|Name & Catalogue No.||Description||Applications|
|*NEW* Rotavirus Antigen EL-35-03||
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Inactivation and Safety
Product Information Sheet
Frequently Asked Questions
1. What’s new with EL-35-03?
Microbix has developed an improved purification process and inactivation procedure for EL 35 03. The product has higher purity and superior antigen titre and performance in most immunoassays compared to EL 35-02 (which has been discontinued).
The characteristics of EL-35-03 are similar to EL-35-AA. The difference is the scale of the production system.
EL-35-03 is designed for use in immunoassays and positive control preparations in antigen detection assays like point-of-care tests. It contains predominantly intact viral particles as well as free viral antigens and non viral proteins. The product is formulated in Bicine/EDTA buffer and it does not contain preservatives.
2. Why are you not reporting the protein concentration on the Product Information Sheet?
We recommend this antigen be used by volume and not by mass. This is because EL-35-03 contains viral particles and some non-viral proteins. Consequently, any protein assay would measure total protein level and not provide a specific concentration of viral proteins as would be necessary for using the product on mass basis.
To provide a consistent concentration of viral protein, Microbix standardizes each lot based on the immunoassay titre. This ensures all lots have uniform level of activity per milliliter, irrespective of total protein concentration, We have not established a specification for total protein, but we expect this to range from 1.0mg/ml to 5.0mg/ml. The overall protein concentration should not impact assay performance when the antigen is used in solution as a positive control.