Hepatitis Test Solutions
Siemens Healthineers offers a comprehensive hepatitis testing menu to simplify laboratory workflow.

Hepatitis Test Solutions
 
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Learn more about hepatitis and share to help raise awareness.

Viral hepatitis is a global health problem that affects hundreds of millions of children and adults. Although multiple pathogens have been associated with hepatitis, three in particular (hepatitis A, B, and C) are responsible for the majority of virally linked hepatitis cases. Chronic viral hepatitis B and C are a major cause of chronic liver disease, which may manifest as liver fibrosis and cirrhosis leading to liver cancer and the need for liver transplantation.

Siemens Healthineers offers hepatitis testing solutions for:

 


Laboratory Testing: Hepatitis B

You can depend on Siemens Healthineers to provide your lab with the test accuracy and efficiency you demand for hepatitis B diagnostic testing.

The HBsAg II assay available on the Atellica® IM Analyzer and ADVIA Centaur Immunoassay Systems is designed with patented acridinium ester (AE) technology, allowing for enhanced precision and sensitivity. Incorporating the zwitterionic AE molecule into the assay format results in greater sensitivity and improved detection of HBsAg mutants. A total of five monoclonal antibodies are used in the HBsAgII assay design, greatly improving the assay’s sensitivity and specificity.

Only the HBsAg II assay from Siemens Healthineers offers a “hot zone” and SMART algorithm for greater lab efficiency.

  • Reduce your test volumes. Samples in the hot zone (initial results ≥50 Index Units) may be reported as reactive. Only samples with initial values between 1 and <50 Index Units require further testing.
  • Improve your lab efficiency. The SMART algorithm automatically repeats testing on samples that require further analysis.

With the use of disposable sample tips on the Atellica IM Analyzer and ADVIA Centaur Systems, potential sample carryover and subsequent risk of false positives are never a concern.


Laboratory Testing: Hepatitis C

The CDC has expanded previous recommendations for hepatitis C virus (HCV) screening of all persons born between 1945 and 1965 (the so-called baby-boomer generation) for HCV infection.1

The Siemens Healthineers’ assay for HCV available on the Atellica® IM Analyzer and ADVIA Centaur® Immunoassay Systems is a true third-generation assay with the ability to detect the NS5 antibody.2 The assay design uses patented acridinium ester (AE) technology for improved sensitivity in detecting low-level analytes and better accuracy and precision.


Laboratory Testing: Importance

From diagnosis through active disease and chronic progression, laboratory testing plays an important role in the identification, treatment, and monitoring of patients with hepatitis.

  • Liver function tests (e.g., ALT, AST) help to determine the extent of liver damage.
  • Immunoassay testing aids in the diagnosis of viral hepatitis and may indicate if the infection is acute or chronic.
  • Nucleic acid testing (NAT) is used to confirm hepatitis diagnosis, guide treatment, and indicate prognosis.
  • Biomarkers, imaging, and biopsy help to stage the degree of fibrosis and liver injury.

The Clinician’s Reference Guide: Diagnostic Testing in the Management of Viral Hepatitis B and Hepatitis C, developed by Siemens Healthineers, helps clarify the role of hepatitis tests as an aid in patient management.

Siemens Healthineers offers diagnostic testing products for screening, diagnosis, and monitoring of hepatitis as well as liver function testing. Product availability varies by region. Contact your local sales representative for a copy of the Siemens Healthineers Hepatitis Product Portfolio Guide appropriate for your country.

Assay Menu

Siemens Healthineers offers a comprehensive disease-management portfolio for hepatitis screening, diagnosis, and monitoring on the Atellica® IM Analyzer, ADVIA Centaur® Immunoassay Systems, IMMULITE® 2000/2000 XPi Immunoassay Systems.

Screening AssaysAtellica® IM AnalyzerADVIA Centaur® XP/XPT Immunoassay SystemsADVIA Centaur® CP Immunoassay SystemIMMULITE® 2000/2000 XPi Immunoassay Systems
Hepatitis A    
HAV IgM 
HAV Total 
Hepatitis B    
Anti-HBe√*√*√* 
Anti-HBs
HBc IgM
HBc Total
HBeAg  
HBsAg
Confirmatory
HBsAg II√* 
HBsAg II
Quant
√*√*  
Hepatitis C    
HCV 

*Not available for sale in the U.S.
Not CE Marked.
§Under development. Not available for sale.
For outside the U.S., the assay is developed, manufactured, and sold by Siemens Healthcare Diagnostics Inc. for Ortho Clinical Diagnostics, Inc. and Grifols Diagnostic Solutions Inc.

Disease Diagnosis:
Quantitative Testing
VERSANT® kPCR
Molecular System*
VERSANT® HCV Genotype 2.0
Products(LiPA)
Fast Track
Diagnostics Assays**
VERSANT HBV DNA 1.0 Assay (kPCR) √*  
VERSANT HCV RNA 1.0 Assay (kPCR) √*  
Disease Diagnosis:
Genotyping
   
VERSANT HCV Genotype 2.0 Assay (LiPA)  √* 
Disease Diagnosis:
Syndromic Testing
   
Hepatitis B virus  ††
Hepatitis C virus  ††
Hepatitis E virus  ††

*Not available for sale in the U.S.
Not CE Marked.
§Under development. Not available for sale.
Assay developed, manufactured, and sold by Siemens Healthcare Diagnostics Inc. for Ortho Clinical Diagnostics, Inc. and Grifols Diagnostic Solutions Inc.
**CE-marked in the EU. FDA-approved in the U.S.
††CE-marked for IVD use in the EU. For research use only in the U.S.


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*Not available for sale in the U.S.

References:
1. Centers for Disease Control and Prevention. Recommendations for the identification of chronic hepatitis C virus infection among persons born during 1945–1965. MMWR. 2012;61(4). [Accessed 20 Jan 2017] Available from: https://www.cdc.gov/mmwr/preview/mmwrhtml/rr6104a1.htm
2. Dwyer R. The ADVIA Centaur® infectious disease assays: a technical review. Journal of Clinical Virology. 2004;30(S1):S1-S5.