Medical Products Supplies Companies

Avenida Americo Vespucio, 5-4, 1ª M-12, 41092 Sevilla
Spain
Telephone +34 955 98 32 15
info@biomedal.com
http://www.biomedal.com

Product Categories

Product categories

03 Diagnostic Tests
03.02 Immunochemistry testing, immunology testing
03.02.02 Diagnostic rapid tests

Diagnostic rapid tests

Our products

Product category: Diagnostic rapid tests
iVYLISA GIP Stool CE
iVYLISA GIP Stool is a quantitative Sandwich ELISA designed to detectandquantify Gluten Immunogenic Peptides (GIP) in stool samples. The capturing and detecting antibody is the G12, which is designed against the 33-mer peptide and which recognizes it and other equivalent immunotoxic peptides 14. These antibodies have shown great sensitivity and specificity when they have been used to certify gluten-free foods in the food industry and therefore have great reliability.

iVYLISA GIP Stool is a direct method, in which the higher the quantity of GIP present in the sample is, the stronger the signal obtained. The Sandwich ELISA assay is commonly used for the analysis of substances in analytical laboratories. This, together with the extremely high specificity and sensitivity, makes it possible for this method to precisely quantify the GIP present in stool samples. Additionally, the method is easily scalable and automatable.

For a large number of samples, iVYLISA GIP Stool can be optionally complemented with Easy Stool Extraction Pack to facilitate the extraction process of the samples.

Product use
This iVYLISA GIP Stool kit is especially indicated for:

Control of the gluten-free diet for patients with celiac disease, non-celiac patients with gluten-sensitivity or a gluten allergy.
Patients with persistent symptoms after following a gluten free diet.
During the first months after celiac disease diagnosis to verify good habits.
Verify sufficient gluten intake during the diagnosis of celiac disease
Verify the adherence to the gluten-free diet in the diagnosis of refractory celiac disease.
To prove gluten free diet adherence or gluten challenge intake in clinical trials for new therapies for celiac disease.
This technique is for professional use and should be used in a clinical analysis laboratory or in an authorized place for the performance of diagnostic tests.

Product category: Diagnostic rapid tests
iVYCHECK GIP Stool CE
iVYCHECK GIP Stool is an immunochromatographic test designed to detect Gluten Immunogenic Peptides (GIP) in stool samples. Firstly, gluten must be extracted from the sample, and then proceeding to the detection of GIP by reaction with the conjugated antibodies present in the strip. In the case of GIP in the sample due to gluten consumption, a red line will appear (positive result), while the absence of this line indicates that there is no GIP in the sample and therefore no gluten has been consumed (negative result, within the limit of detection). A green control line will also appear that indicates the test is properly performed.

Product use
The iVYCHECK GIP Stool kit is especially indicated for:

Control of the gluten-free diet for patients with celiac disease, non-celiac patients with gluten-sensitivity or a gluten allergy.
Patients with persistent symptoms after following a gluten free diet.
During the first months after celiac disease diagnosis to verify good habits.
Correct diagnosis of refractory celiac disease and difficult diagnosis cases of celiac disease when a clinical supervision of the diet is required.
To prove gluten free diet adherence or gluten challenge intake in clinical trials for new therapies for celiac disease.
This technique is for professional use and should be used by doctors, pharmacists or specialists in the field.

Product category: Diagnostic rapid tests
iVYCHECK GIP Urine CE
iVYCHECK GIP Urine is an immunochromatographic test designed to detect Gluten Immunogenic Peptides (GIP) in urine samples.

To perform the test, a urine sample is mixed with a conditioning solution. Then, the detection step is based on the reaction of the GIP present in the sample with the coloured antibody conjugates present in the strip. When there is GIP in the sample due to gluten intake, a red line will appear in the test area indicating a positive result. The absence of this line indicates absence of GIP in the sample and therefore absence of gluten intake (negative result). A green line (control line) will appear if the test was successful. The absence of this line indicates absence of GIP in the sample and therefore absence of gluten intake (negative result). A green line (control line) will appear if the test is properly performed.

This technique allows two options for the reading of the results: a qualitative visual reading and a quantitative digital reading with the iVYCHECK Reader scanner. iVYCHECK Reader combines a highly sensitive optical detector, an integrated electronic system and an effective data processing system.

Product use
The iVYCHECK GIP Urine kit is especially indicated for:

Control of the gluten-free diet for patients with celiac disease, non-celiac patients with gluten-sensitivity or a gluten allergy.
Patients with persistent symptoms after following a gluten free diet.
During the first months after celiac disease diagnosis to verify good habits.
Correct diagnosis of refractory celiac disease and difficult diagnosis cases of celiac disease when a clinical supervision of the diet is required.
To prove gluten free diet adherence or gluten challenge intake in clinical trials for new therapies for celiac disease.
This technique is for professional use and should be used by doctors, pharmacists or specialists in the field.

