TRIPLEX TEST THAT COMBINES HSV 1 & 2 AND VZV ON THE ALINITY M SYSTEM TO HELP:
ALINITY M
HSV 1 & 2 / VZV
HSV 1 & 2 / VZV
DETECT AND DIFFERENTIATE HSV-1, HSV-2, AND VZV IN GENITAL ULCER DISEASE WITH A SINGLE TRIPLEX ASSAY
For in vitro diagnostic use.
DIFFERENTIATE HSV-1, HSV-2, and VZV IN ONE SAMPLE
SIMPLE INTEGRATION INTO ROUTINE TESTING INCLUDING STAT CAPABILITIES
FLEXIBLE SAMPLE COLLECTION AND RESULT REPORTING FOR PERSONALIZED TESTING
TRIPLEX ASSAY INNOVATION
- Triplex real-time PCR detects and differentiates HSV-1, HSV-1, and VZV in a single test. Three results from a single skin lesion sample.
- Dual-target design for HSV-1 and HSV-2 enhances sensitivity and robustness for accurate results. 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.
SIMPLE HSV 1 & 2 / VZV TESTING ON ALINITY M
- IVDR approved assay takes away the burden of running a laboratory-developed assay in the IVDR environment.
- Allows for more testing and less holdup. Random access, mixed-sample loading, and the ease to run up to 20 different assays on Alinity m’s fully automated system.
FLEXIBILITY FROM COLLECTION TO RESULT
- Accepts cutaneous and mucocutaneous lesion specimens in common viral transport media to reduce need for device swap out.
- Flexible result reporting adapts to evolving changes in clinical practice.
- <120 minutes to first result. STAT capability for urgent cases.
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.
The intended users for Alinity m HSV 1 & 2 / VZV AMP Kit are laboratory professionals.
Specifications
| Technology | Multiplex real time PCR | ||
| Time to First Result | <120 minutes | ||
| Throughput | Up to 1008 samples in 24 hours* | ||
| Probe Design | HSV-1 (dual target): US6 + UL1 HSV-2 (dual target): UL1 + UL18 VZV (single target): ORF10 | ||
| Specimen Type | Clinician-collected lesion swab specimens (including cutaneous or mucocutaneous lesion specimens) collected in commercially available viral transport media (VTM)
| ||
| Specimen Stability |
(time specified is from the date of collection.) | ||
| Clinical Performance (Prospective Samples) | Analyte | Sensitivity (%) | Specificity (%) |
| HSV-1 | 97.7 | 98.3 | |
| HSV-2 | 95.4 | 97.5 | |
| VZV | 97.9 | 98.8 | |
| Limit of Detection (LoD) | Analyte | LoD (TCID50/mL) | |
| HSV-1 | 5.90 | ||
| HSV-2 | 2.07 | ||
| VZV | 0.055 | ||
| Cross-reactivity | No cross-reactivity observed with 55 different microorganisms | ||
| Result Reporting | Positive or Negative interpretation. CN number is reported for positive results. Flexible Reporting. | ||
| Sample Input Volume | 400 μL | ||
| Carryover Rate (Overall) | 0.0% (0/360, 95% CI: 0.0%, 1.1%) | ||
| Internal Control (IC) | Exogenous internal control (containing plasmid DNA) | ||
*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
HELPFUL RESOURCES
RELATED PRODUCT
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:
<120 minutes time to first result
THROUGHPUT:
300 samples in ~8 hours
NEED HELP OPTIMIZING YOUR LAB’S WORKFLOW FROM SAMPLE TO RESULT?
Talk to your Molecular sales representative to learn more.
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REFERENCES
- Herpes - STI Treatment Guidelines.” Centers for Disease Control and Prevention, 21 Sept. 2022, www.cdc.gov/std/treatment-guidelines/herpes.htm. Accessed 7 June 2025.
- Pinkbook: Varicella.” Centers for Disease Control and Prevention, Epidemiology and Prevention of Vaccine-Preventable Diseases 9 May. 2024, www.cdc.gov/pinkbook/hcp/table-of-contents/chapter-22-varicella.html. Accessed 7 June 2025.