Allergen detection of particular problems and puzzles
1. Common allergens dust mites, trees/grass pollen, mold, cockroaches, cat and dog dander and peanut, milk, egg, nuts and fruit and other food. But allergens thousands of, any foreign proteins for the body, may be human allergens. Some allergens are not as common or even very rare, but potentially fatal, the detection reagents needed for clinical work. But currently China national food drug supervision management General (CFDA) will allergy original detection reagents into three class medical devices management, these rare allergy original of 1000 cases clinical validation test requirements cannot completely achieved, and registered of high cost more its very low of market capacity, also to bear, so exists with some allergy original detection reagents currently no card illegal sales, but clinical does need of status, for some large three level Hospital of clinical work brings has larger of confused.
2. detection of allergen-specific IgE, there is currently no international standards, because manufacturers use allergen sources of raw material, allergen binding to a carrier and detection methods are different, so different manufacturers on the same samples of allergen-specific IgE testing results may vary. Particularly between quantitative results often fall short of better comparability.
3. Despite European allergy and clinical immune learned (EAACI) and United States allergy, and asthma and immune learned (AAAAI), United States allergy, and asthma and immune College (ACAAI) and the United States National Health Institute (NIH) of related Guide, and Chinese medical will allergy learned of annual in the are had times clear pointed out that allergy reaction of body outside diagnosis should according to allergy original special specific IgE of experiment results, and food allergy original special specific IgG (4) Just food enters the human body normal physiological reactions, its detection in clinical diagnosis of food allergies does not have any value. But the United States BioMerica (baimeike) and Suzhou Murray o ' Brien, on behalf of the company are subject to food intolerance, food allergen IgG product won the CFDA legal registration of medical devices, and avoid the allergens in the mainstream market, at some hospitals ' medical and digestion have been used, access to a differentiated market operation success.
4. at present, the domestic market has two Germany companies, advanced bio-resonance therapy, newly under the name bio-physical therapy into the domestic market, and the CFDA legal registration of medical devices. No reagents to electrodes to monitor allergen substances in vitro "field effect" diagnosis of allergy, and used in clinical treatment, using extremely low cost. Despite this species method in Germany never in any formal hospital in the get using and Medicare paid, and has been yilai by domestic allergy academic field of strongly questioned and against, EAACI and AAAAI/ACAAI guide also clear pointed out that this is without confirmed of test, but the species equipment in domestic skin section clinical field still get has more widely of using, on traditional science of body outside allergy original detection constitute has alternative of market competition.
China allergy original detection of market in past of 15 years in the, get has gradually of development and fast growth, domestic related enterprise business also is rapid rise in the, with whole national of further industrialization process of advance, allergy sex disease of incidence still will continued increased, body outside allergy original detection of market also will keep not below 15% of years increased potential, get further development, believes will has more, more advanced applies of detection products available, and cover more to allergy original detection project.