The aim is to evaluate the clinical performance of the system and verify the claims of reduced interference with biotin and CCDs. The measurements on NOVEOS will be mirrored in this study against the clinical diagnosis, the outcome of skin prick…
ID
Source
Brief title
Condition
- Allergic conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
sIgE against 12 allergens is determined on the NOVEOS system and compared with
the results of the skin prick tests, the clinical diagnosis and sIgE
measurements on the standard method (Siemens Immulite).
Secondary outcome
There will be investigated whether the use of biotin supplements leads to
different results on the NOVEOS compared to the Immulite.
In addition, it will be investigated whether there is less interference of sIgE
against CCDs on the NOVEOS.
Background summary
Allergies are caused by an immunological reaction in which specific IgE (sIgE)
antibodies are formed against certain allergens. Recently a new system has
become available for measuring sIgE; the *NOVEOS Immunoanalyzer*. In this
system, only 4 µl of patient serum is needed to measure sIgE against an
allergen. Because this is about 10% of the amount of serum needed for the
systems currently in use, it is possible to measure sIgE against more allergens
with less patient material (for example in children). In addition, the NOVEOS
system is designed in such a way that there is no interference with biotin in
serum and sIgE against CCDs (so-called Cross-reactive carbohydrate
determinants), which will potentially lower the number of false negative and
false positive test results, respectively. With the NOVEOS sIgE can be measured
against various allergen components and allergen extracts.
The Department of Medical Immunology of the RHMDC, in collaboration with the
Delft Allergy Center in the RDGG, will perform a clinical validation on the
NOVEOS system.
Study objective
The aim is to evaluate the clinical performance of the system and verify the
claims of reduced interference with biotin and CCDs. The measurements on NOVEOS
will be mirrored in this study against the clinical diagnosis, the outcome of
skin prick tests and compared to the performance of the Siemens Immulite that
is currently in use for measuring sIgE. The focus in this study will be on food
allergens.
Study design
In all patients, a specific combination of sIgE against allergens in serum will
be measured on the NOVEOS system and on the Siemens Immulite. To determine
whether sIgE against these allergens also leads to a clinically relevant
allergy and to explain discrepancies between the NOVEOS and Immulite, a skin
prick test will also be performed in these patients. For the NOVEOS system,
clinical specificity, sensitivity and correlation will be determined.
Study burden and risks
Patients are asked to donate a tube of clot blood once and to take a skin prick
test.
Reinier de Graafweg 7
Delft 2625 AD
NL
Reinier de Graafweg 7
Delft 2625 AD
NL
Listed location countries
Age
Inclusion criteria
Age > 3 years
Suspected food allergy to peanut, cow's milk, chicken egg, nuts, sesame seeds,
cod and/or wheat.
Exclusion criteria
Use of anti-IgE injections (Xolair), systemic corticosteroids, or
anti-histamines (which should be discontinued three days before performing a
skin prik test).
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL80255.058.22 |