Download - Monolisa HCV Ag-Ac Ultra
Bio-Rad Laboratories I N F E C T I O U S D I S E A S E T E S T I N G
Monolisa™ HCV Ag-Ab ULTRA AssayPushing The Limits
Bio-Rad Laboratories
For further information, please contact the Bio-Rad office nearestyou or visit our website at www.bio-rad.com/diagnostics
ClinicalDiagnostics Group
Website www.bio-rad.com/diagnostics U.S. 1-800-2BIO-RAD Australia 61-2-9914-2800 Austria 43-1-877-8901 Belgium 32-9-385-5511 Brazil 5521-3237-9400 Canada 1-514-334-4372 China 86-21-64260808 Czech Republic 420-241-430-532 Denmark +45-4452-1000 Finland 358-9-804-22-00 France 33-1-47-95-60-00 Germany +49-(0)89-318-840 Greece 30-210-7774396 Hong Kong 852-2789-3300 Hungary 36-1-455-8800 India 91-124-4029300 Israel 972-3-9636050 Italy +39-02-216091 Japan 81-3-6361-6902 Korea 82-2-3473-4460 Mexico +52(55)5488-7670 The Netherlands +31-318-540666 New Zealand 64-9-415-2280 Norway 47-23-38-41-30 Poland 48-22-3319999 Portugal 351-21-472-7700 Russia 7-495-721-14-04 Singapore 65-6415-3188 South Africa 27-11-442-85-08 Spain 34-91-590-5200 Sweden 46-8-555-127-00 Switzerland 41-61-717-95-55 Thailand 662-651-8311 United Kingdom +44-(0)20-8328-2000
50 17157 Rev B 12/2007
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Monolisa™ HCV Ag-Ab ULTRA Assay
I N F E C T I O U S D I S E A S E T E S T I N G
Ordering InformationCatalog No. Description
72556 Monolisa™ HCV Ag-Ab ULTRA Assay ......................................................................................................... 96 tests72558 Monolisa™ HCV Ag-Ab ULTRA Assay ....................................................................................................... 480 tests
* Reactive samples after 30 minutes incubation
➊
➋
➌
• Microplate coated with: - Monoclonal Ab for HCV Ag detection - Recombinant protein and peptide for HCV Ab detection
• 100 μl of conjugate 1
• 50 μl of control or sample
• Incubate for 90 minutes at 37°C
• 100 μl of conjugate 2 • Incubate for 30 minutes at 37°C
Test Format Sample/Reagent Addition MonitoringColor of well BEFORE dispensing Color of well AFTER dispensing
WASH
READ at dual wavelength 450/620–700 nm
Anti-HCV capsidmonoclonalantibodies
Biotinylated anti-HCVcapsid monoclonal antibodies
WASH
• 80 μl of TMB substrate
• Incubate for 30 minutes in the dark at room temperature (18-30°C)
Peroxidase labeled streptavidine
* *
Mutated capsid peptide, recombinantprotein NS3 genotype 1 and 3,recombinant protein NS4
Peroxidase labeledantibodies to human IgG
• 100 μl of stopping solution
• Cut off = Mean pos. cont. (O.D. R4) /4
Sensitivity on Samples from Hospital LaboratoriesA total of 348 anti-HCV Ab positive samples (confirmed by immunoblot or PCR) mostly from chronically infectedpeople from 2 hospital laboratories were tested.
All of these 348 samples were reactive with Monolisa™ HCV Ag-Ab ULTRA assay giving a sensitivity of 100%
• High sensitivity: early HCV detection
• Dispense monitoring for all steps and OD norms in package insert
• Barcode on reagents
• Quality assurance: CE registered product
• Specific colored packaging for each marker
• Microplate and strip identification
Monolisa™ HCV Ag-Ab ULTRA Assay
Early HCV Exposure Detection70% reduction of the serologic HCV Ab negative Window PeriodA total of 35 commercially seroconversion panels, including subtype 1a, 1b, 2b, 3a, were tested by Monolisa™ HCV Ag-Ab ULTRA assay and by commercial EIA anti-HCV Ab assays. The serologic profile for one representative panel is shown below.
Monolisa™ HCV Ag-Ab ULTRA Assay4th Generation Assay
Example of serological profile of HCV Seroconversion Panel BBI - 917
Window Period Reduction. Ranking on 35 Seroconversions in Days of Delay versus Nucleic Acid Testing
Genotyped HCV Positive Sample DetectionA total of 405 genotyped samples were tested: 133 genotyped from various origin and 272 genotyped from2 hospital laboratories.
