BÜHLMANN Quantum Blue sCAL Manual Del Usuario página 3

ENGLISH
®
The Quantum Blue sCAL lateral flow assay is an
immunoassay designed for the quantitative determination
of MRP8/14 in human serum in combination with the
®
Quantum Blue Reader.
MRP8/14 serum levels can be used to determine the
inflammatory status of patients with chronic inflammatory
diseases such as Rheumatoid Arthritis (RA) e.g. to monitor
the treatment efficiency of drugs such as anti-TNF alpha
antibodies.
For professional use only.
*Canada, Taiwan: For laboratory use only.
The test is designed for the selective measurement of
MRP8/14 antigen by
monoclonal capture antibody which is highly specific for
MRP8/14 is lined onto the 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 diluted serum.
The antibody-gold-conjugate reacts with the MRP8/14 of
the sample and then binds to the anti-MRP8/14 antibody
which is lined onto the membrane (Test Line). The
remaining free MRP8/14-gold-conjugate binds to the goat
anti-mouse antibody which is lined onto the membrane
(Control Line). The signal intensities of the Test Line and
the Control Line, respectively, are measured quantitatively
®
by the Quantum Blue Reader.
REAGENTS SUPPLIED AND PREPARATION
Reagents Quantity
Test Cassette 25 pieces
1 bottle
Chase Buffer
10 mL
2 vials
Controls
Low* / High*
0.5 mL/vials
RFID Chip Card
1 piece
* The controls contain lot specific amounts of MRP8/14. 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.
Safety Precautions
• None of the reagents of this test contains components
of human origin.
• Patient specimens should be handled as if capable of
transmitting infections and should be handled in
accordance with good laboratory practice (GLP) using
appropriate precautions.
Revision date: 2016-11-23
INTENDED USE
PRINCIPLE OF THE ASSAY
sandwich immunoassay.
Code Comments
In vacuum-
B-LFCALUS-TC sealed foil bag
pouch
B-LFMRP-CB Ready to use
B-LFMRP- Ready to
CONSET use
White plastic
B-LFMRP-RCC
card
PRECAUTIONS
• Unused solution should be discarded according to local
State and Federal regulations.
Technical Precautions
Kit Components
• All reagents and test samples must be equilibrated at
room temperature (18-28 °C) before starting the assay.
Mix (vortex) the reagents well before use.
• The chase buffer might show flocculation which does
not have any influence on the quality of the test and the
test result.
• Components must not be used after the expiry date
printed on the labels.
• Do not mix different lots of reagents.
• Test cassettes cannot be re-used.
Assay Procedure
• Read carefully the instructions prior to carrying out the
A
assay. Assay 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.
• Use the white RFID chip card in order to change
lot-specific test parameters.
• The Quantum Blue
programmed for the Quantum Blue
starting the assay (see Quantum Blue
• Patient samples that are not properly handled may
cause inaccurate results.
• Diluted samples should be used within several hours
and cannot be stored for a longer time period.
• Undiluted serum samples can be stored at ≤-20 °C for
at least 2 years.
MATERIALS REQUIRED BUT NOT PROVIDED
• Quantum Blue
code: BI-POCTR-ABS).
• Timer
• Precision pipettes with disposable tips: 1-10 µL and
100-1000 µL
• Centrifuge for micro tubes
• Disposable polystyrene or polypropylene tubes for
Table 1
dilution of samples
• Gloves and laboratory coat
SPECIMEN COLLECTION AND STORAGE
Collect blood into plain venipuncture tubes without any
additives, avoid hemolysis, and let the serum clot at room
temperature (18-28 °C) for at least 20 and for up to 60
minutes. Centrifuge at room temperature and at ~2'000 g
for 15 minutes. Decant the serum. Serum samples can be
stored refrigerated at 2-8 °C for up to 1 month. For longer
storage, keep serum samples at ≤-20 ºC. The samples are
stable for at least 2 years at ≤-20 ºC.
3/24
®
Reader must be switched on and
®
sCAL assay before
®
®
Reader available at BÜHLMANN (order
Reader manual).
LF-MRP25