Titel: FAT MAX 45k - Installation Routine
Erstellt: Georg Mitterer Geprüft: Georg Mitterer Freigegeben: Katrin Freina
Final Acceptance Test (FAT) MAX 45k – Installation Routine
Scope
The document describes the final acceptance test (FAT) of the MAX 45k instruments. The FAT test is part
of the normal installation routine and shall be done after every service visit which might have an effect
on the performance of the MAX 45k analyzer. The aim of the FAT test is to verify that the MAX 45k
instruments generate valid results with the ALEX2 test kits.
Test Design
The ALEX2 assay is performed according to the procedure described in detail in the MAX 45k IFU 16-IFU-
01-EN-xx (see pp. 53 ff.).
The following materials are required to perform the FAT assay:
• Test sample (Lyphochek® Allergen IgE, Panel A) from Bio-Rad Laboratories (Ref. 12000142, 6 x 2ml
or 12000144, 1 x 2ml).
• ALEX2 test kit (Ref. 02-5001-02)
The test results shall be analyzed with the RAPTOR SERVER Analysis Software as outlined in the MAX 45k
IFU 16-IFU-01-EN-xx (see pp. 69 ff.) and the outcome of the FAT test is summarized in the FAT MAX 45k
record sheet.
The Lyphochek® Allergen IgE, Panel A test sample will be tested at five different positions of the cartridge
rotor (1 per cartridge rotor segment) in the FAT procedure. The samples shall be tested at the following
positions of the cartridge rotor:
• Pos.01, Pos.11, Pos.21, Pos.31 and Pos.41
Acceptance Criteria
The automatic plausibility check of the software shall be successful for all tested samples. A successful
plausibility check is visualized by a green “OK” in the RAPTOR SERVER Analysis Software under column
“QC”.
The mean of the 5 test samples will be calculated for each test run. The sum of all signals of the mean of
the test samples will be compared to the reference data set. For a successful FAT test, the sum of all
signals of the mean of the test samples shall be within +/- 25 % of the reference data set and the two data
sets shall have a correlation (R2) of > 0,900. Further, the homogeneity of the test run is checked by the
determination of the CV of the mean of all signals of the test samples. The CV shall be <= 10%.
The response of pre-selected allergens is checked. All pre-selected allergens shall fall within their expected
intervals (see table 1).
Finally, selected allergens shall be below 0,3 kUA/l in the mean of the test samples.
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Titel: FAT MAX 45k - Installation Routine
Erstellt: Georg Mitterer Geprüft: Georg Mitterer Freigegeben: Katrin Freina
Table 1. Target Intervals for the Test Sample
target Value Expected Min Expected Max
Allergen Code
(kUA/l) (kUA/l) (kUA/l)
Alt a 1 m229 11.89 5.00 25.00
Ara h 2 f423 0.85 0.30 3.00
Ara h 9 f427 1.08 0.30 3.00
Art v 1 w231 0.00 0.00 0.30
Asp f 3 m220 2.27 1.00 4.00
Bet v 1 t215 2.08 0.50 5.00
Bos d 2 e100 0.00 0.00 0.30
Bos d 8 f78 1.71 0.50 5.00
Can f 1 e101 7.03 3.00 13.00
Can f 2 e102 7.54 3.00 13.00
Can f 3 e221 9.94 4.00 17.00
Der p 1 d202 5.42 2.00 10.00
Der p 2 d203 8.98 4.00 15.00
Fel d 1 e94 8.60 4.00 21.50
Fel d 2 e220 4.49 1.00 10.00
Phl p 1 g205 5.23 1.00 12.00
Phl p 5.0101 g215 3.81 1.00 10.00
Phl p 7 g210 7.95 2.00 13.00
Pru p 3 f420 1.13 0.30 3.00
The target intervals were created with the Lyphochek Allergen IgE, Panel A, Lot 22640 from Bio-Rad
Laboratories. The above stated values can differ when other lots of the Lyphochek test sample are used
for the testing.
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