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.
Disclaimer: Product availability varies by country. Please consult your local bioMérieux representative for product availability in your country.
- VIDAS Hepatitis Panel Dots
- Overview
- Assays
- Resources
Overview
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 B - Standard Profile
Hepatitis C - Standard Profile
Hepatitis A - Standard Profile
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, Anti-HEV IgG
- 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
Hepatitis E
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
- “Excellent clinical performance, similar to the commercially available assays, in European and non-European populations”4
- 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
VIDAS® Solutions
- Reliable and easy-to-use instruments with random access and small foot-print.
- Well adapted to rapid response laboratories.
- Factory-calibrated, single-dose tests which reduce the need for additional controls.
- Short time to result.
- Reagents can be used immediately after removal from the refrigerator.
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.
Assays
Technical Specifications
| Assays | Reference | Code | Tests per Kit | Time to Result | Decisional Cut-Offs |
|---|---|---|---|---|---|
| VIDAS® HAV IgM | 30307 | HAVM | 30 | 60 min | Qualitative test: Negative, Positive, or Equivocal |
| VIDAS® Anti-HAV Total | 30312 | HAVT | 30 | 90 min | 15-400 mIU/mL |
| VIDAS® HBs Ag Ultra | 30315 | HBS.HBL | 60 | 60/90 min | Qualitative test: Negative or Positive |
| VIDAS® Anti-HBs Total II | 30318 | AHBS | 60 | 60 min | 3-500 mIU/mL |
| VIDAS® Anti-HBc Total II | 30314 | HBCT | 60 | 90 min | Qualitative test: Negative, Positive, or Equivocal |
| VIDAS® HBc IgM II | 30439 | HBCM | 30 | 55 min | 0-200 PEIU/mL |
| VIDAS® HBe/Anti-HBe | 30305 | HBE | 30 | 90 min | Qualitative test: Negative or Positive |
| VIDAS® Anti-HCV | 30308 | HCV | 60 | 40 min | Qualitative test: Negative or Positive |
| VIDAS® Anti-HEV IgM | 418115 | HEVM | 30 | 40 min | Qualitative test: Negative or Positive |
| VIDAS® Anti-HEV IgG | 418116 | HEVG | 30 | 40 min | Quantitative: 0.10-10.00 U/mL |
BECAUSE IT MAKES SENSE ON VIDAS®
