THE BÜHLMANN FECAL CALPROTECTIN ASSAYS
Calprotectin is the best marker for IBD. It is an established measure to discriminate IBD from IBS and a very valuable tool to monitor the disease course of IBD patients (Crohn’s and ulcerative colitis). The technology platforms offered by BÜHLMANN range from the gold standard ELISA assay, BUHLMANN fCAL®, to the POC test, Quantum Blue®, to the new IBDoc® home test and to the automated random access BÜHLMANN fCAL® turbo assay. With this portfolio all possible applications for measuring calprotectin are covered from the patient’s home test to the high throughput lab.
BÜHLMANN has launched its first assay for fecal calprotectin testing more than 10 years ago and is today considered as the gold-standard.
The BÜHLMANN calprotectin assays appear in more than 100 clinical publications thereby demonstrating the reliability and the quality in diagnosis and monitoring of IBD.
Quantum Blue® fCAL
The Quantum Blue® fCAL product line offers lateral flow-based quantitative calprotectin testing within 15 minutes. BÜHLMANN offers tests covering 2 different ranges suitable for diagnosis and therapy follow-up of IBD patients. Several independent clinical studies have proven the reliability and diagnostic accuracy of the Quantum Blue® fCAL assays.
Calprotectin – Differentiating IBD from non-inflammatory Diseases
Inflammatory Bowel Disease (IBD) affects approximately 2 million people in Europe and shows increasing prevalence all over the world. Crohn’s Disease (CD) and Ulcerative Colitis (UC) are incurable serious chronic diseases of the intestinal tract. Symptoms of IBD strongly resemble those of non-inflammatory diseases such as the irritable bowel syndrome (IBS), polyps or even gastrointestinal infections. Calprotectin has proven itself as a very good surrogate marker in the diagnosis of IBD and helps therefore to reliably select patients for further invasive diagnostic procedures.
Calprotectin – Monitoring IBD Disease Activity
The clinical course of most patients with IBD is marked by periods of remission with intermittent relapses characterized by increased intestinal inflammation. Numerous published studies by Tibble et al. and others, have studied the levels of calprotectin in patients during the course of the disease. The results show that calprotectin is a good predictor of relapse in patients with IBD, thus giving clinicians an effective tool to adapt the patients treatment accordingly and to ease the relapse severity.
THERAPEUTIC DRUG MONITORING (TDM)
Over the past two decades great improvements in therapy of chronic inflammatory diseases have been made. The rise of TNFα biologics like adalimumab and infliximab has been a great step forward to ameliorating disease course and keep inflammations at remission levels for prolonged periods of time. Patients with suboptimal drug concentrations have worse outcomes than those with adequate drug levels. Therapeutic drug monitoring (TDM) for adalimumab and infliximab has a great potential for the management of anti TNF therapy.
A- Quantum Blue® Adalimumab
The biologic drug Adalimumab is a therapeutic monoclonal antibody. It acts as an antagonist to TNF alpha, thus effectively blocks the inflammatory process in numerous chronic inflammatory diseases like Crohn’s disease, ulcerative colitis and inflammatory arthritis. The BÜHLMANN Quantum Blue® Adalimumab is the first rapid test to measure adalimumab trough levels in patient’s serum to allow immediate decision making for potential drug dose adjustments.
B- Quantum Blue® Anti-Adalimumab
The presence of anti-drug antibodies (ADA) against adalimumab can diminish the clinically beneficial effect of the drug. The Quantum Blue® Anti-Adalimumab rapid test allows for reliable detection of antibodies against adalimumab within 15 min.
C- Quantum Blue® Infliximab
The biologic drug Infliximab is a therapeutic monoclonal antibody. It acts as an antagonist to TNF alpha, thus effectively blocks the inflammatory process in numerous chronic inflammatory diseases like Crohn’s disease, ulcerative colitis and inflammatory arthritis. The BÜHLMANN Quantum Blue® Infliximab is the first rapid test to measure infliximab trough levels in patient’s serum to allow immediate decision making for potential drug dose adjustments.
D- Quantum Blue® Anti-Infliximab
The presence of anti-drug antibodies (ADA) against infliximab can diminish the clinically beneficial effect of the drug. The Quantum Blue® Anti-Infliximab rapid test allows for a highly specific detection of antibodies against infliximab within 15 min.