Product category: Diagnostic rapid tests
iVYCHECK Reader
iVYCHECK Reader is designed to scan the iVYCHECK GIP Urine cassettes to obtain quantitative and reliable data regarding the amount of Gluten Immunogenic Peptides (GIP) present in the analyzed urine samples. iVYCHECK Reader is a small, simple, light and portable device that can be battery powered to increase its portability. This device is a combination of an optic detector with high sensitivity, an integrated electronic system and an effective system for data processing. The reader can be connected to a PC through a USB port to upload calibration functions and to download the readings/data. iVYCHECK Reader is operated via a single button and is extremely easy to use. The results, together with the date, time, test parameter, raw data, product lot, operator ID, etc., are saved in the memory of the reader, and are obtained in few minutes. Sold only for RUO (Research Use Only).

Product use
Once the qualitative iVYCHECK GIP Urine test has been performed following the procedure indicated in its manual of use and the incubation time is done, the iVYCHECK GIP Urine cassette is ready to be read by the iVYCHECK Reader.

Insert the iVYCHECK GIP Urine cassette into the iVYCHECK Reader.
Press the ‘Start’ button.
The quantitative result in ng GIP/ml of urine is shown in less than one minute.

Materials provided

Reader device: iVYCHECK Reader.
Installation CDs: Control and Manager Software.
Power and USB connection wires.
International adapters for power connection.

Product category: Diagnostic rapid tests
GlutenDetect
The GlutenDetect Urine and GlutenDetect Stool kits are rapid home tests that have been designed to detect Gluten Immunogenic Peptides (GIP) in either urine or stool samples.

These products are indicated for people who want to self-monitor the gluten-free diet or detect gluten intakes at home, without the necessity of going to a medical center. They are user friendly and quick, as the results are obtained in less than 15 minutes.

The kits are composed of lateral flow strips, similar to a pregnancy test. They also contain everything necessary to treat the urine or stool sample easily, quickly and conveniently at home.

If there are GIP in the sample (and therefore gluten has been consumed) a red line will appear in the test area indicating a positive result. The absence of this line indicates absence of GIP in the sample (negative result). Additionally, a green line will appear (control line) if the test has been properly performed.

Product category: Diagnostic rapid tests
CeliacDetect CE
CeliacDetect is a rapid immunocromatographic test for home use that detects the presence of anti-tissue tranglutaminase (anti-tTG) IgA antibodies in blood samples. The kit is intended as an aid in the diagnosis of celiac disease which should be confirmed by a physician.

The kit contains an automatic lancet for comfortable blood sampling from the finger, a bottle with sample dilution solution and a cassette in which the blood sample is added to obtain the results in 10 minutes.

If the sample contains anti-tTG IgA antibodies, a red line will appear (positive result), indicating the possibility of suffering from celiac disease. The absence of this line (negative result), confirms that the blood sample does not contain anti-tTG antibodies within the limits of detection of the kit and, therefore, the possible absence of celiac disease. Additionally, a control line will appear indicating that the test has been properly performed.

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About Us

Company details
Biomedal S.L. is a biotechnology company founded in the year 2000 in Seville (Spain). Our vision is to be an international reference in innovative products and services for the diagnosis and monitoring of celiac disease and other chronic immune diseases as well as supporting the food industry in the identification of allergens and contaminants.

Our mission is the research, development and commercialization of new technologies and services for direct use by patients and doctors, as well as for the pharmaceutical and food market. Our aim is excellence, quality and reliability for our clients.

Our objective with quality has made us be among the first laboratories in Spain for the detection of allergens, with the highest number of ISO17025 certifications for this purpose, being chosen as an external laboratory by the most important food companies in Spain.

Biomedal enhances the talent of its team with the collaboration of a growing network of internationally recognized scientists and technologists.

Biomedal has more than 1000 sqm of facilities equipped with the best technology for the research, development and manufacture of in vitro diagnostic products and analytical food services. Our management, marketing and sales team is located at Cartuja Technological Science Park in Seville (Spain).

The company develops its activities in Laboratory Services and iVYDAL In Vitro Diagnostics®.

iVYDAL In Vitro Diagnostics® unit
iVYDAL In Vitro Diagnostics® includes medical devices for the diagnosis and monitoring of celiac disease, the products directly monitor the adherence to gluten-free diet by identifying gluten immunogenic peptides (GIP) in urine and stools. The products in this division are intended for both professional use and for home use.

Unit of Laboratory Services
Analytical Services: comprehensive and quick service to the food industry, including customized technical assistance. This service provides the highest reliability to our clients. It stands out in a high number and variety of ISO1725 certifications for the analysis of food allergens.

Life Science:development and commercialization of customized services and products for Science Life Research.

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