INNO-LiPA HBV INNO-LiPA HBV

The complete portfolio for the molecular identification of the Hepatitis B Virus
INNO-LiPA HBV Genotyping INNO-LiPA HBV Multi-DR INNO-LiPA HBV PreCore

Test procedure Ordering Information

Fast, easy and highly specific DNA hybridization tests. Product Article no.
Assays

March 2014, Fujirebio Europe

Step 1 Step 2 Step 3 Step 4 INNO-LiPA HBV Genotyping CE 80691
results

INNO-LiPA HBV Multi-DR CE 81383

INNO-LiPA HBV Genotyping RUO 80070
Hybridization on strips Manual Automated
DNA extraction PCR interpretation interpretation INNO-LiPA HBV Multi-DR RUO 81382
INNO-LiPA HBV PreCore RUO 80883

INNO-LiPA test principle and main steps Software

1. Denaturation of amplified biotinylated DNA LiRAS for LiPA HBV v1 CE 81387
2. Hybridization with specific oligonucleotide probes LiRAS for LiPA HBV v1 RUO 81386
immobilized as parallel lines on membrane-based strips
3. Remove non-specific and unbound DNA Automation
4. Incubation with conjugate and substrate resulting in
Auto-LiPA 48 CE 80628
a purple precipitate
AutoBlot 3000H CE 81149

HBV LiPA compatibility

All LiPA HBV assays References
1. Yang et al. Clinica Chimica Acta 2010;411(23-24):1951-1956 16. Lampertico et al. Hepatology 2005;42:1414-1419
- use the same program on AutoBlot 3000H or AutoPatient:
-LiPA 48
not supplied Sample ID: 20120511_001_pos control INNX 2. Lok et al. J Clin Microbiol 2002;40:3729-3734 17. Cornberg et al. Z Gastroenterol 2007;45:1-50
- have the same manual protocol 3. Chen et al. J Med Virol 2004;74:536-42 18. Lok AS, McMahon BJ. Hepatology 2009;Vol.50,No.3
4. European Association for the Study of the Liver. J Hepatol 2012;57(1):167-185 19. European Association for the Study of the Liver.
- have identical LiPA reagents J Hepatol 2009;50(2):227-42
5. Janssen et al. Lancet 2005;365:123-129
Amplicon of INNO-LiPA HBV Multi-DR can also be used for INNO-LiPA HBV Genotyping 6. Zllner et al. Hepatology 2004;39(1):42-50 20. Zoulim et al. J Viral Hepat 2007;14 Suppl 1:29-36
Assay Report - LiPA HBV Multi-DR Revision 1/1 7. Tuaillon et al. PLoS ONE 2012;7(3):e32143 21. Sablon et al. Expert Rev Mol Diagn 2003;3(5):535-47
8. Lin CL, Kao JH. J Gastroenterol Hepatol 2011;26(Suppl 1):123-130 22. Hussain et al. J Clin Microbiol 2003;41(8):3699-3705
LiRAS for LiPA HBV: Test Data
Sample ID
Entered On
:
:


9. Martinot-Peignoux et al. Poster presented at EASL, 18-22 April 2012 23. Ozasa et al. Hepatology 2006;44(2):326-34
10. Congly et al. Poster presented at AASLD, 9-13 November 2012 24. Malik et al. PLoS One 2012;7(6):e39028
easy and objective interpretation software for the developed strips
Patient Code :
Physician Code :
Work List : 11. Martinot-Peignoux et al. Poster presented at AASLD, 4-8 November 2011 25. Hayashi et al. Intervirology 2009;52(1):22-8
User Name (Login) :
Comment : 12. Moucari et al. Antivir Ther 2009;14:1183-1188 26. Xiao et al. J Med Virol 2011;83(9):1544-50
Scanning mode with integrated calibration 13. Gish et al. J Viral Hepat 2010;17(1):16-22 27. Ren et al. J Viral Hepat 2010;17(12):887-95
Interpretation IE v1.24

