NADAL Legionella, rapid test
General information about this test
:
The NADAL IgE is a rapid immunoassay for detection of immunoglobulin E (IgE) in whole blood, plasma or serum. This test is suitable for fast detection of IgE-mediated allergic and autoimmune disorders.
Reagents and material supplied
:
10 NADAL IgE test cassettes (incl. disposable droppers)
1 package insert
Test time
: 10 min
Performance characteristics
:
The analytical sensitivity of the NADAL IgE Test is 80 IU/ml.
The NADAL IgE Test does not show cross reactivity with: Human immuno-globulin A (400 mg/dL), Human immuno-globulin G (400 mg/dL), Human immuno-globulin M (400 mg/dL),
Acinetobacter calcoaceticus
,
Proteus vulgaris
,
Salmonella typhi
,
Acinetobacter spp
,
Staphylococcus aureus
,
Candida albicans
,
Neisseria gonorrhoeae
,
Escherichia coli
,
Moraxella catarrhalis
,
Gardnerella vaginalis
,
Neisseria meningitidis
,
Streptococcus faecalis
,
Neisseria lactamica
,
Streptococcus faecium
,
Pseudomonas aeruginosa
,
Trichomonas vaginalis
.
None of the following substances intereferes with the results of NADAL IgE Test: Acetamiophen (20 mg/dl), Acetyl salicylic acid (20 mg/dl), Albumin (20 mg/ml), Ascorbic acid (20 mg/dl), Atropine (20 mg/dl), Bilirubin (10 mg/dl), Caffeine (20 mg/dl), Creatinine (20 mg/dl), Gentesic acid (20 mg/dl), Glucose (2,000 mg/dl), Glucose (10 mg/ml), Ketones (40 mg/dl), Lithium heparin (3 mg/dl), Mestranol (3 mg/dl), Nitrite (20 mg/dl), Penicillin (40,000 U/dl), Prostatic acid phosphatase (1 mg/ml), Sodium heparin (3 mg/dl), Triglyceride (500 mg/dl).
The diagnostics sensitivity and specificity of the NADAL IgE Test were confirmed by comparison of the results of this test with those obtained by applying quantitative IgE ELISA test kits (MP Biomedicals, NY, USA). The specimens tested were obtained from patients showing allergic symptoms.
Relative sensitivity: 97.5 %
Relative specificity: 96.0%
Test principles
:
The NADAL IgE Test is a qualitative sandwich immunoassay for detection of IgE in whole blood, plasma or serum. The test line region (T) of the nitrocelulose membrane is pre-coated with goat anti-IgE antibodies and goat anti-mouse antibodies are immobilized in the control line region © of the membrane.
Upon addition of sample to the sample well on the test cassette IgE (if found in concentration higher than 80 IU/ml) bind to the colloidal gold coupled mouse anti-IgE antibodies, thus forming antigen-antibody-colloidal gold complexes. Further, this complex migrates along the membrane and reaches the test line region (T) where it is captured by anti-IgE antibodies. An antibody-antigen (analyte)-antibody -colloidal gold praticles complex is formed. It gives red coloration to the T region of the membrane, indicating a positive result.
A colored line should always appear in the control line region (C), it serves as a procedural control, indicating that the proper volume of specimen has been added and membrane wicking has occurred.
Clinical significance
:
Immunoglobulin E (IgE) is associated with allergic and autoimmune disorders. Normally, it is found in the blood and tissues in small amounts. While IgG is produced for fighting viral, bacterial or fungal infections, IgE provides immunity against protozoan or helminth infections such as schistosomiasis or trichinosis. The immune system of people with allergies react to certain factors in the environment with excessive production of IgE which does not normally cause reaction in non-allergic individuals. IgE bind to mast cells (specialized cells in the tissue) and basophils (a type of white blood cells) in the bloodstream. Mast cells are found in tissues throughout the body but are highest in concentration in the skin, respiratory system and gastrointestinal tract. The next time the allergic person encounters the same substance it reacts with the bound IgE and thus provokes release of histamine and other chemicals which results in an allergic reaction