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

• 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

Certifications/Compliance

FDA approved*

Content And Storage

2°C to 8°C

Control Sets

Included

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

CE Marker

Yes

Clia Complexity

High

Detectable Analytes

Herpes simplex virus type 1, Herpes simplex virus type 2, Varicella-zoster virus

DoA Calibrators

No

Sample Type

Cutaneous or Mucocutaneous Swab Specimens

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%

Type

Molecular Testing

For Use With (Application)

RT-PCR

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

Includes

Tests and controls

Packaging Type

Kit

Quantity

96 Tests/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%

Test Time

<60 min.

Form

Liquid