Our Test

Test Details
GastroPanel gives information on the structure and function of the stomach mucosa, and of the risks caused by a possible abnormal mucosa. Based on the GastroPanel results, it is possible to get information to support the diagnosis of:
• Healthy stomach mucosa
• Functional and organic dyspepsia (when GastroPanel results indicate a healthy stomach mucosa, the cause of stomach problems is often functional dyspepsia or a disease outside the stomach).
• Atrophic gastritis (damaged stomach mucosa that is severly dysfunctional) and likelihoods of the conditions specifically in the corpus and antrum areas of the stomach (normal, gastritis or atrophic gastritis).
• Helicobacter pylori infection.
• Achlorhydria of the stomach (anacidic stomach).

Biomarkers
Pepsinogen I
• Pepsinogen II
• Gastrin-17
• Helicobacter pylori IgG

Company
BioHit

Test Details
Peptest is an accurate, painless and inexpensive test that tells you conclusively if you have reflux.

It measures the presence of a stomach enzyme called pepsin in a sample of your saliva.

Because pepsin is only produced in the stomach, if it is found in the oesophagus, the throat, the mouth or the lungs – then we know it has been refluxed.

Biomarkers
The Peptest kit is an immunological in-vitro diagnostic medical device that contains two pepsin monoclonal antibodies; it allows you to identify pepsin in a clinical sample of saliva/ sputum quickly and easily.

Company
RDBIOMED

Test Details
NutriSMART® tests for 57 of the most common foods,Food Intolerance Rapid Test
1 drop of blood, 30 minutes, 57 foods

Biomarkers
The NutriSMART Test is measuring the reactivity of specific IgG4  antibodies from the blood to various foods. Testing for sIgG4 may not necessarily reflect a reaction to the food itself, but may be an indirect indicator of intestinal permeability (i.e. leaky gut). Exclusion diet based on sIgG4 antibody testing has been shown to improve symptoms in patients suffering from Irritable Bowel Syndrome.
• At times, there is also an overlap of food allergy with food intolerance. However, it has to be noted that food intolerance is usually due to our body’s inability to process the food and its compounds whereas food allergy is the IgE mediated immune system reaction to allergens/proteins within food.

Company
DST Diagnostics

Test Details
The BIOHIT Total 25OH vitamin D ELISA kit is a quantitative immunoenzymatic assay. While detecting both 25OH vitamin D2 and D3, the kit provides clinically relevant information on the vitamin D status. Reliability of the results is ensured by validation against the ID-LC/ MS-MS Reference Measurement Procedure (Ghent method) as approved by the Vitamin D Standardization Program (VDSP) with R>0.97.

Biomarkers
Two major forms of vitamin D are important in the human body, vitamin D2 (ergocalciferol) and vita¬min D3 (cholecalciferol). Vitamin D3 is the form synthesized in the skin in response to sunlight UVB exposure yet can also be obtained from ani¬mal based foods. Vitamin D2, on the other hand, is the form synthesized by plants and is obtained from plant derived foodstuff. Both are metabo¬lized in the liver to their respective 25OH vitamin D3 and D2 forms which are in turn converted to their active form in the kidneys.

Company
BioHit

Test Details
• Suspected enteric protein loss
• Crohn’s disease
• Necrotic enterocolitis
• Chronic mesenterial ischemia
• Viral, bacterial, allergic or autoimmune-induced gastrointestinal inflammation

Biomarkers
Protein loss is a serious consequence of various systemic or local gastrointestinal diseases (e.g. allergies, chronic inflammation, malignancies). These pathologies
damage the mucosal integrity and/or cause lymphostasis, thereby leading to an increased transfer of plasma proteins into the bowel lumen. Subsequently, hypoproteinemia accompanied with edema may develop. This condition is diagnosed by exclusion of other sources of protein loss and by proof of an elevated α1 -antitrypsin concentration in stool. An elevated α1 -antitrypsin stool concentration is therefore a widely recognized marker for intestinal protein loss and for an increased mucosal permeability. In clinical routine, the α1 -antitrypsin clearence (ratio of the α1 -antitrypsin ELISA values of stool and serum samples) has been established along with the sole determination of the 24h α1 -antitrypsin secretion in stool.

