July 14, 2014 MKT/BF/ 351 BIO FLASH HSV-2 IgG Launch

July 14, 2014
MKT/BF/ 351
BIO FLASH HSV-2 IgG Launch
Further to our plans to offer the broadest menu in Infectious Disease Serology on our
BIO-FLASH® Chemiluminescence platform, we are pleased to announce the launch of the
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new BIO-FLASH HSV-2 IgG assay.
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BIO-FLASH HSV-2 IgG is the second reagent of a group of 3 products for diagnosing
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Herpes 1 and 2: BIO-FLASH HSV-1 IgG, HSV-2 IgG and HSV IgM. BIO-FLASH HSV-1 is
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already being marketed and BIO-FLASH HSV IgM is in the final stages of research. These
3 reagents are part of the TORCH panel (Toxoplasma, Rubella, Cytomegalovirus and
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Herpes) of the BIO-FLASH platform, crucial blood tests for screening pregnant women and
newborn babies for antibodies to these infectious diseases.
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The BIO-FLASH HSV-2 IgG is a fully automated, two-step chemiluminescent immunoassay
(CLIA) for qualitative measurement of IgG antibodies to HSV type 2 in human serum or
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plasma (EDTA, Li-Heparin, Na-Heparin and Na-Citrate) on the BIO-FLASH instrument. The
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use of recombinant HSV-2 glycoprotein G (gG2) in the new BIO-FLASH HSV-2 IgG allows
determining only HSV-2 type-specific antibodies avoiding serological cross-reactivity with
HSV-1.
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The gG2 protein included in the new BIO-FLASH HSV-2 IgG is a specific recombinant
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protein produced by IBES technology that uses living insects as bioreactors. It’s an
innovative technology that Algenex has licensed to Biokit.
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The performance demonstrated by the new BIO-FLASH HSV-2 IgG is excellent; as shown
in several evaluations:
n
Internal evaluation:
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BIO-FLASH HSV-2 IgG vs. commercial
EIA HSV-2 IgG
External evaluation:
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BIO-FLASH HSV-2 IgG vs. HerpeSelect®2 ELISA
IgG method (VISION)
Serology Laboratory of the National Microbiology
Centre,Instituto Carlos III Madrid (Spain)
CDC Herpes 2012 Human Serum Panel BIO®
FLASH HSV-2 IgG.
o
o
Sensitivity
2.173
100 samples
(50 patients)
Specificity
99%
99.8%
100%
(277/277)
99.96%
(144/147)
100.0%
100.0%
Total agreement was obtained in an evaluation with serum from pregnant women (n=67)
vs. EIA HSV-2 IgG, with 100% co-positivity and 100% co-negativity.
Another important feature is the ability to discriminate positive and negative results. For this
reason there is no gray area. Samples with a concentration < 1.0 S/CO are considered
non-reactive (negative) and samples >1.0 S/CO are considered reactive (positive).
BIOKIT S.A.
Can Malé, s/n. 080186 Lliçà d’Amunt
Barcelona, Spain
Tel. +34 93 860 9000
Fax +34 93860 9009
www.biokit.com
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This new BIO-FLASH Herpes reagent completes our TORCH panel, positioning Biokit as one of the few
IVD companies that offer this complete menu in CLIA format.
We already have the following references, needed to work with this new assay, in stock in our
warehouse:
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3000-8605: BIO-FLASH HSV-2 IgG (50 tests)
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3000-8606: BIO-FLASH HSV-2 IgG Calibrators
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3000-8607: BIO-FLASH HSV-2 IgG Controls
Remember that the BIO-FLASH® HSV-1 IgG Reagent, Calibrator and Control are also available:
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3000-8596: BIO-FLASH HSV-1 IgG (50 tests)
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3000-8597: BIO-FLASH HSV-1 IgG Calibrators
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3000-8598: BIO-FLASH HSV-1 IgG Controls
A Complete “Launch Pack” is available on request for your local launch activities:
Launch Pack:
Launch Pack
BIO-FLASH® HSV-2 IgG
Assay tools
Assay Kit Slides (Assay description, performance, competitors …)
Package insert (Assay, Cal & Controls)
White Paper
Publications & posters
MSDS
BIO-FLASH® Reagents Table
BIO-FLASH® Reagent Salesman Dossier
Assay & HSV general Bibliography
Price strategy
Others
Biokit Marketing Team
Ricard Forns
Marketing and Technical Service Director
[email protected]
Montse Armengol
Marketing Assistant
[email protected]
Joaquín Ortiz
Ernest Mas
Group Product Manager
Rapid Tests, ELISA & Western Blot
MKTG & Sales Support LatAm
[email protected]
Laura Marco
Product Specialist
[email protected]
Jordi Gómez
Key Account Manager
OEM & Raw Materials
[email protected]
Carlos Fernández
Product Manager Instrumentation
MKTG & Sales Support SEA
[email protected]
Product Manager
BIO-FLASH Infectious Diseases
[email protected]
Sandra Roselló
Product Manager
Turbidimetry
MKTG & Sales Support EEMEAI
[email protected]
Joan Vilà
Key Account Manager
Werfen Products
MKTG & Sales Support WE & NOA
[email protected]
Fran Sánchez
Product Manager Instrumentation
Technical Service
[email protected]
www.biokit.com
Biokit Phone: +34-938609000 Biokit Mktg Fax: +34-938609017
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