VaxArray® Influenza Pandemic Neuraminidase (NA) Potency Test
The VaxArray Influenza Pandemic Neuraminidase Potency Assay is a quantitative multiplexed immunoassay specific for pandemic N9 neuraminidase. The assay relies on broadly reactive yet subtype specific monoclonal antibodies in a microarray format. This innovative system significantly reduces cost and testing time. The VaxArray Influenza Pandemic NA Potency Assay exhibits excellent correlation with enzymatic activity and can be used as an easy alterative to enzymatic activity assays. When paired with appropriate calibration antigens, the kit can be used to quantify NA even in relatively complex media such as allantoic fluid, 40% sucrose, and alum or squalene adjuvants.
The VaxArray NA kit is manufactured using cGMP in an ISO 13485:2016 certified facility. Reagent kit performance was verified in accordance with ICH Guidelines for the Validation of Analytical Procedures. Refer to the literature tab for strain specific technical notes. The operational software enables straightforward customer compliance with FDA 21 CFR Part 11 and EU Annex 11.
The VaxArray® Influenza Pandemic NA v1.0 Potency Assay Kit contains 32 microarrays and the reagents needed to quantify the neuraminidase content of N9 subtype antigens. VaxArray is a multiplexed immunoassay in which a panel of monoclonal antibodies is used to capture subtype-specific antigen. Results are based on fluorescence from an antigen-specific antibody label conjugated with a proprietary fluorophore. The arrangement of monoclonal capture antibodies within each microarray (i.e. within each well) is shown in the figure below.
Assay features include:
- Subtype Specific. The microarray utilizes multiple antibodies for N9 subtype antigens with 9 replicates per antibody in a single test, providing high confidence in protein quantification results.
- Excellent Correlation with Enzymatic Activity. Each antibody within the microarray has been shown to exhibit excellent correlation with enzymatic activity, including after forced thermal degradation.
- More Robust than Activity Assays. No need for finicky enzymes, the assay is conducted at room temperature and the quantification range is generally 10-100x larger than the typical range for enzymatic activity assays.
- Stability Indicating. The assay has been demonstrated to quantify biologically relevant, conformationally intact forms of NA.
- Compatibility with Adjuvants. NA quantification is robust even in the presence of common adjuvants at dose-sparing antigen concentrations including alum and squalene (MF-59).
- Off-the-Shelf Kit. Eliminates need for in-house preparation of plates or gels; streamlines analysis.
- 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 Literature tab for links to scientific publications as well as application and technical notes.
- Each kit contains two 16-well microarray slides (total of 32 arrays) and all required wash buffers and protein blocking buffers
- The microarray layout within each well is shown on the overview page along with a basic description of each capture antibody
- Each capture antibody is spotted in 9 replicates
- Kit is intended for use with the VaxArray Imaging System and Analysis Package (P/N VX-6000)
- Label antibodies must be purchased separately (see Label Antibodies tab)
- Reference antigens and lysis reagent not provided
Reagent Kit Contents and Storage
- 2 VaxArray Influenza Pandemic Neuraminidase v1.0 Slides, P/N VXI-7450 (store at +2 to +8°C)
- 1 VaxArray Protein Blocking Buffer, P/N VX-6302 (store at +2 to +8°C)
- 2 VaxArray Wash Buffer 1 Concentrate, P/N VX-6303 (store at +2 to +27°C)
- 2 VaxArray Wash Buffer 2 Concentrate, P/N VX-6304 (store at +2 to +27°C)
- 1 VaxArray Strip Tubes, 6 strips, P/N VX-6201 (store at +2 to +27°C)
VaxArray® Starter Kit, P/N VX-STARTER
There are a few ancillary materials needed to get started with VaxArray. New users may wish to consider a Starter Kit, which includes:
- VaxArray Imaging System with 21 CFR Part 11 compatible software (P/N VX-6000)
- VaxArray Accessory Kit (P/N VX-6200)
- VaxArray Air Compressor for slide drying (P/N VX-6208)
- IQ/OQ Package (P/N VX-6210)
- 10 VaxArray Assay Kits of your choice with selected antibody labels
- Installation and training (P/N VX-TRN)
VaxArray users must select and order the appropriate fluor-tagged label antibody from the range offered by InDevR (see below for the pandemicNA mAb list). In general, for egg-propagated flu vaccines we recommend the nearly universal polyclonal antibody (VXI-7616) for ease of use and broad applicability. For cell-propagated flu vaccines, recombinant proteins, or virus-like particles, it is recommend that you review the Label Selection Guide or, better yet, speak with our scientists about which label antibodies to try. It is sometimes necessary to experimentally evaluate a panel of label antibodies in order to optimize sensitivity.
Conjugated Antibodies Available as Labels for N9 subtypes:
- NA A&B pAb Label (10x) – P/N: VXI-7616
- A N9-17 mAb Label (10X) – P/N: VXI-7617
Please refer to the Literature tab for the Label Selection Guide.
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
The VaxArray Influenza Pandemic NA Assay Kit is manufactured under cGMP conditions within ISO 13485:2016 certified facilities. Refer to the literature tab for strain specific technical notes.
· Microarray imaging system with integrated 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 conforms with all CE standards, including the IEC 61010-1 (Ed. 2.0). Refer to the literature tab for the Declaration of Conformity.
- A Neuraminidase Potency Assay for Quantitative Assessment of Neuraminidase in Influenza Vaccines
- VaxArray for Hemagglutinin and Neuraminidase Potency Testing of Inﬂuenza Vaccines
- VaxArray Assessment of Influenza Split Vaccine Potency and Stability
- Titer on Chip: New Analytical Tool for Influenza Vaccine Potency Determination
- VaxArray Pandemic Neuraminidase Operation Manual
- VaxArray Imaging and Analysis Operation Manual
- VaxArray Influenza Assay Reference Guide
Safety Data Sheets (SDS)