Company
Immunodiagnostics

Test Details
The FilmArray® Gastrointestinal (GI) Panel tests for most common gastrointestinal pathogens including viruses, bacteria and parasites that cause infectious diarrhea and other gastrointestinal symptoms

BioMarkers
Bacteria Diarrheagenic E. coli/Shigella
Campylobacter (jejuni, coli & upsaliensis)
Clostridium difficile (Toxin A/B)
Plesiomonas shigelloides
Salmonella
Yersinia enterocolitica
Vibrio (parahaemolyticus, vulnificus, & cholerae)
Vibrio cholerae

E. coli O157
Enteroaggregative E. coli (EAEC)
Enteropathogenic E. coli (EPEC)
Enterotoxigenic E. coli (ETEC) lt/st
Shiga-like toxin-producing E. coli (STEC) stx1/stx2 E. coli O157
Shigella/Enteroinvasive E. coli (EIEC)

Viruses Parasites
Adenovirus F 40/41
Astrovirus
Norovirus GI/GII
Rotavirus A
Sapovirus (I,II, IV, and V)
Cryptosporidium
Cyclospora cayetanensis
Entamoeba histolytica
Giardia lamblia

Company
BioMeriux

Test Details
Biohit Calprotectin ELISA is a quantitative test which provides a reliable differentiation between inflammatory bowel diseases (IBD) and irritable bowel syndrome (IBS). IBD is commonly associated with conditions such as ulcerative colitis and Crohn’s disease. Patients suffering from either IBS or IBD may experience similar symptoms and a clinical examination alone may not be sufficient to give a specific diagnosis. Furthermore, these conditions may appear from early childhood to late adulthood and the diagnosis is often delayed due to vague symptoms or reluctance to perform endoscopy.

Biomarkers
With Biohit Calprotectin ELISA, the determination between inflammatory bowel diseases (IBD) and irritable bowel syndrome (IBS) can be made non-invasively and in-expensively from a stool sample. In organic disorders like IBD, the concentration fecal calprotectin increases significantly, whereas with functional disorders like IBS this does not occur.

Company
BioHit

Test Details
Biohit Active B12 test provides a solution to this diagnostic paradox: this test directly measures (holoTC) – the biochemically active form of vitamin B12 – from the human serum. This test is well suited for the screening of patients with a suspected vitamin B12 deficiency. Biohit Active B12 test can also be used for confirming the vitamin B12 status in the large number of patients who get an inconclusive result from total vitamin B12 tests.

Biomarkers
The traditional method of diagnosing vitamin B12 deficiency has been to measure the concentration of total vitamin-B12 in the serum. The total vitamin B12 concentration essentially reflects vitamin-B12 which is bound to its two carrier proteins forming, holohaptocorrin (holoHC) and holotranscobalamin(holoTC). Whilst holoHC accounts for 70 % – 80 % of the vitamin B12 in serum, only holoTC (active vitamin B12) can be used by human cells. Measurement of total vitamin B12 can hence give erroneous results because it measures the vitamin B12 which is in circulation but does not indicate the active vitamin B12 that is available to the cells of the body.

Company
BioHit

Test Details
The celiac disease quick test allows the diagnosis of celiac disease from fingertip blood sample. Celiac disease is a relatively common autoimmune disease in which the rye, wheat and barley protein (gluten) causes inflammation and mucosal damage of the small intestine,  which interferes with the absorption of nutrients.

Biomarkers
The Celiac Quick test is an immunochromatographic test designed for the qualitative detection of antibodies (IgA/IgG/IgM) against human tissue transglutaminase in whole blood sample

Company
BioHit

Scientific Relevance
Chymotrypsin is a serine protease, which is secreted as anexcretory enzyme from the pancreas after food intake into the duodenum. Here food proteins are hydrolytically cleaved, preferentially next to aromatic residues. A small part of the active form of the enzyme is exreted in the stool. In pancreas insufficiency secondary to a chronic pancreatitis, the secretion of the enzyme is reduced markedly. In the past an exocrine pancreatic insufficiency within the scope of a chronic pancreatitis was diagnosed e.g. by determining faecal elastase or chymotrypsin activity in stool. The colorimetric determination of chymotrypsin
activity, however, is less reliablebecause the enzyme´s activity is influenced by enzyme inhibitors in stool.

