• VIDAS® Hepatitis panel

VIDAS® Hepatitis panel

Routine and confirmation testing of Hepatitis A, B C and E

The VIDAS® Hepatitis panel includes 11 markers for the diagnosis of recent infection, monitoring of chronic hepatitis, pre- or post-vaccination immunity controls and screening during pregnancy.

  • Comprehensive panel for the differential diagnosis of hepatitis
  • Rapid, simple and reliable testing in less than 2 hours
  • Flexible and cost-effective solution
  • Includes hepatitis E testing in only 40 minutes
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Viral hepatitis affects over 500 million people worldwide. With prevalence higher than that of HIV or cancer, it represents one of the major global health problems. The role of diagnostics is key as hepatitis infections are “silent” and the majority of those infected are unaware.

The VIDAS® Hepatitis panel includes 11 automated assays offering a complete solution for the diagnosis and monitoring of Hepatitis A, B C and E. Used together, they enable clinicians to provide a differential diagnosis for patients presenting with symptoms suggestive of hepatitis.
 

A complete panel to address a complex clinical picture

Hepatitis, especially hepatitis B, presents a complex clinical picture. Various markers are necessary for accurate diagnosis and efficient monitoring:


Hepatitis B infection kinetics

 


Hepatitis A infection kinetics

 


Hepatitis C infection kinetics

Hepatitis E infection kinetics

The VIDAS® Hepatitis assays provide answers to different clinical situations:

  • Screening and aid to diagnosis of recent infection: HAV IgM, HBs Ag Ultra, HBc IgM II, Anti-HCV, Anti-HEV IgM
  • Monitoring of chronic hepatitis: HBs Ag Ultra, HBe/Anti-HBe, Anti-HBs Total II
  • Determination of hepatitis immune status (pre-post vaccination): Anti-HAV Total, Anti-HBs Total II, Anti-HBc Total II
  • Screening during pregnancy: HBs Ag Ultra, Anti-HCV
     

Solution benefits

Easy to perform:

  • Automated assays
  • Load and Go

Cost-effective:

  • Single-dose tests: 1 patient = 1 test = 1 result
  • Convenient kit size: 30 or 60 tests
  • All-inclusive kits

Reliable:

  • The performance of each marker has been verified by reference laboratories
  • No cross-contamination
  • Robust system: MTBF>700 days
     

Expertise in Infectious Diseases

The history of bioMérieux is directly linked to the fight against infectious diseases, which has been our priority for 50 years. Our research teams constantly focus on pushing back the frontiers of disease detection by dedicating the majority of their activities to the prevention and diagnosis of infection risk.

bioMérieux provides tests for the early detection of numerous diseases, including HIV/AIDS, hepatitis, tuberculosis, respiratory infections, CNS infections, sepsis, C. difficile

Hepatitis E Virus (HEV) is the most common cause of acute viral hepatitis worldwide1, with 20 million infections and 3.3 million acute cases every year2. Hepatitis E is a food- and water-borne infection. The risk is higher in developing countries with unsafe water and poor sanitation, but you can catch it anywhere. In Europe, the number of reported cases has increased 10-fold over the last decade3

In its fulminant form, Hepatitis E can be fatal in pregnant women, infants or patients with pre-existing liver disease. It is therefore important to think E for all patients with clinical signs and symptoms of Hepatitis. Our new VIDAS® Anti-HEV IgM and Anti-HEV IgG assays allow you to perform in-house testing for better patient management.

1 virus, 2 epidemiological patterns

Hepatitis E infection is found worldwide, but epidemiological characteristics vary according to the genotype present in a particular area:

 

 Geographical distribution and characteristics of HEV genotypes

Easy in-house testing

Perform Hepatitis E testing in your own lab because it makes sense on your VIDAS® system:

  • Rapid and actionable results:
    • Automated tests
    • On-demand testing adapted to small volumes
    • Result in only 40 minutes
  • Cost-efficient solution: 1 patient = 1 test

Improve your efficiency and offer your clinicians same-day complete hepatitis diagnosis (A, B, C, E).

Excellent performance

  • Evaluation by a National Reference Center for Hepatitis E
  • Clear results for the diagnosis of acute Hepatitis E:

 

VIDAS® Anti-HEV IgM
QUALITATIVE Assay

VIDAS® Anti-HEV IgG
QUANTITATIVE Assay

97.65%*

Positive concordance
for viremic phase

96.67%*

Positive concordance

99.34%*

Negative concordance

96.42%*

Negative concordance

* Immunocompetent population
See package insert

  • “Excellent clinical performance, similar to the commercially available assays, in European and non-European populations”4

References:
1. N. Kamar, et al., Hepatitis E, Lancet 379 (9835) (2012) 2477–2488.
2. WHO, Hepatitis E Factsheet, July 2017.
3. ECDC Surveillance report: Hepatitis in the EU/EEA, 2005-2015.
4. Abravanel F, et al. Poster presented at ESCV 2017.

Parameter

 Reference 

 Tests/kit 

Sample type

Sample volume

Time to result (minutes)

Calibration frequency

Hepatitis A

VIDAS® HAV IgM 30307 30 Serum, plasma (EDTA, Hep.) 100 µl 60 14 days
VIDAS® Anti-HAV Total 30312 30 Serum, plasma (Hep., EDTA, Cit.) 150 µl 90 14 days

Hepatitis B

VIDAS® HBs Ag Ultra 30315 60 Serum, plasma (EDTA, Hep.) 150 µl 60(HBS)
90(HBL)
14 days
VIDAS® HBs Ag Ultra Confirmation 30317 30       14 days
VIDAS® Anti-HBs Total II 30318 60 Serum, plasma (Hep., EDTA, Cit.) 200 µl 60 28 days
VIDAS® Anti-HBc Total II 30314 60 Serum, plasma (Hep., EDTA, Cit.) 150 µl 90 14 days
VIDAS® HBc IgM II 30439 30 Serum, plasma (Hep., EDTA, Cit.) 100 µl 55 14 days
VIDAS® HBe/Anti-HBe 30305 30 Serum, plasma (Hep., EDTA, Cit.) 150 µl 90 14 days

Hepatitis C

VIDAS® Anti-HCV 30308 60 Serum, plasma (Hep.) 100 µl 40 28 days

Hepatitis E

VIDAS® Anti-HEV IgM                 418115     30             Serum, plasma                         100 µl 40           28 days
VIDAS® Anti-HEV IgG                 418116     30             Serum, plasma                         100 µl 40           28 days

 

Find more technical details on www.myvidas.com.

Consult your local bioMérieux representative for product availability in your country.

Pioneering Diagnostics