Thermo Scientific Phadia 100, Руководство пользователя

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Phadia 100 - User Manual Quality Assurance
12-3501-20/12 Page 8.15
8
Expected Results
All
in vitro
allergy, asthma and autoimmunity testing are immunodiagnostic
procedures. For such procedures it is not possible to obtain the %CV in the same
range as for “classical” clinical chemistry analytes like sodium, glucose, etc. in
external quality assessment programs.
For most immunodiagnostic procedures, such programs normally give CV in
ranges of 10 to 15%. Normally only one, mostly well-defined molecule is
handled. For this molecule are also international reference preparations avail-
able.
For Total IgE, the WHO international reference preparation is the basis for all
calibrations. Thus Total IgE tests are comparable to other immunodiagnostic
tests from external quality assessment program point of view.
For Specific IgE the situation is somewhat different. The allergen preparations
used are of biological origin with no international reference preparations
available. They consist of a complex mixture of many different protein
components. As an example, peanut allergen consists of 25 different major and
minor allergenic components. There are many possibilities for batch-to-batch
variation of the allergen source material (natural variation).
These complex mixtures must be handled in a way to allow reproducibility
throughout the whole production process in order to secure high-quality test
results.
Although the process involves such complex mixtures, laboratories in more
than 10 different countries, use different production lots of allergen ImmunoCAP,
they obtain only slightly higher coefficients of variation in the Quality Club
program than for other immunodiagnostic procedures.
External quality assessment programs involving different specific IgE methods
show Phadia 100 to be the most robust user-independent and reproducible
specific IgE test on the market.