Indication
• Chronic pancreatitis
• Exocrine pancreas insufficiency

Company
Immunodiagnostics

Scientific Relevance
Like lipase and elastase, pancreatic amylase is synthesised in the pancreas. In the case of chronic pancreatitis, pancreatic amylase concentration is decreased. Some forms of disease (alcoholism, accidental trauma, fibrosis), are associated with a pancreatic insufficiency. In the routine laboratory pancreatic amylase has proved itself to be a genuine alternative to elastase-I in stool diagnosis with apparently higher clinical specificity and
sensitivity.

Indication
• Chronic pancreatitis

Company
Immunodiagnostics

Scientific Relevance
Pancreatic elastase is an anionic endoprotease of the serine protease family with a molecular weight of 26 kDa. Together with other digestive enzymes it is synthesized as an inactive pro-enzyme in the acinar cells of the pancreas and is secreted into the duodenum. After its activation, pancreas elastase cleaves peptides after neutral
amino acids. Pancreas elastase is mainly bound to bile salts during intestinal passage and is not degraded. In human feces it is 5-6 fold more concentrated than in pancreatic juice. The stool concentration reflects the secretory capacity of the pancreas.

Indication
• Diagnosis/exclusion of exocrine pancreas insufficiency in case of unexplained diarrhea, constipation, steatorrhea, flatulence, weight loss, upper abdominal pain, and food intolerances
• Monitoring of exocrine pancreas function in cystic fibrosis, diabetes mellitus, or chronic pancreatitis

Company
Immunodiagnostics

Scientific Relevance
The pancreatic lipase (triacylglycerol acylhydrolase) is a specific pancreatic enzyme which hydrolyzes primarily glycerol ester of long chain fatty acid. The activity of this enzyme is elevated in patients with acute pancreatitis. The determination of pancreatic lipase is therefore an important parameter for the detection and differentiation of pancreatic diseases, esp. in combination with the determination of the pancreatic amylase.
Conventional turbidimetric methods to assess lipase activity are complex, non-specific and exhibit a low sensitivity. In contrast, our ELISA detects human pancreatic lipase in serum quantitatively and with high specificity.

Indication
• Acute pancreatitis
• Detection and differentiation of pancreatic diseases

Company
Immunodiagnostics

Scientific Relevance
The celiac/coeliac disease is caused by the gliadin fraction of wheat gluten and similar proteins of rye and barley. The disease is manly manifested as chronic digestion
insufficiency in children or young adults. In addition, patients with celiac disease have a greatly increased risk of developing malignant T-cell lymphoma of the small bowel, as T-cell lymphoma was found in 6 of 10 patients with coeliac sprue. Early diagnosis of celiac disease is important, because there is evidence that a gluten-free diet might help to prevent complications and malignancies (including intestinal lymphoma). The measurement of anti-gliadin-sIgA-antibodies may be useful as a screening criterion before jejunal biopsy, the „Gold Standard“, and for the monitoring of the gluten-free diet treatment.

Indication
• Poor appetite and failure to gain weight
• Iron-deficiency anaemia
• Neurological disturbances (e.g., depression, lethargy)
• Infertility
• Recurrent abortions (Untreated pregnant women are at risk of miscarriage and at risk of having a baby with
a congenital malformation)
• Dermatitits herpetiformis Duhring
• Rheumatoid arthritis symptoms

Company
Immunodiagnostics

Scientific Relevance
EDN (eosinophil-derived neurotoxin, eosinophil protein x, EPX) measuring in stool is recommended for diagnosing a food allergy with an immediate reaction or to test the clinical efficiency of an elimination diet. EDN measurements also support an examination about the integrity of the intestinal mucous, when looking into an inflammable intestinal disease, investigating Colon Carcinoma or testing for an intestinal parasite EDN, a cationic glycoprotein, which is released by activated eosinophiles, has strong cytotoxic characteristics and plays a large part in virus prevention. It is released by the eosinophile granules in places where eosinophiles are mainly to be found, in the skin, lungs, urogenital, gastrointestinal tract, that is in the organs which act as an entry point for pathogen. The accumulation of EDN in the intestine is associated with tissue damage.

