|
TGA IgA Orkit®
Cat. # TGA-100: 96
well kit
Note: this product is not available
in all countries, please contact us for a detailed information.
| Transglutaminase antibodies
testing and celiac disease |
Coeliac disease or
gluten-sensitive enteropathy is a chronic disease in which an
intestinal mucosal legion impairs nutrient absorption. Recent
studies strongly suggest that the incidence of coeliac disease is
often underestimated and that mild forms in adults are not
diagnosed properly.
In a large majority of untreated celiac patients, high
concentrations of antibodies against gliadin, the alcohol soluble
fraction of gluten, are detected in saliva, intestinal secretions
and in the blood stream. These antibodies gradually disappear
after gluten exclusion from the patient’s diet.
Testing for serum
IgA and/or IgG gliadin antibodies:
| - |
is a simple
and unexpensive method to select more efficiently
candidates to jejunal biopsy among children or adults
clinically suspected of coeliac disease. |
| - |
represents a
cost-effective screening method for populations at risk
(short-stature children, unexplained anemia, hypocalcemia
or osteomalacia, delayed puberty, insulin-dependent
diabetes, first-degree relatives of patients with coeliac
disease, autoimmune thyroiditis and mixed connective
tissue diseases. |
|
| Main
characteristics |
|
|
|
Human
transglutaminase (recombinant) is
used as target (coating) antigen.
|
|
|
|
Quantitative
determination with alternative screening
protocol.
|
|
|
|
Ready-to-use
Controls with individual
color-coding.
|
|
|
|
Ready-to-use,
stable Conjugate and Chromogen for simpler
handling.
|
|
|
|
Breakaway
wells, ideally suited for small runs and for
maximum cost-efficiency.
|
|
|
|
Room
temperature incubations, standardized
pipetting volumes and
protocol for easy handling or adaptation to ELISA
automatic processors.
|
|
|
|
Non-specific
reagents (Wash Buffer, Chromogen, Stop Solution) are
common to all Orkit assays and can be used across the
entire product line, regardless of batch numbers.
|
|
| Practical
information |
Kit insert and other
documents
|
|
Note: to view and print these
documents, you need Acrobat Reader. If not installed on your computer,
click on the icon to download it free of charge.
|
|
| Samples
Human serum only (20 µl)
Kit contents
|
|
Transglutaminase coated microwells (96
wells) |
|
|
IgA
Conjugate (11 ml)
|
|
|
Cut-off Control
(1 ml): 10 U/ml
|
|
|
Positive Control
(1 ml): 40 U/ml
|
|
|
Negative Control
|
|
|
Diluent,
Wash Buffer, TMB and Stop Solution
|
Assay procedure
|
TGA
IgA |
Dilute
samples
|
|
Add
100 µl samples / Controls |
|
|
Incubate 30 min. (Room
Temparature) |
|
Wash |
|
Add
Conjugate: 100 µl |
|
|
Incubate 30 min. (Room
Temparature) |
|
Wash |
|
Add Substrate: 100 µl |
|
|
Incubate 30 min. (Room
Temparature) |
|
Add Stop Solution:
100 µl |
|
Read at 450 nm
|
|
|
| Assay
performances |
Sensitivity
Minimum detectable dose: 3.5 U/ml
Precision
| r=12 |
Sample
1 |
Sample
2 |
Sample
3 |
| Mean concentration (U/ml) |
7 |
12 |
34 |
| Standard deviation (U/ml) |
0.6 |
0.7 |
1.7 |
| Coefficient of variation (%) |
8.5 |
5.8 |
5.0 |
Reproducibility
| n=8 |
Sample
1 |
Sample
2 |
Sample
3 |
| Mean concentration (U/ml) |
7 |
13 |
32 |
| Standard deviation (U/ml) |
1.1 |
1.2 |
2.1 |
| Coefficient of variation (%) |
15.7 |
9.2 |
6.5 |
|
| Expected
results |
|
Serum anti-transglutaminase
antibodies in celiac disease and in other gastrointestinal disorders.
| Clinical status |
n |
Number of positive cases (%)
for transglutaminase abs |
Number of positive cases (%)
for endomysial abs |
| Celiac disease - untreated |
45 |
45 (100) |
45 (100) |
| Celiac disease - treated |
62 |
12(19.3) |
13
(20.9) |
| Dermatitis herpetiformis -
untreated |
7 |
7
(100) |
7
(100) |
| Dermatitis herpetiformis - dapsone
treated |
3 |
1
(33) |
1
(33) |
| Other gastrointestinal disorders -
adults |
20 |
0 |
0 |
| Other gastrointestinal disorders -
children |
35 |
0 |
0 |
| Controls |
120 |
3 (2.5) |
4 (3.3) |
|
|
