A unique diagnostic solution
for functional assessment of
the complement system
– Simple and accurate ELISA kits
– All three pathways
– Lectin pathway with both MBL and Ficolin-3
2
ALL–IN–ONE DIAGNOSTIC SOLUTION
EURO DIAGNOSTICA
®
Understand the
full picture
With the Euro Diagnostica complement assay solution
complete picture of the complement function is provided
The increased awareness and interest in the complement
system has augmented the need for a simple and objective
method to assess the function of complement activity.
Euro Diagnostica, working closely with key opinion leaders,
has developed an assay solution which allows you to assess
the function of respective pathway of the complement system
in a simple, objective ELISA format. The properties of the
solution make it well-suited as an analytical tool for a range
of disorders related to complement deficiency.
One test for all three pathways and Ficolin -3
— separately or together
The Euro Diagnostica complement ELISA solution is unique as
it allows for a complete assessment of all three pathways
sim­ultaneously and with no interference, saving time and effort
in securing an accurate diagnosis. To further strengthen the
ana­­lytical potential of the lectin pathway, the assay so­lution
includes a test for the functional assessment of the Ficolin-3
triggered pathway, available for research use only. This enables
both detection of Ficolin-3 deficiency and determination of
mutated and dysfunctional MASP2.
Simple to use and interpret
The Euro Diagnostica complement system assay is purposely
designed for ease of use and maximum accuracy. Results are
easy to interpret (Table), and being in an ELISA format the
assay can be used with a wide variety of open systems.
Methodology
The Euro Diagnostica complement system assay combines
principles of the functional hemolytic assay for complement
activation with ease of use and objective ELISA format employing antibodies specific for a neoepitope expressed by the
formation of the MAC as a result of complement activation.
The wells of the microtitre strips are coated with specific
activators of the classical, or the lectin (MBL or Ficolin-3), or
the alternative pathway.
Patient serum is diluted in diluent containing specific blocker
to ensure that only the respective pathway is activated.
During the incubation of the patient serum, complement is
activated by the specific coating. Finally, the neoepitope
formed by C5b-9 is detected. The amount of the neoepitope
generated is proportional to the functional activity of the
particular complement pathway.
The assay for the functional assessment of the classical pathway (COMPL CP310) has been redesigned to further optimize
objective quantification. A separate calibration curve is now
included in the assay procedure.
A valuable diagnostic tool in a number
of clinical situations
Deficiencies of complement components are generally
associated with an increased susceptibility to a wide range
of infections. The complement system has been suspected
to be involved in the development or progression of a number
of autoimmune diseases. In recent years, a number of other
diseases and clinical situations including therapy, where the
immune system is compromised, have been suggested to be
affected by complement activity. Examples from the
literature are :
Systemic lupus erythematosus (SLE) — Antiphospholipid
antibody syndrome (APS) — Sjögren’s syndrome —
Rheumatoid arthritis — Artherosclerosis — Sepsis — Hemolytic uremic syndrome (HUS) — Age-related macular degeneration (AMD) — Alzhei-mer’s disease — Organ transplantation
complications — Chemo-therapy — HIV infection — Celiac
disease — Ulcerative colitis — Crohn’s disease — Monitoring
pharmacological inhibition of complement activity.
Classical Pathway
Lectin Pathway (MBL)
Lectin Pathway (Ficolin-3)
Alternative Pathway
Possible deficiency
Positive
Positive
Positive
Positive
None
Negative
Positive
Positive
Positive
C1q, C1r, Cls
Positive
Positive
Positive
Negative
Properdin, Factor B,D
Positive
Negative
Positive
Positive
MBL
Positive
Positive
Negative
Positive
Ficolin 3
Positive
Negative
Negative
Positive
MASP2
Negative
Negative
Negative
Negative
C3, C5, C6, C7, C8, C9
Negative
Negative
Negative
Positive
C4, C2 or combination
Table
In the Euro Diagnostica complement
assay system, assessment of the
Ficolin-3 Pathway (RUO) will add
information regarding MASP2 functionality as shown in the table.
ALL – in – one diAgnostic soLution
ALL–IN–ONE DIAGNOSTIC SOLUTION
EURO DIAGNOSTICA
®
Principle of Euro Diagnostica diagnostic solution
Principle
of Euro
Diagnosticaassessment
diagnostic solution
for functional
complement
for functional complement assessment
Specific coating
Classical Pathway
Lectin Pathway
Bibliography
Bibliography
Alternative Pathway
MBL
C1q
C3b /Factor B
Ficolin
3
— Chen, M et al.
Chen,
The complement
—
M, Daha MR,system
Kallenberg
in systemic autoimmune
CGM. The complement system
disease. J Autoimmunity,
in systemic autoimmune
34 (2009), J276–J286
disease. J Autoimmunity, 34
— (2009),
Munthe-Fog
L et al.
J276–J286
Munthe-Fog
Immuno­deficiency
—
L, Hummelshöj
T,associated
with
Honoré C et
al. FCN3
Immuno deficiency
mutation and
Ficolin-3with
associated
FCN3
deficiency.
