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Bio-Rad Laboratories INFECTIOUS DISEASE TESTING Monolisa HBs Ag ULTRA Assay Pushing The Limits

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Page 1: INFECTIOUS DISEASE TESTING Bio-Rad Laboratories …kimhung.vn/.../HBSAG-ULTRA-V2/catalogs.pdf · INFECTIOUS DISEASE TESTING Bio-Rad Laboratories Monolisa

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™ HBs Ag ULTRA AssayPushing The Limits

Bio

-Rad

, S.N

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50 0

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0 71

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44 D

Monolisa™ HBs Ag 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

Easy-to-Use and Excellent Instrument Integration• Short protocol: total incubation time 2 hours• One-step procedure• Only 100 μl of sample• Substrate stable for 6 hours

• All reagents colored and easy to use• Homogeneity with other EIA Bio-Rad product for wash buffer, colored substrate, stopping solution

Ordering InformationCatalog No. Description

72346 Monolisa™ HBs Ag ULTRA Assay ...................................................................................................................... 96 tests72348 Monolisa™ HBs Ag ULTRA Assay ................................................................................................................... 480 tests

• 100 μl of control or sample

• Microplate coated with: 3 monoclonal Ab

• 50 μl of conjugate: polyclonal and monoclonal Ab

• Incubate for 1 hour 30 minutes at 37°C

• 100 μl of TMB colored substrate

• Incubate for 30 minutes at room temperature (18–30°C) in the dark

• 100 μl of stopping solution

• Cut off = neg. mean (R3 + 0.050)

Test Format Sample/Reagent Addition MonitoringColor of well BEFORE dispensing Color of well AFTER dispensing

WASH

READ at dual wavelength 450/620–700 nm

clear to yellow

yellow to orange

clear to pink

blue to yellow*

Anti-HBs AgMonoclonal Ab

HBs Ag Anti-HBs Ag Monoclonaland Polyclonal Ab Conjugate

* Reactive sample

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 17195 Rev B 12/2007

Page 2: INFECTIOUS DISEASE TESTING Bio-Rad Laboratories …kimhung.vn/.../HBSAG-ULTRA-V2/catalogs.pdf · INFECTIOUS DISEASE TESTING Bio-Rad Laboratories Monolisa

Outstanding SensitivitySensitivity limits on an Etablissement Français du Sang (EFS) panel: EFS HB batch 01/08/0222G/02/B mixtures of HBs Ag ad and ay subtypes on EvOLIS™ system.

* Sensitivity detection limit in ng/ml after linear regression with the 5 dilutions from 0 to 0.45 ng/ml

Sensitivity = Detects less than 50 picograms/ml

TotalNumberof TestedSamples

Total Number of Detected Samples

70 SeroconversionPanels Tested

282 95 120

ClosedSystem

A

MicroplateCompetitor

B

MicroplateCompetitor

O

MicroplateCompetitor

D

MicroplateCompetitor

M

144 148 95

Monolisa™

HBs Ag ULTRA

170 128

Monolisa™

HBs AgPLUS

Earliest Detection of HBV SeroconversionHBs Ag EIA competitor kit analysis versus Monolisa™ HBs Ag ULTRA assay on EvOLIS™ system with 70 commercialseroconversion panels.

* The NAT data come from Boston Biomedica Inc. as recorded in the certificate of analysis. The days zero represent the first day positive with Nucleic Acid Testing such as PCR on HBV infection seroconversion panels: 27 commercial seroconversions (104 samples) tested: number PHM 903, 904, 908, 909, 910, 911, 912, 914, 916, 917, 918, 919, 920, 921, 923, 924, 925, 926, 927, 928, 929, 930, 931, 932, 933, 934, 935A HB Ag EIA assay data come from internal data.

Monolisa™ HBs Ag ULTRA Assay4th Generation Assay

Monolisa™ HBs Ag ULTRA AssayEIA for Detection of HBs AntigenHigh Security Features• High sensitivity: don’t miss the beginning of HBs Ag sero conversion, variant strains, or low HBs Ag chronic carriers

• All reagents colored with dispense monitoring for all steps (sample, reagent and substrate) and OD norms in the package insert

• Microplate and strip identification

• Barcode on reagents

• Quality assurance: CE-registered product

Shorten HBs Ag Negative Window Period after Hepatitis B InfectionAverage day of delay for detection of Hepatitis B infection on 27 commercial seroconversions with Monolisa™ HBs Ag ULTRA assay and HBs Ag EIA competitor kits versus nucleic acid testing (PCR).