405 genotyped samples tested
All these samples from different genotype were found positive: 100% sensitivity (405/405)
Number
Genotype
Number
Genotype
405
TOTAL
2,1444,2632,4303,564
12,401
,
Blood Bank Specificity
Example of serological profile of HCV Seroconversion Panel BBI - 917
Very low rate of repeat reactive samples. Specificity: 99.85%
Number
Genotype
Number
Genotype
405
TOTAL
2,1444,2632,4303,564
12,401
,
40 60 20 0
0
1
2
3
4
5
6
7
8
9
80 100 120 140 160
cut-off
HCV RNA detection + - - - - - - + ++
HCV Ab assay
HCV Ag assay Monolisa HCVAg-AbULTRA assay™
Among these 35 serocoversion panels, Monolisa™ HCV Ag-Ab ULTRA assay detects exposure to HCV at least17 days earlier than the other anti-HCV Ab assays tested: 70% reduction of the serologic HCV Ab negative Window Period with Nucleic Acid Testing (HCV RNA detection) as reference. Monolisa™ HCV Ag-Ab ULTRA assay is able to detect 126 out of 145 (87%) of HCV RNA positive/anti-HCV negative samples tested.
Rat
io: S
amp
le/c
ut-o
ff
Bleed date (Days)
8 12 4 0 16 20 24 Days
HCV Ab microplate assay: D
4.4
HCV Ab automated assay: A
4.4
24
HCV Ab microplate assay: F
HCV Ab automated assay: E
HCV Ab automated assay: C
21.6
22.8
say: D
22.9
24.9
2323
23.5
HCV Ab microplate assay: B
Monolisa HCVAg-Ab ULTRA
™
NAT
det
ectio
n si
ngle
uni
t
Average Day of Delay
Reduction of Anti-HCV Ab Negative Window Period70% reduction of the serologic HCV Ab negative Window Period
Easily Automatable, Robust and Secure
EIA for Detection of HCV Ag and HCV Ab
Bio-Rad Laboratories I N F E C T I O U S D I S E A S E T E S T I N G
Sensitivity on Samples from Hospital LaboratoriesA total of 348 anti-HCV Ab positive samples (confirmed by immunoblot or PCR) mostly from chronically infectedpeople from 2 hospital laboratories were tested.
All of these 348 samples were reactive with Monolisa™ HCV Ag-Ab ULTRA assay giving a sensitivity of 100%
• High sensitivity: early HCV detection
• Dispense monitoring for all steps and OD norms in package insert
• Barcode on reagents
• Quality assurance: CE registered product
• Specific colored packaging for each marker
• Microplate and strip identification
Monolisa™ HCV Ag-Ab ULTRA Assay
Early HCV Exposure Detection70% reduction of the serologic HCV Ab negative Window PeriodA total of 35 commercially seroconversion panels, including subtype 1a, 1b, 2b, 3a, were tested by Monolisa™ HCV Ag-Ab ULTRA assay and by commercial EIA anti-HCV Ab assays. The serologic profile for one representative panel is shown below.
Monolisa™ HCV Ag-Ab ULTRA Assay4th Generation Assay
Example of serological profile of HCV Seroconversion Panel BBI - 917
Window Period Reduction. Ranking on 35 Seroconversions in Days of Delay versus Nucleic Acid Testing
Genotyped HCV Positive Sample DetectionA total of 405 genotyped samples were tested: 133 genotyped from various origin and 272 genotyped from2 hospital laboratories.
405 genotyped samples tested
All these samples from different genotype were found positive: 100% sensitivity (405/405)
Number
Genotype
Number
Genotype
405
TOTAL
2,1444,2632,4303,564
12,401
,
Blood Bank Specificity
Example of serological profile of HCV Seroconversion Panel BBI - 917
Very low rate of repeat reactive samples. Specificity: 99.85%
Number
Genotype
Number
Genotype
405
TOTAL
2,1444,2632,4303,564
12,401
,
40 60 20 0
0
1
2
3
4
5
6
7
8
9
80 100 120 140 160
cut-off
HCV RNA detection + - - - - - - + ++
HCV Ab assay
HCV Ag assay Monolisa HCVAg-AbULTRA assay™
Among these 35 serocoversion panels, Monolisa™ HCV Ag-Ab ULTRA assay detects exposure to HCV at least17 days earlier than the other anti-HCV Ab assays tested: 70% reduction of the serologic HCV Ab negative Window Period with Nucleic Acid Testing (HCV RNA detection) as reference. Monolisa™ HCV Ag-Ab ULTRA assay is able to detect 126 out of 145 (87%) of HCV RNA positive/anti-HCV negative samples tested.
