Quality Control - BÜHLMANN Quantum Blue Manuel D'utilisation

3.1. Method <CAL_720> with internal timer
• Load the test cassette onto the test cassette holder of
the Reader.
• Add 60 µL of diluted stool extract onto the sample
loading port of the test cassette.
• Close the cassette holder and start the measurement by
pressing the start button.
• The scan starts automatically after 12 minutes (720
seconds).
• For low / high controls: Repeat step 3.1 using 60 µL of
controls instead of diluted stool extract.
3.2. Method <CAL_0> without internal timer
• Add 60 µL of diluted stool extract onto the sample
loading port of the test cassette.
• Incubate for 12 minutes +/-1 minute
(set a timer manually).
• Load the test cassette onto the test cassette holder of
the Reader.
• Scan the cassette with the Quantum Blue
pressing the start (<ENTER>) button immediately.
• For low / high controls: Repeat step 3.2 using 60 µL of
control instead of diluted stool extract.
Remark: Please refer to the Quantum Blue
manual to learn more about the basic functions and how to
initialize and operate the reader, especially how to select
test methods, and how to load lot specific parameters from
the RFID chip card on the Quantum Blue® Reader.

QUALITY CONTROL

• If the precision of the assay does not correlate with the
established limits and repetition excludes errors in
technique, check the following issues: i) pipetting,
Release date: 2020-10-30
temperature controlling and timing ii) expiration dates of
reagents and iii) storage and incubation conditions.
• Result of the self-test of the Quantum Blue
performed at startup has to be valid.
VALIDATION OF RESULTS
• For a valid test result, the control line (C) must be visible
in any case (see figures 1A and 1B). It is used as
functional test control only and cannot be used for the
interpretation of the test line (T). If the test line (T) is not
detectable after 12 minutes of incubation time (figure
1A), the concentration of calprotectin present in the
stool sample is below the detection limit. If a test line (T)
is detectable after 12 minutes of incubation time (figure
1B), the calprotectin concentration present in the stool
sample is calculated by the Quantum Blue
• If only the test line (T) is detectable after 12 minutes of
incubation time (figure 1C), the test result is invalid and
the calprotectin assay has to be repeated using another
test cassette.
• If neither the control line (C) nor the test line (T) are
detectable after 12 minutes of incubation time (figure
1D), the test result is invalid and the calprotectin assay
has to be repeated using another test cassette.
• As the Quantum Blue
evaluation of the test (T) and control (C) lines, an
additional validity check of the control line (C) is
undertaken. If the signal intensity of the control line (C)
is below a threshold after 12 minutes of incubation time,
the test result is also invalid and the Quantum Blue
fCAL assay has to be repeated using another test
cassette.
STANDARDIZATION
• The Quantum Blue
BÜHLMANN fCAL
• The Quantum Blue
curve to calculate the calprotectin concentration. This
lot-specific standard curve is generated with the median
® Reader by
values (n ≥10 measurements each) from at least 10
calibration points obtained from different stool samples
with known calprotectin concentrations. The assay
range is between 30 and 300 µg/g.
• For quantitative measurements, unknown samples
reading above 300 µg/g can be re-tested in the
BÜHLMANN Quantum Blue
code: LF-CHR25).
LIMITATIONS
• Reagents delivered with the BÜHLMANN Quantum
® Reader
Blue
®
calprotectin levels in human stool samples only.
• Fecal calprotectin values are intended as an aid to
diagnosis in distinguishing organic disease from
functional disease. Results should always be interpreted
in combination with other clinical and laboratory
findings.
• Patients who are taking NSAIDs regularly may have
elevations in their fecal calprotectin levels.
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® Reader allows a quantitative
® fCAL is standardized against the
® ELISA (order code: EK-CAL).
® Reader uses a lot-specific standard
®
fCAL kit are intended for the determination of
Reader
®
Reader.
®
®
fCAL high range (order
Quantum Blue® fCAL