The development of LENTICULES™ as reference materials for noroviruses

Area of Science:

• Virology
• Molecular Diagnostics
• Reference Material Development

Background:

• Noroviruses (NoV) are a leading cause of gastroenteritis globally.
• Accurate quantification of NoV is crucial for public health surveillance and food safety.
• Existing reference materials for NoV are limited, hindering inter-laboratory comparisons.

Purpose of the Study:

• To evaluate LENTICULES™ as potential reference materials (RMs) for noroviruses (genogroups I and II).
• To determine the homogeneity and stability characteristics of NoV LENTICULES™.
• To assess their suitability for quantitative real-time RT-PCR assays.

Main Methods:

• Norovirus strains (GI and GII) were selected from human faecal material.
• LENTICULES™ were produced using modified lenticulating technology according to ISO Guide 34.
• Homogeneity was assessed using established statistical procedures.
• Stability was evaluated over 52 weeks at -15°C and 7 days at ambient temperature.

Main Results:

• A batch of 500 LENTICULES™ containing both GI and GII noroviruses was successfully produced.
• The LENTICULES™ demonstrated sufficient homogeneity.
• Stability was confirmed for medium-term frozen storage and short-term ambient storage.

Conclusions:

• Lenticulation is an effective method for preserving detectable noroviruses.
• NoV LENTICULES™ are homogeneous and stable, suitable for use as reference materials.
• LENTICULES™ offer advantages in ease of manipulation and quality assurance for NoV detection assays.