Simplexa HSV 1 & 2 Direct Kit
Simplexa HSV 1 & 2 Direct Kit
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.
Benefits
Reliability
In a thorough clinical study, our Simplexa HSV 1 & 2 Direct assay demonstrated 100% agreement with CSF from HSV molecular positive patients and retrospective cutaneous/mucocutaneous swab samples.
| Type | Agreement with Postives | Agreement with Negatives |
| HSV 1 | 100.0% (13/13) 95% CI: 77.2% to 100.0% | N/A |
| HSV 2 | 100.0% (42/42) 95% CI: 91.6% to 100.0% | N/A |
SWAB PERFORMANCE-SIMPLEXA HSV 1&2 DIRECT
CUTANEOUS SWAB SAMPLES (RETROSPECTIVE)
| Type | Agreement with Positives | Agreement with Negatives |
| HSV 1 | 100.0% (63/63) 95% CI: 94.3% to 100.0% | 100.0% (119/119) 95% CI: 96.9% to 100.0% |
| HSV 2 | 100.0% (60/60) 95% CI: 94.0% to 100.0% | 100.0% (122/122) 95% CI: 96.9% to 100.0% |
MUCOCUTANEOUS SWAB SAMPLES (RETROSPECTIVE)
| Type | Agreement with Positives | Agreement with Negatives |
| HSV 1 | 100.0% (58/58) 95% CI: 93.8% to 100.0% | 100.0% (119/119) 95% CI: 96.9% to 100.0% |
| HSV 2 | 100.0% (59/59) 95% CI: 93.9% to 100.0% | 100.0% (118/118) 95 CI: 96.8% to 100.0% |
Comprehensive
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
For use on
Ordering Info
| PRODUCT | CODE | REACTIONS |
| Simplexa HSV 1 & 2 Direct Kit | MOL2150 | 24 |
| Simplexa HSV 1 & 2 Direct Positive Control Pack | MOL2160 | 10 x 100uL |
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- Product: Simplexa HSV 1 & 2 Direct Kit
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