VaxArray® Seasonal Influenza Neuraminidase (NA) Potency Test
Rapid Quantification of Neuraminidase
The VaxArray Influenza Seasonal NA Potency test is a quantitative multiplexed immunoassay specific for seasonal NA subtypes, N1, N2 and B-NA. The test relies on broadly reactive yet subtype specific monoclonal antibodies in a microarray format. This innovative multiplexed system enables simultaneous analysis of all neuraminidase antigens within multivalent vaccines, significantly reducing cost and testing time. The VaxArray NA test 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 or 40% sucrose.
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 Seasonal Neuraminidase (NA) Potency Test Kit contains 32 microarrays and most of the reagents needed to quantify N1, N2, and B NA from both B/Yamagata-like and B/Victoria-like viruses. The test is a multiplexed immunoassay in which a panel of monoclonal antibodies is used to capture subtype-specific antigen. Readout is based on fluorescence from an antigen-specific “label” antibody 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 and Multiplexed. Quantify any or all components of a quadrivalent formulation (note that B NA has not diverged for the two HA lineages). The microarray utilizes multiple antibodies for each subtype with 9 replicates per antibody in a single test, providing high confidence in results for protein quantification.
- 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.
- Most 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 test has been demonstrated to quantify biologically relevant forms of NA.
- Compatibility with Adjuvants. NA quantification is robust even in the presence of common adjuvants at dose-sparing antigen concentrations.
- Off-the-Shelf Kit. Eliminates need for in-house preparation of plates or gels; streamlines testing.
- 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 virion lysing detergent not included
Reagent Kit Contents and Storage
- 2 VaxArray Influenza Seasonal Slides, P/N VXI-7350 v1.0 (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 Fiducial Label, P/N VX-6301 (store at +2 to +8°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 reagent 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 anti-NA 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 NA:
- NA A&B pAb Label (10x) – P/N: VXI-7616
- A N1-15 pAb Label (10X) – P/N: VXI-7615
- A N2-12 mAb Label (10X) – P/N: VXI-7612
Not sure what label to choose? 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 NA kit is manufactured under cGMP conditions within ISO 13485:2003 certified facilities. Refer to the literature tab for strain specific 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.
- A neuraminidase potency assay for quantitative assessment of neuraminidase in influenza vaccines
- VaxArray for Hemagglutinin and Neuraminidase Potency Testing of Inﬂuenza Vaccines
Talks & Posters
- Quantification of Neuraminidase in Vaccines
- Compatibility with Adjuvanted Vaccines
- Crude (In-Process) Samples
- VaxArray Influenza Seasonal HA Operation Manual
- VaxArray Instrument Operation Manual
- VaxArray Imaging Instrument Quick Setup Guide
Safety Data Sheets (SDS)