流感疫苗效價測試系統

VaxArray®流感疫苗效價測試系統基于多重免疫測定，其速度比SRID快24倍，并且靈敏度高出幾個數量級

VaxArray®平臺,簡化和加*能測試

VaxArray流感效力測試的速度是SRID的24倍，靈敏度是100倍。與SRID相比，這些測試套件可全年使用-甚至在參考試劑可用之前。易于使用的檢測試劑盒基于多重夾心免疫分析法，可在2小時內準確定量流感疫苗的效力。該測試試劑盒依賴于微陣列形式的廣泛反應性但亞型特異性的單克隆抗體。這種創新的多重系統能夠同時分析疫苗中的多種抗原，從而大大降低了成本和測試時間。 VaxArray試劑盒是在cGMP條件下通過ISO 13485：2016認證的設施生產的。該操作軟件與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
• Literature
• 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.