ALINITY M
HSV 1 & 2/VZV ASSAY
HSV 1 & 2/VZV ASSAY
For in vitro diagnostic use. Rx only.
With complex instruments, different platforms, sample types, and tubes, sexual health workflows consume excessive time – even for lower-volume tests like HSV 1 & 2 and VZV. This takes time away from labs to innovate testing, staffing, and business models.
TRIPLEX TEST THAT COMBINES HSV 1 & 2 AND VZV ON THE ALINITY M SYSTEM TO HELP:
DIFFERENTIATE HSV 1, HSV 2, AND VZV IN ONE SAMPLE
Reduce manual tasks with an end-to-end testing strategy
Free your team's time with flexible results reporting and collection methods
TRIPLEX ASSAY INNOVATION
- Triplex real-time PCR detects and differentiates HSV-1, HSV-2, 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 gene target for VZV detection to minimize the risk of loss of detection from mutation
- Internal control provides confidence in results by monitoring for adequate sample processing, assay validity, and inhibitions
BREAK THE BATCH WITH EFFICIENT HSV 1 & 2 AND VZV TESTING ON ALINITY M:
- Alinity m is a fully-automated system and provides the ability to eliminate batching procedures in order to improve laboratory workflow with random access
- Consolidating HSV 1 & 2 and VZV workflows, along with STI workflows, on Alinity m helps to reduce redundancy and manual tasks, to free your team’s time to invest in the future of your lab
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 the 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 cutaneous or mucocutaneous lesion swab specimens from symptomatic patients suspected of active herpes simplex virus 1, herpes simplex virus 2 and/or varicella-zoster virus infection. The Alinity m HSV 1 & 2 / VZV assay is intended to aid in the diagnosis of herpes simplex virus 1, herpes simplex virus 2 and/or varicella-zoster virus active cutaneous or mucocutaneous infections. Negative results do not preclude herpes simplex virus type 1, herpes simplex virus type 2 or varicella-zoster virus infections and should not be used as the sole basis for diagnosis, treatment or other management decisions.
The Alinity m HSV 1 & 2 / VZV assay is not intended for use with cerebrospinal fluid (CSF) or to aid in the diagnosis of HSV or VZV infections of the central nervous system (CNS). The Alinity m HSV 1 & 2 / VZV assay is not intended for use in prenatal screening.
LIMITATIONS OF THE PROCEDURE
- This device has been evaluated for use with human specimen collected from cutaneous and mucocutaneous lesions, indicating active infection.
- Negative results do not preclude infection with HSV-1, HSV-2, or VZV and should not be the sole basis of a treatment decision.
- Test results from the Alinity m HSV 1 & 2 / VZV assay should be evaluated in conjunction with other clinical and laboratory findings evaluating the patient.
- Improper collection, storage, or transport may lead to false negative results.
- False-negative results may occur due to the presence of sequence variants in the viral target or may occur if HSV or VZV is present at a level that is below the analytical sensitivity of the assay.
- The instruments and assay procedures reduce the risk of contamination by amplification product. However, nucleic acid contamination from the positive controls or specimens must be controlled by good laboratory practice and careful adherence to the procedures specified in the package insert.
Specifications
| Technology | Multiplex real-time PCR | ||
| Time to First Result | <120 minutes | ||
| Throughput | Up to 1,008 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 (measured from the date of collection) |
*Avoid more than 3 freeze-thaw cycles | ||
| Clinical Performance (Prospective Samples) | Analyte | Sensitivity (%) | Specificity (%) |
| HSV-1 | 97.6 | 98.9 | |
| HSV-2 | 99.2 | 99.2 | |
| VZV | 97.70 | 99.80 | |
| 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.
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