Infectious Disease Testing

Geenius Solution
A Game Changer

Geenius HIV 1/2 Confirmatory
The Bio-Rad Geenius HIV 1/2 Confirmatory Assay is a single-use immunochromatographic test for theconfirmation and differentiation of individual antibodies to Human Immunodeficiency Virus Types 1 and 2(HIV-1 and HIV-2) in fingerstick whole blood, venous whole blood, serum or plasma samples.

HIV-1 & HIV-2 confirmationand differentiation< 30 minutes

Room temperature storage

Automatic reading

12|3456|C1 Band 1 - gp36 (HIV-2, Envelope peptide) HIV-2 ENV
2 Band 2 - gp140 (HIV-2, Envelope peptide) HIV-2 ENV
3 Band 3 - p31 (HIV-1, Polymerase peptide) HIV-1 POL
4 Band 4 - gp160 (HIV-1, Envelope recombinant protein) HIV-1 ENV
5 Band 5 - p24 (HIV-1, Core recombinant protein) HIV-1 GAG
6 Band 6 - gp41 (Group M and O) HIV-1 ENV (HIV-1, Envelope peptide)

RT

CER

IF IE DTIFI

ED

ED

CE

C Control Band - Protein A

CER I FITn	Listed on the following regulatory certifications:

CE, FDA, TGA, ANVISA, Health Canada, CDSCO India,Thai FDA, Taiwan FDAn

Listed on the WHO prequalified IVD products list

Geenius HCV SupplementalGeenius HCV Supplemental Assay is a qualitative single-use immunochromatographic test for the confirmationof the presence of antibodies associated with infection caused by the Hepatitis C Virus (HCV) in human venous
whole blood, serum or plasma specimens from blood donors or hospitalized patients.

Unitary HCV Supplemental Assay

20 minutes

Room temperature storage

Automatic reading

1|2|3|4|C

1 Band 1 - NS4 antigen peptides
2 Band 2 - NS5 recombinant protein
3 Band 3 - Core antigen peptides
4 Band 4 - NS3 recombinant protein

RTCER

IF IE DTIFIEDEDCEC Control Band - Protein A

CER I FITn	CE-marked

Geenius Solution
A Game Changer

One Patient. One Cartridge. One Result.
Accurate Results	Very high level of sensitivity and specificityn	Simple positivity criteria for easy overall interpretationn	Excellent differentiation raten

Geenius Controls

Automatic Reading & Interpretationnnn	A tiny system with mighty possibilities, that can findits place easily in every laboratory
Automated interpretation of each individual band	Automatic conclusion of patient status using expert
software and proprietary algorithmsnIntuitive and user friendly interfacenMinimal training required

Full Traceability & SafetynUnique datamatrix barcode on each cassettenAutomatic reader calibrationnAutomatic checking of lot validationn

Positive identification of controls and patientsn

Detailed report including cassette picturenSecure data archivingnBidirectional interfacing with LIS

Geenius Assays

Visit www.bio-rad.com/diagnostics
for more information.

Key Bio-Rad Milestones for Innovation
in HIV and HCV Detection
2019

1st single use cassette for HCV confirmation with automated reading
and interpretation in less than 30 minutes

2014

BioPlex HIV Ag-Ab CE-marked

2013

Improvement of the 4th generation HCV Ag-Ab Combo screening assay

2005

4th generation of HCV screening assay 1st HCV Combo assay

2001

3rd generation of HCV Ab screening assay

2000

HIV Ag-Ab Combo screening assay

1996

2nd generation of HCV Ab screening assay and supplemental assay

1995

HIV-1 & HIV-2 sandwich format with recombinant proteins and peptides
screening assay

1992

HIV-1 & HIV-2 IgG and IgM screening assay

1991

1st version of HCV screening assay and 1st HCV supplemental assay

1990

1st HIV-1 & HIV-2 differentiation assay

1987

1st HIV-2 screening and confirmatory assay

1985

HIV-1 screening assay

1st unitary and automated HIV-1 and HIV-2 confirmatory assay

Advance Discovery. Improve Lives.

HIVHCVProtocol Geenius HIV 1/2 Confirmatory
1 Dispense Controls or Samples into well 1

3 Buffer

5 Drops into well 2Controls/Serum/Plasma
5 µl

Whole Blood
15 µl

Wait 20 minutesor2 Buffer

2 Drops into well 1
Read, interpret and report results
Wait 5-7 minutes

Protocol Geenius HCV Supplemental
1 Dispense Controls or Sample in “Sample + Buffer” Well

2 Buffer

4 Drops into “Sample + Buffer” WellorVenous
whole blood
15 µl

Controls/Serum/Plasma
5 µl
20 minutes
Read, interpret and report results
Read, interpret and report results

Assays Ordering Information

System Ordering Information

Catalog #Description

Catalog #Description

72460
72329

Geenius HIV 1/2 Confirmatory Assay, 20 tests
Geenius HIV 1/2 Confirmatory Controls(1 Positive + 1 Negative), 2 x 120 µl

92501
92502

Geenius HCV Supplemental Assay, 20 tests
 eenius HCV Supplemental Controls
G(1 Positive + 1 Negative), 2 x 150 µl

92465
12017081
92461
94197

Geenius Reader, 1 unit
Geenius PC + SW OUS (Dell 3510 Win10), 1 unit
Geenius Software, 1 unit
Anti-theft System, 1 unit

Bio-RadLaboratories, Inc.

ClinicalDiagnostics Group

Bulletin PF357

BIO-RAD and BIOPLEX are trademarks of Bio-Rad Laboratories, Inc. in certain
jurisdictions.
GEENIUS, MONOLISA and DECISCAN are trademarks of Bio-Rad Europe, GmbHin certain jurisdictions.
All trademarks used herein are the property of their respective owner.

For further information, please contact the Bio-Rad office nearest you
or visit our website at www.bio-rad.com/diagnostics

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