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ALINITY m HSV 1 & 2 / VZV ASSAY

ALINITY m BKV ASSAY image
ALINITY m BKV ASSAY image
ALINITY m BKV ASSAY image

Unlock time by consolidating HSV 1 & 2 and VZV workflows
on the fully-automated Alinity m system

Multiplex test that combines
HSV 1 & 2 and VZV on the
Alinity m system, to help:
Consolidate workflows
Reduce manual tasks
Free your team's time

Improved Efficiency & Productivity

  • Multiplex assay design eliminates the need for separate reagents for HSV 1 & 2 and VZV testing.
  • Consolidate HSV 1 & 2 and VZV testing workflows, along with sexual health testing workflows on Alinity m to help reduce redundancy and manual tasks.
  • Alinity m is a continuous and random-access molecular analyzer with a time to first result of less than 115 minutes that provides the ability to eliminate batching procedures and leads to improved laboratory workflow.

Improved Flexibility

  • Alinity m HSV 1 & 2 / VZV assay compatibility with samples collected in commercially available viral transport media (VTM) helps reduce the need for device swap out.
  • STAT capability helps to prioritize urgent tests.
  • Flexible result reporting adapts to evolving changes in clinical practice.

Improved Clinical Confidence

  • Dual target assay design helps provide robust, accurate and sensitive detection of HSV 1 and HSV 2.
  • Single, highly conserved gene target for VZV detection to minimize the risk of loss of detection from mutation.
  • Internal control provides confidence in results by monitoring for proper sample processing, assay validity, and inhibitions.
  • Gain a more holistic view of a patient's infection status with up to three results from a single skin lesion sample.
Instructions For Use
VIEW ORDERING INFORMATION

INTENDED USE
 

The Alinity m HSV 1 & 2 / VZV assay is an in vitro real-time polymerase chain reaction (PCR) assay for use with the automated Alinity m System for the direct qualitative detection and differentiation of Herpes Simplex Virus 1 (HSV-1), Herpes Simplex Virus 2 (HSV-2), and Varicella Zoster Virus (VZV) DNA from clinician-collected lesion swab specimens (including cutaneous or mucocutaneous lesion specimens).

The Alinity m HSV 1 & 2 / VZV assay is intended for use as an aid in the diagnosis of HSV-1, HSV-2 and/or VZV infections in symptomatic patients.

SPECIFICATIONS
TechnologyMultiplex RT-PCR
Time to First Result<115 minutes
ThroughputUp to 1,080 samples in 24 hours*
Probe DesignHSV-1 (dual target)
HSV-2 (dual target)
VZV (single target)
Specimen TypeClinician-collected lesion swab specimens (including cutaneous or mucocutaneous lesion specimens) collected in commercially available viral transport media (VTM):

• Copan UTM
• BD UVT
• Remel M4RT
Specimen Stability15°C to 25°C ≤ 4 days
2°C to 8°C ≤ 14 days
-25°C to -15°C ≤ 90 days†
-70°C or colder: ≤ 90 days†
Clinical Performance
AnalyteSensitivity (%)Specificity (%)
HSV-197.798.3
HSV-295.497.5
VZV97.998.8
Limit of Detection (LoD)
AnalyteLOD (TCID50/mL)
HSV-15.90
HSV-22.07
VZV0.055
Cross-reactivityNo cross-reactivity observed with 55 different microorganisms
Result ReportingPositive or Negative interpretation. CN number is reported for positive results. Flexible Reporting.
Sample Input Volume600 µL
Carryover Rate (Overall)0.0% (0/360, 95% CI: 0.0%, 1.1%)
Internal ControlExogenous internal control (containing plasmid DNA)

RT-PCR = reverse transcription polymerase chain reaction
*Number of actual samples per 24-hour period may vary based on laboratory practice and workflow.
The Alinity m HSV 1 &2 / VZV AMP kit is an in vitro diagnostic device, which is CE marked. Notified body number 2797.
† Avoid more than 3 freeze-thaw cycles

AMPLIFY YOUR IMPACT WITH ALINITY m

Alinity m is a fully integrated and automated molecular diagnostics analyzer that uses ReadiFlex technology to deliver the next level of flexibility and efficiency to your lab. 
 

FLEXIBILITY: True random access to perform any test, any time
TURNAROUND TIME: <115 minutes time to first result
THROUGHPUT: 300 samples in ~8 hours

LEARN MORE

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