VaxArray® Nucleoprotein (NP) Assay Kits
Rapid quantification of NP in influenza vaccines
There is a growing awareness that influenza nucleoprotein (NP) is an important but often overlooked component of split virus vaccines, which comprise the majority of influenza vaccines used today. While NP concentrations are not currently regulated, recent studies and incidents have created a demand for better understanding its role in vaccine efficacy and potential adverse effects. In response to a growing demand for tracking NP levels in influenza vaccines, InDevR developed a rapid assay for NP quantification.
VaxArray Nucleoprotein Assay Kits contain 32 microarrays and reagents needed to quantify influenza nucleoprotein in crude samples or final vaccine formulations. The test is a multiplexed immunoassay in which a panel of monoclonal antibodies are used to capture nucleoprotein for quantification. Results are based on fluorescence from an antigen-specific detection label conjugated with a proprietary fluorophore.
Assay features include:
- Compatible Throughout Process: VaxArray enables rapid antigen quantification throughout the manufacturing process without changing methods along the way.
- Specific and Multiplexed: Quantify monovalent or quadrivalent formulations.
- Stability Indicating: As an immunoassay, VaxArray Influenza measures biologically relevant forms of HA.
- Compatibility with Adjuvants: Quantification is unaffected by the presence of adjuvant at dose-sparing concentrations.
- Off the Shelf: Eliminates need for in-house preparation of plates or gels; streamlines testing (time to result is less than 2hrs) and can be used with or without standardized reagents.
- Fast & High Throughput: With a turn-around time of <2 hours, a single analyst can easily quantify 48 samples in a half day.
- Automated Image and Data Processing: Software developed with FDA 21 CFR Part 11 + EU Annex 11 compatible features reduces time spent processing data, enables straightforward data integrity compliance, and maintains digital records with audit log traceability.
Please refer to the Resource Library for links to scientific publications as well as application and technical notes.
Assay (exact metrics are strain specific):
- Time to result ≤ 2 hours
- Precision ≤ 10% CV
- Limit of detection < 10 ng/mL
- Linear dynamic range ≥ 100
- Stability indicating - yes
VaxArray Assay Kits are manufactured under cGMP conditions within ISO 13485:2016 certified facilities. Reagent kit performance was verified in accordance with ICH Guidelines for the Validation of Analytical Procedures. Refer to the literature tab for technical notes.
- Microarray imaging system with internal computer
- Operating system – Windows 7
- Spatial resolution - 6.7 μm
- Signal resolution - 16 bit
- Camera pixel resolution - 964 x 960
- Electrical supply - 100-240V, 50/60 Hz
- Dimensions, length x width x height - 17.25" x 13.5" x 10"
- Weight – 32.8 pounds
- Operating environment +15°C to +35°C 10% to 75% humidity (non-condensing)
- Storage temperature - +5°C to +40°C
- Shipping temperature - +5°C to +40°C
The VaxArray Microarray Imaging System was tested to conform with all CE standards, including the IEC 61010-1 (Ed. 2.0). Refer to the literature tab for the Declaration of Conformity.
VaxArray users must select and order the appropriate fluor-tagged label antibody from the range offered by InDevR (see below for the NP list). Our polyclonal label for NA detection is also compatible with detection of NP.
Conjugated Antibody Available as Detection Label for NP:
NA A&B pAb Label (10x) – P/N: VXI-7616