1 2 3 4 5 6 7 8

Competitor A4.5 Days

Microplate Competitor M5.0 Days

Microplate Competitor D5.9 Days

Monolisa™

HBs Ag Plus5.2 Days

Microplate Competitor O7.4 Days

Microplate Competitor B7.6 Days

Days

NA

T D

etec

tion

Monolisa™

HBs Ag ULTRA2.1 Days

MicroplateCompetitor

M

MicroplateCompetitor

D

MicroplateCompetitor

O

MicroplateCompetitor

B

CompetitorA

MutatedHBs Ag Rec. Proteins

Ratio (Positive if >1)

RM - 1RM - 2RM - 3RM - 4RM - 5RM - 6RM - 7RM - 8RM - 9RM - 10RM - 11RM - 12RM - 13RM - 14RM - 15

6.91322579324

35.602138.532272.581772.852102.801.58133

417202047243

18.471429401.181421.381.83150252155113

0.280330451440330.680350400471010521.18033031073

0.480350.16252014024

15.982.762402192;035.62

2992930102

3041312.841720721000.611321431351211491441090.96

Number ofSamplesDetected

15/15 14/15 3/15 10/15 12/15

Improved Variant Hepatits B Virus Strain DetectionHBs Ag EIA competitor kit sensitivity on mutated HBs Ag recombinant protein samples from plasmidic construction.

A panel of 15 diluted variant recombinant HBs Ag proteins was used to evaluate HBs Ag variant detection efficiency of HBs Ag EIA assays. This panel represented a total of 30 single or multiple mutations located at 22 different amino acid positions in the “a” determinant of HBs Ag. These mutations represent the clinically relevant mutation reported by the literature.

Monolisa™ HBs Ag ULTRA assay detects all of these mutations. Four out of five HBs Ag EIA competitor kits miss at least one sample in this mutated/variant HBs Ag panel.

Regions Localization of HBs Ag Mutations Tested

HBs 1 Y 100 SL 109 PS 113 TT 114 ST 118 A, T 118 V

HBs 3 P 120 S, P 120 TT 123 N

C 124 RT 125 MT 126 SP 127 T, P 127 AQ129 RG130 NN131 TK 133 I, M133 TF 134 N

HBs 4 P 142 ST 143 L, T 143 S,S 143 LD 144 A, D 144 EG145 R, G 145 K

HBs 5 Y 161 FA 166 V

Monolisa™

HBs Ag ULTRA

8.574.848.0350342124311434712903.874216.08514370252

15/15

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

Page 3: INFECTIOUS DISEASE TESTING Bio-Rad Laboratories …kimhung.vn/.../HBSAG-ULTRA-V2/catalogs.pdf · INFECTIOUS DISEASE TESTING Bio-Rad Laboratories Monolisa

HB EFSPanelng/ml

Monolisa™ HBs Ag ULTRA

0.032 0.059 0.078 0.080 0.134 0.090 0.090 0.170SensitivityDetection

Limit*

Monolisa™

HBs Ag PLUSMicroplateCompetitor

D

MicroplateCompetitor

M

MicroplateCompetitor

O

MicroplateCompetitor

B

ClosedSystem

A

ClosedSystem

C

Outstanding SensitivitySensitivity limits on an Etablissement Français du Sang (EFS) panel: EFS HB batch 01/08/0222G/02/B mixtures of HBs

Ag ad and ay subtypes on EVOLIS™ system.

* Sensitivity detection limit in ng/ml after linear regression with the 5 dilutions from 0 to 0.45 ng/ml

Sensitivity = Detects less than 50 picograms/ml

TotalNumberof TestedSamples

Total Number of Detected Samples

70 SeroconversionPanels Tested

282 95 120

ClosedSystem

A

MicroplateCompetitor

B

MicroplateCompetitor

O

MicroplateCompetitor

D

MicroplateCompetitor

M

144 148 95

Monolisa™

HBs Ag ULTRA

170 128

Monolisa™

HBs AgPLUS

Earliest Detection of HBV SeroconversionHBs Ag EIA competitor kit analysis versus Monolisa™ HBs Ag ULTRA assay on EVOLIS™ system with 70 commercial

seroconversion panels.

* The NAT data come from Boston Biomedica Inc. as recorded in the certifi cate of analysis. The days zero represent the fi rst day positive with Nucleic Acid Testing such as PCR on

HBV infection seroconversion panels: 27 commercial seroconversions (104 samples) tested: number PHM 903, 904, 908, 909, 910, 911, 912, 914, 916, 917, 918, 919, 920, 921, 923,

924, 925, 926, 927, 928, 929, 930, 931, 932, 933, 934, 935A HB Ag EIA assay data come from internal data.Monolisa™ HBs Ag ULTRA Assay

4th Generation Assay

Monolisa™ HBs Ag ULTRA Assay

EIA for Detection of HBs AntigenHigh Security Features• High sensitivity: don’t miss the beginning of HBs Ag sero

conversion, variant strains, or low HBs Ag chronic carriers

• All reagents colored with dispense monitoring for all steps

(sample, reagent and substrate) and OD norms in the

package insert

• Microplate and strip identifi cation

• Barcode on reagents

• Quality assurance: CE-registered product

Shorten HBs Ag Negative Window Period after Hepatitis B InfectionAverage day of delay for detection of Hepatitis B infection on 27 commercial seroconversions with Monolisa™ HBs Ag ULTRA

assay and HBs Ag EIA competitor kits versus nucleic acid testing (PCR).

