anti-HBs positivity alone as recovery from hepatitis B infection and immunity. Anti-HBs also develops after successful vaccination. Total anti-HBc indicates past or ongoing infection at an undefined time, and IgM anti-HBc indicates recent infection (less than 6 months). This confirmatory test is applied to samples that give a repeatedly reactive result on the screening test. Results are interpreted together with the whole set of hepatitis B serologic markers and the clinical picture.
Technical information
- Product: Elecsys HBsAg Confirmatory Test (Roche, CPS_000717)
- Intended use: in vitro qualitative confirmation of the presence of HBsAg
- Sample: human serum and plasma (sodium heparin, lithium heparin, K2-EDTA and sodium citrate)
- Pack size: 2 × 1 mL
- Sample volume and test time are in the Roche method sheet
Use and compatibility
The Roche product page lists these systems:
- cobas e 402
- cobas e 411
- cobas e 601 and cobas e 602
- cobas e 801
System pages: cobas e 411 and cobas e 402. Other immunoassay reagents are on the test kits page.
The confirmation algorithm and the reporting of results are the responsibility of the laboratory concerned and of national guidelines.
Frequently asked questions
According to the Roche product page, the test is used to qualitatively confirm the presence of HBsAg in samples that give a repeatedly reactive result with Elecsys HBsAg II.
The Roche product page specifies human serum and plasma and lists sodium heparin, lithium heparin, K2-EDTA and sodium citrate for plasma.
According to the CDC, HBsAg is a protein on the surface of the hepatitis B virus and can be detected at high levels in serum during acute or chronic infection.
Contact
For product, quotation and technical information requests, use the contact form or write to info@tiliamedical.com.
