Quidel™ Lyra Direct HSV 1+2/VZV Molecular Assay

Multiplex RT-PCR IVD detect/differentiate herpes simplex virus type 1 and 2, varicella-zoster virus nucleic acids isolated/purified from cutaneous/mucocutaneous specimens, FDA approved for use Applied Biosystems™ 7500 FastDx RT-PCR, QuantStudioDx RT-PCR, Cepheid™ SmartCycler™ II

Manufacturer:  Quidel™ M102

Catalog No. 23-044-001

Description

• RT-PCR
• One-step reagent setup
• Results in <60 minutes
• No freezer necessary
• Refrigration storage
• Long shelf-life
• Flexible testing format
• Includes 12 x 8 master mix, rehydration solution and liquid process controls
• Sample preparation kit includes all consumables

Specifications

• Certifications/Compliance: FDA approved*
• Control Sets: Included
• CE Marker: Yes
• Detectable Analytes: Herpes simplex virus type 1, Herpes simplex virus type 2, Varicella-zoster virus
• Format: Molecular Testing
• Sensitivity: Cutaneous: HSV-1 100.0%, HSV-2 97.1%, VZV 96.3%; Mucocutaneous: HSV-1 95.1%, HSV-2 97.9%, VZV 100.0%
• For Use With (Application): RT-PCR
• Includes: Tests and controls
• Quantity: 96 Tests/Kit
• Test Time: <60 min.

• Content And Storage: 2°C to 8°C
• Description: Qualitative detection and differentiation of herpes simplex virus type 1, herpes simplex virus type 2, and varicella-zoster virus DNA isolated and purified from cutaneous or mucocutaneous lesion samples obtained from symptomatic patients suspected of active herpes simplex virus 1, herpes simplex virus 2 and/or varicella-zoster infection
• Clia Complexity: Highly Complex
• DoA Calibrators: No
• Sample Type: Cutaneous or Mucocutaneous Swab Specimens
• Type: Molecular Testing
• For Use With (Equipment): FDA approved for use on Applied Biosystems™ 7500 Fast Dx Real-Time PCR Instrument, QuantStudioTM Dx Real-Time PCR Instrument and Cepheid™ SmartCycler™ II
• Packaging Type: Kit
• Specificity: Cutaneous: HSV-1 98.8%, HSV-2 96.7%, VZV 96.4%; Mucocutaneous: HSV-1 98.2%, HSV-2 97.1%, VZV 99.3%

Safety and Handling

ShelfLife : 2 Years from DOM