Thermo Scientific Phadia 100, User Manual

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Routine Assay Run Phadia 100 - User Manual
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Verification of Instrument Performance
To verify the instrument performance before using the instrument in routine runs,
please follow the instructions below.
A number of laboratories have accreditation for running specified tests. To
receive and obtain this accreditation proof regarding the quality of the results is
requested. Below find a suggestion on how to test the performance of different
methods in Phadia100.
This protocol also can be used just to check the performance of a specific method
or Phadia100 instrument. Examples are given below.
Other methods can use a suiting protocol as one of the examples below, for
example to verify Specific IgA the protocol for Specific IgG can be used and to
verify Tryptase the protocol for ECP can be used.
The following general reagents are required:
Development Kit
Washing Solution
ImmunoCAP Specific IgE 0-100
Reagents for ImmunoCAP Specific IgE 0-100
ImmunoCAP Specific IgE
ImmunoCAP Specific IgE Calibrators 0-100
ImmunoCAP Specific IgE Control
ImmunoCAP Specific IgE Negative Control
Anti-IgE ImmunoCAP
ImmunoCAP Allergen d1
ImmunoCAP Allergen e1
ImmunoCAP Allergen t3
or other allergens included in ImmunoCAP Specific IgE Control;
d1, e1, g6, m6, t3, w1, or ImmunoCAP Specific IgE f1 Control
Protocol for acceptance of ImmunoCAP Specific IgE 0-100
Run 1:
• Full calibration curve (0, 0.35, 0.7, 3.5, 17.5, 100 kU IgE/l, in duplicates this
is set as default in the software when a calibration curve is requested).
• ImmunoCAP Specific IgE Control tested for three allergens in duplicate
(define controls according to Chapter 4, Assay Run Editing Functions)