Chemistry: analytical and immunological testing – Involving iga – igd – ige – or igm
Patent
1987-05-26
1990-11-06
Kepplinger, Esther L.
Chemistry: analytical and immunological testing
Involving iga, igd, ige, or igm
435 7, 435805, 436518, 436810, 422 56, 422 57, 422 58, 424434, 424435, 424436, 424437, 424 9, G01N 33563, G01N 33548
Patent
active
049686330
DESCRIPTION:
BRIEF SUMMARY
The present invention relates to a mucous membrane allergy immunoassay test as well as to a device for carrying out said test for the in situ detection of specific and total IgE. More particularly, this invention relates to an allergy immunoassay test in which, by means of an application device, the allergen or the anti-IgE antibody, both linked to a support, are contacted direct with the mucous membrane, preferably with the nasal mucous membrane, performing an in situ incubation with the mucous membrane IgE, after which the in vitro determination is carried out of the specific and total IgE. Moreover, said testing procedure and the device for carrying out the same, also allow to perform simultaneously a particular test of specific challenging, for instance a specific challenging nasal test.
As is well known, at the present state of the art, the diagnosis of allergic diseases is performed through the following fundamental tests.
Skin tests (A) consist in the application of the suspected allergens on the skin of the patient, for example by pricking or scratching; in that way a local reaction is stimulated (reddening and swelling), which reaction is produced by the linking of the allergen with the IgE.
The in vitro determination of the amount of the IgE in the blood of the patient (B), the blood being drawn by pricking a vein, is carried out through radioimmunological or immunoenzymatic methods. Such quantitative determination consists in contacting the serum of the patient in vitro with a support bearing the allergen or the anti-IgE antibody linked to itself, and in the successive determination of the IgE of the patient which become linked to the same.
The specific challenging tests (C) consist mainly in provoking the nasal, ocular or bronchial symptomatology etc. contacting such mucous membrane surfaces directly with the suspected allergens which can be administered for instance in the form of a spray, aerosol, or by installation and so on.
After the clinical investigation, the skin tests (A) form the first diagnostic approach, which can be replaced by the quantitative determination (B) of the specific IgE in the serum in the case of impossibility of performing the skin tests or anyway in the case of diagnostic doubts.
If that second investigation also gives no satisfying results, specific challenging or provoking tests (C) can be carried out.
Such diagnostic procedures show some limitations which in the case of skin tests consist in:
a--impossibility of performing the test in the case of patients suffering from spread skin diseases (serious eczema, urticaria);
b--falsely positive result of the test due to the employment of unsuitable allergenic extracts (poor purification, excessive concentration) or to the absence of effective aetiological meaning (preclinical, subclinical or postclinical allergy);
c--falsely negative result of the test which can occur during an antiallergic treatment, for example with antihistaminic compounds, in the case of a reduced skin reactivity (for instance in the early childhood or in old patients or in patients with hyperpigmented skin or with the skin seriously affected with Lichen), because of the presence of the immunoglobulins E at the mucous membrane surfaces level only and not in the skin and the blood, or otherwise because of the degradation of the allergenic extracts;
d--poor acceptance and difficulties in carrying out the procedure in the case of patients in their early childhood, as the testing procedure is relatively painful and asks for some cooperation on the patient's part;
e--possibility of inducing, though rarely, serious general reactions (anaphylactic shocks) as a result of the absorption of the allergen into the circulatory system.
In the cases mentioned above, and anyway when there is no agreement between the clinical suspicion and the skin tests (A), it is necessary to perform the quantitative determination (B) of the amounts of the specific and total IgE in the serum.
That second procedure gives the advantages of a high sensitivity, a good standardization
REFERENCES:
patent: 3509872 (1970-05-01), Truhan
patent: 3941876 (1976-03-01), Marinkovich
patent: 4294817 (1981-10-01), Burgett et al.
patent: 4454226 (1984-06-01), Ali et al.
patent: 4459360 (1984-07-01), Marinkovich
patent: 4587099 (1986-05-01), Rothe et al.
Bushnell Richard
Kepplinger Esther L.
Spiegel Carol A.
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