English - BÜHLMANN Quantum Blue Manuel D'utilisation

ENGLISH

INTENDED USE
The BÜHLMANN Quantum Blue
diagnostic test for the quantitative determination of
calprotectin in human stool specimens intended as an aid
to the assessment of intestinal mucosal inflammation. The
assay results can be used as an aid to diagnosis in
distinguishing organic,
gastrointestinal tract (inflammatory bowel disease, IBD,
specifically Crohn's disease or ulcerative colitis, UC) from
functional disease (irritable bowel syndrome, IBS) (ref. 1-7),
in patients with chronic abdominal pain.
For laboratory use only.
EU: For professional use.
PRINCIPLE OF THE ASSAY
The test is designed for the selective measurement of
calprotectin antigen by
monoclonal capture antibody (mAb) highly specific for
calprotectin is coated onto the test membrane. A second
monoclonal detection antibody conjugated to gold colloids
is deposited onto the conjugate release pad and released
into the reaction system after addition of the extracted and
diluted stool sample. The calprotectin/anti-calprotectin gold
conjugate binds to the anti-calprotectin antibody coated on
the test membrane (test line) and the remaining free anti-
calprotectin gold conjugate binds to the goat anti-mouse
antibody coated on the test membrane (control line). The
signal intensities of the test line (T) and the control line (C)
are measured quantitatively by the BÜHLMANN Quantum
Blue ® Reader.
REAGENTS SUPPLIED AND PREPARATION
Reagents Quantity
Test Cassette 25 pieces
1 bottle
Extraction Buffer
125 mL
2 vials,
Controls
Low* / High*
0.5 mL
RFID Chip Card 1 piece
* The controls contain lot specific amounts of native human calprotectin.
Refer to the additional QC data sheet for actual concentrations.
STORAGE AND SHELF LIFE OF REAGENTS
All kit components are stable at 2-8 °C until the expiration
date printed on the labels.
Release date: 2020-10-30
fCAL is an in vitro
®
inflammatory disease
sandwich immunoassay.
Code Comments
vacuum-
B-CAL-TC sealed in a
foil pouch
B-CAL-EX Ready to use
B-LFCAL-
Ready to use
CONSET
White plastic
B-LFCAL-RCC
card
REAGENTS & MATERIAL SUPPLIED
SUPPLEMENTARY
Fecal extraction devices
Fecal extraction devices described below are not delivered
with the kit and either of them has to be ordered with the
kit.
Extraction device
of the
Kits
CALEX ® Cap
device
Smart-Prep
ScheBo ® Quick-
Prep TM
A
MATERIALS REQUIRED BUT NOT PROVIDED
• Vortex mixer for stool extraction
• Precision pipettes with disposable tips: 10-200 µL and
1 mL
• Centrifuge
• 5 mL polypropylene or polystyrene tubes for the dilution
of the extracts
• Timer (optional)
• Quantum Blue
(order code: BI-POCTR-ABS)
• Soft tissues or blotting paper
PRECAUTIONS
Safety precautions
• The controls of this test contain components of human
origin. Although tested and found negative for HBV
surface antigen, HCV and HIV1/2 antibodies, the
reagents should be handled as if capable of transmitting
infections and should be handled in accordance with
Good Laboratory Practices (GLP) using appropriate
precautions.
• Patient specimens should be handled as if capable of
Table 1
transmitting infections and should be handled in
accordance with Good Laboratory Practice (GLP) using
appropriate precautions.
• Reagents: Avoid contact of reagents with the skin, eyes,
or mucous membranes. If
immediately wash with generous amounts of water;
otherwise, irritation can occur.
• Reagents and chemicals have to be treated as
hazardous waste according to the national biohazard
safety guideline or regulation.
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Quantity
Packages of 50, 200 or 500
tubes available, filled with
5 mL extraction buffer
Ready to use
50 tubes consisting of
spatulas and base caps
50 tubes consisting of tube,
cone & dosing tip, each filled
with 1.3 mL extraction buffer
Ready to use
® Reader available from BÜHLMANN
contact does
Quantum Blue® fCAL
Code
B-CALEX-C50
B-CALEX-C200
B-CALEX-C500
B-CAL-RD
B-CAL-SO50
Table 2
occur,