Simplexa® HSV 1 & 2 Direct Kit
The Only FDA Cleared HSV Molecular Test for CSF, Cutaneous and Mucocutaneous Swab Samples
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. 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.
1. CDC, http://www.cdc.gov/std/herpes/stdfact-herpes-detailed.htm.
Why to choose it
The only FDA cleared HSV molecular test for CSF, cutaneous and mucocutaneous swab samples. The CLIA moderate complexity assay allows for HSV 1 and HSV 2 detection and differentiation in about an hour using only 50 µl of sample. 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 Simplexa® HSV 1 & 2 Direct assay demonstrated 100% agreement with CSF from HSV molecular positive patients and over 96% agreement with prospective 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 (Prospective)
| Type | Agreement with Positives | Agreement with Negatives |
|---|---|---|
| TypeHSV 1 | Agreement with Positives100.0% (30/30) 95% CI: 88.7% to 100.0% |
Agreement with Negatives96.3% (182/189) 95% CI: 92.6% to 98.5% |
| TypeHSV 2 | Agreement with Positives97.0% (32/33) 95% CI: 84.4% to 99.5% |
Agreement with Negatives97.9% (182/186) 95% CI: 94.6% to 99.2% |
Mucocutaneous Swab Samples (Prospective)
| Type | Agreement with Positives | Agreement with Negatives |
|---|---|---|
| TypeHSV 1 | Agreement with Positives98.2% (162/165) 95% CI: 99.4% to 99.6% |
Agreement with Negatives97.5% (703/721) 95% CI: 96.1% to 98.4% |
| TypeHSV 2 | Agreement with Positives99.5% (193/194) 95% CI: 97.1% to 100.0% |
Agreement with Negatives96.7% (669/692) 95 CI: 95.1% to 97.8% |
The Most Comprehensive Sample Type Coverage with Lowest Sample Volume Requirements
Our Simplexa® 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 Simplexa® HSV 1 & 2 Direct Kit
* Direct Amplification Discs included in kit |
Code MOL2150 | Reactions 24 |
| Product Simplexa® HSV 1 & 2 Direct Positive Control Pack |
Code MOL2160 | Reactions 10 x 100 μL |
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