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 leaves too little time for labs to innovate testing, staffing, and business models.
For In Vitro Diagnostic Use Only. Rx Only.
Multiplex 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.
Compatibility with samples collected in commercially available viral transport media (VTM) helps reduce the need for device swap out.
STAT capability of Alinity m helps to prioritize urgent tests and flexible result reporting adapts to evolving changes in clinical practice.
Dual target 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.
Gain a more holistic view of a patient's infection status with up to three results from a single skin lesion sample
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.
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.
| Specifications1-4 | ||||||||||||||||||||||||||
| Technology | Multiplex RT-PCR | |||||||||||||||||||||||||
| Time to First Result | < 115 minutes | |||||||||||||||||||||||||
| Throughput | Up to 1,080 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)
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| Specimen Stability |
*Avoid more than 3 freeze-thaw cycles | |||||||||||||||||||||||||
| Clinical Performance | Prospective Samples
Retrospective Samples
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| 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 | 600μL | |||||||||||||||||||||||||
Carryover Rate (Overall) | 0.0% (0/360, 95% CI: 0.0%, 1.1%) | |||||||||||||||||||||||||
| Internal Control (IC) | Exogenous internal control (containing plasmid DNA) | |||||||||||||||||||||||||
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