Choice between data entry model: scanned 14. Jaroszewicz et al. J Hepatol 2010;52(4):514-522 28. Sonneveld et al. Hepatology 2012;56(1):67-75

or manual entry
Result 15. Libbrecht et al. J.Clin.Microbiol 2007;45(12):3935-3941 29. Tacke F, Shirvani-Dastgerdi E. Hepat Mon 2012;12(6):357-60 - Fast, accurate and genotypes
- Fast, accurate and informative - Sensitive detection of (mixed) genotypes
Codon 80 173 180/181 204 236 184 194 202 250
Class WT WT MT/WT MT WT WT WT WT MT
informative - - Easy to perform
Customized reports: standard or summary Test Info - Easy to perform - Earliest detection
Sensitive detection of (mixed) - Earliest detection of drugof drug resistance
report, adjustable to your needs Strips - Highly sensitive - Accurate determination of the true HBeAg status
Saves electronic image of each strip
LiPA HBV Multi-DR v2 Strip:
Lot #: , Assay Date: on Sheet: (Position ) .
Line Reactivity: - Full patient profiling with 1 method - HBV treatment management
User-friendly and customizable interfaces
Filter management: e.g. 100 samples with
LiPA HBV Multi-DR v3 Strip:
Lot #: , Assay Date: on Sheet: (Position ) .
Line Reactivity:

genotype A from January till March Fujirebio Europe N.V.

Technologiepark 6- B-9052 Gent - Belgium
Patient follow-up*: overview of test Scanner Settings
Scanner: EPSON Perfection 1650/1660
T +32 (0)9 329 13 29 - F +32 (0)9 329 17 75
www.fujirebio-europe.com
performed per patient and follow-up of drug resistance patterns over time
Brightness: -60, Contrast: -60, Gamma: 1
Calibrated on 11/05/2012 (14:39:07) (Grey Scale: AGFA CUSTOM, Lot#: 001)

Test Review
* Only for CE version
Review Info
INNO-LiPA HBV Genotyping INNO-LiPA HBV Multi-DR INNO-LiPA HBV PreCore
Line probe assay for the identification of hepatitis B virus genotypes A to H Line probe assay for the simultaneous detection Line probe assay for the simultaneous detection of HBV wild-type motif and mutations
of hepatitis B virus wild-type motif and resistance associated mutations in the basal core promotor (BCP) and PreCore regions

Strip lay-out Strip lay-out Strip lay-out

Features and benefits Features and benefits

Clear identification of mixed infections: LiPA detects up to 16.3% more mixtures than direct se- More sensitive than direct sequencing for the detection of mixed sequences in precore (PC) and
quencing, confirmed by clonal analysis [1,2] basal core promotor (BCP) region[22]
Sensitive detection of genotypes: LiPA is more sensitive than PCR-RFLP (98.8% vs 65.0%) [3] Prediction of increased risk for hepatocellular carcinoma and progression of liver disease[23-27]
and more sensitive than sequencing [2]
Determine cause of HBeAg negativity: treatment response or PC/BCP mutations?[28-29]
Amplicon of INNO-LiPA HBV Multi-DR can also be used for INNO-LiPA HBV Genotyping
Features and benefits
Relevance of HBV PreCore in clinical practice
Clinical relevance of HBV Genotyping Relevant, accurate and up-to-date detection of drug resistance associated mutations as well as
known compensatory mutations Indication on treatment response and duration:
Genotyping linked with treatment response and part of clinical guidelines : HBV genotypes A
[4]
- Pegylated IFN-a therapy response: patients without PC/BCP mutations are good candidates for interferon treatment,
LiPA is highly sensitive and specific and offers the earliest timepoints for detection of mutants:
and B are associated with a better response to pegylated IFN-a than genotypes C and D.[5] - 2,8 times greater chance for LiPA to detect a given mutation than direct sequencing at any moment in time [15] independent of the HBV genotype [28]
The mutational pattern of lamivudine drug resistance differs between genotypes A and D.[6] - early detection of genotypic resistance allows rapid and effective HBV suppression [16] - Nucleos(t)ide analogues treatment + PC/BCP mutations + drug resistance mutations might lead to a higher or lower
replication fitness of the resistant virus [29]
The correlation between levels of Hepatitis B surface antigen (HBsAg) and the HBV genotype HBV drug resistance testing: part of clinical guidelines [17-19]
Risk of fulminant hepatitis and hepatocellular carcinoma: chronic hepatitis B patients infected
makes both markers valuable tools for prognosis and management of chronic hepatitis B: with PC/BCP mutant viruses are more susceptible to severe hepatitis and acute-on-chronic liver
HBsAg levels differ according to HBV genotype prior to treatment [7-12], during treatment with Clinical relevance of HBV drug resistance testing failure (ACLF) [23-27]
pegylated IFN-a [8, 12] and nucleos(t)ide analogues [13] and during the natural course of HBV Antiviral drug resistance in patients with chronic hepatitis B leads to antiviral treatment failure.[20]
infection. [14] Resistance should be identified as early as possible before viral load rebound and before rise of
ALT (alanine aminotransferase) levels.[21]
As soon as drug resistance is identified, an appropriate therapy can be initiated with the most
effective antivirals now available.[16]