OPTIGEN® - Hitachi Chemical Diagnostics
OPTIGEN® - Hitachi Chemical Diagnostics
OPTIGEN® - Hitachi Chemical Diagnostics
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III Extraction Process and Quality Control<br />
The allergen is one of the most critical components of an in vitro allergy test. HCD fully<br />
understands the need for tight control of both raw materials and extraction procedures<br />
in order to maintain consistent quality. Figure 5 shows the process and approvals from<br />
raw material to extract.<br />
Purchase<br />
Extract from<br />
Vendor as<br />
per HCD<br />
Specifications<br />
Purchase<br />
Raw Material<br />
from Vendor<br />
as per HCD<br />
Specifications<br />
QA<br />
Approval<br />
QA<br />
Approval<br />
Yes<br />
Reconstitute<br />
Extract if<br />
Lyophilized<br />
Extraction<br />
SDS-PAGE<br />
No<br />
Return to<br />
Vendor<br />
Scrap Extract<br />
No<br />
All Allergenic<br />
Proteins<br />
Present<br />
No<br />
Approve<br />
Extract for<br />
Immobilization.<br />
Perform Protein<br />
Determination<br />
Yes<br />
Band Present<br />
Per<br />
Specification<br />
Yes<br />
Western<br />
Blots<br />
Fig. 5 | Process from Raw Material to Extract at HCD<br />
7
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