Simtomax^®

Introducing Simtomax^®

Simtomax^® places the power of screening for Celiac Disease in the hands of the healthcare professionals, at the point of care. Using a small drop of blood, Simtomax^® delivers lab-accurate results for:

• Immunoglobulin-A (IgA) anti-deamidated gliadin peptide
• Immunoglobulin-G (IgG) anti-deamidated gliadin peptide
• Total IgA level

Having 3 results from a single measurement makes Simtomax^® an invaluable tool in the screening of Celiac Disease in presence of risk factors or non-specific symptoms. It is the shortest route from risk assessment to treatment options and counseling.

Key Features

• Lab-accurate quality
• Immediate feedback for on-the-spot care decisions
• Tests require only a simple fingerstick
• Fast, easy 1-step procedure
• Provides the status for Celiac Disease and IgA deficiency
• Easy and inexpensive
• Small, lightweight design. Does not require a reading device
• CE marked
• Tests reimbursable by national healthcare systems in most countries and various private payors

Intended Use

Simtomax^® is a one-step semi-quantitative analysis intended to be used as a first line screening test to diagnose Celiac Disease and IgA deficiency. Testing must always be performed prior to introducing a gluten-free diet. The diagnosis must be confirmed with an intestinal biopsy.

Simtomax® Specifications
Method	Multiplex lateral flow immunochromatography with unique mid-strip analyte positioning.
Analysis	- Immunoglobulin-A (IgA) anti-deamidated gliadin peptide - Immunoglobulin-G (IgG) anti-deamidated gliadin peptide - Total IgA level
Sample type	works independently with whole blood, serum or plasma - venous whole blood: 25µl - EDTA plasma: 20µl - Heparinted plasma: 20µl - Serum 20µl
Performance	See all data under Accuracy and Reproductibility
Time to result	10 minutes
Storage	Room temperature (5°C - 25°C)
Shelf life	24 months
Results interpretation	Visual
Registration	CE marked for professional use only