QUANTUM BLUE
The Quantum Blue® calprotectin rapid test is a sensitive, non-invasive tool to pre-select patients requiring colonoscopy for confirmation of organic bowel disease (IBD). Quantitative results for calprotectin concentration (in ug/g stool) are available within 12 minutes and are very comparable to the established BÜHLMANN fCAL® ELISA.
IBDOC
IBDoc® is the first in-vitro diagnostic home testing device measuring the inflammatory marker fecal calprotectin at home. The CalApp® turns your smartphone into a test cassette reader using state of the art image processing. Stool preparation is performed using the Calex® Valve that is characterized by its simple and convenient handling of stool samples. The secure connection of CalApp® with IBDoc® Portal allows Health Care Professionals to directly monitor patient results.
AUTOMATION
Immunoturbidimetry allows fast, flexible and random access applications with high precision. BÜHLMANN offers immunoturbidimetric solutions for the two gastroenterological markers fecal calprotectin and pancreatic elastase. The combination of both tests with the CALEX® Cap stool preparation device provides the best possible degree of automation for quantitative stool analysis.
Flexible turbidimetric assay applicable on all major clinical analyzers. The high through-put assay offers a measuring range from 20-8000 µg/g and is standardized against the BÜHLMANN fCAL® ELISA.
CALEX CAP
CALEX® Cap stool preparation device offers an efficient, convenient and hygienic preparation of stool samples. Its simple design makes it an ideal preparation device characterized not only by high safety but also by offering high stability of stool samples.
CALEX CAP COLLECTION STOOL SET
The CALEX® Cap stool preparation device offers a very useful solution when it comes to handling samples for fecal calprotectin and pancreatic elastase, outsourcing the collection step of stool to the patient. A simple to use patient kit that includes a buffer filled CALEX® Cap tube containing viricide and bactericide components, stool collection sheets, a user guide and plastic bag with patient label, allows for the sample to be safely sent or brought to lab collection sites and hospitals for further logistics and analysis.
BÜHLMANN FPELA® TURBO (PANCREATIC ELASTASE)
BÜHLMANN fPELA® turbo, the turbidimetric immunoassay, is a flexible solution to be applied on most clinical chemistry analyzers. The technology is a milestone in automation of pancreatic elastase quantification. It allows very rapid and flexible random access use, as well as being the ideal solution for high throughput applications in the routine laboratory. The fPELA turbo assay reduces the hands-on time dramatically and allows reporting pancreatic elastase results from human stool samples within shortest time.
Flexible turbidimetric assay applicable on most clinical chemistry analyzers. The assay offers random access work-flow with a measuring range from 10 – 5000 ug/g.
The CALEX® Cap extraction device is the ideal combination with the BÜHLMANN fPELA® turbo. The extracts are ready to analyse and the CALEX device can be applied directly into the clinical chemistry analyzer. The same extraction buffer for pancreatic elastase AND fecal calprotectin allows the quantitation of both analytes from the same sample preparation.
Fecal Pancreatic Elastase results within 10 minutes § Optimize your workflow by automation § Integrate fecal samples into routine
ACE KINETIC
Automated Enzymatic Assay
The ACE kinetic kit from BÜHLMANN provides ready to use Substrate and highly stable Calibrator and Controls, offering a maximum convenience and accuracy. Reconstituted Calibrator and Controls provided with the kits are stable for 6 months at 2-8°C. The substrate has an onboard-stability up to 3 months. Different package sizes are available (2×50, 100 and 1200 tests). Validated application notes are available for most common clinical chemistry analyzers.
Angiotensin Converting Enzyme
In vivo, ACE catalyses the conversion of Angiotensin I to Angiotensin II and inactivates bradykinin during regulating blood pressure via Renin-Angiotensin-System.
Elevated levels of serum ACE have been measured in patients suffering from various disorders. They often indicate a poor prognosis or rapid progression of the disease. Elevated serum ACE levels are reported in granulomatous-inflammatory diseases such as Sarcoidosis and Mixed-Connective-Tissue Disease (MTCD), Nephropathies associated with Diabetes and Glomerulonephritis, Cardiovascular diseases such as left ventricular hypertrophy, brain and myocardial infarction.
The main application is Sarcoidosis. Other areas of application are Chronic Berylliosis and monitoring of compliance under ACE inhibitor therapy.
High Sensitive Methods
In cerebrospinal fluid (CSF) normal ACE activity is far below the detection limit of any commercially available ACE kinetic assay. BÜHLMANN offers a solution to reliably detect even this low ACE activity. The ACE high sensitive assay (kinetic assay; order code: KK-ACF) with a detection limit of 1 U/L.
