Assessment of the Alinity m HSV1&2/VZV assay for quantitative analysis across multiple off-label sample types

Area of Science:

• Clinical Virology
• Molecular Diagnostics
• Infectious Diseases

Background:

• The Alinity m HSV1&2/VZV assay is designed for detecting herpesviruses in lesion swabs.
• Its performance in alternative specimen types requires validation.

Purpose of the Study:

• To evaluate the reliability of the Alinity m assay for detecting and quantifying HSV-1, HSV-2, and VZV in alternative specimen types.
• To compare its performance against the ELITe BeGenius system.

Main Methods:

• Reference panels and clinical lesion swabs were tested using the Alinity m and ELITe BeGenius systems.
• Specimens included amniotic fluid, bronchoalveolar lavage, cerebrospinal fluid, plasma, and viral transport media.

Main Results:

• The Alinity m assay detected all targets but had higher limits of detection (LoD) than the ELITe system across various matrices.
• Adjusting thresholds improved LoDs for HSV-1, HSV-2, and VZV in specific matrices.
• Five discrepancies were noted in clinical samples, mainly with low viral loads.

Conclusions:

• The Alinity m assay is suitable for lesion swabs but shows limitations in alternative matrices.
• It may be viable for plasma testing, but the ELITe system offers superior sensitivity for low viral loads.