BÜHLMANN Quantum Blue®

Quantum Blue Overview

In 2013 NICE published the DG11 guidance supporting the use of calprotectin as a cost-effective method to differentiate between IBD and IBS. Since that time, the level of testing within laboratories has increased significantly and BÜHLMANN has expanded its product portfolio to assist with evolving hospital requirements. BÜHLMANN offers the widest range of calprotectin assays, all standardised together to help support testing across the healthcare network.

With the implementation of NHS Improvement Pathology Networking, many trusts are now operating on a hub and spoke model with locations taking responsibility for specific tests within the trust. This can save costs, but potentially could also result in a reduced service in the spoke settings.

Placing a Quantum Blue reader in spoke settings enables for single tests to be performed when there a requirement for a rapid result to help support clinical decision making and giving a result that will correlate with the other BÜHLMANN assays, be that the fCAL® turbo, fCAL® ELISA or the IBDoc®.

It is simple to use in either the clinic or laboratory setting.

Based on established lateral flow technology
Quantitative measurement of Calprotectin in faecal samples
Results in 12 minutes
Excellent correlation with other BÜHLMANN Calprotectin assays
Simple, rapid extraction and test process
Unilateral connectivity to LIMs via dedicated middleware
Compact benchtop reader with touch screen or optional barcode data entry
Results directly printable or downloadable to USB
There are two kits available for testing calprotectin in stool samples:
Quantum Blue® fCAL High Range (LF-CHR25) – measurable range 100-1800µg/g for monitoring IBD positive patients
Quantum Blue® fCAL Extended Range (LF-CALE25) – measurable range 30-1000µg/g for diagnosis and monitoring purposes

The excellent correlation to the more automated laboratory methods enables the Quantum Blue to support the pathology consolidation ‘hub & spoke’ model. The main hub lab may be running the fCAL ELISA or the fCAL turbo method, but the spoke settings can have a Quantum Blue reader for testing urgent samples supporting the calprotectin service across the healthcare network.

Correlation Across the Healthcare Network:

Correlation of the Quantum Blue Calprotectin Test and the BÜHLMANN fCAL ELISA:

Correlation of the Quantum Blue Calprotectin Test and the BÜHLMANN fCAL turbo:

“This rapid bedside test can facilitate clinical decisions on hospital admission, such as deciding whether the IBD treatment should be intensified. Similarly, in the ambulatory setting, it is crucial when determining whether a patient should undergo endoscopy or not”

Moniuszko et al., Polish Archives of Internal Medicine 2017

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Quantum Blue Calprotectin Product Information
Test	Quantum Blue® fCAL High Range	Quantum Blue® fCAL Extended	CALEX® Cap Collection Set	Pipette Dual Bulb 60µl Pastette®
Time to result	15 min (approx.)	12 min (approx.)	–	–
Sample Type	Faeces	Faeces	Faeces	–
Standard Range	100-1800 µg/g	30-1000 µg/g	–	–
Sensitivity	<100 µg/g	<30 µg/g	–	–
Controls (Included)	0.5ml each (High/low)	0.5ml each (High/low)	–	–
Pack Size	25 Tests	25 Tests	25 Tests	500
Product Code	LF-CHR25	LF-CALE25	B-CALEX-CCSET25	LW4750-500

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Key Literature

Quantum® Blue fCAL Technical Brochure

Supporting Clinical Decision Making with Quantum Blue®

Applications

Quantum Blue® fCAL provides the perfect solution when calprotecin test requests are low or when a result is required rapidly within point-of-care (POCT) applications. It utilises a highly specific monoclonal antibody in a cassette based lateral flow assay that is read on a small desk top instrument.

Its simplicity and ease-of use fits well into the clinic setting providing a triage type assessment. This can help guide the clinician’s decision on proceeding with further investigation such as colonoscopy or investigating at a dietary and lifestyle solution for suspected Irritable Bowel Syndrome (IBS) sufferers.

In addition a calprotectin POCT is helpful for monitoring known Inflammatory Bowel Disease (IBD) patients, being useful in predicting flares and managing therapy regimes.

The extended range kit (LF-CALE25) (30-1000µg/g) for use with Quantum Blue Two second generation instruments (Serial no. >1000) enables diagnosis and monitoring within a single test format to simplify procedures and improve stock management.

Four Easy Steps to a Quantitative Result with Quantum Blue® fCAL

1. The Quantum Blue® Calprotectin assays are fully compatible with the BÜHLMANN stool extraction device CALEX® Cap.

3. Immediately after loading, the timer is started which controls the incubation time and reads the casette automatically.

