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Hepatitis Test SolutionsSiemens Healthineers offers a comprehensive hepatitis testing menu to simplify laboratory workflow.
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 diagnostic laboratories, with assays for the :
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 Assays | Atellica® IM Analyzer | ADVIA Centaur® XP/XPT Immunoassay Systems | ADVIA Centaur® CP Immunoassay System | IMMULITE® 2000/2000 XPi Immunoassay Systems |
Hepatitis A |
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HAV IgM | √ | √ | √ |
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HAV Total | √ | √ | √ |
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Hepatitis B |
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Anti-HBe | √* | √* | √* |
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Anti-HBs | √ | √ | √ | √ |
HBc IgM | √ | √ | √ | √ |
HBc Total | √ | √ | √ | √ |
HBeAg | √ | √ |
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HBsAg | √ | √ | √ | √ |
HBsAg II | √ | √ | √* |
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HBsAg II | √* | √* |
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Hepatitis C |
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HCV | à | à | à |
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*Not available for sale in the U.S.
†Not CE Marked.
§Under development. Not available for sale.
Genotyping Assays | Auto-LiPA 48 Instrument |
Hepatitis C |
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HCV genotypes 1–6 and 15 subtypes, including 1a, | X |
Monitoring Assays |
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Hepatitis E †† |
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Infectious Disease Research |
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Hepatitis B (RUO) ††† |
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Hepatits C (RUO) ††† |
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** IVDD, CE marked. Product availability varies from country to country and is subject to local regulatory requirements. VERSANT is a registered trademark of Siemens. All other marks are the property of their respective owners.
††Fast Track Diagnostics HEV assay is CE-marked for IVD use in the EU. Please see the compatibility list to learn more about our compatible instruments. Customer is responsible for validating the assay on instruments listed in the compatibility list.
†††Fast Track Diagnostics HBV and HCV assays are for research use only (RUO). Please see the compatibility list to learn more about our compatible instruments. Customer is responsible for validating the assay on instruments listed in the compatibility list.
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References
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
Dwyer R. The ADVIA Centaur® infectious disease assays: a technical review. Journal of Clinical Virology. 2004;30(S1):S1-S5.