OPTIGEN® - Hitachi Chemical Diagnostics
OPTIGEN® - Hitachi Chemical Diagnostics
OPTIGEN® - Hitachi Chemical Diagnostics
You also want an ePaper? Increase the reach of your titles
YUMPU automatically turns print PDFs into web optimized ePapers that Google loves.
V Qualification Procedure VI Universal Panel 20<br />
A random sample of assembled devices is tested with positive and negative control sera that<br />
have been qualified for OPTIGEN. The expected performance of these sera has been characterized<br />
for different allergens and is documented. The flow of the qualification procedure is<br />
shown in Figure 10.<br />
Device<br />
Assembly<br />
Qualification with<br />
Positive and<br />
Negative Sera<br />
Specifications<br />
Met<br />
Fig. 10 | Summary of the Qualification Procedure for OPTIGEN<br />
The first marketed panel using OPTIGEN technology is the Universal Panel 20 (Figure 11).<br />
This panel was selected with the aid of allergists and pediatricians in different countries and<br />
targets the most common allergens worldwide. This panel is ideal for pediatric use due to the<br />
low amount of serum sample needed for 20 results.<br />
ALLERGEN<br />
Birch, White<br />
Ragweed Mix I<br />
Timothy Grass<br />
Mugwort<br />
Latex<br />
Soybean<br />
Rice<br />
Codfish<br />
Wheat<br />
Peanut<br />
Egg white<br />
Cow’s Milk<br />
Aspergillus<br />
Cladosporium<br />
Alternaria<br />
Dog<br />
Cat<br />
Cockroach Mix<br />
Mite p<br />
Mite f<br />
No<br />
Reject<br />
LATIN NAME<br />
Yes<br />
Release for<br />
Packaging<br />
Betula verrucosa (alba, pendula)<br />
Ambrosia elatior/Ambrosia trifida<br />
Phleum pratense<br />
Artemisia vulgaris<br />
Hevea brasiliensis<br />
Glycine max<br />
Oryza sativa<br />
Gadus morhua<br />
Triticum aestirum<br />
Arachis hypogaea<br />
Gallus gallus<br />
N/A<br />
Aspergillus fumigatus<br />
Cladosporium herbarum/Cladosporium cladosporiodes<br />
Alternaria alternata (tenuis)<br />
Canis<br />
Felis domesticus<br />
Blatella germanica/Periplaneta americana<br />
Dermatophagoides pteronyssinus<br />
Dermatophagoides farinae<br />
Fig. 11 | Allergens in the Universal Panel 20<br />
11
Change language