NEJM,
360,
mutation
and
Ficolin-3
deficiency.
(2009), 2637–2644
NEJM, 360, (2009),
Specific blocking
— 2637–2644
Seelen MA et al.
Seelen
Functional
of the
—
MA, analysis
Roos A, Wieslander
Jclassical,
alternative,
and of
et al. Functional
analysis
the
MBLclassical,
pathways
of the and
alternative,
MBL
complement
pathwayssystem:
of the comple ment
standardization
and
system: standardization
and
validation
of a of
simple
validation
a simple
ELISA.
ELISA. JJ Immunol
Immunol Meth
Meth 296
(2005),
296 (2005),
187–198
187–198
C3
—
Jönsson G,
— Sjöholm
Heinen SAG,
et al.
JHand
et al.
Comple Braconier
Monitoring
modeling
deficiency
and disease:
ment
treatment
of atypical
hemo­ An
lytic
uremicMol
syndrome.
Mol
update.
Immunol
43
(2006),
Immunol
54 (2013), 84-88
78–85
—
S, G
Frederiksen
PD,L. — Thiel
Sturfelt
& Truedsson
JC.inClinical
Jensenius
Complement
the maniof mannan-binding
festations
immunopathogenesis
of
deficiency.
Mol
Immunol
lectin
rheumatic
disease.
Nature
(2006),
86–96
43
Reviews
Rheumatology
8
Universal detection
C3
Membrane
Attack
Complex
Classical Pathway
Lectin Pathway
MBL
C9
C9
C8
C7
C3
C4 C2
C7
C1
C3
MBL
qrs
MASP-2
IgM
Mannan
C8
C7
C7
C6
C5
C4 C2
C9
C8
C6
C5
Altenative Pathway
C9
C8
C6
C5
Lectin Pathway
Ficolin-3
C6
C5
C3
C4 C2
FICOLIN 3
MASP-2
AcBSA
C3
P
FB
FD
LPS
(2012), 458-68
— Wada T & Nangaku M.
Novel roles of complement
in renal diseases and their
therapeutic consequences.
Kidney International 84
Illustration
(2013), 441-50
The complement system is composed of at least 30 proteins present
in the circulation or different body
Illustration
fluids.
The activitysystem
of complement
The
complement
is com- is
in the form
of a cascade
withpresent
highly
posed
of at least
30 proteins
regulated
chemical
steps through
in
the circulation
or different
body
three separate
pathways,
each actifluids.
The activity
of complement
is
vated
by different
targetwith
molecules.
in
the form
of a cascade
highlyregulated chemical steps through
All three
pathways
lead toeach
the actithree
separate
pathways,
activation
of C3, and
thereafter
all
vated
by different
target
molecules.
three pathways share complement
All
three pathways
lead to the
cascade
components.
activation of C3, and thereafter all
three
pathways
share complement
The Euro
Diagnostica
complement
cascade
components.
assay solution
allows diagnosis
of all three pathways together or
The Euro Diagnostica complement
individually, providing accurate anassay solution allows diagnosis
swers quickly and enabling suitable
of all three pathways together or
intervention.
individually, providing accurate
answers quickly and enabling suitable intervention.
3
3
Euro Diagnostica
Answers to you
Euro Diagnostica is a full service diagnostic solutions company.
We produce top quality assay kits for disease assessments, so
clinicians can make qualified decisions about treatment. With
so much at stake, our focus is on getting the correct diagnosis
every time.
We’re rigorous about the quality of our kits, and develop our
assays in collaboration with scientific experts in the field. The
unique Euro Diagnostica complement ELISA solution is just one
example of our ongoing commitment to continous research and
development of new assessment possibilities for improving
patient care.
Product info
COMPL 3001 / COMPL 300 RUO2
ELISA kit for total functional assessment of the Complement Syystem
96 wells
ls break-apart
COMPL CP3101 / COMPL CP310 RUO2
ELISA kit for total functional assessment of the Classical Pathw
way
96 wells
ls break-apart
COMPL MP3201 / COMPL MP320 RUO2
ELISA kit for total functional assessment of the Lectin Pathwayy (MBL)
96 wells
ls break-apart
COMPL AP3301 / COMPL AP330 RUO2
ELISA kit for total functional assessment of the Alternative Path
hway
ls break-apart
96 wells
COMPL F3 RUO2
ELISA kit for total functional assessment of the Lectin Pathwayy (Ficolin-3)
96 wells
ls break-apart
All devices are CE-marked for IVD use unless otherwise noted.
1. Please contact your local representative for availability in your country, not available in US.
2. For research use only, contact your local representative for research use availability in your country.
November 2014, E-028-GB01
Euro Diagnostica AB
Mail address:
P.O. Box 50117
SE - 202 11 Malmö,
Sweden
Visiting address:
Lundavägen 151
Malmö
Sweden
T
F
E
W
+46 40 53 76 00
+46 40 43 22 88
[email protected]
www.eurodiagnostica.com
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www.eurodiagnostica.com