• Allersys® is a chemiluminescent immunoassay (CLIA) for the quantitative determination of Total IgE and Specific IgE in serum.

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The Allersys® Total and Specific IgE assays are designed in accordance with CLSI Guideline I/LA20-A2 (Analytical Performance Characteristics and Clinical Utility of Immunological Assay For Human Immunoglobulin E (IgE) Antibodies and Defined Allergy Specificities; Approved Guideline – Second Edition).

Total IgE Test Principle

Allersys® Total IgE is an immunoassay for the quantitative detection of circulating IgE in human serum.
  1. Biotinylated anti-human IgE and the patient sample (10 μl) are incubated. Any IgE will bindTotal IgE Test Principle with biotinylated anti-human IgE.
  2. The streptavidin coated magnetic microparticles and the biotinylated anti-IgE – IgE complex are incubated.
  3. Following a wash step, an acridinium-labelled anti-human IgE antibody conjugate is added and forms a sandwich with the IgE captured on the microparticles.
  4. After incubation and another wash cycle, trigger solutions A and B are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of IgE in the sample and the RLUs detected by Allersys optics. To evaluate the test result the response for the patient sample is converted to concentration with the use of a calibration curve calibrated against the IRP for Human IgE 75/502.
    Assay range: 3-3000 kU/l.

Specific IgE Test Principle

Allersys® Specific IgE is an immunoassay for the quantitative detection of circulating allergen specific IgE in human serum.
  1. Biotinylated allergens and the patient sample (50 μl) are incubated. Any allergen specific IgE Specific IgE Test Principlewill bind the corresponding allergen.
  2. The streptavidin coated magnetic microparticles and the biotinylated allergen – specific IgE complex are incubated.
  3. Following a wash step, an acridinium-labelled anti-human IgE conjugate is added and forms a sandwich with the allergen specific IgE captured on the microparticles.
  4. After incubation and another wash cycle, trigger solutions A and B are added to the reaction mixture. The resulting chemiluminescent reaction is measured as relative light units (RLUs). A direct relationship exists between the amount of allergen specific IgE in the sample and the RLUs detected by Allersys optics. To evaluate the test result the response for the patient sample is converted to concentration with the use of a calibration curve calibrated against the IRP for Human IgE 75/502. Assay range: 0.1- 100 kU/l.

Specific IgE Performance

In accordance with CLSI guideline EP09-A2 (Method Comparison and Bias
Estimation using Patient Samples), multiple allergens were compared with CAP (ThermoFisher).

 

Passing Bablock - 450 samples

450 serum samples were tested for 11 different allergens; d1 (44), d2 (48), f1 (37), f78 (42), g3 (39), g6 (40), m6 (51), t2 (37), t3 (33), t4 (47) and t9 (32).

Passing Bablock

 

Class-to-class concordance table - 492 samples

492 serum samples were tested for 11 different allergens; d1 (49), d2 (54), f1 (38), f78 (58), g3 (40), g6 (46), m6 (51), t2 (41), t3 (36), t4 (47) and t9 (32).

Class-to-class concordance table

Mites

ODD001Y D001 House dustmite - Dermatophagoides pteronyssinus
ODD002Y D002 House dustmite - Dermatophagoides farinae

 

Epithermals

ODE001Y E001 Cat dander
ODE005Y E005 Dog dander
ODE094Y E094 nFel d 1

 

Foods - Eggs

ODF001Y F001 Egg white
ODF245Y F245 Hen's egg

 

Foods- Fish/Shellfish

ODF003Y F003 Fish (cod)
ODF037Y F037 Mussel

 

Foods - Milk

ODF002Y F002 Cow's milk
ODF076Y F076 Alpha-lactalbumin
ODF077Y F077 Beta-lactoglobulin
ODF078Y F078 Casein

 

Foods-Fruits

ODF084Y F084 Kiwi

 

Foods - Nuts

ODF013Y F013 Peanut
ODF202Y F202 Cashew nut

 

Grass Pollens

ODG001Y G001 Sweet vernal grass - Anthoxanthum odoratum
ODG002Y G002 Bermuda grass - Cynodon dactylon
ODG003Y G003 Orchard grass/cocksfoot - Dactylis glomerata
ODG004Y G004 Meadow fescure - Festuca elatior
ODG005Y G005 Rye grass - Lolium perenne
ODG006Y G006 Timothy grass - Phragmites communis
ODG007Y G007 Common reed - Phragmites communis
ODG008Y G008 Meadow grass - Poa pratensis
ODG012Y G012 Cultivated rye - Secale cereal
ODG013Y G013 Velvet grass/holcus - Holcus lanatus
ODG014Y G014 Cultivated oat - Avena sativa
ODG015Y G015 Cultivated wheat - Triticum aestivum
ODG201Y G201 Barley - Hordeum vulgare

 

Venoms

ODI001Y I001 Honey bee venom - Apis mellifera

 

Occupational

ODK082Y K082 Latex

 

Micro-organisms

ODM003Y M003 Aspergillus fumigatus
ODM006Y M006 Alternaria alternata

 

Tree Pollens

ODT002Y T002 Alder - Alnus glutinosa
ODT003Y T003 Common Silver Birch - Betula verrucosa
ODT004Y T004 Hazel - Corylus avellana
ODT008Y T009 Olive - Olea europaea
ODT025Y T025 European Ash - Fraxinus excelsior

 

Weed Pollens

ODW006Y W006 Mugwort - Artemisisa vulgaris
ODW009Y W009 Plantain - Plantago lanceolata

 

Common Reagents

OD900Y Total/Specific IgE Reagent Kit
ODTOTCY Total IgE Control Kit
ODG6CY Positive Specific IgE Control Kit (Timothy grass)
ODF3CY Positive Specific IgE Control Kit (Cod)
ODNEGCY Negative Specific IgE Control Kit