Diagnostic kits and assays

BIOHIT’s diagnostic products are widely utilised across the world within diverse clinical and research environments. As a diagnostic kits’ supplier our product portfolio is tailored to offer innovative diagnostic assays designed for screening, diagnosing, and monitoring gastrointestinal disorders and associated health concerns, including diagnostic tests for stomach issues and diarrhoea. Our range encompasses a mix of patented and distinctive assays alongside top-performing routine tests, all encapsulated within diagnostic kits.

Improving patient pathways

Operational across various healthcare tiers, our diagnostic tests are strategically pitched towards optimising patient care routes and fostering superior clinical outcomes. A significant aspect of our proficiency lies in conducting clinical trials. Our loyal customer base within pathology and gastroenterology endeavour to seamlessly integrate our assays into standard clinical practice. As both a diagnostic kits manufacturer and supplier, we are committed to advancing healthcare accessibility and efficacy worldwide.

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SmarTest® FIT Home test (Preventis®)

Preventis® SmarTest® FIT Home test is a quantitative home test system for measuring hidden (occult) traces of blood in stool samples. This in vitro diagnostic device (IVD) is intended for self-testing to support screening for colorectal cancer and adenomatous polyps in patients who may benefit from further investigations.

SmarTest® Calprotectin Home test (Preventis®)

Preventis SmarTest Calprotectin Home test is a quantitative home test system for measuring calprotectin in stool samples. This in vitro diagnostic device (IVD) is intended for self-testing and individual monitoring of disease activity and treatment efficacy for patients with chronic inflammatory bowel disease (IBD).

GA-map® Dysbiosis Test Lx

The GA-Map Dysbiosis test is the first clinical test that identifies and characterises dysbiosis based on faecal specimens. It does this by exploiting single nucleotide differences in the 16S rRNA gene – a gene that is common to all bacteria. With 48 highly specific probes, the GA-map Dysbiosis Test identifies over 300 species of bacteria using cutting edge high throughput technology.

Anti-SARS-CoV-2 IgG (quantitative) ELISA (IDK®)

The IDK anti-SARS-CoV-2 quantitative IgG ELISA is for the specific detection and quantification of human IgG antibodies against the SARS-CoV-2 spike protein.

GastroPanel® Quick Test NT

The BIOHIT GastroPanel Quick Test is a rapid and quantitative immunochromatographic test for the detection of Helicobacter pylori (H. pylori) and atrophic gastritis in a clinic or point-of-care setting.

IDK® TurbiPEL®

The IDK TurbiPEL is a particle enhanced turbidimetric immunoassay (PETIA) that uses monoclonal antibodies for the determination of human pancreatic elastase in stool samples.

IDK® TurbiFIT®

The IDK TurbiFIT is a particle enhanced turbidimetric immunoassay (PETIA) that uses polyclonal antibodies for the determination of human haemoglobin in stool samples.

IDK® TurbiCAL®

The IDK TurbiCAL is a particle enhanced turbidimetric immunoassay (PETIA) that uses monoclonal antibodies for the determination of human calprotectin (MRP 8/14; S100A8/A9) in stool samples.

CalDetect 50/200® (PreventID®)

PreventID CalDetect 50/200 is a rapid immunochemical test that semi-quantitatively screens and measures calprotectin in stool samples in just 10 minutes. Faecal calprotectin is an exceptionally accurate and convenient marker for investigating bowel inflammation in patients presenting with abdominal symptoms, or monitoring those with inflammatory bowel disease (IBD).

SmarTest Pro® Vitamin D (Preventis®)

Preventis SmarTest Pro Vitamin D is a rapid test system for the quantitative determination of 25(OH) vitamin D in finger-prick blood samples, ideal for GPs, pharmacies and outpatient clinics. This quantitative test supports fast and effective vitamin D supplement optimisation, and enables close monitoring of 25(OH) vitamin D levels in a point of care setting. The kit contains everything needed to prepare, collect and test a finger-prick blood sample in combination with the SmarTest Vitamin D app.

COVID-19 Fecal Test Kit (GA-map®)

The CE-marked GA-map COVID-19 Fecal Test is designed to qualitatively detect SARS-CoV-2 RNA in faecal samples. This kit is suitable for patients exhibiting symptoms of COVID-19 (confirmation and management), as well as those in the recovery phase (surveillance and clearance), asymptomatic individuals concerned about possessing and transmitting the virus (prevention), and for screening faecal microbiota transplant (FMT) donors.

Helicobacter pylori IgG ELISA Kit

BIOHIT’s series of unified kits feature methods that have been standardised across all analytes and optimised for automation. This assay is part of the BIOHIT GastroPanel product.

GastroPanel® (Pepsinogen I, Pepsinogen II, H. pylori IgG and Gastrin-17 ELISAs)

Most people experience stomach discomfort, upsets, or abdominal pain at some point throughout their lives and in the majority of cases these are caused by transient issues or functional dyspepsia.

Gastrin-17 Advanced ELISA Kit

The BIOHIT Gastrin-17 kit is a microplate-based quantitative ELISA for the determination of human amidated gastrin-17 from plasma or serum samples. This test identifies Helicobacter pylori (H. pylori)-infected patients who have advanced atrophic gastritis in the gastric antrum.

ColonView Hb and Hb/Hp Test

BIOHIT ColonView Hb and Hb/Hp test can be used to screen for lower gastrointestinal (GI) organic pathologies, such as colorectal cancers and large adenomas that bleed. ColonView is a new generation lateral flow faecal immunochemical test (FIT), intended for the rapid detection of faecal occult blood (FOB) in stool samples.