2. A defined amount of stool extract is loaded onto the sample loading port of the test cassette.

4. At the end, the test result is displayed in µg/g. The Quantum Blue® Reader is ready for the next sample.

Benefits

When testing volumes are low or a rapid indication of the calprotectin level is required, the Quantum Blue makes an excellent solution that can be performed in either the clinic or the laboratory setting:

Can be used in spoke settings to support clinical decision making when a rapid result is required
Can be used to help triage endoscopy lists

“This rapid bedside test can facilitate clinical decisions on hospital admission, such as deciding whether the IBD treatment should be intensified. Similarly, in the ambulatory setting, it is crucial when determining whether a patient should undergo endoscopy or not”

Moniuszko et al., Polish Archives of Internal Medicine 2017

The Quantum Blue reader is also an ideal solution for private gastroenterology clinics enabling discussions to take place on an appropriate investigative or treatment pathways immediately (IBS or IBD), alleviating anxiety and meeting patient expectations of immediate results from private consultation.

Simple and rapid extraction and test process
Quantitative results within 12 minutes
Excellent correlation with the BÜHLMANN Calprotectin fCAL ELISA and the fCAL turbo
Two kit formats available for faecal calprotectin dependent on diagnostic or monitoring applications:
- Quantum Blue® fCAL High Range (LF-CHR25) – measurable range 100-1800µg/g
- Quantum Blue® fCAL Extended Range (LF-CALE25) – measurable range 30-1000µg/g
No need for batch testing – cassettes are individually packaged
New QB III reader has touch screen data input and can be linked to the LIMs system so that results can go into the electronic patient record

Quantum Blue is also available for Calprotectin in Serum and therapeutic drug and antibody monitoring for infliximab and adalimumab.

Case Studies

Why Wait for Results? The Benefits of Rapid and Point-of-Care Monitoring of Therapeutic Drugs

Biochemical testing to support clinical decision making is essential, but certain

From BÜHLMANN Quantum Blue® to fCAL turbo®

Follow the Evolution of Calprotectin Testing at James Cook University Hospital This

Out of Africa: Using Faecal Calprotectin Assays in the African Setting and Screening for Intestinal Schistosomiasis

Professor Russell Stothard and Dr Amaya Bustinduy Liverpool School of Tropical

The Pitfalls of Diagnosing IBS without Checking Calprotectin

In this case study, Arne Roseth reflects on a case last

Point of Care Testing for Calprotectin

Dr Sean Nugent, Consultant Gastroenterologist,of The Whitfield Clinic, Waterford, Ireland, talks

Royal Berks takes a Quantum Leap

In autumn 2010, the Clinical Chemistry Dept at the Royal Berkshire

Videos

BÜHLMANN Quantum Blue® 3rd Generation fCAL Tutorial

New – Quantum Blue® 3rd Generation Reader

Using the Quantum Blue® Device

BUHLMANN Quantum Blue® fCAL Tutorial

Non-Invasive Quantitative Diagnostic for Bowel Inflammation: Analysis

Posters

Fecal calprotectin as a non-invasive indicator for ulcerative colitis disease activity in the Korean cohort

FC level showed significant correlation with the disease activity of UC, endoscopic indices and other serum inflammatory biomarkers in the Korean cohort. UCEIS showed a better correlation with FC level than Mayo endoscopic subscore. Fecal calprotectin could be used as a reliable non-invasive indicator to evaluate the disease activity and mucosal healing of UC.

Lee et al. (2017) ECCO European Crohn’s and Colitis Organisation. Poster P148

Home smart-phone based measurement of fecal calprotectin by IBD patients: correlation with laboratory assay and applicability as patient-friendly monitoring tool

Despite some numeric quantitative divergence, the results of the home fecal calprotectin test (IBDoc) correlate well with values-ranges obtained using conventional lab-based calprotectin test. Smart-phone based fecal calprotectin test may be a useful patient-friendly tool for monitoring of IBD patients at home, with minimal interference to their routine.

Ungar et al. (2017) ECCO European Crohn’s and Colitis Organisation. Poster P181

Fecal calprotectin is elevated with clinical disease activity during pregnancy in women with Inflammatory Bowel Disease

Women with IBD who had clinically active disease during preconception and pregnancy had higher fecal calprotectin levels than women who had clinically inactive disease. Fecal calprotectin has the potential to be used as a biomarker for assessing disease activity during pregnancy in women with IBD.

Huang et al (2015) ECCO European Crohn’s and Colitis Organisation. Poster P279