1 2 3 4 5 6 7 8

Competitor A4.5 Days

Microplate Competitor M5.0 Days

Microplate Competitor D5.9 Days

Monolisa™

HBs Ag Plus5.2 Days

Microplate Competitor O7.4 Days

Microplate Competitor B7.6 Days

Days

NA

T D

etec

tion

Monolisa™

HBs Ag ULTRA2.1 Days

MicroplateCompetitor

M

MicroplateCompetitor

D

MicroplateCompetitor

O

MicroplateCompetitor

B

CompetitorA

MutatedHBs Ag Rec. Proteins

Ratio (Positive if >1)

RM - 1RM - 2RM - 3RM - 4RM - 5RM - 6RM - 7RM - 8RM - 9RM - 10RM - 11RM - 12RM - 13RM - 14RM - 15

6.913.225.793.24

35.602.138.532.272.581.772.852.102.801.581.33

4.172.020.472.43

18.471.429.401.181.421.381.831.502.521.551.13

0.280.330.451.440.330.680.350.400.471.010.521.180.330.310.73

0.480.350.162.520.140.24

15.982.762.402.192;035.62

29.929.301.02

3.041.312.841.720.721.000.611.321.431.351.211.491.441.090.96

Number ofSamplesDetected

15/15 14/15 3/15 10/15 12/15

Improved Variant Hepatits B Virus Strain DetectionHBs Ag EIA competitor kit sensitivity on mutated HBs Ag recombinant protein samples from plasmidic construction.

A panel of 15 diluted variant recombinant HBs Ag proteins was used to evaluate HBs Ag variant detection effi ciency of HBs Ag EIA assays. This panel represented a total of 30 single

or multiple mutations located at 22 different amino acid positions in the “a” determinant of HBs Ag. These mutations represent the clinically relevant mutation reported by the literature.

Monolisa™ HBs Ag ULTRA assay detects all of these mutations. Four out of fi ve HBs Ag EIA competitor kits miss at least

one sample in this mutated/variant HBs Ag panel.

Regions Localization of HBs Ag Mutations Tested

HBs 1 Y 100 SL 109 PS 113 TT 114 ST 118 A, T 118 V

HBs 3 P 120 S, P 120 TT 123 N

C 124 RT 125 MT 126 SP 127 T, P 127 AQ129 RG130 NN131 TK 133 I, M133 TF 134 N

HBs 4 P 142 ST 143 L, T 143 S,S 143 LD 144 A, D 144 EG145 R, G 145 K

HBs 5 Y 161 FA 166 V

Monolisa™

HBs Ag ULTRA

8.574.848.035.034.212.43

11.434.712.903.874.216.085.143.702.52

15/15

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 • HBS Ag Ultra12.indd 2MONOLISA • HBS Ag Ultra12.indd 2 8/01/08 15:27:278/01/08 15:27:27

Page 4: INFECTIOUS DISEASE TESTING Bio-Rad Laboratories …kimhung.vn/.../HBSAG-ULTRA-V2/catalogs.pdf · INFECTIOUS DISEASE TESTING Bio-Rad Laboratories Monolisa

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™ HBs Ag ULTRA AssayPushing The Limits

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 •

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™ HBs Ag 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

Easy-to-Use and Excellent Instrument Integration• Short protocol: total incubation time 2 hours• One-step procedure• Only 100 μl of sample• Substrate stable for 6 hours

• All reagents colored and easy to use• Homogeneity with other EIA Bio-Rad product for wash buffer, colored substrate, stopping solution

Ordering InformationCatalog No. Description

72346 Monolisa™ HBs Ag ULTRA Assay ...................................................................................................................... 96 tests72348 Monolisa™ HBs Ag ULTRA Assay ................................................................................................................... 480 tests

• 100 μl of control or sample

• Microplate coated with: 3 monoclonal Ab

• 50 μl of conjugate: polyclonal and monoclonal Ab

• Incubate for 1 hour 30 minutes at 37°C

• 100 μl of TMB colored substrate

• Incubate for 30 minutes at room temperature (18–30°C) in the dark

• 100 μl of stopping solution

• Cut off = neg. mean (R3 + 0.050)

Test Format Sample/Reagent Addition MonitoringColor of well BEFORE dispensing Color of well AFTER dispensing

WASH

READ at dual wavelength 450/620–700 nm

clear to yellow

yellow to orange

clear to pink

blue to yellow*

Anti-HBs AgMonoclonal Ab

HBs Ag Anti-HBs Ag Monoclonaland Polyclonal Ab Conjugate

* Reactive sample

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 17195 Rev B 12/2007