Indication
 Proof of a food allergy with immediate reaction „
Assessment of an elimination diet „
Proof of damaged integrity of the intestinal mucous membrane caused by an invasive disease (e.g. CED, CC etc.)„
Proof of intestinal parasites

Company
Immunodiagnostics

Scientific Relevance
Patients with active celiac disease showed higher levels of zonulin and anti-zonulin antibodies compared to non-celiac patients and patients in remission, who were eating a gluten-free diet. It is suggested that increased levels of zonulin are a contributing factor to the development of celiac disease and other autoimmune disorders such as insulin dependent diabetes, multiple sclerosis, and rheumatoid arthritis.

Indication
Determination of Zonulin

Company
Immunodiagnostics

Scientific Relevance
Patients with celiac disease suffer from abdominal pain, severe diarrhea and diversedeficieny syndromes. These are caused by an autoimmune reaction to gluten. Themain gluten in wheat is called gliadin. Its fragment gliadin 33mer has been identifiedas the antigen responsible for the symptoms of celiac disease.

Indication
• gluten-induced autoimmune reaction
• celiac disease symptoms despite gluten-free diet

Company
Immunodiagnostics

Test Details
Reduced ß-defensin levels with Crohn’s disease (HBD-2). Increased ß-defensin levels with Colitis Ulcerosa (HBD-2)

Biomarkers
The ß-defensins are an integral part of the congenital immune system and contribute with their antimicrobial effect to the barrier function of intestinal epithelial cells.
Defensins exert a variable degree of antimicrobial activity against bacteria, fungi, and some enveloped viruses. Vertebrate defensins are classified as alpha- or betadefensins, based on their pattern of disulfide bridges. Nine human defensins of epithelial origin have been found, three of them being ß-defensins (HBD-1, -2 and -3).
The expression of ß-defensins is induced by the pro-inflammatory cytokines and also through microorganisms (e.g. E. coli, H. pylori or P. aeruginosa).
A ß-defensin-2 deficiency can, for example, be observed in the intestinal mucous of patients with Crohn’s disease. The defense system of the mucous membrane is therefore restricted and allows an increased invasion of bacteria, which could possibly lead to a typical infection in Crohn’s disease patients.
Whether the ß-defensin-2 deficiency could even play a role in the development of Crohn’s disease is currently being researched. As is the possibility that it is the probiotic bacterium, which produces ß-defensin.

Company
Immunodiagnostics

Test Details
• Detection of intestinal inflammatory activity
• Monitoring of disease activity in inflammatory bowel disease (IBD)
• Prediction of relapse of IBD
• Assessment of IBD treatment response

Biomarkers
Lactoferrin is a 76 kDa iron-binding glycoprotein which is synthesized and stored in the secondary granules of neutrophils. It is also present in several secretory fluids,
such as milk, saliva, tears, and nasal secretions.
Lactoferrin can exist in different polymeric forms ranging from monomers to tetramers; it tends to polymerize especially at high concentrations. The physiological activities of lactoferrin include regulation of iron homeostasis, innate defense against a broad range of microbial infections, anti-inflammatory activity,
regulation of cellular growth and differentiation and protection against cancer development and metastasis.
During intestinal inflammation, polymorphonuclear neutrophils infiltrate the mucosa and release lactoferrin by degranulation, which results in an increased excretion
of lactoferrin into the feces. Fecal lactoferrin is therefore a marker for neutrophilic intestinal inflammation.

Company
Immunodiagnostics

Test Details
• Diagnosis and monitoring of Crohn’s disease, Boech’s disease (in serum)
• Bacterial, viral, allergenic or autoimmune related bowel inflammations of
allergenic or auto immune origin

Biomarkers
Lysozyme (muramidase) is a protein with a molecular weight of approx. 15 kDa and belongs to the group of alkaline glycosidases. Lysozyme is synthesised by
granulocytes, monocytes and macrophages. The main source of faecal lysozyme is the intestinal granulocytes.
Lysozyme can be detected in all cells of the inflammatory infiltrate during an acute flare of Crohn‘s disease. To some extent, lysozyme is also secreted actively by mononuclear cells into the bowel lumen.

