BÜHLMANN Quantum Blue Manuel D'utilisation page 4

Technical precautions
Kit components
• All reagents and test samples must be equilibrated to
room temperature (18-28 °C) before starting the assay.
• Components must not be used after the expiration date
printed on the labels.
• Do not mix different lots of reagents.
• Test cassettes cannot be re-used.
Test procedure
• Read the instructions carefully prior to carrying out the
test. Test performance will be adversely affected, if
reagents are incorrectly diluted, handled or stored under
conditions other than those as detailed in this instruction
for use.
• The Quantum Blue
®
programmed for the Quantum Blue
(CAL_0 or CAL_720) before starting the test (see
Quantum Blue Reader manual).
®
• Use the white RFID chip card in order to change lot-
specific test parameters.
• Patient samples that are not properly handled may
cause inaccurate results.
• In order to receive reliable and quantitative results it is
important to homogenize the stool sample entirely in the
extraction device.
• Diluted samples should be used within several hours
and cannot be stored for a longer time period.
• With BÜHLMANN Smart-Prep and ScheBo
Prep TM , it is important to centrifuge the extracts before
storage. Centrifuge the tubes for 5 minutes at 3000 x g.
After centrifugation the supernatant must be transferred
into a fresh storage tube.
SPECIMEN COLLECTION, STORAGE, STABILITY
For the extraction procedure, less than 1 g of native stool
specimen is required. Collect stool specimen into plain
tubes.
Important: The specimen must be collected without any
chemical or biological additives.
Specimen transport
Stool specimens should be received for processing by the
laboratory within 3 days of collection. The specimens may
be transported at room temperature or refrigerated.
Specimen storage
Stool specimens should be refrigerated at 2-8 °C and
extracted within 3 days of receipt at the laboratory. Do not
store samples at elevated temperatures.
Extract stability
Fecal calprotectin extracts obtained with the CALEX
device are stable at room temperature (23 °C) for 7 days
and at 2-8 °C for up to 15 days. For longer storage, freeze
extracts at -20°C. Frozen extracts are stable for a period of
up to 23 months.
CALEX ® Cap extracts can be stored and frozen directly
within the CALEX ® Cap device. Extracts can be subject to
four freeze-thaw cycles. Prior to measurement, allow frozen
extracts to equilibrate to room temperature. For re-use / re-
Release date: 2020-10-30
Reader must be switched on and
® fCAL assay
measurement of the extracts see step 2 under the chapter
assay procedure.
Fecal calprotectin extracts obtained by manual weighing
method, by BÜHLMANN Smart-Prep or by ScheBo
Prep™ is stable at 2-8 °C for ≤7 days or at -20 °C for
36 months.
ASSAY PROCEDURE
The assay procedure consists of three steps:
1. Extraction of stool samples
The extraction is described in the instruction for use
delivered with the respective extraction devices.
CALEX® Cap device: Liquid stool samples can be
pipetted directly into the CALEX® Cap device. Unscrew
the blue cap and pipet 10 μL of stool sample into the
device. Recap the CALEX
with vortexing step according to the extraction
procedure described and illustrated in the instruction for
use delivered with the CALEX
2. Sample processing
• Smart-Prep or ScheBo
extract settle for 10 minutes after extraction. Dilute the
supernatant 1:16 with extraction buffer (e.g. 20 µL
extract and 300 µL extraction buffer) and mix well. Let
the samples equilibrate for at least 5 minutes to 18-
28 °C prior to proceeding to the next step (step no. 3).
• CALEX
®
extract settle for 10 minutes with the white head of the
device down. Unscrew the blue cap and dilute the
® Quick-
supernatant 1:1.6 with extraction buffer (e.g. 200 µL
extract and 120 µL extraction buffer) and mix well. Let
the samples equilibrate for at least 5 minutes to 18-
28 °C prior to proceeding to the next step (step no. 3).
3. Lateral flow assay procedure and readout
There are two alternative methods available on the
Quantum Blue
Select one of these methods before starting the
experiments.
Load the lot specific parameters from the white RFID
chip card.
Cap
®
4/36
® Cap device and proceed
Cap device.
®
® Quick Prep
Cap device: After extraction, let the stool
Reader: <CAL_720> and <CAL_0>.
®
® Quick-
TM : Let the stool
Quantum Blue® fCAL