流感疫苗效价测试系统

VaxArray®流感疫苗效价测试系统基于多重免疫测定，其速度比SRID快24倍，并且灵敏度高出几个数量级

VaxArray®平台,简化和加*能测试

VaxArray流感效力测试的速度是SRID的24倍，灵敏度是100倍。与SRID相比，这些测试套件可全年使用-甚至在参考试剂可用之前。易于使用的检测试剂盒基于多重夹心免疫分析法，可在2小时内准确定量流感疫苗的效力。该测试试剂盒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疫苗中的多种抗原，从而大大降低了成本和测试时间。 VaxArray试剂盒是在cGMP条件下通过ISO 13485：2016认证的设施生产的。该操作软件与21 CFR Part 11附件兼容

The VaxArray® Platform

Simplify & Accelerate Potency Testing

The VaxArray Influenza Potency test is 24x faster and 100x more sensitive than SRID. In contrast to SRID, these test kits are available for year-round use – even prior to reference reagent availability. The easy-to-use test kits are based on multiplexed sandwich immunoassays that accurately quantify the potency of influenza vaccines within 2 hours. The test kits rely on broadly reactive yet subtype specific monoclonal antibodies in a microarray format. This innovative multiplexed system enables simultaneous analysis of multiple antigens within vaccines, significantly reducing cost and testing time. VaxArray reagent kits are manufactured under cGMP conditions within ISO 13485:2016 certified facilities. The operational software is 21 CFR Part 11 +Annex compatible.

• Product Details
• Overview
• Applications
• Compatibility
• Software
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• FAQs

VaxArray® Imaging System and Software

The VaxArray Imaging System (VX-6000) is a compact instrument that enables high-resolution fluorescence imaging of both microarray slides and 96 well plates.  The system is sold with intuitive 21 CFR Part 11 +Annex compatible software for use with the VaxArray Influenza potency test kits.

VaxArray Potency Test Kits

Each kit comes with two, 16 microarray slides and enables quantitative analysis of up to 24 samples or qualitative analysis of up to 32 samples.  With two exceptions, the kit contains all of the ancillary reagents needed to conduct the assay (e.g., wash buffers, protein blocking buffer, etc.). 

The VaxArray Potency Test Kits for hemagglutinin currently offered by InDevR are:

VaxArray® Influenza Seasonal HA Potency Test; Part number VXI-7100  v1.2

VaxArray® Influenza Seasonal HA Potency Test; Part number VXI-7101  v2.0

VaxArray® Influenza Seasonal NA Potency Test; Part number VXI-7300 v1.0

VaxArray Influenza Pandemic HA Potency Test; Part number VXI-7200 v1.0

VaxArray® Influenza Pandemic NA Potency Test; Part number VXI-7400 v1.0

Reference Antigens.  The user must identify and obtain an appropriate reference antigen, which can be an ERL-approved standard or an internal standard characterized by a purity adjusted total protein method.

Choose the Best Fluor-Tagged Antibody Label.  The user must select and order the appropriate fluor-tagged label antibody from the range offered by InDevR.  In general, for egg-propagated vaccines we recommend the nearly universal polyclonal vaccine (VXI-7601) for ease of use and broad applicability.  For cell-propagated 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 evaluate a panel of label antibodies to optimize sensitivity.