The Allergy Explorer (ALEX) is a quantitative in vitro diagnostic test for the measurement of allergen specific IgE (sIgE) and a semi-quantitative in vitro diagnostic test for the measurement of total IgE (tIgE) in human serum or plasma (exception EDTA-plasma).
Description
INTENDED USE
The Allergy Explorer (ALEX) is a quantitative in vitro diagnostic test for the measurement of allergen specific IgE (sIgE) and a semi-quantitative in vitro diagnostic test for the measurement of total IgE (tIgE) in human serum or plasma (exception EDTA-plasma). It is to be used by clinical chemistry laboratories, trained laboratory personnel and medical professionals for the purpose of supporting the clinical diagnosis of IgE mediated diseases, in conjunction with other clinical findings or diagnostic test results.
ImageXplorer
The ImageXplorer is an imaging device to be used in combination with the Raptor Analysis Software to acquire images of ALEX arrays after they have been processed by the laboratory user. Raptor Analysis Software
The Raptor Analysis Software is intended for in vitro diagnostics (IVD) use in combination with the ALEX – Allergy Explorer test kits. Raptor performs a quantitative analysis for allergen-specific IgE (sIgE) and semiquantitative analysis for total IgE (tIgE). The testing system of the ImageXplorer and Raptor in combination with ALEX test arrays is an aid in the clinical diagnosis of patients with allergies in conjunction with other clinical and laboratory findings. The software is to be used in clinical laboratories by skilled and trained operators.
ALEX kit components include:
- 20x ALEX test arrays
- 2 x 50 мл ALEX Washing Solution
- 1x9 мл ALEX Sample Diluent
- 1x11 мл ALEX Detection Antibody
- 1x1,1 мл ALEX Substrate Solution
- 2x1,1 мл ALEX Stop Solution
ALEX Starter kit includes:
- Arrayholder (optional)
- ImageXplorer
- Lab Rocker (vertical rocker, WxDxH – 28x15x33 cm, inclination angle 8°, required speed 8 rpm)
- Incubation chamber (WxDxH – 35x25x2 cm)
- Raptor analysis software
- PC/Laptop
ALEX Starter kit contains all required equipment, except PC/Laptop – REF 01-0010-00.
Single items of the Starter kit are available on request. PC/Laptop is provided only on request
For detailed information please consult with the Instruction for Use.