The technology

Advice

Innovations
Current NHS pathway or current care pathway
Population, setting and intended user
Costs
Costs of standard care
Resource consequences

The technology

Elevated faecal calprotectin (FC) is a marker of intestinal inflammation, including that caused by inflammatory bowel disease (IBD). NICE diagnostics guidance recommends FC testing for the diagnosis of IBD; this briefing summarises the available information on the use of FC to monitor treatment response in patients with IBD.

There are 3 types of FC test available: point of care (used by healthcare professionals), home use (used by patients or carers) and laboratory (used by laboratory scientists). This briefing includes only point‑of‑care and home‑use tests because laboratory tests are widely available in the NHS, although their usage varies.

Point‑of‑care tests provide rapid results on FC levels. They come as single-use, disposable kits which are usually used with a dedicated, reusable reader (connected to a computer). The tests use lateral flow immunoassays specific to FC. The patient provides a stool sample that is collected and an extract from the sample is prepared for analysis by a healthcare professional. This typically involves placing the extracted sample into an extraction solution which is mixed together using a vortex mixer or centrifuge. Once this step is complete, the extracted sample is then added to the test plate, which is inserted into a reader. Results are displayed on the connected computer. The results can be quantitative or semi-quantitative; the latter show the results as ranges or as a traffic light rating scale. The result is shown 10 to 15 minutes after applying the sample to the test plate.

Home‑use tests allow patients to monitor their own FC levels and transmit the results directly to their healthcare professional. Most home‑use tests need a smartphone with camera, which is not provided with the test. Home‑use tests generally consist of a stool sample collection kit, a sample extraction tube, FC extraction solution, the test plate, a smartphone camera calibrator and a smartphone app to interpret and transmit the results.

To use the tests, the user logs into an app on their smartphone. A stool sample is collected, a small sample of which is placed into an extraction tube with some extraction solution. The tube is shaken by hand for a few minutes and left to process. Once this stage is completed, 1 or 2 drops of the sample are released from the sample tube (by turning a lever or squeezing the tube) onto the test plate. The test is left to develop and the smartphone camera is used to capture an image of the completed test. The app interprets the test and provides the user with the test results and transmits them to a healthcare professional if needed. The test itself takes 10 to 15 minutes to complete; however, some tests require the sample to be left in the extraction solution for at least 2 hours before transferring to the test plate. Like point‑of‑care tests, home‑use tests provide either quantitative or semi-quantitative data. Semi-quantitative results will not display slight variations in calprotectin levels; this can avoid unnecessary stress or anxiety, but rising calprotectin levels may precede a relapse. If the test reports an abnormal FC level, the healthcare professional is alerted either manually by the patient or automatically by the app, depending on the settings. The clinician can make an informed decision about the person's condition and whether to change their treatment regimen based on the data provided.

Table 1 below summarises the 5 FC tests included in this briefing.

Table 1: Summary of technologies

Technology	Type	Additional information	Regulatory status
IBDoc (Buhlmann)	Home use; quantitative	Results range from 30 to 1,000 mcg/g. They can be presented in a traffic light rating scale with patient-specific thresholds established by the clinician. An Android or iOS smartphone is needed. The app can be setup so that the patient does not see their own results.	IVD (March 2015)
Quantum Blue (Buhlmann)	Point of care; quantitative	Three kits are available: results range from: LF-CAL25: 30 to 300 mcg/g LF-CHR25: 100 to 1,800 mcg/g LF-CALE25: 30 to 1,000 mcg/g. A separate test reader is needed.	IVD (LF‑CAL25 and LF‑CALE25: February 2017; LF‑CHR25: May 2017)
Calprosmart Home (Calpro)	Home use; quantitative	Results range from 70 to 1,500 mcg/g. They can be presented as 1 of 3 ranges: <200, 200–500 and >500 mcg/g. An Android or iOS smartphone is needed for the home version. The app can also be setup so that the patient does not see their own results.	IVD (December 2015)
Calprosmart Office (Calpro)	Point of care; quantitative		IVD (December 2015)
Calfast (Eurospital)	Point of care; semi-quantitative	Results range from less than 50 to over 300 mcg/g. Exact values are shown for results between 51 and 300 mcg/g. A separate test reader is needed.	IVD (July 2011)

Innovations

Point‑of‑care FC tests may enable treatment decisions to be made during a single clinic visit, without having to wait for laboratory test results, ensuring that ineffective treatments are stopped as early as possible.

In addition, home‑use FC tests are designed to reduce avoidable clinic visits; in some cases an app interprets the results based on a locally determined, predefined threshold. These can be setup so that they automatically alert healthcare professional if the results are abnormal. Establishing patient-specific thresholds needs regular testing to determine the normal range. This is not possible through traditional testing methods that require a patient to attend a clinic.

Current NHS pathway or current care pathway

NICE diagnostics guidance on faecal calprotectin diagnostic tests for inflammatory diseases of the bowel recommends using FC tests in conjunction with clinical symptoms, monitoring and blood tests (C-reactive protein [CRP] and erythrocyte sedimentation rate [ESR]) for distinguishing between inflammatory and non-inflammatory bowel diseases. It does not include recommendations on monitoring treatment response.