Company
Immunodiagnostics

Test Details
• Marker for inflammatory activities in the gastrointestinal tract
• Renal transplant rejection

Biomarkers
The granules of neutrophils (approx. 70 % of the white blood cells) contain a large number of different enzymes. Myeloperoxidase (MPO) catalyses the oxidation of substances via H2O2. The MPO H2O2 system has a toxic effect on many microorganisms such as bacteria, fungi, viruses and mycoplasma . The efficiency of the bacteriocide myeloperoxidase H2O2 system is increased by PMN-Elastase. THE MPO determination in the stool reflects the inflammatory activity of Crohn’s disease or ulcerative colitis.

Company
Immunodiagnostics

Test Details
• Diagnosis of Crohn’s disease
• Chronic arthropathy
• Pancreatitis
• Bacterial infection, sepsis

Biomarkers
PMN Elastase from human polymorphonuclear granulocytes is a glycoprotein of 30 kDa and belongs to the group of serine proteases. Active PMN Elastase is released
from azurophil granula of neutrophil granulocytes after irritation or disintegration. The determination of the PMN Elastase in stool is used to record inflammatory reactions where neutrophil granulocytes are involved. Especially in Crohn’s disease the inflammatory processes go hand in hand with an increased phagocytic activity
and the biological decay of these cells and thus leads to an increased release of PMN Elastase and other lysosomal enzymes.

Company
Immunodiagnostics

Test Details
ColonView lateral flow quick test is intended for simple detection of fecal occult blood (FOB) in stool samples. The test is based on highly sensitive immunochemical detection of hemoglobin and hemoglobin/haptoglobin complex. The principal use of the Biohit ColonView Hb and Hb/Hp test is to screen for lower gastrointestinal (GI) pathologies, such as colorectal cancers and large adenomas that bleed. With the combination of two biomarkers, the ColonView quick test detects bleeding derived from both lower and upper gastrointestinal tract.

Biomarkers
ColonView Hb and Hb/Hp Fecal Occult Blood Test (FOB) test was designed to aid diagnosis of lower GI  pathologies, such as colorectal cancers and large adenomas that bleed. Colorectal cancer is one of  the  most commonly diagnosed cancers and a leading cause of cancer death in the United States. Screening  for colorectal cancer probably increases the cancer detection rate at an early stage, therefore reducing the mortality.

Company
BioHit

Test Details
• Proof of an imbalanced immunological barrier of the intestinal mucosa
• Autoimmune diseases

Biomarkers
Secretory IgA consists of two IgA monomers, which are connected to each other by a J-chain and contain a secretory component. They are produced in plasma cells
located in the lamina propria of the mucous membranes and are found in body secretions, such as saliva, tears, nasal mucus, tracheobronchial mucus, gastrointestinal
secretions, breast milk and colostrum. The formation of secretory IgA occurs independently of the serum IgA synthesis. Therefore, a lack of serum IgA does not necessarily mean a lack of secretory IgA. Neonates and infants are supplied with sIgA through breast milk and are therefore passively immunized against gastrointestinal infections. Conclusions concerning the endogenic defence of the intestinal mucosa can be drawn from the concentration of the sIgA in stool. A deficiency of sIgA points to a diminished activity of the mucosa immune system, whereas increased sIgA values indicate increased activity and a local inflammation of the intestinal mucosa.

Company
Immunodiagnostics

Test Details
• Occult blood in stool
• Crohn´s disease; ulcerative colitis
• Suspicion of colon carcinoma
• Polyps in the colorectum

Biomarkers
Secretory IgA consists of two IgA monomers, which are connected to each other by a J-chain and contain a secretory component. They are produced in plasma cells
located in the lamina propria of the mucous membranes and are found in body secretions, such as saliva, tears, nasal mucus, tracheobronchial mucus, gastrointestinal
secretions, breast milk and colostrum. The formation of secretory IgA occurs independently of the serum IgA synthesis. Therefore, a lack of serum IgA does not necessarily mean a lack of secretory IgA. Neonates and infants are supplied with sIgA through breast milk and are therefore passively immunized against gastrointestinal infections. Conclusions concerning the endogenic defence of the intestinal mucosa can be drawn from the concentration of the sIgA in stool. A deficiency of sIgA points to a diminished activity of the mucosa immune system, whereas increased sIgA values indicate increased activity and a local inflammation of the intestinal mucosa.

Company
Immunodiagnostics