Simplexa™ HSV 1 & 2 Direct Kit
A Comprehensive HSV 1 & 2 Molecular Test for CSF, Cutaneous and Mucocutaneous Swab Samples
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KIT for Infectious Diseases Overview
Background
HSV 1 & 2 cause a variety of diseases with multiple presentations, ranging from mucocutaneous and cutaneous lesions to fulminate encephalitis that can have devastating results.
Encephalitis occurs in all ages, from neonates to adults, and during all seasons. HSV encephalitis may have devastating results. 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. Most cases of recurrent genital herpes are caused by HSV 2. The WHO estimated in 2015 that 417 million people aged 15-49 years have HSV 2 infection.
Why to choose it
A CLIA moderate complexity assay that allows for HSV 1 and HSV 2 differentiation using only 50 µl of CSF or cutaneous and mucocutaneous swab samples. Improved efficiency with a true sample-to-answer workflow without DNA extraction providing results in about an hour. The coverage of multiple sample types in a moderate complexity assay enables laboratories to easily manage various HSV testing needs with one assay.
For use on
Benefits
Reliable Performance
In a thorough clinical study, our SimplexaTM HSV 1 & 2 Direct assay demonstrated 100% agreement with CSF from HSV molecular positive patients and retrospective cutaneous/mucocutaneous swab samples.
CSF Performance-Simplexa® HSV 1&2 Direct
HSV Molecular Positive Patients (Retrospective/Preselected)
| Type | Agreement with Positives | Agreement with Negatives |
|---|---|---|
| TypeHSV 1 | Agreement with Positives100.0% (13/13) 95% CI: 77.2% to 100.0% |
Agreement with NegativesN/A |
| TypeHSV 2 | Agreement with Positives100.0% (42/42) 95% CI: 91.6% to 100.0% |
Agreement with NegativesN/A |
Swab Performance-Simplexa® HSV 1&2 Direct
Cutaneous Swab Samples (Retrospective)
| Type | Agreement with Positives | Agreement with Negatives |
|---|---|---|
| TypeHSV 1 | Agreement with Positives100.0% (63/63) 95% CI: 94.3% to 100.0% |
Agreement with Negatives100.0% (119/119) 95% CI: 96.9% to 100.0% |
| TypeHSV 2 | Agreement with Positives100.0% (60/60) 95% CI: 94.0% to 100.0% |
Agreement with Negatives100.0% (122/122) 95% CI: 96.9% to 100.0% |
Mucocutaneous Swab Samples (Retrospective)
| Type | Agreement with Positives | Agreement with Negatives |
|---|---|---|
| TypeHSV 1 | Agreement with Positives100.0% (58/58) 95% CI: 93.8% to 100.0% |
Agreement with Negatives100.0% (119/119) 95% CI: 96.9% to 100.0% |
| TypeHSV 2 | Agreement with Positives100.0% (59/59) 95% CI: 93.9% to 100.0% |
Agreement with Negatives100.0% (118/118) 95 CI: 96.8% to 100.0% |
The Most Comprehensive Sample Type Coverage with the Lowest Sample Volume Requirements
Our SimplexaTM HSV 1 & 2 Direct assay utilizes only 50 µl of sample and is cleared for BOTH CSF and mucocutaneous/cutaneous swabs. Broad coverage that includes samples collected from lesion locations including:
- anorectal
- genital
- nasal
- ocular
- oral
- urethra
- skin
Ordering info
| Product | Code | Reactions |
|---|---|---|
| Product SimplexaTM HSV 1 & 2 Direct Kit*
* Direct Amplification Discs included in kit |
Code MOL2150 | Reactions 24 |
| Product SimplexaTM HSV 1 & 2 Direct Positive Control Pack |
Code MOL2160 | Reactions 10 x 100 μL |
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