• Test Principle ImmunoCAP Phadiatop/Phadiatop Infant

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ImmunoCAP Phadiatop/Phadiatop Infant

 

ImmunoCAP Phadiatop is a blood test designed to help differentiate between atopic and non-atopic patients. Results indicate high or low probability for atopy.

Clinical value

Phadiatop is an assay for the determination of atopy with qualitative results.

Qualitative results

Phadiatop results are expressed as positive or negative. A positive Phadiatop result is indicative of atopy. A negative result likely indicates that the patient is non-atopic, i.e. not sensitized to inhalant allergens. In order to determine the concentration of allergen specific IgE antibodies, it is recommended to retest the sample with the appropriate ImmunoCAP Specific IgE allergens.

The following clinical results were obtained from clinical trials including 836 patients with suspected allergy:

Final diagnosis
Atopy/non-atopy
 
ImmunoCAP Phadiatop results  
PositiveNegativeTotal
Atopy 483 38 521
Non-atopy 34 281 315
Total 517 319 836
  • Sensitivity 93%
  • Specificity 89%

All tests were run using the 0.35 kU/l specific IgE calibrator as cut off.

Specimen collection and preparation

  • Serum and plasma (EDTA or heparin) samples from venous or capillary blood can be used
  • Collect blood samples using standard procedures
  • Keep specimens at room temperature (RT) for shipping purposes only
  • Store at 2–8 °C up to one week, otherwise store at –20 °C
  • Avoid repeated freezing and thawing

Important note

As in all diagnostic testing, a definitive clinical diagnosis should not be based solely on the results of a single test method. A diagnosis should be made by the clinician after evaluation of all clinical and laboratory findings.