Helicobacter pylori Quick Test (BIOHIT)

The BIOHIT H. pylori Quick Test is a rapid, one-step urease test to detect H. pylori infection from a biopsy sample during gastroscopy. It can also be used to evaluate the success of eradication therapy. This easy-to-use, gel-based test employs a simple colour indicator that allows easy visual confirmation of positive results in as little as two minutes – and negative results after 30 minutes – without specialist training.

Helicobacter pylori ULTRA-FAST UFT300 Quick Test (BIOHIT)

The BIOHIT UFT300 Helicobacter pylori Quick Test is an ultra-fast urease test that has revolutionised the way H. pylori infection is diagnosed and reported in gastroscopy. With extremely high accuracy and every result available within five minutes, this ready-to-use test is the choice for endoscopists.

Total 25OH Vitamin D ELISA (BIOHIT)

The BIOHIT Total 25OH Vitamin D ELISA is a quantitative immunoenzymatic assay for the determination of 25-hydroxyvitamins D2 and D3 (25OHD2 and 25OHD3) in serum and plasma, to aid in the diagnosis of vitamin D deficiency, insufficiency or intoxication.

Calprotectin ELISA (BIOHIT)

The BIOHIT Calprotectin ELISA is a quantitative sandwich ELISA method for the detection of calprotectin in stool samples. It can be used to help identify organic diseases of the small or large intestine, and to monitor disease activity and response to treatment in patients with ulcerative colitis or Crohn’s disease.

Active B12 (holotranscobalamin) ELISA (BIOHIT)

The BIOHIT Active B12 (holotranscobalamin) ELISA directly measures holotranscobalamin (holoTC) – the biochemically active form of vitamin B12 – from human serum. This test is well-suited for the screening of patients with a suspected vitamin B12 deficiency, and overcomes the problems associated with traditional testing methods that measure total, rather than just active, vitamin B12 concentration.

Celiac Quick Test (BIOHIT)

The BIOHIT Celiac Quick Test is a rapid immunochromatographic test for the qualitative detection of antibodies (IgA, IgG, IgM) against human tissue transglutaminase (tTG2A) in capillary whole blood samples.

Peptest

Peptest is an innovative, non-invasive diagnostic test to help identify reflux, and is especially critical in detecting silent reflux. Based on quantitative lateral flow technology, Peptest detects the presence of pepsin in clinical samples from the upper digestive and respiratory tracts.

Lactose Intolerance Quick Test (BIOHIT)

The BIOHIT Lactose Intolerance Quick Test supports the diagnosis of lactose intolerance (hypolactasia of the small intestine) by detecting lactase enzyme activity in a duodenal biopsy specimen.

Pepsinogen II ELISA Kit (BIOHIT)

The BIOHIT Pepsinogen II kit is a microplate-based quantitative ELISA for the determination of human pepsinogen II from plasma or serum samples. This test is intended as an additional tool in the diagnosis of atrophic corpus gastritis, which is also a risk state for gastric cancer.

Pepsinogen I ELISA Kit (BIOHIT)

The BIOHIT Pepsinogen I kit is a microplate-based quantitative ELISA for the determination of human pepsinogen I from plasma or serum samples. This test is intended to identify patients who have advanced atrophic gastritis in the gastric corpus, and are therefore at increased risk of developing gastric cancer.

Zonulin (Stool) ELISA (IDK®)

The IDK Zonulin (Stool) ELISA is a quantitative assay for the determination of zonulin in stool samples. Zonulin is a protein that is involved in intestinal barrier function, and has been highlighted as a potential marker of so called “leaky gut” syndrome. 

Zonulin (Serum) ELISA (IDK®)

The IDK Zonulin (Serum) ELISA is a quantitative assay for the determination of zonulin in serum. Zonulin is a protein that is involved in intestinal barrier function, and has been highlighted as a potential marker of so called “leaky gut” syndrome.

Pancreatic Elastase ELISA (IDK®)

The IDK Pancreatic Elastase ELISA is a quantitative enzyme immunoassay for the determination of pancreatic elastase in stool samples. This supports the diagnosis of exocrine pancreatic insufficiency in a range of cases including unexplained diarrhoea, gut microbiota, dysbiosis, IBS/IBD, steatorrhoea, flatulence, weight loss, upper abdominal pain and dietary intolerances.

Helicobacter pylori Stool Antigen ELISA (IDK®)

The IDK H. pylori Stool Antigen ELISA is used for the detection of H. pylori in stool samples, for confirmation of active H. pylori infection in the absence of atrophic gastritis, bleeding ulcer and use of proton pump inhibitors.

Faecal Lactoferrin ELISA (IDK®)

The IDK Lactoferrin ELISA is an enzyme immunoassay for the quantitative determination of lactoferrin – a well-established biomarker for neutrophilic intestinal inflammation – in stool samples. Faecal lactoferrin measurement supports monitoring of disease activity in inflammatory bowel disease (IBD), prediction of relapse of IBD and assessment of treatment response in IBD.

Faecal Calprotectin ELISA (IDK®)

The IDK Faecal Calprotectin ELISA is an enzyme immunoassay for the quantitative determination of human calprotectin (MRP 8/14; S100A8/A9) in stool samples, to rule out and monitor inflammatory bowel diseases (IBDs) non-invasively.

Faecal Bile Acids assay (IDK®)

The innovative IDK Faecal Bile Acids assay allows quantitative determination of bile acids in stool samples. This rapid photometric assay can aid the diagnosis of bile acid diarrhoea in patients with diarrhoea-predominant irritable bowel syndrome (D-IBS) or can be used to support differential diagnosis of bile acid malabsorption.

Faecal Haemoglobin ELISA (IDK®)

The IDK Faecal Haemoglobin ELISA is an enzyme immunoassay for the reliable quantitative determination of human haemoglobin in stool samples, which can be used as marker for gastrointestinal bleeding, colorectal cancer and adenomatous polyps.