VaxArray流感季节性神经氨酸酶效能测试系统， Influenza Seasonal Neuraminidase Potency Test Kit

VaxArray? Seasonal Influenza Neuraminidase (NA) Potency Test

神经氨酸酶的快速定量

VaxArray流感季节性NA效价测试是针对季节性NA亚型N1，N2和B-NA的定量多重免疫测定法。 该测试依赖于微阵列形式的广泛反应性但亚型特异性的单克隆抗体。 这种创新的多重系统能够同时分析多价疫苗中的所有神经氨酸酶抗原，从而大大降低了成本和测试时间。 VaxArray NA测试与酶活性具有极好的相关性，可以用作酶活性测定的简便替代方法。 与适当的校准抗原配对后，该试剂盒甚至可以用于相对复杂的培养基（如尿囊液或40％蔗糖）中定量NA。

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)

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)