Meridian Bioscience™ Alethia™ HSV 1 and 2 DNA Amplification Assay

Qualitative in vitro diagnostic test for direct detection and differentiation of herpes simplex virus type 1 and type 2 in cutaneous and mucocutaneous lesion specimens.

Supplier:  Meridian Bioscience™ 480650

Catalog No. 23-029-010

Includes: 25 Tests each for HSV-1 and HSV-2.

Description

illumigene HSV 1&2 utilizes loop-mediated isothermal DNA amplification (LAMP) to detect HSV-1 and HSV-2. Results are available in less than one hour to reduce turn around time, eliminate send-out costs and aid in same day diagnosis, treatment and counseling of patients.

• Results in less than one hour
• High sensitivity and specificity improves accuracy of diagnosis
• Testing requires <2 minutes of hands-on time
• Expanded molecular menu
• Reduce cost and increase profitability
• No capital expense or service contract required
• Moderately complex with minimal hands-on time
• Small footprint, easily adaptable to any laboratory

Specifications:

• HSV-1 Sensitivity: Cutaneous: 94.1%, Mucocutaneous: 95.0%
• HSV-2 Sensitivity: Cutaneous: 100%, Mucocutaneous: 98.6%
• HSV-1 Specificity: Cutaneous: 97.2%, Mucocutaneous: 94.9%
• HSV-2 Specificity: Cutaneous: 95.1%, Mucocutaneous: 95.6%
• Acceptable Sample Types: Cutaneous: skin and genital (penis); Mucocutaneous: anorectal and genital (vaginal/cervical, nasal, ocular, oral, urethral)
• Assay Format: Isothermal DNA amplification

Certifications

CE marked

Specifications

• Certifications/Compliance: CE Marked
• Clia Complexity: Moderate
• Sample Type: Mucocutaneous and Cutaneous
• Type: HSV 1& DNA Amplification Assay
• Includes: 25 Tests each for HSV-1 and HSV-2
• Specificity: HSV-1: Cutaneous: 97.2%, Mucocutaneous: 94.9%; HSV-2: Cutaneous: 95.1%, Mucocutaneous: 95.6%

• Content And Storage: Store kits at 2°C to 30°C and external controls at 2°C to 8°C.
• Detectable Analytes: HSV-1/2
• Sensitivity: HSV-1: Cutaneous: 94.1%, Mucocutaneous: 95.0%; HSV-2: Cutaneous: 100%, Mucocutaneous: 98.6%
• For Use With (Application): Detects and differentiates HSV-1 and HSV-2
• Quantity: 25 Each
• Test Time: <1 hr.

Safety and Handling

ShelfLife : 18 Months