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Simplexa® HSV 1 & 2 Direct Kit

The Only FDA Cleared HSV Molecular Test for CSF, Cutaneous and Mucocutaneous Swab SamplesComprehensive direct testing for detection and differentiation of HSV 1 & HSV 2

INFECTIOUS DISEASE

The quality of treatment starts with diagnosis.

HSV causes a wide spectrum of clinical manifestationsHerpes simplex virus (HSV 1 & 2) can cause a variety of diseases with multiple presentations, ranging from mucocutaneous and cutaneous lesions to fulminate encephalitis that can have devastating results.

HSV is a common cause of meningitis and encephalitis. Encephalitis occurs in all ages, from neonates to adults, and during all seasons. Untreated HSV central nervous system (CNS) infection can reach mortality rates as high as 70% and for those who survive, only a minority will achieve full recovery.

HSV is also one of the most common causes of sexually transmitted disease. The CDC estimates that 776,000 people in the United States get new herpes infections annually.1 Nationwide, 15.7% of persons aged 14-49 years have HSV 2 infection.1 Recognition of genital herpes is important to prevent transmission and provide counseling.

First of its kind coverage for HSV testing needs

• Comprehensive sample types: For use with CSF, cutaneous and mucocutaneous swab samples.

• The smallest sample volume: Only requires 50 μL of precious CSF sample.

• Fast, sample to answer workflow: CLIA moderate complexity with minimal hands-on time providing results in about an hour.

• Flexibility to run as few as 1 and up to 8 samples at a time.

Simplexa® HSV 1 & 2 Direct Kit

Comprehensive, Fast and Accurate Molecular HSV TestingDirect detection and differentiation of HSV 1 & HSV 2 in CSF, cutaneous and mucocutaneous swab samples

INFECTIOUS DISEASE

REFERENCES: 1. http://www.cdc.gov/std/herpes/stdfact-herpes-detailed.htm. 2. MOL2150, Simplexa® HSV 1 & 2 Direct instructions for use.

Accurate performance for confidence when testing multiple different sample typesConsolidate your CSF, cutaneous and mucocutaneous swab sample testing.

CSF Clinical Agreement2

HSV 1 HSV 2

Population Agreement with Positives

Agreement with Negatives

Agreement with Positives

Agreement with Negatives

Encephalitis Patients 100.0% (3/3) 98.8% (159/161) 85.7% (6/7) 99.4% (156/157)

HSV Molecular Positive Patients 100.0% (13/13) N/A 100.0% (42/42) N/A

Cutaneous & Mucocutaneous Clinical Agreement2

HSV 1 HSV 2

Prospective Population

Agreement with Positives

Agreement with Negatives

Agreement with Positives

Agreement with Negatives

CutaneousLesion Swabs 100.0% (30/30) 96.3% (182/189) 97.0% (32/33) 97.9% (182/186)

MucocutaneousLesion Swabs 98.2% (162/165) 97.5% (703/721) 99.5% (193/194) 96.7% (669/692)

The Simplexa® HSV 1 & 2 Direct assay is a CLIA moderate complexity assay. The LIAISON® MDX provides results in about an hour bypassing conventional DNA extraction procedures.

SCAN samples and reagents.

PIPETTE samples and reagents directly onto the disc.

LOAD and press RUN.

Streamlined, simple workflow

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Everything you need for molecular HSV testing

Ordering information – Simplexa® HSV 1 & 2 Direct

CATALOG NUMBER DESCRIPTION REACTIONS/KIT

MOL2150 Simplexa® HSV 1 & 2 Direct Kit* 24

MOL2160 Simplexa® HSV 1 & 2 Positive Control Pack 10 x 100 µL

*Direct Amplification Discs are provided with kit.

p: +1 (562) 240-6500 e: cs.molecular@diasorin.com w: www.molecular.diasorin.com

Cypress, CA USA

Simplexa and the associated logo are all trademarks or registered trademarks of DiaSorin Molecular LLC in the U.S. and/or other countries. ©2016 DiaSorin Molecular LLC. All rights reserved.

The use of Scorpions® probes for human in vitro diagnostic purposes is covered by a license to DiaSorin Molecular LLC from QIAGEN Manchester, UK. Scorpions is a registered trademark of QIAGEN Manchester, UK.

Black Hole Quencher, CAL Fluor, Quasar dyes are trademarks of Biosearch Technologies, Inc. DiaSorin products incorporating the Black Hole Quencher, CAL Fluor, and Quasar dye technology are licensed and sold pursuant to an agreement with Biosearch Technologies, lnc., and these products are sold exclusively for clinical, diagnostic, or research and development purposes.

Product availability subject to required regulatory approvals.

Contact DiaSorin Molecular today! Call +1 (562) 240-6500 or visit: www.molecular.diasorin.com