Thermo Scientific Phadia 100, User Manual

Page: 180 / 357

Phadia 100 - User Manual Quality Assurance
12-3501-20/12 Page 8.5
8
ImmunoCAP Gliadin IgA Control H are human serum pools at a high concentration
level. Ready to use.
ImmunoCAP Gliadin IgA/IgG Control L are human serum pools at a low
concentration level. Ready to use.
ImmunoCAP Gliadin IgG Control H are human serum pools at a high concentra-
tion level. Ready to use.
ImmunoCAP Gliadin IgA/IgG Control LMH are human serum pools at three
different concentration levels; low, medium and high. Ready to use.
ImmunoCAP Tryptase Control
is a lyophilized human serum at one concentration
level.
ImmunoCAP Thyroid Peroxidase IgG Antibodies Control NLH are human serum
pools at three different levels; normal, low and high, to be used with ImmunoCAP
Specific IgG together with ImmunoCAP Thyroid Peroxidase ImmunoCAP.
ImmunoCAP Thyroglobulin IgG Antibodies Control NLH are human serum pools
at three different levels; normal, low and high, to be used with ImmunoCAP
Specific IgG together with ImmunoCAP Thyroglobulin ImmunoCAP.
EliA ANA Control positive, negative are human serum pools to be used with EliA
IgG together with ANA tests.
EliA ANCA/GBM Control
positive, negative are human serum pools to be used
with EliA IgG together with ANCA/GBM tests.
EliA APS Control
positive, negative is a human serum to be used with EliA IgG/
IgM/IgA together with APS tests.
EliA CCP Control positive, negative is a human serum to be used with EliA IgG
together with CCP tests.
EliA Celiac Control positive, negative are human serum pools to be used with EliA
IgG together with Celikey/Gliadin tests.
Origin:
• Human samples from allergic/autoimmune (positive) and non-allergic/non-
autoimmune (negative) donors.
Control:
• All sera have been tested by immunoassay and found negative for
hepatitis B surface antigen, hepatitis C and antibodies to HIV virus.
Characterization:
• All selected sera used for IgE testing are tested for total IgE and a broad panel
of relevant allergens. All sera used for IgA/IgG, ECP, Tryptase, and EliA IgG
testing are analyzed with the respective test method.
Phadia Diagnostic Sample Unit:
• All sera are stored in Phadia Diagnostic Sample Unit, which has over 25,000
characterized serum samples. This allows for the pooling of sera for specific
control purposes. It also enhances continuity with our internal quality assur-
ance and uniformity of our products.