FCP_20

Allergy & Food Intolerance
Diagnostics

FastCheckPOC® 20 rapid allergy test covers some of the most prevelant allergies, inhalation and food, worldwide. FastCheckPOC® 20 is ideal for healthcare professionals to screen their patients for allergies during consultation. FastCheckPOC® 20 results are semi-quantitative, i.e. the visual categorization into 5 levels enables the classification of the allergy test results into respective CAP classes.

FastCheckPOC 20®

Allergies to pollen, grasses, foods, etc. have a negative impact on patients’ daily life. A fast and reliable diagnosis is the key to alleviating symptoms and to a successful treatment of the causes. Symptoms of allergy can be different and varied in severity. Some of the most common symptoms are:

Seasonal and perennial rhinitis and conjunctivitis
Allergic asthma
Allergic eczema
Allergic rhinitis
Allergic gastrointestinal disorders

Patient-friendly

FastCheckPOC® 20 is also ideal for testing as secure alternative to common test methods that could lead to anaphylactic shocks and are not indicated, e.g. for pregnant women, children, patients with acute skin conditions or taking antihistamines.

Fast and reliable

  • Efficiency: Allergy testing for allergen-specific IgE in only 30 minutes with 20 test parameters in one test
  • Optical evaluation: Semi-quantitative results can be classified into 5 levels with correlation to CAP
  • 90% of the most common allergies covered*
  • Fast, simple handling: no laboratory environment needed
  • Reliable diagnosis with just a few drops of blood (200 microlitres) from the finger tip
  • Test can be performed by healthcare professionals
  • Prompt: Fast results meet patient expectations
  • Highest quality of allergens and reagents
  • In accordance with the recommendations of internationally renowned allergy experts

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With the test kit you receive

  • FastCheckPOC® 20 test cassette
  • Small reagent rack with color-coded test tubes
  • Syringe for injecting the blood sample and reagents
  • Blood collection set with alcohol swab, safety lancet,
    capillary tube (lithium heparin), cotton   swab and adhesive bandage
  • Descriptive instructions with pictures
  • Evaluation sheet for the patient’s test results

Correlation between FastCheckPOC® – Levels, sensitisation, and CAP classes and sIgE concentrations

FCP 20-LevelSensitisationCAP ClasssIgE [kUA/L]Signal
1low0 - 20 - 3.4level1
2*moderate2 - 30.7 - 17.4level2
3high3 - 43.5 - 49.9level3
4*very high4 - 517.5 - 100level4
5very high5 - 6>50level5
Legend

FastCheckPOC® 20 Performance Study

FastCheckPOC 20 ATOPY was tested in a multi-center performance study at 6 sites including hospitals, allergy centers, and medical practices. In total 200 patients were tested using the FastCheckPOC 20 ATOPY, results were compared to laboratory test (ImmunoCAP).

How to perform the test? – Video

Concordance between FastCheckPOC 20 and laboratory tests:

  • 83 % Concordance
  • 11 % FCP 20 positive
  • 6 % FCP 20 negative
• 83% of FastCheckPOC 20 ATOPY results conformed to the laboratory test
• 11% showed positive results but negative results in the laboratory test
Sensitivity of FastCheckPOC 20 was 82%, specificity was 84%.

Note:  The above FastCheckPOC 20 study results are in line with other published study results comparing different laboratory methods for measuring specific IgE. The study by Goikoextea et. al. concluded that methods for detection of specific IgE from different manufacturers are not comparable and that there would be differences in results as the test results depend on the type and source of allergen extract used in the method. (Goikoetxea, M.J., et. al. (2013) Recommendations for the Use of In Vitro Methods to Detect Specific Immunoglobulin E: Are They Comparable?, J Investig Allergol Clin Immunol 2013; Vol. 23 (7): 448-454)

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