流感季節(jié)性神經(jīng)氨酸酶效能測(cè)試系統(tǒng)，VaxArray Influenza Seasonal NA Potency Test Kit v1.0, P/N VXI-7300

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 m*lent 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. 

VaxArray® Influenza Seasonal NA Potency Test Kit v1.0, P/N VXI-7300

• 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)

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.

Instrument:

• 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.

Publications

A neuraminidase potency assay for quantitative assessment of neuraminidase in influenza vaccines
VaxArray for Hemagglutinin and Neuraminidase Potency Testing of In?uenza Vaccines
VaxArray potency assay for rapid assessment of pandemic influenza vaccines
VaxArray Assessment of Influenza Split Vaccine Potency and Stability
Titer on Chip: New Analytical Tool for Influenza Vaccine Potency Determination

Talks & Posters

Neuraminidase Potency Assay for Seasonal Influenza Vaccines

Application Notes

VaxArray Quantification of Neuraminidase in Vaccines
VasArray Compatibility with Adjuvanted Vaccines
VaxArray Crude (In-Process) Samples

Label Information

Seasonal Neuraminidase Label Selection Guide
Seasonal Neuraminidase Label Antibodies Product Insert
Technical Notes

VaxArray Layout and Specificity, Seasonal NA v1.0
VaxArray Comparison with IDMS and Activity

Product Information

VaxArray Influenza Seasonal NA Product Sheet 
VaxArray Imaging System Declaration of Conformity

Validation Reports

VaxArray Seasonal Neuraminidase Validation Report
 

Operation Manuals

Operation Manual for VaxArray Influenza Potency Assays
VaxArray Imaging and Analysis System Operation Manual
Reference Guide for VaxArray Influenza Assays
 

Safety Data Sheets (SDS)

SDS VaxArray Label Antibodies
SDS VaxArray Wash Buffer 1 Concentrate
SDS VaxArray Wash Buffer 2 Concentrate
SDS VaxArray Protein Blocking Buffer
SDS VaxArray Protein Blocking Buffer 2.0
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