After diagnosis, FC testing can be used to monitor FC levels at check-ups, or in-between if symptoms reoccur. The British Society of Gastroenterology guidance on the use of faecal calprotectin testing in IBD does not recommend the routine use of FC testing for monitoring treatment response in IBD, but suggests it can be used circumstantially as an aid to treatment decisions. FC levels are measured using in vitro diagnostics, such as ELISA, completed in a laboratory by a trained HCPC-registered biomedical scientist or clinical scientist. ELISA is considered to be the gold standard in measuring FC levels. For monitoring treatment response, laboratory ELISA, clinical monitoring, CRP and ESR are all regularly used in NHS practice, although local protocols vary. Colonoscopy may be considered if the previous tests are inconclusive.

Population, setting and intended user

FC testing would be used for people with IBD to monitor remission and treatment response. Elevated FC levels are also associated with colorectal cancer and so this must be ruled out before treatment decisions are made.

Home‑use tests can be used by the patient without supervision. Training is needed in the form of a demonstration by a trained healthcare professional, or using instructions for the test (either written or a video tutorial). Training is also essential because the home tests require handling of stool samples, so there is a biohazard risk. Healthcare professionals may verify that the first home test is done correctly.

Point‑of‑care FC tests are used by GPs, specialist nurses or gastroenterologists in primary or secondary care. The sample can be posted to the clinic if needed. Many companies offer training and support for healthcare professionals using their tests.

Costs

Table 2 shows the costs of the FC tests included in this briefing.

Table 2: Technology costs

Technology	Costs	Total cost per use	Additional information
IBDoc home‑use test (Buhlmann)	£64.35 per test. One appointment with nurse (25 minutes, including patient training; first appointment only) £17.92. Checking results sent from patients' mobile (5 minutes) £3.58.	First test: £85.85 Later tests: £67.93	Expendables: £512 for 8 tests (including training). An annual £350 maintenance fee applies. No reader is needed.
Quantum Blue point‑of‑care test (Buhlmann)	£23.22 per test. One appointment with nurse (15 minutes) £10.75.	£33.97	Expendables: £508.93 for 25 tests (including training). Reader: £2,864.63.
Calprosmart Home home‑use test (Calpro)	£50.00 per test. One appointment with nurse (25 minutes, including patient training; first appointment only) £17.92. Checking results sent from patients' mobile (5 minutes) £3.58.	First test: £71.50 Later tests: £53.38	–
Calprosmart Office point‑of‑care test (Calpro)	£30 per test. One appointment with nurse (15 minutes) £10.75.	£40.75	Cost of test includes training. No reader is needed.
Calfast (Eurospital)	£12.52 per test. One appointment with nurse (15 minutes): £10.75.	£23.27	Expendables: £211.17 for 20 tests (including training) Reader: £1,960.
All costs exclude VAT. Maintenance and reader costs were divided by 1,000, based on the assumption that the test will be used by 1,000 patients. Nursing costs are taken from PSSRU 2016.

Costs of standard care

Standard care includes symptom monitoring, ESR, CRP and colonoscopy (if clinically indicated).

Table 3 shows the estimated costs of standard care.

Table 3: Cost of standard care for monitoring people diagnosed with IBD

Treatment	Cost (excluding VAT)	Additional information
ELISA in laboratory	£23.30	Including test cost and 11–12 minutes of staff time at grade 6/7. This cost was uplifted*.
Clinical monitoring	£126.51	Weighted based on these assumptions: 20.4% of people with IBD are children (Betteridge et al. 2013) All children with IBD are in secondary care 24% of adults with IBD are in primary care, 76% are in secondary care (UK IBD primary care questionnaire 2012).
ESR	£3.75	This cost was uplifted*.
CRP	£1.97	This cost was uplifted*.
Colonoscopy	£458.00 (adults), £1,705.30 (children).	Colonoscopy should only be used if clinically indicated.
All monitoring (no colonoscopy)	£155.53	Costs are higher with colonoscopy: £613.53 (adults) and £1,860.83 (children).
* These costs were uplifted to 2016/17 prices using the hospital community health services index. When possible, costs are taken from NICE guidance or NHS reference costs.

Resource consequences

Quantum Blue is currently used by 9 NHS hospitals in the UK. IBDoc is used in 1 NHS hospital. None of the other FC tests included in this briefing is routinely used in the UK.

All 5 included FC tests would represent additional acquisition costs compared with standard care. Training is needed in their use but this is generally included in the purchase price. Point‑of‑care tests need a healthcare professional to prepare the sample and carry out the test.

The higher acquisition costs could be offset if using the tests reduces the need for colonoscopy or for clinic attendance for check-ups involving symptom monitoring. Compared with standard care, point‑of‑care and home‑use FC tests may allow for faster identification of disease relapse. No published evidence on the resource consequences of adopting FC tests for monitoring people with IBD was found.