Rat
io: S
amp
le/c
ut-o
ff
Bleed date (Days)
8 12 4 0 16 20 24 Days
HCV Ab microplate assay: D
4.4
HCV Ab automated assay: A
4.4
24
HCV Ab microplate assay: F
HCV Ab automated assay: E
HCV Ab automated assay: C
21.6
22.8
say: D
22.9
24.9
2323
23.5
HCV Ab microplate assay: B
Monolisa HCVAg-Ab ULTRA
™
NAT
det
ectio
n si
ngle
uni
t
Average Day of Delay
Reduction of Anti-HCV Ab Negative Window Period70% reduction of the serologic HCV Ab negative Window Period
Easily Automatable, Robust and Secure
EIA for Detection of HCV Ag and HCV Ab
Bio-Rad Laboratories I N F E C T I O U S D I S E A S E T E S T I N G
Bio-Rad Laboratories I N F E C T I O U S D I S E A S E T E S T I N G
Monolisa™ HCV Ag-Ab ULTRA AssayPushing The Limits
Bio-Rad Laboratories
For further information, please contact the Bio-Rad office nearestyou or visit our website at www.bio-rad.com/diagnostics
ClinicalDiagnostics Group
Website www.bio-rad.com/diagnostics U.S. 1-800-2BIO-RAD Australia 61-2-9914-2800 Austria 43-1-877-8901 Belgium 32-9-385-5511 Brazil 5521-3237-9400 Canada 1-514-334-4372 China 86-21-64260808 Czech Republic 420-241-430-532 Denmark +45-4452-1000 Finland 358-9-804-22-00 France 33-1-47-95-60-00 Germany +49-(0)89-318-840 Greece 30-210-7774396 Hong Kong 852-2789-3300 Hungary 36-1-455-8800 India 91-124-4029300 Israel 972-3-9636050 Italy +39-02-216091 Japan 81-3-6361-6902 Korea 82-2-3473-4460 Mexico +52(55)5488-7670 The Netherlands +31-318-540666 New Zealand 64-9-415-2280 Norway 47-23-38-41-30 Poland 48-22-3319999 Portugal 351-21-472-7700 Russia 7-495-721-14-04 Singapore 65-6415-3188 South Africa 27-11-442-85-08 Spain 34-91-590-5200 Sweden 46-8-555-127-00 Switzerland 41-61-717-95-55 Thailand 662-651-8311 United Kingdom +44-(0)20-8328-2000
50 17157 Rev B 12/2007
Bio
-Rad
, S.N
.C. a
u ca
pita
l de
50 0
00 0
00 E
uros
, Loc
atai
re-G
éran
t, 4
49 9
9071
2 R
CS
Nan
terr
e •
N°
Intr
acom
mun
auta
ire F
R 6
2 44
9 99
0 71
2 •
Sire
t 44
9 99
0 71
2 00
019
• C
ode
AP
E 2
44 D
Monolisa™ HCV Ag-Ab ULTRA Assay
I N F E C T I O U S D I S E A S E T E S T I N G
Ordering InformationCatalog No. Description
72556 Monolisa™ HCV Ag-Ab ULTRA Assay ......................................................................................................... 96 tests72558 Monolisa™ HCV Ag-Ab ULTRA Assay ....................................................................................................... 480 tests
* Reactive samples after 30 minutes incubation
➊
➋
➌
• Microplate coated with: - Monoclonal Ab for HCV Ag detection - Recombinant protein and peptide for HCV Ab detection
• 100 μl of conjugate 1
• 50 μl of control or sample
• Incubate for 90 minutes at 37°C
• 100 μl of conjugate 2 • Incubate for 30 minutes at 37°C
Test Format Sample/Reagent Addition MonitoringColor of well BEFORE dispensing Color of well AFTER dispensing
WASH
READ at dual wavelength 450/620–700 nm
Anti-HCV capsidmonoclonalantibodies
Biotinylated anti-HCVcapsid monoclonal antibodies
WASH
• 80 μl of TMB substrate
• Incubate for 30 minutes in the dark at room temperature (18-30°C)
Peroxidase labeled streptavidine
* *
Mutated capsid peptide, recombinantprotein NS3 genotype 1 and 3,recombinant protein NS4
Peroxidase labeledantibodies to human IgG
• 100 μl of stopping solution
• Cut off = Mean pos. cont. (O.D. R4) /4